9Dec
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

RediTrex Receives FDA Approval
Cumberland Pharmaceuticals received U.S. Food and Drug Administration (FDA) approval on November 27, 2019, for RediTrex™, an injectable form of methotrexate. It is indicated as second-line treatment for adults who have psoriasis or rheumatoid arthritis (RA) and children who have polyarticular juvenile idiopathic arthritis (pJIA). To be dispensed in boxes of four single-dose, prefilled syringes, it is indicated for once-weekly subcutaneous (SC) self-injection into the abdomen or thigh. To treat psoriasis, the recommended dose is 10mg to 25mg; for RA, 7.5mg; and for pJIA, 10mg/m2. Methotrexate also is available as an oral solution (Xatmep ® – Silvergate Pharmaceuticals), oral tablets (Trexall ® – Teva Women’s Health and generics), generic powder for reconstitution to inject and two other auto-injectors (Otrexup™ - Antares Pharmaceuticals) and (Rasuvo™ - Medexus Pharma). RediTrex will be marketed in the same strengths (7.5mg, 10mg, 12.5mg, 15mg. 17.5mg, 20mg, 22.5mg and 25mg) as the other self-injectable brands. A boxed warning on all methotrexate products cautions that it can cause severe side effects in the bone marrow, gastrointestinal (GI) system, kidneys, liver and lungs. Additionally it can trigger hypersensitivity responses, infections or skin reactions. If methotrexate is used during pregnancy, the fetus may be harmed severely. Cumberland has not yet disclosed its launch or pricing plans. Express Scripts currently is investigating the data around RediTrex for a possible utilization management strategy. It also will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete. Full prescribing information for RediTrex can be found here.
 

Ogivri, a Herceptin Biosimilar, Launched
Two years after its Food and Drug Administration (FDA) approval, Ogivri™ (trastuzumab-dkst) was introduced in the U.S. on December 2, 2019. Co-developed by Mylan and Biocon Biologics, the biosimilar for Genentech’s Herceptin® (trastuzumab) is used to treat breast cancers and metastatic stomach cancers (gastric or gastroesophageal junction adenocarcinomas) that overexpress the HER2 gene (HER2+).  It is given as an intravenous (IV) infusion at varying loading/maintenance doses and on schedules that also vary according to the cancer being treated. All trastuzumab products have boxed warnings that they may cause birth defects, heart failure, respiratory distress or severe allergic reactions. Ogivri will compete not only with Herceptin, but also with Kanjinti™ (trastuzumab-anns), a biosimilar from Amgen and Allergan that was released in the U.S. on July 18, 2019, and with other FDA-approved biosimilars that have not yet been released for sale. However, Ogivri is not interchangeable with Herceptin, Kanjinti or any other Herceptin biosimilar. Although exact pricing is not yet known, Mylan intends to distribute Ogivri at a “competitive discount” to Herceptin. It will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete. For its prescribing information, click here.

Expanded Indication for Tecentriq
The Food and Drug Administration (FDA) approved a new indication for Tecentriq® (atezolizumab - Genentech) on December 4, 2019, as initial therapy for previously untreated adults who have metastatic non-squamous non-small cell lung cancer (NSCLC) that does not have genomic aberrations in epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK). It will be used along with two chemotherapy (chemo) drugs, carboplatin and Abraxane® (paclitaxel protein-bound particles for injectable suspension – Abraxis BioScience). For the new indication, Tecentriq is infused IV once every three weeks at a dose of 1200mg. If it is administered on the same day as chemo, it should be given first. Following four to six chemo cycles, dosing for Tecentriq may be adjusted to once every two, three or four weeks at differing doses. It should be used as long as the cancer does not spread or the patient is unable to tolerate further treatment. To see updated prescribing information for Tecentriq, click here.

Generics Approved, but Not Launched, for Gilenya
Biocon, HEC Pharma and Sun Pharmaceuticals all received Food and Drug Administration (FDA) approval on December 5, 2019, for generics to the Novartis drug, Gilenya ® (fingolimod) capsules. First FDA approved in 2010, fingolimod is an oral, disease-modifying treatment for patients as young as 10 years old who have relapsing forms of multiple sclerosis (MS). Taken once daily, it decreases inflammation by decreasing the entry of immune cells into the central nervous system (CNS). A Medication Guide given to patients outlines the side effects, including a slow heart rate and a higher risk of infections. Taking fingolimod also may be associated with progressive multifocal leukoencephalopathy (PML), a very rare infection of the brain, which may affect balance, coordination, strength, thinking or vision. Patients using it should have frequent checks for liver function, infection symptoms and vision changes. Although sales of Gilenya have been declining slightly, they still accounted for approximately $2.4 billion during the first three quarters of 2019. Pending court decisions could allow the generics to launch in 2020, but lawsuits are more likely to keep the generic versions off of the U.S. market until 2023 or 2024, according to analysts.

 
5Dec
From the CEO

From the CEO

As 2019 ends, I find myself reflecting on the past year and looking forward to the upcoming new year. I truly appreciate our loyal American Foreign Service Protective Association (AFSPA) members as well as the employees who provide you with your deserved unparalleled service. Our staff demonstrate a daily desire to serve AFSPA members. We hope to continue our strong relationship with you in 2020.

Open Season ends on Monday, December 9. You have a few days to review your options and make changes to your following enrollments:

Whether you have the Foreign Service Benefit Plan (FSBP), or another Federal health plan, we want you to make informed decisions for you and your family. Choose a plan that serves your needs and fits your everyday life.


Flu Prevention

As winter approaches – and it may have arrived for some already – so comes the flu season. Please take care of yourself and arrange the best defense possible. The Center for Disease Control and Prevention (CDC) recommends everyone six months of age and older get an annual flu vaccine.

FSBP covers flu vaccinations at 100%, when obtained at an in-network provider or provider outside the U.S.

Getting vaccinated each year remains the single best way to prevent seasonal flu. However, covering your cough, washing your hands, and practicing good health habits – can help stop the spread of germs and prevent respiratory illnesses (like the flu). There also are flu antiviral drugs that can treat and prevent flu.

Click here to see a full list of CDC tips and resources to protect you and others from the flu and limit the spread of germs.


Supplemental Insurances

Open Season can be a great time to review ALL your benefits including supplemental insurances, such as dental, life, and disability.

Life Insurance

AFSPA offers three (3) life insurances. You may want to add life insurance to your overall portfolio or supplement your existing life policy. Spouses, domestic partners, and dependent children can purchase coverage as well.

Disability Insurance

Currently, the Federal government does not offer disability insurance. AFSPA provides two (2) long-term disability options. Both plans cover 60% of your annual salary, up to $5,000/month – if you become medically disabled. For new Federal employees with limited sick leave, this insurance type can protect you against lost wages – due to a non-permanent illness or injury. And, our Cigna Disability plan covers medically-necessary maternity and/or complications resulting from pregnancy.

Explore all AFSPA’s supplemental products at afspa.org/aip. Apply anytime – No Open Season required!


Holiday Stress

Finally, the holiday season can bring joyful moments, but stressful ones as well. Money worries, travel concerns, or preparing your home for visitors – all can add anxiety. Depression and stress may hurt your health.

FSBP offers many services to support you, such as myStrength, health coaching, and telehealth counseling appointments. In fact, our 2020 theme is “Mental Wellness Leads to Better Physical Health.”  Next year, we will feature FSBP programs to help you cope with life’s challenges. This could include balancing work and life, dealing with a chronic condition, or just managing everyday stress.

You are not alone! Regardless of where you are in the world, FSBP wants to help.


As always, it is our honor to provide you with “unparalleled service.” We thank you for entrusting us with your health care needs this past year – and want to continue serving you in 2020. I personally wish you and your loved ones a wonderful and healthy holiday season.

To Your Health,

Paula S. Jakub, RHU
CEO, AFSPA
Executive Director, Senior Living Foundation


Other News:

AFSPA CEO, Paula S. Jakub, RHU on Federal News Radio

On Monday, November 25, 2019, Paula S. Jakub, RHU, CEO of AFSPA, was featured as a guest on the "For Your Benefit" show on Federal News Network radio. She talked about how to get the most out of the Health Plan you choose. If you missed it, click here to listen to the recording.

Teledoc: FSBP's New Telehealth vendor Effective January 2020

FSBP changed our telehealth vendor to Teladoc. U.S. based members can access several medical/health specialties, from home, hotel, etc. A sticker with Teledoc’s website and phone number will be mailed before the end of 2019. Attach it to the back of your existing FSBP ID card. New FSBP enrollees will receive cards with Teledoc’s information already printed.

Follow Us on Facebook: http://www.facebook.com/afspacares

 
3Dec
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

FDA Approves a New Dosage Form for Riluzole 
Aquestive Therapeutics received U.S. Food and Drug Administration (FDA) approval for Exservan™ (riluzole). It is an oral-film formulation of the glutamate inhibitor that is used to treat amyotrophic lateral sclerosis (ALS). A progressive neurological disease, ALS destroys the nerves that control muscle movement, eventually leaving patients unable to move. The ALS Association estimates that roughly 16,000 Americans have ALS -- with around 5,000 new cases diagnosed annually. The large majority of cases occur spontaneously with no known genetic link. Although some people who have the disease, such as Dr. Stephen Hawking, live many years; only about 50% of patients survive for three years after diagnosis. Riluzole neither cures ALS nor reduces its symptoms, but it may help to extend survival time. Riluzole tablets are available generically and as the brand, Rilutek ® (Covis Pharma). An oral suspension, Tiglutik™ (ITF Pharma) also is marketed in the U.S. However, as ALS advances, patients lose the ability to swallow. Using patented PharmFilm ® technology, Exservan dissolves on the patient’s tongue without the need for water. Recommended dosing is 50mg (one film) allowed to dissolve on the tongue twice each day. Doses should be taken at least one hour before or at least two hours after consuming food, and patients should not chew the film, spit out any part of it or talk while it is dissolving. Because riluzole may damage the liver, patients should be tested for liver enzymes before treatment and periodically while riluzole is being taken. Exservan films will be packaged individually in small envelopes. A launch date and pricing are not yet available as Aquestive seeks a distribution partner for the U.S. Express Scripts currently is investigating the data around Exservan for a possible utilization management strategy. It also will be excluded at launch on the Express Scripts national preferred formulary (NPF) until our formulary development process is complete. Click here for Exervan’s full prescribing information.

Pediatric Indication Approved for Toujeo
Sanofi’s Toujeo® (insulin glargine injection) 300 Units/mL, was granted Food and Drug Administration (FDA) approval on November 27, 2019, to improve glycemic control for children as young as six years old who need insulin to manage diabetes. A once-daily, long-acting basal insulin, it originally was indicated only for patients who are at least 18 years old. Results from a clinical trial that involved more than 450 children and teens who have type 1 diabetes were similar for Toujeo and for Lantus® (insulin glargine injection) 100 Units/mL, also made by Sanofi. Toujeo and Lantus are the same kind of insulin, but it is concentrated in Toujeo to allow for a lower injection volume and a longer duration of action. Its dosing is individualized based on several factors – primarily the patient’s weight. Toujeo should be administered at the same time each day as a subcutaneous (SC) injection. It is available in prefilled pens that should be used only for a single patient; they should not be shared. For Toujeo’s revised prescribing information, click here.

 

 
27Nov

Happy Thanksgiving

In observance of the Thanksgiving holiday, AFSPA will close at 3PM ET on Wednesday, November 27. We will remain closed on Thursday November 28 and Friday, November 29. We will resume normal business hours at 8:30 am ET on Monday, December 2.

Thank you for trusting us to serve you and your family. We wish each of you a very Happy Thanksgiving!

 
25Nov
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Abrilada, a Biosimilar for Humira Wins Approval
Pfizer’s Abrilada™ (adalimumab-afzb) injection, was approved by the U.S. Food and Drug Administration (FDA) on November 15, 2019. The fifth biosimilar to Humira (adalimumab – AbbVie), it is a tumor necrosis factor (TNF) inhibitor that helps to inhibit inflammation. It is indicated to treat a number of inflammatory conditions including ankylosing spondylitis (AS), adult Crohn's disease, juvenile idiopathic arthritis (JIA), plaque psoriasis, psoriatic arthritis (PsA), rheumatoid arthritis (RA) and ulcerative colitis (UC). Generally, it will be given once every other week as a subcutaneous (SC) injection at doses that vary according to the condition being treated. A boxed warning on the labels of all TNF blockers outlines the increased risks of cancer and serious infections that may be associated with their use. Patients should be screened for tuberculosis (TB) before starting treatment and periodically while therapy continues. Abrilada is not interchangeable with Humira or with the other Humira biosimilars that already are FDA approved - Amjevita™ (adalimumab-atto - Amgen), Cyltezo ® (adalimumab-adbm - Boehringer Ingelheim), Hadlima™ (adalimumab-bwwd – Samsung Bioepis) and Hyrimoz (adalimumab-adaz - Sandoz). Under the terms of an agreement with AbbVie, which is similar to settlements with the other Humira biosimilar manufacturers, Pfizer expects to launch Abrilada in November of 2023. It will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete. Click here for its complete prescribing information.

Calquence Receives New FDA Indication
Calquence® (acalabrutinib) capsules was given additional U.S. Food and Drug Administration (FDA) approval on November 21, 2019 as treatment for adults who have chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Originally approved by the FDA in October 2017, Calquence is a next-generation Bruton tyrosine kinase (BTK) inhibitor that also is indicated as second-line therapy for mantle cell lymphoma (MCL). For its new indications, it can be used for patients new to treatment and for those who have had previous therapy. Recommended dosing for all indications is one capsule (100mg) every 12 hours. For Calquence’s full prescribing information, click here.

The new indications were approved under the FDA’s Project Orbis, an international agreement that allows drug regulatory agencies in Australia, Canada and the U.S. to share information about new drugs and new indications. All three countries approved the new indications for Calquence at the same time. Eventually, the project will include agencies from additional countries. It also aims to standardize the conducting and reporting of clinical trials for cancer drugs so that they can be approved more quickly. More information about Project Orbis may be found on the FDA’s website here.

FDA Approves Xcopri to Treat Epilepsy
On November 21, 2019, SK Life Science, Inc., the U.S. subsidiary of SK Biopharmaceuticals, received FDA approval for Xcopri® (cenobamate) tablets. The drug has at least two actions – it blocks voltage-gated sodium currents and it modulates gamma-aminobutyric acid (GABA) channels to interrupt nerve impulses and decrease the risk of seizures for adults who have partial-onset seizures. Patients taking it will be started on 12.5mg once a day and then gradually increased to a maintenance dose of 200mg once daily. Some patients may need the maximum dose of 400mg/day. Xcopri can be used alone or in combination with other antiepileptic drugs. Dosages may need to be modified, however, when antiepileptics from different classes are taken at the same time. In clinical trials, some patients took doses of Xcopri that were raised over six weeks to either 100mg, 200mg or 400mg/day. The doses were maintained for an additional six or 12 weeks. Compared to a 24% decrease among patients taking a placebo, seizure frequency was reduced by 38% for patients taking 100mg and 55% for patients receiving 200mg or 400mg doses of Xcopri. Some actively treated patients were completely seizure free during the maintenance parts of the studies. SK Life Science expects to launch Xcopri in the second quarter of 2020 after the U.S. Drug Enforcement Agency (DEA) determines the controlled substance category for it. Pricing has not yet been disclosed. Xcopri will be excluded at launch on the Express Scripts NPF until our formulary development process is complete. Prescribing information can be found here.

 

 
21Nov
Express Scripts News Flash

Express Scripts News Flash

Food and Drug Administration approves GivlaariTM
The U.S. Food and Drug Administration (FDA) approved Givlaari™ (givosiran – Alnylam Pharmaceuticals) injection on Nov. 20, 2019. It is indicated to treat adults who have a rare genetic disease, acute hepatic porphyria (AHP). Patients who have the condition are missing or have defects in some of the liver enzymes important in eliminating byproducts of making heme, the iron-rich part of blood that moves oxygen around the body. As a result of the toxins (porphyrins) that accumulate, patients who have AHP experience sudden attacks that often involve intense pain; that may last for several days or weeks; and that can lead to hypertension, neurologic damage, respiratory failure, seizures and even death. Givlaari is a small interfering RNA (siRNA) molecule that reduces the levels of aminolevulinic acid synthase 1 (ALAS1) to decrease the toxins. Recommended dosing for it is 2.5mg/Kg given subcutaneously (SC) once every month by a healthcare provider. Injections should be administered in a facility that is equipped and staffed to handle any anaphylactic reactions that may occur. Alnylam expects a launch before the end of 2019 at a wholesale acquisition cost (WAC) of $39,000 per vial. Givlaari will be dispensed through a limited small network of specialty pharmacies that includes Accredo. Its full prescribing information is here.

  • Brand (Generic) Name: Givlaari™ (givosiran)
  • Manufacturer: Alnylam Pharmaceuticals
  • Date Approved: Nov. 20, 2019
  • Indication: to treat adults who have acute hepatic porphyria
  • Dosage Forms Available: single-dose vials of 189mg/mL for subcutaneous injection
  • Launch Date: by the end of 2019
  • Estimated Annual Cost: $575,000 (WAC)
  • Specialty Status: Givlaari will be added to Express Scripts’ specialty drug list.
  • Acute hepatic porphyria (AHP), caused by gene mutations, has four distinct subtypes. All are due to missing or deformed genes that produce enzymes involved in the production of heme. Because particles generated in the process of making heme cannot be cleared by patients who have AHP, toxins that build up in the liver cause unpredictable episodes of pain and other symptoms. Attacks may be associated with triggers, such as certain drugs, smoking or stress; but many have no identifiable cause. Not all patients have frequent episodes, however, and some cases are milder than others.
  • In the United States, about one person in 25,000 is believed to have some form of porphyria – equaling around 13,000 patients. Porphyria affects all ethnic groups and approximately as many men as women have it. Alnylam estimates that roughly 1,700 patients could qualify for treatment with Givlaari.
  • Currently, treatments for AHP address only the symptoms, not the causes of the condition. They include antihypertensives, pain relievers and infusions of hemin (an enzyme inhibitor). 
  • In the phase III ENVISION study of 94 patients who have AHP, those receiving Givlaari had only 30% of the attacks as those who received a placebo. Treated patients had less need for hemin infusions, emergency room services and hospitalizations, as well.
  • The FDA approved Givlaari, also designated as an Orphan Drug, under both its Breakthrough Therapy and Priority Review programs.

Implications: Express Scripts currently is investigating the data around Givlaari for a possible utilization management strategy. It also will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete.

 
19Nov
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

FDA Approval for a New Antibacterial, Fetroja
Shionogi’s new cephalosporin-class antibiotic, Fetroja® (cefiderocol) for injection, was approved by the U.S. Food and Drug Administration (FDA) on Nov. 14, 2019. It is indicated for adults who have few or no alternatives after other antibiotics have failed to resolve complicated urinary tract infections (cUTIs) caused by susceptible gram-negative bacteria. Fetroja is effective against several bacteria, including some antibiotic-resistant strains of Enterobacter, Escherichia and Pseudomonas. In addition to diffusing into bacterial cells like other antibiotics, Fetroja uses a unique way to enter and attack bacterial cells. It piggybacks onto iron molecules that are needed by bacteria to survive and divide. In the clinical trial that the FDA used to approve Fetroja, infections cleared for about 19% more of the patients who were receiving Fetroja (72.6%) than those using the current standard of care, which is imipenem/cilastatin (54.6%). Recommended dosing is 2gm infused intravenously (IV) over three hours once every eight hours for seven days to 14 days. Fetroja was approved under the FDA’s Fast Track and Priority Review programs. It also is a qualified infectious disease product (QIDP), an FDA designation to promote the approval of antibacterial and antifungal drugs to treat serious or life-threatening infections that have limited patient populations. Shionogi plans to launch it early in 2020. It will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete. Here is its prescribing information.


FDA Approves Brukinsa to Treat Mantle Cell Lymphoma
On Nov. 14, 2019, the U.S. Food and Drug Administration (FDA) approved Brukinsa™ (zanubrutinib - BeiGene) capsules. It is a Bruton’s tyrosine kinase (BTK) inhibitor indicated to treat mantle cell lymphoma (MCL) that has been treated at least once previously for patients who are 18 years of age and older. The recommended dose for Brukinsa is 320mg per day, taken either as 160mg (two capsules) twice a day or 320mg (four capsules) once daily. Launch is expected in the next few weeks, but cost estimates are not yet available. It will be dispensed through a limited small network of specialty pharmacies that does not include Accredo. For Brukinsa’s full prescribing information, look here.

Adakveo Approved for Sickle Cell Disease
The U.S. Food and Drug Administration (FDA) approved Adakveo® (crizanlizumab-tmca - Novartis) on Nov. 15, 2019.  It is indicated to treat vaso-occlusive crises (VOCs) for patients 16 years of age and older who have sickle cell disease. A first-in-class P-selectin inhibitor, Adakveo blocks the activity of a cell adhesion protein involved in VOC, keeping blood cells from clumping and helping to maintain blood flow. It will be administered by a healthcare professional as a 30-minute intravenous (IV) infusion at a dose of 5mg/Kg. The first two treatments will be two weeks apart, then one infusion will be given every four weeks. Novartis plans to launch Adakveo in the coming weeks at a wholesale acquisition cost (WAC) of $2,357 per vial. It will be available through open distribution. Its full prescribing information is available here.

 

 
12Nov
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Talicia Receives Food and Drug Administration Approval
A new combination product, Talicia® (omeprazole magnesium 10mg/amoxicillin 250mg/rifabutin 12.5mg) delayed-release capsules, was approved by the U.S. Food and Drug Administration (FDA) on November 1, 2019. Containing a proton-pump inhibitor (PPI) and two antibacterial drugs, it is indicated for the short-term treatment of adults who have Helicobacter pylori (H. pylori) infections. Although several similar combination drugs are available, Talicia is the first to contain rifabutin, an antimycobacterial drug more frequently used to treat tuberculosis (TB). By including rifabutin in Talicia, the manufacturer, Redhill Biopharma, hopes to reduce the spread of bacterial resistance, which is increasing to more commonly used antibiotics. H. pylori bacteria are strongly associated with peptic ulcers and some forms of stomach cancer. An estimated 2.5 million American adults are treated for H. pylori-related conditions, each year. After a planned launch in the first quarter of 2020, Talicia will be dispensed in bottles of 84 capsules or cartons of 168 capsules with recommended dosing of four capsules taken together at the same time once every eight hours for 14 days. Patients should not take it while they are taking the antifungal drug, voriconazole, or certain drugs used to treat HIV infections. Because it was approved as an FDA Qualified Infectious Disease Product (QIDP) -- an antibacterial or antifungal drug that treats serious or life-threatening infections with limited patient populations, Talicia will have extended exclusivity before it faces potential generic competition. Express Scripts currently is investigating the data around Talicia for a possible utilization management strategy. It also will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete. Full prescribing information can be found here.
 

Ziextenzo, a Third Biosimilar to Neulasta, Wins Approval
The Sandoz division of Novartis received Food and Drug Administration (FDA) approval on November 4, 2019, for Ziextenzo™ (pegfilgrastim-bmez) injection. A biosimilar to Amgen’s Neulasta® (pegfilgrastim) injection, it is indicated to reduce the incidence of infection, expressed by febrile neutropenia, for patients who have nonmyeloid cancers, which are being treated with myelosuppressive antineoplastic drugs that are associated with clinically significant febrile neutropenia. Some forms of chemotherapy (chemo) suppress the activity of bone-marrow cells that generate neutrophils, white blood cells that protect against infections. Pegfilgrastim is a PEGylated form of the granulocyte colony-stimulating factor (G-CSF) analog, filgrastim, which causes bone marrow to produce more neutrophils. For adults, it will be given as 6mg subcutaneously (SC) once in each cycle of chemo. Doses for children who weigh less than 45Kg (99 pounds) are based on body weight. Injections should be administered at least 14 days before or 24 hours after chemo. Sandoz expects to introduce Ziextenzo in 6mg prefilled syringes later in 2019. In addition to the brand product, it will compete with other biosimilars -- Fulphila® (pegfilgrastim-jmdb – Mylan/Biocon) and Udenyca® (pegfilgrastim-cbqv – Coherus BioSciences), both already on the U.S. market. None of the biosimilars is interchangeable with Neulasta or with each other, however. Ziextenzo will be added to Express Scripts’ specialty drug list. Express Scripts currently is investigating the data around Ziextenzo for a possible utilization management strategy. It also will be excluded at launch on the Express Scripts NPF until our formulary development process is complete. See Ziextenzo’s prescribing information here.

First Rituxan Biosimilar to Launch in the U.S.
Teva and Celltrion have announced that they will introduce Truxima® (rituximab-abbs) injection for intravenous (IV) use to the U.S. market the week of November 11, 2019. The first Food and Drug Administration (FDA) approved biosimilar to Genentech’s Rituxan®, Truxima is indicated for use alone or in combination with chemotherapy (chemo) to treat adult patients who have chronic lymphocytic leukemia (CLL) or some types of CD20-positive, B-Cell non-Hodgkin’s lymphoma (NHL). Rituximab is an infused monoclonal antibody that targets CD20 receptors on cancerous and normal B-cells resulting in their destruction. Due to patent protection, Truxima currently is approved only for Rituxan’s NHL and CLL indications. However, a settlement agreement with Genentech may allow Truxima to be FDA approved in the second quarter of 2020 for treating some of Rituxan’s other indications -- rheumatoid arthritis (RA) and granulomatosis with polyangiitis and microscopic polyangiitis (GPA/MPA). Ruxience™ (rituximab-pvvr), Pfizer’s Rituxan biosimilar, which was FDA approved on July 23, 2019, is indicated to treat adults who have NHL, CLL and granulomatosis with GPA/MPA. While its launch date still is uncertain, it is expected to become available early in 2020. Although the three products do not have clinically significant differences in safety, purity or effectiveness, they are not interchangeable. Rituximab products must be given by healthcare providers in facilities that are equipped and staffed to handle severe adverse effects. Doses and timing vary according to the condition being treated and other therapy the patient is receiving. A boxed warning on their labeling lists potentially fatal side effects, including infusion-related reactions, mucocutaneous (skin and mucus membrane) reactions, progressive multifocal leukoencephalopathy (PML) and reactivation of hepatitis B. Truxima’s wholesale acquisition cost (WAC) is $845.55 for a 100mg vial and $4227.75 for a 500mg vial – about 90% of the WAC for Rituxan. Express Scripts currently is investigating the data around Truxima for a possible utilization management strategy and it will be evaluated for exclude at launch on the Express Scripts National Preferred Formulary (NPF). For Truxima’s prescribing information, click here.
 

The U.S. Food and Drug Administration Approves Reblozyl®
The U.S. Food and Drug Administration (FDA) approved Reblozyl® (luspatercept-aamt) on November 8, 2019. The first erythroid maturation agent (EMA) to be approved in the U.S., it is indicated to treat anemia for adult patients who have beta thalassemia and who need regular transfusions of red blood cells (RBCs). The most common in a group of hereditary conditions, beta thalassemia is a result of mutations in hemoglobin beta (HBB) genes. Patients who have a thalassemia cannot make enough hemoglobin (the part of the blood that carries iron) or their hemoglobin is abnormal. As long as a patient’s hemoglobin (Hgb) level is 11Gm/dL or lower, Reblozyl will be given as subcutaneous (SC) injections once every three weeks at a beginning dose of 1mg/Kg. The dose may be increased to a maximum of 1.25mg/Kg if the need for RBC transfusions does not decrease after two injections. If Hgb is 11.5mg/dL or higher, doses may be delayed. The manufacturers, Celgene and Acceleron Pharma, expect to launch within the week at an estimated wholesale acquisition cost (WAC) of $3,441 for a 25mg vial and $10,324 for each 75mg vial. The distribution network has not yet been announced. Complete prescribing information is available here.

 
5Nov
From the CEO

From the CEO

Welcome to November 2019! As the year ends, we already are planning for the upcoming year. Open Season starts this month – a great time to examine your benefits. Think about adding AFSPA’s dental coverages, life insurances, or disability plans. For stateside members, consider our Discount Care Programs to save on dental, vision, Lasik, and/or hearing aids.

Open Season Activities 
This year’s Open Season starts November 11 and ends December 12. AFSPA staff travel overseas, in preparation for this annual enrollment period. Any direct hire Federal employee who is enrolled or is eligible to enroll in the Federal Employees Health Benefits (FEHB) Program can attend. These briefings offer valuable information on FEHB, FEDVIP, and FSAFEDS to make informed decisions. AFSPA staff also will attend over 70 domestic agency Open Season health fairs this year. If you are in the area nationally or internationally, plan to attend an Open Season event. For information on our upcoming sessions, visit AFSPA’s Facebook page.

Federal employees can choose from a plethora of supplemental insurances. To assist with making dental decisions, consider these points:

  • FEDVIP dental plans cover dependent children up to age 22. AFSPA dental plans cover dependents up to age 26
  • Most FEDVIP plans cover overseas dental services as out-of-network. Processing the itemized bills/receipts requires English translation. AFSPA offers Cigna International that covers services outside the U.S. at a higher benefit. Claims are processed in any language and any currency. Over 100,000 pre-screened network dentists exist, in over 160 countries
  • Enroll in AFSPA dental plans and the discount dental/vision plan (U.S. only) anytime – not just during an Open Season

Learn more at afspa.org/dental.

November is Diabetes Awareness Month  

You don’t get good at dealing with diabetes overnight. But, in time, you have learned to take it in stride. Remember when you were first diagnosed with diabetes – and, when you first learned the basics of taking care of yourself…

  • Make and eat healthy food.
  • Be active most days.
  • Test your blood sugar often.
  • Take medicines as prescribed, even if you feel good.
  • Learn ways to manage stress.
  • Cope with the emotional side of diabetes.
  • Get regular checkups.

Managing diabetes can affect family, work, school, holidays, and everything else. We want to help. Start by identifying what is important to you. Being fit? Having fun? Gaining energy? By taking care of yourself – you can make diabetes a part of life, instead of a life all about diabetes!

Foreign Service Benefit Plan (FSBP) offers diabetes programs to assist:

  • In Touch Care – personal support to help manage chronic conditions, including 1-on-1 calls with a nurse and digital support resources
  • Mediterranean Wellness Program – an interactive on-line, 8-week program that assists you in maintaining a desirable weight and keeping healthy
  • Livongo – a diabetes monitoring program that provides support through a cellular enabled meter, mobile app, and personalized interventions

Click here to find more diabetes resources.

Thanksgiving

Thanksgiving is approaching – a time to see family, reflect on good fortune, and recognize how lucky we are to celebrate this American holiday.

We cherish Thanksgiving dinner; however, the traditional foods contain high fat and many calories. This holiday kicks off 6 weeks of overeating that ends on New Year’s Day. However, little changes can make a big difference. Reduce your salt intake, take less mashed potatoes and stuffing, and load up on vegetables. Watch your portion sizes and burn a few calories with an after-dinner walk. Start new healthy traditions. I plan to enjoy the holiday, in moderation – and I’ll do my best to walk off my 2,000-calorie meal.

As Thanksgiving approaches, I want to express my gratitude for your ongoing loyalty. Thank you for your trust and for giving us the opportunity to serve you.

To Your Health,

Paula S. Jakub, RHU
CEO, AFSPA
Executive Director, Senior Living Foundation

 
4Nov
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Expanded Indication for Baxdela 
Baxdela® (delafloxacin), a fluoroquinolone antibiotic first Food and Drug Administration (FDA) approved in June 2017 to treat acute bacterial skin and skin structure infections (ABSSSI), now has an additional indication. It was approved on October, 24, 2019, to treat adults who have community-acquired bacterial pneumonia (CABP). Results of its use in a key clinical trial were comparable to those from a similar antibiotic, moxifloxacin. Both drugs are available in intravenous (IV) and oral forms, meaning that either can be started as an IV in the hospital and then continued in oral form once the patient is discharged. In either form, Baxdela is given once every 12 hours, at 300mg IV or 450mg orally, for five to 10 days to treat CABP. Like all fluoroquinolone antibiotics, Baxdela has a boxed warning about its potential to worsen myasthenia gravis and to cause peripheral neuropathy, central nervous system (CNS) side effects and inflammation or tears in tendons. A Medication Guide that explains its risks is dispensed with each Baxdela prescription. Its manufacturer, Melinta Therapeutics, plans to delay promoting the new indication until it resolves some financial issues. For updated prescribing information, click here.

Food and Drug Administration Expands Indication for Liletta
Medicines360, a nonprofit women's pharmaceutical company, received extended Food and Drug Administration (FDA) approval on October 25, 2019, for Liletta® (levonorgestrel-releasing intrauterine system). A long-term intrauterine device (IUD) for use by women who want to prevent pregnancy, each system now is approved to be used for up to six years. After insertion by a trained healthcare provider, Liletta releases the progestin, levonorgestrel, in gradually decreasing, but continually effective, doses for periods as long as six years. While Liletta can be removed by a healthcare professional at any time that contraception is no longer needed, it must be removed by the end of the sixth year. A new device can be inserted immediately, however. Using Liletta is not recommended for women who already are pregnant or who have endometriosis, a history of pelvic inflammatory disease or uterine abnormalities. It is not appropriate for emergency contraception. Full prescribing information for Liletta can be found here.

Food and Drug Administration Approves Biogen and Alkermes' Vumerity™
Biogen and Alkermes received approval from the U.S. Food and Drug Administration (FDA) for Vumerity™ (diroximel fumarate) delayed-release capsules, a new oral drug to treat multiple sclerosis. It is indicated to treat adult patients who have relapsing forms of MS, including clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS) and active secondary progressive MS (SPMS). For initial treatment, patients will take one 231mg capsule twice a day. After one week, the dose increases to two capsules (462mg) twice daily. Biogen will market Vumerity in near future, but a target date and pricing are not yet available. It will be available through a large network of specialty pharmacies that includes Accredo. Complete prescribing information can be found here.
 

 
29Oct
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Amzeeq Approved to Treat Acne
Amzeeq™ (minocycline) topical foam, 4% was approved by the U.S. Food and Drug Administration (FDA) on Oct. 18, 2019. It is indicated for treating patients at least nine years old who have moderate to severe non-nodular acne. The first commercial topical formulation of an antibiotic used orally to treat acne, it uses “Molecule Stabilizing Technology” patented by its manufacturer, Foamix. The planned launch date is in January 2020; pricing information is not yet known. It will be available in 30 Gm canisters. Recommended dosing is a once daily application patted lightly onto affected areas, avoiding the eyes and mucous membranes. Amzeeq should not be used around open flames or people who are smoking because its propellant is flammable. A patient Medication Guide will accompany each prescription filled. Express Scripts currently is investigating the data around Amzeeq for a possible utilization management strategy. It also will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete. For prescribing information, click here.
 

Farxiga Granted New Indication
AstraZeneca’s sodium-glucose cotransporter 2 (SGLT2) inhibitor, Farxiga® (dapagliflozin) tablets received Food and Drug Administration (FDA)  approval for a cardiovascular (CV) indication. Based on data from the 17,000-patient DECLARE-TIMI 58 clinical trial, it was approved on Oct. 18, 2019, to decrease the risk of heart-failure related hospitalizations for adult patients who have type 2 diabetes and who also have CV disease or several risk factors for CV disease. Its original indication is in combination with dietary restrictions and exercise to manage glycemic control for adults who have type 2 diabetes. Farxiga’s recommended dose for its CV indication is 10mg once a day. Because SGLT2 inhibitors decrease glucose reabsorption in the kidneys causing more glucose to be excreted in urine, kidney function should be checked before patients start treatment and periodically during therapy with an SGLT2 inhibitor. Click here for updated prescribing information for Farxiga.

Second Indication for Ultomiris  
Ultomiris™ (ravulizumab-cwvz - Alexion) injection was approved by the Food and Drug Administration (FDA) on Oct. 18, 2019, to treat atypical hemolytic uremic syndrome (aHUS) for patients as young as one month old. A rare, life-threatening hereditary disease, aHUS affects only about two individuals per million. It causes blood clots in small blood vessels throughout the body, so it can lead to end-stage renal disease, heart attacks and death, if it is not treated. The only presently marketed long-acting C5 complement inhibitor, Ultomiris is administered by intravenous (IV) infusion. Recommended dosing depends on the patient’s weight with a minimum weight of 5 Kg (about 10 pounds). Two weeks after a loading dose, it is given once every four weeks for patients weighing less than 20 Kg (44 pounds) or once every eight weeks for patients whose weight is 20 Kg or more. The labeling for Ultomiris contains a Boxed Warning that highlights an increased risk of serious meningococcal infections. Patents should be vaccinated with a meningococcal vaccine at least two weeks prior to receiving their first dose. During therapy, patients also should be monitored for early signs of meningococcal infections. Ultomiris is available only through a restricted program under a Risk Evaluation Mitigation Strategy (REMS). Prescribers must enroll in the program and patients are required to receive a Medication Guide that describes the risks associated with the use of Ultomiris. The previous Ultomiris indication, from December 2018, is for the treatment of adults who have another rare condition, paroxysmal nocturnal hemoglobinuria (PNH). Complete prescribing information for Ultomiris may be found here.

New Stelara Indication 
On Oct. 18, 2019, the Food and Drug Administration (FDA) granted Janssen’s Stelara® (ustekinumab) a new indication to treat adults who have active cases of ulcerative colitis (UC) that are moderate to severe. UC, which involves progressing chronic inflammation of the large intestines, is believed to affect about 900,000 American adults. Stelara reduces inflammation by blocking two interleukins – IL-12 and IL-23. For UC, it will be given in two phases. First is one IV infusion of 260mg, 390mg or 520mg — based on the patients weight and delivered in a healthcare facility by a health professional. Beginning eight weeks after the IV dose, 90mg will be given by subcutaneous (SC) injection once every eight weeks. A patient or caregiver should be able to give the SC doses, however, using prefilled syringes. A Medication Guide warns patients that using Stelara may raise the risk of having some kinds of cancer, serious infections (including tuberculosis) or a rare brain condition known as reversible posterior leukoencephalopathy syndrome (RPLS). For its full prescribing information, click here.

New Pediatric Indication for Botox
Allergan’s Botox® (onabotulinumtoxinA) was approved by the Food and Drug Administration (FDA) on Oct. 18, 2019, to treat lower limb spasticity (muscle contractions, inflexibility or stiffness in the legs) for children two years old and older, with the exception of children and adolescents whose spasticity is due to cerebral palsy. Children who have head injuries, multiple sclerosis (MS), spinal cord injuries or strokes also may have problems with spasticity. To treat it in the legs, the recommended Botox dose is between four units/Kg and eight units/Kg administered intramuscularly (IM) by a healthcare provider and divided among the affected muscles. For one affected leg, each treatment should be limited to the lower of eight units/Kg or 300 units. If two limbs (both arms, both legs or one arm and one leg) are being treated at the same time, the limits increase to the lesser of 10 units/Kg or 340 total units. Treatments should be given at least three months apart. All botulinum toxin products have Medication Guides and boxed warnings that they may migrate away from the areas where they are injected -- possibly causing widespread side effects, such as muscle weakness and vision changes. Rarely, serious breathing or swallowing problems can occur. Migration and side effects can happen even several months after the product has been injected. Children may be especially prone to having adverse effects. Botox has multiple other medical and cosmetic indications for both adult and pediatric patients. Complete prescribing information can be found here.

Fiasp Approved for Use in Insulin Pumps
Fiasp® (insulin aspart injection), 100Units/mL, Novo Nordisk’s rapid-acting insulin, was Food and Drug Administration (FDA) approved on Oct. 21, 2019, for use in insulin pumps. It is used to manage blood sugar levels by adult patients who have either type 1 or type 2 diabetes. Each patient is advised to be sure that the pump being used is appropriate for use with Fiasp and then to follow the instructions for dosing from the pump’s manufacturer. Also available in SC and IV forms, Fiasp is intended to be injected right before a meal or during a meal up to no later than 20 minutes after the patient begins eating. The Fiasp supply in the pump reservoir should be changed every six days or sooner, if the pump manufacturer requires more frequent replacement. Patients also should keep another form of Fiasp (a 10mL vial and syringes, a FlexTouch pen or a PenFill device) at hand in case of a pump failure. For revised prescribing information, look here.

Orenitram Labeling Revised
As of Oct. 18, 2019, the Food and Drug Administration (FDA) is allowing United Therapeutics Corp. to include new information on the labeling for Orenitram® (treprostinil) extended-release tablets. Used alone to improve exercise ability for patients who have pulmonary arterial hypertension (PAH), its label now also states that taking it with another oral drug used to treat PAH can postpone worsening of the condition. The clinical study that lead to the revision included nearly 700 patients who took either Orenitram or a placebo along with a phosphodiesterase type 5 inhibitor (such as sildenafil), an endothelin receptor blocker (such as bosentan) or the soluble guanylate cyclase stimulator, Adempas® (riociguat). PAH progression was decreased by 61% among patients taking Orenitram compared to patients taking placebo. The recommended starter dose is either 0.125mg three times a day at eight-hour intervals or 0.25mg taken once every 12 hours. Total daily doses can be increased every three to four days by 0.125 mg (for three daily doses) or 0.25mg (for twice daily dosing) to the highest dose the patient can stand to take. To discontinue Orenitram, doses should be reduced gradually over several weeks because stopping it suddenly can cause PAH to get worse. Updated prescribing information can be found here.

New Indication for Zejula
Tesaro, the oncology business unit of GlaxoSmithKline, got a new indication from the Food and Drug Administration (FDA) for the use of Zejula® (niraparib) capsules as late-stage therapy for certain cancer patients. Specifically, the new indication, granted on Oct. 23, 2019, is for treating women whose ovarian, fallopian tube or primary peritoneal cancer has advanced more than six months following the last of at least three rounds of chemotherapy (chemo). The cancer also must be positive for a homologous recombination deficiency (HRD) as indicated by either a deleterious/suspected deleterious BRCA mutation or a genomic instability. Zejula is a poly (ADP-ribose) polymerase (PARP) inhibitor that initially was FDA approved early in 2017 as maintenance treatment for women who have a recurrence of one of the same three cancers and who are in complete or partial response to platinum-based chemo. The recommended dose for both indications is 300mg (three capsules) taken together once each day. For revised prescribing information, click here.

Trikafta Approved for Cystic Fibrosis
The U.S. Food and Drug Administration (FDA) approved Trikafta™ (elexacaftor 100mg/tezacaftor 50mg/ivacaftor 75mg and ivacaftor 150mg - Vertex) on Oct. 21, 2019. The combination of two already approved drugs (tezacaftor and ivacaftor) with a next-generation CFTR corrector, it is indicated for treating cystic fibrosis (CF) in patients 12 years of age and older who have at least one F508del mutation (the absence of protein F508) on the cystic fibrosis transmembrane conductance regulator (CFTR) gene. It will be dispensed as cartons of four one-week blister card “wallets” containing 14 combination tablets that are to be taken as two tablets together once each morning and seven tablets of ivacaftor 150mg that is taken as one each evening – about 12 hours after the morning dose. All the tablets should be taken with food that contains fat. The wholesale acquisition cost (WAC) is $23,896 for each 28-day carton. It was launched upon approval and should be available shortly through a large network of specialty pharmacies that includes Accredo. Complete prescribing information is available here.  

 

 
28Oct
State of Emergency Issued in California Due to Wildfires

State of Emergency Issued in California Due to Wildfires

The Governor of California has expanded the state of emergency to include ALL counties in California due to extreme fire weather conditions.

Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an Emergency Access to Benefits/Refill Too Soon override that allows pharmacies, at the point of sale (POS), to override certain benefit coverage/edits such as an early refill during a government-defined emergency. In addition, if your home delivery of medications is affected by the emergency, you may provide a temporary alternate address (either online at www.express-scripts.com or by calling 1-800-818-6717) or request a local fill as needed.

The Emergency Access to Benefits/Refill Too Soon override process will be implemented with an effective date of Oct. 27, 2019, and expiration date of Nov. 26, 2019.

 
21Oct
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Reyvow Approved for Acute Migraine Treatment
Eli Lilly received approval from the U.S. Food and Drug Administration (FDA) on October 11, 2019, for Reyvow™ (lasmiditan) tablets. It is the first in a novel class of oral drugs, serotonin (5-HT) 1F receptor agonists (ditans) that are indicated for acute, but not preventive, treatment of adults who have migraine headaches. Recommended dosing for Reyvow is 50mg, 100mg or 200mg taken once a migraine has started. No more than one dose should be taken per day and no safety information is available for using more than four doses in a one-month period. Because it may cause sleepiness, patients are advised to wait at least eight hours after taking it to drive or do other tasks that require mental alertness. The Migraine Research Foundation (MRF) estimates that in the United States, around 18% of women and 6% of men have migraines – mostly averaging one or two per month. During their headaches, about 90% of migraine sufferers cannot participate normally in regular activities, such as school or work. Direct and indirect costs of migraines may be as high as $36 billion per year, according to the MRF. Reyvow’s launch date depends on an evaluation of its potential for abuse. The U.S. Drug Enforcement Agency (DEA) is expected to take about three months to decide on a controlled substance schedule for it. Express Scripts currently is investigating the data around Reyvow for a possible utilization management strategy. It also will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete. Pricing information currently is unavailable, but Reyvow’s prescribing information is here.

Secuado Receives FDA Approval
On October 11, 2019, the Food and Drug Administration (FDA) approved a new topical dosage form for an atypical antipsychotic drug that also is available from a different manufacturer as sublingual (SL) tablets. Secuado® (asenapine) transdermal system is indicated to treat adult patients who have schizophrenia. It will be marketed in three strengths – 3.8mg/24 hours, which roughly parallels an SL dose of 5mg twice a day; 5.7mg/24 hours (similar to twice daily 10mg SL doses) and 7.6mg/24 hours. One patch at a time is applied to clean, dry, intact skin on the patient’s abdomen, hip, upper arm or upper back, and worn for 24 hours. Secuado’s manufacturer, Noven Pharmaceuticals, has not announced a definite launch date, but it intends to introduce Secuado as soon as possible in the U.S. A boxed warning cautions that, like all atypical antipsychotic drugs, Secuado should not be used by elderly patients who have psychoses due to dementia because it increases their chance of dying. Express Scripts currently is investigating the data around Secuado for a possible utilization management strategy. It also will be excluded at launch on the Express Scripts NPF until our formulary development process is complete. Prescribing information can be found here.

New Dosage Form for Cetirizine
The first injectable cetirizine product was Food and Drug Administration (FDA) approved on October 4, 2019. Quzyttir™ (cetirizine) injection is indicated to treat acute urticaria (hives) for patients who are at least six months old. Usually in response to an allergen, urticaria causes itchy skin bumps, which typically last no more than a day or two. Quzyttir blocks histamine-1 (H-1) receptors to relieve itching. It will be administered as an intravenous (IV) push injection of 2.5mg for patients between six months and six years old, 5mg or 10mg for those between six years and 12 years, and 10mg for patients over the age of 12 years. If subsequent doses are needed, they will be given once daily. In clinical studies, Quzyttir was about as effective as the current standard of care, diphenhydramine injection, when itching was rated at two hours after the drug was given. Fewer patients treated with it had to have further treatment after using it, however; and the average time to treatment effectiveness was about one-half hour shorter (1.7 hours for Quzyttir compared to 2.1 hours for diphenhydramine). The manufacturer, JDP Therapeutics, has not yet disclosed launch or pricing plans for it. It will be excluded at launch on the Express Scripts NPF until our formulary development process is complete. For prescribing information, click here.

Xarelto’s Indication Extended
Xarelto® (rivaroxaban – Janssen/Bayer) tablets was Food and Drug Administration (FDA) approved on October 11, 2019, to prevent venous thromboembolisms (VTEs) for acutely ill medical patients who are hospitalized and who are at risk for VTE complications, but who do not have a significant risk of excessive bleeding. An oral anticoagulant, Xarelto blocks the activity of blood clotting factor Xa to reduce the ability of the blood to form clots. For its new indication, the recommended dose is 10mg per day, started in the hospital and maintained for a total of 31 days to 39 days of continuous treatment. A boxed warning and patient Medication Guide inform users that abruptly stopping any oral anticoagulant before the scheduled end of therapy may cause potentially life-threatening blood clots to form. Additionally, patients are advised that undergoing a spinal procedure, such as a spinal tap, while taking Xarelto could cause an accumulation of clotted blood that may result in paralysis. It has other indications for preventing and treating several kinds of blood clots and lowering the possibility of cardiovascular events. Click here for its updated prescribing information.

Expanded Indication for Xofluza
The Food and Drug Administration (FDA) broadened its approval for Genentech’s Xofluza® (baloxavir marboxil) tablets on Oct. 16, 2019. It originally was approved last October to treat acute uncomplicated influenza (flu) for otherwise healthy patients at least 12 years old who have had flu symptoms for no more than 48 hours. Based on results from a clinical trial, its indication now includes patients with underlying conditions, such as asthma, diabetes and heart disease, which make them more likely to experience complications from having the flu. In the study, symptoms began to resolve slightly more than one day sooner for patients taking Xofluza compared to patients who took a placebo (an average of 73 hours vs 102 hours, respectively). Xofluza works differently than other antiviral drugs that treat flu. It blocks the activity of an enzyme that helps flu viruses replicate. Recommended dosing is 40mg (two 20mg tablets) for those who weigh between 40kg (about 88 pounds) and 80kg (about 175 pounds). Patients weighing 80kg or more should receive a single dose of 80mg (two 40mg tablets). Xofluza is not approved for patients weighing less than 40kg. Taking it should be separated by several hours from eating or drinking dairy foods, using antacids and taking mineral supplements. For updated prescribing information, click here.


Sprinkle Form of Duloxetine Launched
Following its Food and Drug Administration (FDA)  approval on July 19, 2019, Drizalma Sprinkle™ (duloxetine delayed-release) capsules has been launched by Sun Pharmaceuticals. It is a serotonin/norepinephrine reuptake inhibitor (SNRI) that treats depression, anxiety and some types of pain for adults. It also is indicated to treat generalized anxiety disorder (GAD) for patients as young as seven years old. Specifically formulated for patients who are in long-term care facilities and who cannot swallow tablets easily, Drizalma Sprinkle capsules can be opened for the sprinkles to be blended with a small amount of applesauce for the patient to eat. Capsule contents also may be mixed into about one ounce of water and delivered through a nasogastric (NG) tube. Dosing varies according to the condition being treated. Labeling for Drizalma Sprinkle carries the same boxed warning on all antidepressants – that children, teens and young adult patients taking it may be more prone to consider, attempt or commit suicide. Express Scripts currently is investigating the data around Drizalma Sprinkle for a possible utilization management strategy. It also will be excluded at launch on the Express Scripts NPF until our formulary development process is complete. Click here for full prescribing information for Drizalma Sprinkles.

Nplate’s Dosing Recommendations Revised 
Labeling for Amgen’s Nplate® (romiplostim) was Food and Drug Administration (FDA) approved on October 17, 2019, to include treatment for patients who are one year old or older and who had a diagnosis of immune thrombocytopenia (ITP) less than six months earlier, but who have not responded well to usual treatment with corticosteroids, immunosuppressants or spleen removal. ITP is a rare, but often serious bleeding disorder caused by low blood levels of platelets. Many of the estimated 20,000 patients in the U.S. who are diagnosed with ITP annually have only mildly decreased platelet counts with few symptoms. However, some patients experience extensive bruising, excessive bleeding or other severe symptoms. An injectable drug, Nplate works in much the same way as thrombopoietin (TPO), a natural protein that stimulates platelet production in the bone marrow to increase platelet counts. From a recommended starting dose of one mcg/kg per week by subcutaneous (SC) injection, dosing can be adjusted based on the patient’s platelet levels. Initially approved in 2008 as a later-stage treatment for adult ITP patients, Nplate received a pediatric indication in December 2018. An associated risk evaluation and mitigation strategy (REMS) and Medication Guide for patients summarize possible severe side effects of using Nplate, which is available only through a restricted distribution program called Nplate NEXUS (Network of Experts Understanding and Supporting Nplate and Patients). Only healthcare providers and patients registered with the program are able to prescribe and receive Nplate. Click here for its revised prescribing information.

 

 
15Oct
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Bonsity Wins Food and Drug Administration Approval
Bonsity (teriparatide injection) for subcutaneous (SC) use was approved by the U.S. Food and Drug Administration (FDA) on October 4, 2019. It is indicated to be self-injected once-daily for up to two years as treatment for some patients who are at a high risk of bone fractures due to osteoporosis. Bonsity was approved through the FDA’s 505(b)(2) pathway, which allowed its developer, Pfenex, Inc., to use documentation from a similar drug that already is FDA approved rather than requiring a repeat of the clinical trials. Like its reference drug, Forteo® (teriparatide – Eli Lilly), Bonsity is a parathyroid hormone analog that regulates calcium and phosphate metabolism in bones and kidneys. Known as PF708 during its development, it will be marketed in the United States by Alvogen, a partner company to Pfenex. Launch depends on the results of an ongoing head-to-head comparison between Bonsity and Forteo, due later in 2019. If the two drugs produce similar enough results, Pfenex has requested an “A” equivalency rating from the FDA. If the A rating is granted, Bonsity could be interchanged with Forteo and substituted for it in states that allow automatic substitution. Because the use of teriparatide was associated with a higher rate of osteosarcoma in laboratory animals, Bonsity and Forteo have a boxed warning against their use by patients who have Paget’s disease of the bone or other conditions that may make osteosarcoma more likely. According to Eli Lilly’s 2018 annual report, U.S. sales of Forteo amounted to nearly $758 million last year. Express Scripts currently is investigating the data around Bonsity for a possible utilization management strategy. It also will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete. It will be added to Express Scripts’ specialty drug list. Prescribing information can be found here.

Food and Drug Administration Approves Aklief to Treat Acne
The Food and Drug Administration (FDA) approved Galderma’s Aklief® (trifarotene) cream, 0.005% on October 4, 2019, to treat acne for patients at least nine years old. A new retinoid that is comparable to several other topical products that are available as both brands and generics, it is indicated for acne on the face, back, chest and shoulders. With a planned launch date before the end of November, it will be dispensed in 30Gm, 45Gm and 75Gm pump devices. Cost information is not yet available. Directions are to apply a thin layer of Aklief to clean, dry areas that are affected by acne once each evening. It should not be used in the eyes or on genital areas and mucous membranes. Patients using it are cautioned either to avoid long exposure to natural and artificial sunlight or to use a strong sunscreen because retinoids increase the risk of sunburn. Express Scripts currently is investigating the data around Aklief for a possible utilization management strategy. It also will be excluded at launch on the Express Scripts NPF until our formulary development process is complete. For its full prescribing information, click here.

New Indications for Wilate
Wilate® (von Willebrand factor/coagulation factor VIII complex [human]) now has Food and Drug Administration (FDA) approved indication for patients who have hemophilia A. It was first approved in 2009 to treat bleeding episodes and control bleeds associated with surgery for adult and pediatric patients who have von Willebrand disease (VWD). A bleeding disorder caused by deficiencies in von Willebrand clotting factor, VWD affects approximately 1% of the U.S. population – both males and females about equally. On October 8, 2019, the manufacturer, Octapharma, announced that the FDA also has approved Wilate to prevent bleeding episodes and to manage bleeds for teens and adults who have hemophilia A. Affecting males almost exclusively, hemophilia A is a different type of bleeding disorder that results from the lack of coagulation factor VIII (factor VIII). Around 20,000 patients in the U.S. have it. Wilate’s dosing for hemophilia A is based on the patient’s weight. To prevent excessive bleeding, it is given by intravenous (IV) infusion at between 20 international units (IU) and 40 IU per kilogram once every two or three days. Once a bleed starts, the severity of the bleeding, the patient’s blood levels of factor VIII and other aspects of the episode also are considered to determine the dose, the timing of infusions and the length of treatment. Go here for updated prescribing information.

Beovu Approved for Wet Age-Related Macular Degeneration
On October 8, 2019, Novartis received approval from the U.S. Food and Drug Administration (FDA) for Beovu® (brolucizumab-dbll) injection for the treatment of wet age-related macular degeneration (AMD). Beovu is administered as injection into the back of the eye by a healthcare professional. The recommended dose for Beovu is 6mg once monthly for three months followed by 6mg every 8-12 weeks. Novartis plans to launch Beovu within the next two weeks. It will be available through open distribution. Full prescribing information can be found here.

Scenesse Approved For Erythropoietic Protoporphyria
On October 8, 2019, the U.S. Food and Drug Administration (FDA) approved Clinuvel’s Scenesse® (afamelanotide), the first drug approved to increase pain-free light exposure in patients with a rare condition known as erythropoietic protoporphyria (EPP). The drug, a melanocortin-1 receptor agonist, increases the production of eumelanin which offers some protection from light. Recommended dosing is one implant places subcutaneously  by a trained healthcare professional every two months. Clinuvel has not yet released pricing information. The company plans to distribute the drug directly to hospitals within the next 12 months. Complete prescribing information can be found here.

 
8Oct
From the CEO

From the CEO

Greetings and welcome to Fall 2019! I am pleased to announce the 2020 Premiums for the Foreign Service Benefit Plan (FSBP):

FOREIGN SERVICE BENEFIT PLAN 2020 Premiums

Self Only (Code 401)

Bi-Weekly: $68.99

Monthly: $149.47

 

Self Plus One (Code 403)

Bi-Weekly: $171.79

Monthly: $372.21

 

Self & Family (Code 402)

Bi-Weekly: $170.67

Monthly: $369.79

We continue to offer a comprehensive benefit package, at very competitive rates. The Plan is committed to providing the unparalleled service that our unique worldwide membership requires. We strive to demonstrate that daily through our programs and through our premiums – which increased less than 3% from 2019.


October Awareness Months

Breast Cancer Awareness

National Breast Cancer Awareness Month increases awareness of this disease. Breast cancer affects 1 in 8 women, making it one of the most common cancers in women. The chance of survival increases, if the cancer is found and treated early. FSBP covers mammograms, including 3D breast tomosynthesis, once per calendar year – for women age 35 and older. If you have a family history or a high-risk factor, you can be screened more frequently. Talk to a doctor about your risk and how often to get mammograms.

National Chiropractic Health Month

Back pain remains a common reason that patients visit doctors. Providers often prescribe opioid pain medications for this disabling condition. Opioid abuse remains a top U.S. public health issue. However, treatments like spinal manipulation safely address lower back pain. FSBP offers generous chiropractic, acupuncture, and massage therapy benefits. Each covered family member receives 40 visits of each service, every year (up to $60/visit). Chiropractic care can help with headaches, back aches, arm/leg pain, etc. With 40 annual visits included in your health plan, why not give it a try?

Talk about Prescriptions Month

Speaking of managing pain, October is also Talk About Prescriptions Month. It encourages you to stay informed about your medication. Know your expected outcomes, possible side effects, benefits, and potential risks. All medication can be dangerous, even deadly, if abused. Express Scripts (ESI), FSBP’s Pharmacy Benefit Manager, offers resources to assist. Use ESI’s Cobranded website and ESI’s app to review your medicines, track your prescription deliveries, contact a Specialist Pharmacist, and more. And, if you prefer to use paper (versus an app) to track your medication, click here.


Immediate Benefit Plan for State Employees

We are offering an Open Enrollment for the Immediate Benefit Plan (IBP) term life insurance, underwritten by Prudential.

From September 16 to December 13, 2019, active duty State Department employees (foreign and civil service) can enroll – no health questionnaire required. Also, during this period, current IBP enrollees can opt to increase their current $15,000 benefit to the NEW $20,000 benefit (for $2.55/pay period). IBP pays the enrollee’s beneficiary (ies) within two (2) business days of AFSPA’s official notification of death. The monies can assist with funeral expenses, medical bills, mortgages, etc.

I encourage State employees to take advantage of this opportunity – only offered every 3-4 years. Learn more here .


Open Season Fast Approaching

This year, Open enrollment is from November 11 to December 9, 2019. AFSPA staff travel to various regions of the globe in preparation for Open Season. Any Direct Hire Federal employees who are eligible for the Federal Employees Health Benefits Program can attend. We will send notices to alert members when we will be in your area. Also, we attend many domestic agency health fairs in the DC area and throughout the U.S. Check our website and Facebook page to find out where we will be. If you are available, please plan to participate in one of our Open Season activities.


As always, thank you for your trust and loyalty. We truly appreciate you giving us the opportunity to serve you.

To Your Health,

Paula S. Jakub, RHU

CEO, AFSPA

Executive Director, Senior Living Foundation

 
7Oct
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Descovy Receives New FDA Indication for Pre-Exposure Prophylaxis (PrEP)
As part of the government’s plan to decrease the number of new HIV-1 infections in the U.S., the Food and Drug Administration (FDA) granted Descovy® (emtricitabine 200mg/tenofovir alafenamide 25mg - Gilead Sciences) an additional approval on October 3, 2019. It now is indicated to prevent HIV-1 infection for certain adults and teens who weigh 35Kg (77 pounds) or more. In addition to following safe sex practices, such as using condoms, HIV-1 negative men and transgender women who are at high risk of getting HIV by having sex with men should take one Descovy tablet every day. It is not indicated for women who engage in receptive vaginal sex. Like Gilead’s Truvada® (emtricitabine 200mg/tenofovir disoproxil fumarate 300mg), the only other drug FDA approved for PrEP, Descovy contains two nucleoside analog reverse transcriptase inhibitors (NRTIs). Updated prescribing information for Descovy can be found here.

Rituxan Approved to Treat Rare Conditions for Children
The first pediatric indications for Rituxan® (rituximab – Genentech) were granted by the U.S. Food and Drug Administration (FDA) on September 27, 2019. For children as young as two years old, it can be used to treat granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA). Two severe forms of a rare autoimmune vasculitis, they cause inflammation and damage in the small blood vessels of the kidneys, lungs and other organs. Rituxan is an infused monoclonal antibody that targets CD20 receptors on B-cells. Since it originally was FDA approved in November 1997 to treat Non-Hodgkin’s Lymphoma (NHL), it has received new indications for treating adults who have acute and chronic lymphocytic leukemias (ALL and CLL) mantle cell and small lympocytic leukemias (MCL and SLL), GPA, MPA, macroglobulinemia and rheumatoid arthritis (RA). For its new pediatric indications, it will be administered along with a glucocorticoid, such as methylprednisolone, and given as an intravenous (IV) infusion of 375mg/m2 once each week for four weeks. If the patient responds to treatment, recommended maintenance dosing is one 250mg/m2 infusion followed by a second one after two weeks, then one every six months. Boxed warnings on the label advise that some patients using Rituxan may experience infusion-related or severe mucocutaneous (skin and mucous membrane) reactions, reactivation of hepatitis B virus or progressive multifocal leukoencephalopathy (PML). For revised prescribing information, click here

Expanded Crysvita Indication and Label Information
Ultragenyx Pharmaceutical Inc. received Food and Drug Administration (FDA) approval on September 27, 2019, for Crysvita® (burosumab - twza) to treat patients as young as six months old. Crysvita is a monoclonal antibody that blocks the activity of fibroblast growth factor 23 (FGF23). It was approved in April 2018 to restore more normal phosphate reabsorption and increase blood levels of vitamin D for patients age one year and older who have X-linked hypophosphatemia (XLH). A rare, hereditary bone disease, XLH is believed to affect between 12,000 and 16,000 patients in the U.S. For patients who have XLH, overproduction of FGF23, a hormone that controls phosphate elimination and vitamin D production in the kidneys, causes too much phosphate to be lost in the urine. Not enough minerals deposit in bones and teeth, which can cause rickets (weak bones), bone and tooth pain, increased fracture risk, shortness and hearing loss. The Food and Drug Administration (FDA) also is allowing labeling revisions that state Crysvita produced better outcomes and improved symptoms better for clinical trial patients than standard treatment with oral phosphate and vitamin D supplements. For adults, recommended Crysvita dosing is 1mg/Kg rounded to the nearest 10mg injected subcutaneously (SC) once every four weeks. For children, the dose is 1mg/Kg (rounded to the closest 1mg) for patients who weigh less than 10Kg (about 20 pounds) and 0.8mg/Kg (rounded to the nearest 10mg) for those heavier than 20Kg. Children receive injections once every two weeks. The maximum single dose for patients of any age and weight is 90mg. Check here for Crysvita’s updated prescribing information.

Food and Drug Administration Approves Pediatric Indication for Entresto
A Novartis combination drug, Entresto® (sacubitril/valsartan) gained Food and Drug Administration (FDA) approval on October 1, 2019, for treating specific patients who are at least one year old. It contains a neprilysin inhibitor and an angiotensin receptor blocker to treat children and teens who have symptomatic heart failure (HF) with systemic left ventricular systolic dysfunction. Its original approval, from July 2015, is for reducing the risk of CV death and hospitalization for HF in patients with chronic HF (NYHA Class II-IV) and reduced ejection fraction. Most often, it is used along with HF drugs from other therapeutic classes, but it should not be taken at the same time as an angiotensin-converting enzyme (ACE) inhibitor. Patients who also have diabetes should not take Entresto along with a drug that contains aliskiren. For children who cannot swallow Entresto tablets, a pharmacy can make a liquid form that can be stored at room temperature for a maximum of 15 days. Doses for patients who weigh less than 50Kg (110 pounds) are based on body weight, taken two times a day and increased, if needed, in two stages that are each two weeks apart. Entresto has a boxed warning that it can cause birth defects, so women and teenage girls should stop taking it if they become pregnant. For its full revised prescribing information, click here.

Food and Drug Administration Approval for Fasenra Pen Device
An auto-injector pen for AstraZeneca’s Fasenra® (benralizumab) was Food and Drug Administration (FDA) approved on October 3, 2019. As an add-on to other asthma drugs, Fasenra reduces severe asthma attacks for patients who are at least 12 years old and who have asthma with an eosinophilic phenotype. It blocks interleukin-5 (IL-5) receptors on eosinophils, white blood cells that contribute to increased sensitivity of the airways among affected patients. The U.S. Centers for Disease Control and Prevention (CDC) estimates that up to one-half of the 100,000 to 200,000 Americans who have severe asthma also have the eosinophilic phenotype. In clinical studies, patients using Fasenra had up to 50% fewer asthma attacks per year than patients receiving a placebo. Additionally, three-quarters of the patients using it were able to reduce or discontinue their oral corticosteroids. Previously administered only by a healthcare provider, Fasenra now has the option of being self-administered or injected at home by a caregiver. It is used once every two months after the first three doses are administered one month apart. To find its prescribing information, by clicking this link.

 

 
1Oct
Product Recall Ranitidine Hydrochloride

Product Recall Ranitidine Hydrochloride

PRODUCT RECALL: Express Scripts Ranitidine Hydrochloride Capsules 150mg and 300mg Recall

Sandoz Inc. is voluntarily recalling all quantities and lots within expiry of Ranitidine Hydrochloride Capsules in the U.S. to the consumer level because of confirmed contamination with N-Nitrosodimethylamine (NDMA) above levels established by the FDA in batches of Sandoz Ranitidine Hydrochloride Capsules. To date, Sandoz has not received any reports of adverse events related to use of the product as part of this recall.

Express Scripts impact includes 3,892 patients. Express Scripts will send communications to all potentially impacted patients instructing them to reach out to Sandoz for return of recalled drug product.  Note: no information regarding reimbursement has been released by Sandoz at this time.

Additional Information:

  • Product:  Ranitidine Hydrochloride Capsules 150mg and 300mg
  • Manufacturer: Sandoz, Inc.
  • Lots impacted: For impacted lots, click here.
  • Type of recall: Voluntary
  • Reason for Recall: due to confirmed contamination with N-Nitrosodimethylamine (NDMA) above levels established by the FDA.
  • Return/Replacement information: There is no return/replacement information. Sandoz will be managing return of all recalled products.

 

 

 

 
30Sep
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

FDA Approves Jynneos to Prevent Smallpox and Monkeypox
Bavarian Nordic’s Jynneos™ (smallpox and monkeypox vaccine, live, non-replicating) suspension for injection was approved by the U.S. Food and Drug Administration (FDA) on September 24, 2019. Both smallpox and monkeypox are viral diseases that produce body aches, fever and large blistery rashes. Highly contagious, smallpox spreads from person to person, but monkeypox is carried by rodents and other animals. Jynneos is indicated to prevent either disease for patients age 18 years and older who are immunocompromised or who have other conditions that could make them particularly vulnerable to getting one of the diseases. Healthcare providers who have been exposed to either virus, and military personnel stationed in areas where the viruses are prevalent, should be vaccinated, as well. The recommended dosing is two subcutaneous (SC) injections given one month apart. Although other smallpox vaccines may be available, Jynneos is the first to use live viruses that are not able to produce additional viral particles, which makes it less likely to cause adverse reactions. It also is the only vaccine against monkeypox -- a less common and usually milder illness than smallpox -- that is found mainly in Central and Western Africa. In 2003, however, nearly 50 monkeypox cases were confirmed or suspected in six states of the midwestern United States. The outbreak was traced to imported animals, which had infected prairie dogs that were being kept as pets. Because naturally-occurring smallpox was essentially eliminated by 1980, widespread vaccination is no longer suggested for entire populations. Global researchers and government agencies maintain samples of the virus, though, and accidental releases are possible. The use of smallpox as a biological weapon also is a real potential threat. As a precaution, the U.S. Strategic National Stockpile will store enough frozen doses of Jynneos to assure adequate coverage for general emergencies. In addition to FDA’s Priority Review, Jynneos received a Material Threat Medical Countermeasure (MCM) Priority Review Voucher, which Bavarian Nordic has indicated it plans to sell to another pharmaceutical company. Click here for the full prescribing information.

Mavyret Approval Extended
The shortest dosing regimen of AbbVie’s Mavyret® (glecaprevir 300mg/pibrentasvir 120mg) now can be used for additional hepatitis C patients. On September 26, 2019, the Food and Drug Administration (FDA) approved an eight-week course of Mavyret treatment for newly diagnosed patients age 12 years and older who weigh at least 45 Kg (about 100 pounds), who have any of the six known types of hepatitis C and who also have compensated cirrhosis. Previously, only patients who do not have cirrhosis were eligible for the shorter treatment. Some patients still will need 12 weeks or 16 weeks of therapy, however. The recommended dose is three tablets taken together once every day. Labeling includes a boxed warning that taking Mavyret can activate hepatitis B virus (HBV) for patients who have or who have had HBV. Patients should be tested for HBV before treatment begins, and then monitored for signs of infection with it during and for several months after treatment ends. For Mavyret’s full prescribing information, click here.  

Expanded Indication for Darzalex
Also on September 26, 2019, the Food and Drug Administration (FDA) approved an addition to the indications for Darzalex® (daratumumab – Genmab/Janssen) solution for injection. Used together with three drugs known as VTd, which include Velcade® (bortezomib – Millennium), Thalomid® (thalidomide – Celgene) and dexamethasone, it can be used as first-line treatment of adults who are candidates for autologous stem-cell transplants to treat multiple myeloma. In the clinical trial of over one thousand patients, some are receiving VTd while others also get Darzalex. For patients on the four drug regimen, the chance of progression free survival (PFS) increased by 53% compared to those on VTd. The dose for Darzalex is an intravenous (IV) infusion of 16mg/Kg once a week for eight weeks, then once every two weeks for four more doses as induction therapy. At least one month after the patient receives high doses of chemotherapy (chemo) and the stem-cell transplant, the consolidation phase of treatment includes four Darzalex infusions given at two-week intervals. Darzalex also can be used in several other combinations and alone to treat different stages of multiple myeloma. To see its complete prescribing information, click here.

New Dysport Indication 
Ipsen Biopharmaceuticals received Food and Drug Administration approval for an additional Dysport® (abobotulinumtoxinA) indication on September 25, 2019. It already was approved for several adult conditions, including cervical dystonia and upper limb spasticity (inflexibility, spasms or stiffness in the muscles) and to treat lower limb spasticity for children as young as two years old. Now, it also is indicated for children, except those whose arm and hand spasticity is caused by cerebral palsy, who are at least two years old and who have spasticity in their upper limbs. Spasticity is fairly common for children who have had head injuries, multiple sclerosis (MS), spinal cord injuries or strokes. Recommended total pediatric dosing for each treatment depends on the weight of the patient, the number of affected muscles and the severity of spasticity. The range is 8 units to 16 units per Kg of body weight injected intramuscularly (IM) into affected muscles of each arm or hand. Dosing should not exceed 16 units/Kg or 640 units per treatment and treatments should be separated by at least 16 weeks. All botulinum toxin products, including Dysport, carry a boxed warning that they may migrate away from the areas where they are injected and may possibly cause widespread side effects that rarely may include serious breathing or swallowing problems. Migration and side effects can happen even several months after the product has been injected. Children may be especially prone to having adverse effects. Complete prescribing information for Dysport is here.

 

 
24Sep
FREE Life Insurance Webinar on Wednesday, Sept 25 for AFSPA Members

FREE Life Insurance Webinar on Wednesday, Sept 25 for AFSPA Members

In recognition of Life Insurance Awareness month, the American Foreign Service Protective Association (AFSPA) will be hosting a special lunchtime webinar – Life Insurance 101. This online presentation will introduce you to the basics of Life Insurance and answer your Life Insurance related questions. Our partners at The Prudential Insurance Company of America will be providing an experienced speaker to give you a fresh perspective on the Life Insurance industry. This interactive session will expand your knowledge of this unique coverage that can help to protect your family’s financial future. 
 

What: Life Insurance 101 Live Webinar
sponsored by AFSPA

When: Wednesday, September 25, 2019

Time: 12:00pm - 1:00pm EST

Register Now

 
Open to all
AFSPA Members

The session will cover the following: 

  • The different types of life insurance and what may be the best fit for you
  • How much coverage you may need
  • How your needs can change as you enter new stages of life
  • Common misconceptions and mistakes people make when purchasing life insurance 
  • A product overview of Group Enhanced Life (GEL), Accidental Death & Dismemberment Insurance (AD&D), and the Immediate Benefit Plan (IBP) offered through the AFSPA Insurance Program
  • General information on retirement planning

You don’t want to miss this opportunity to learn more about life insurance and benefits you can take advantage of. Even if you can't join LIVE, click here and we'll send you the recorded webcast to watch at your convenience.

For more information on AFSPA’s Life Insurance products, visit afspa.org/life or call 202-833-4910.

 

PruBYC_BlueBlack_ (002).png Logo_AFSPA (1)-01.png

 

Group Insurance coverages are issued by The Prudential Insurance Company of America, a Prudential Financial company, Newark, NJ. The Booklet-Certificate contains all details, including any policy exclusions, limitations, and restrictions, which may apply.  

1025994-00001-00

 
24Sep
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

FDA Approves New Oncology Drug Regimen
On September 17, 2019, the U.S. Food and Drug Administration (FDA) approved the use of Keytruda® (pembrolizumab - Merck) and Lenvima® (lenvatinib - Eisai) together to treat endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). Eligible patients are not appropriate for treatment with radiation or surgery and they have cancer that has progressed despite previous systemic treatment. In a clinical trial of 94 patients, 10 of those treated with the Keytruda/Lenvima combination had complete clearing of their tumors and another 26 had at least some improvement. Responses lasted six months or longer for about 70% of patients who were helped by the drugs. For the new indication, the suggested dose of Keytruda is 200mg infused intravenously (IV) once every three weeks. Two 10mg capsules of Lenvima are taken once every day. Treatment lasts for two years, until the cancer begins to spread or until the patient can no longer tolerate the drugs’ side effects. Keytruda’s revised prescribing information is here; Lenvima’s here

The approval marks the first time that drugs have been reviewed and approved simultaneously in the U.S. and other countries. The Keytruda/Lenvima regimen also was approved in Canada and Australia. Under the FDA Oncology Center of Excellence’s Project Orbis initiative, drug regulatory bodies of each participating nation evaluate applications for the same oncology drugs at the same time – sharing information with the immediate goal to quickly approve therapies for cancer patients. Eventually, the project will include agencies from additional countries and it also aims to standardize conducting and reporting of clinical trials for cancer drugs. More information about Project Orbis may be found on the FDA’s website here.

Erleada Approved for Metastatic Castration-Sensitive Prostate Cancer
The Food and Drug Administration (FDA) approved a second indication for Janssen’s Erleada® (apalutamide), on September 17, 2019. Originally FDA approved in February 2018 to treat patients who have castration-resistant prostate cancer that has not spread, the androgen receptor inhibitor now can be taken for treating metastatic castration-sensitive prostate cancer, as well. The recommended dose for both conditions is 240mg (four tablets) taken once a day. For patients who have not had a bilateral orchiectomy (surgical castration), a gonadotropin-releasing hormone (GnRH) analog, such as Zoladex® (goserelin) implants, also should be used. Janssen estimates that the new indication extends the use of Erleada to as many as 40,000 additional patients annually in the U.S. For its full prescribing information, please look here.  

New Indication for Pifeltro and Delstrigo
Two Merck HIV drugs, Pifeltro™ (doravirine) tablets and Delstrigo™ (doravirine/lamivudine/tenofovir disoproxil fumarate) tablets were approved by the FDA on September 19, 2019, for treating certain adults who have HIV-1 that is suppressed by other drug therapy to a viral load of less than 50 copies of HIV-1 RNA per mL. Patients also must have been on a stable regimen of antiretroviral therapy, have had no failures during treatment and have no substitutions that relate to resistance to the ingredients in either drug. Previously, they were approved only for patients new to HIV treatment. Pifeltro is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that must be used along with other HIV drugs, but Delstrigo is a complete therapy that is taken alone. Both are taken once daily. In the clinical trials that led to the approvals, the effectiveness and safety of treatment with Delstrigo or Pifeltro plus other antiretroviral drugs was comparable to that of other antiretroviral regimens after patients switched. Delstrigo’s labeling includes a boxed warning that discontinuing the use of lamivudine or tenofovir disoproxil fumarate can activate hepatitis B virus (HBV) for patients who have or who have had HBV. Patients should be monitored for signs of HBV before, during and for several months after treatment with Delstrigo. Check here for Pifeltro’s revised prescribing information, and here for Delstrigo’s.

 

 
23Sep
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

FDA Approves New Oncology Drug Regimen
On September 17, 2019, the U.S. Food and Drug Administration (FDA) approved the use of Keytruda® (pembrolizumab - Merck) and Lenvima® (lenvatinib - Eisai) together to treat endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). Eligible patients are not appropriate for treatment with radiation or surgery and they have cancer that has progressed despite previous systemic treatment. In a clinical trial of 94 patients, 10 of those treated with the Keytruda/Lenvima combination had complete clearing of their tumors and another 26 had at least some improvement. Responses lasted six months or longer for about 70% of patients who were helped by the drugs. For the new indication, the suggested dose of Keytruda is 200mg infused intravenously (IV) once every three weeks. Two 10mg capsules of Lenvima are taken once every day. Treatment lasts for two years, until the cancer begins to spread or until the patient can no longer tolerate the drugs’ side effects. Keytruda’s revised prescribing information is here; Lenvima’s here

The approval marks the first time that drugs have been reviewed and approved simultaneously in the U.S. and other countries. The Keytruda/Lenvima regimen also was approved in Canada and Australia. Under the FDA Oncology Center of Excellence’s Project Orbis initiative, drug regulatory bodies of each participating nation evaluate applications for the same oncology drugs at the same time – sharing information with the immediate goal to quickly approve therapies for cancer patients. Eventually, the project will include agencies from additional countries and it also aims to standardize conducting and reporting of clinical trials for cancer drugs. More information about Project Orbis may be found on the FDA’s website here.

Erleada Approved for Metastatic Castration-Sensitive Prostate Cancer
The Food and Drug Administration (FDA) approved a second indication for Janssen’s Erleada® (apalutamide), on September 17, 2019. Originally FDA approved in February 2018 to treat patients who have castration-resistant prostate cancer that has not spread, the androgen receptor inhibitor now can be taken for treating metastatic castration-sensitive prostate cancer, as well. The recommended dose for both conditions is 240mg (four tablets) taken once a day. For patients who have not had a bilateral orchiectomy (surgical castration), a gonadotropin-releasing hormone (GnRH) analog, such as Zoladex® (goserelin) implants, also should be used. Janssen estimates that the new indication extends the use of Erleada to as many as 40,000 additional patients annually in the U.S. For its full prescribing information, please look here.  

New Indication for Pifeltro and Delstrigo
Two Merck HIV drugs, Pifeltro™ (doravirine) tablets and Delstrigo™ (doravirine/lamivudine/tenofovir disoproxil fumarate) tablets were approved by the FDA on September 19, 2019, for treating certain adults who have HIV-1 that is suppressed by other drug therapy to a viral load of less than 50 copies of HIV-1 RNA per mL. Patients also must have been on a stable regimen of antiretroviral therapy, have had no failures during treatment and have no substitutions that relate to resistance to the ingredients in either drug. Previously, they were approved only for patients new to HIV treatment. Pifeltro is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that must be used along with other HIV drugs, but Delstrigo is a complete therapy that is taken alone. Both are taken once daily. In the clinical trials that led to the approvals, the effectiveness and safety of treatment with Delstrigo or Pifeltro plus other antiretroviral drugs was comparable to that of other antiretroviral regimens after patients switched. Delstrigo’s labeling includes a boxed warning that discontinuing the use of lamivudine or tenofovir disoproxil fumarate can activate hepatitis B virus (HBV) for patients who have or who have had HBV. Patients should be monitored for signs of HBV before, during and for several months after treatment with Delstrigo. Check here for Pifeltro’s revised prescribing information, and here for Delstrigo’s.

MedWatch Updates
CDK 4/6 Inhibitors 

The Food and Drug Administration (FDA) issued a safety communication for cyclin-dependent kinase (CDK) 4/6 inhibitors on September 13, 2019. It is warning that the drugs – Ibrance® (palbociclib - Pfizer), Kisqali® (ribociclib - Novartis), Kisqali®/Femara® Co-Pack (ribociclib/letrozole - Novartis) and Verzenio® (abemaciclib – Lilly USA) – may cause rare but severe inflammation in the lungs of patients using them. All are taken orally, along with a hormone, to treat some forms of advanced breast cancer. Patients should not stop taking their drugs, however, unless they have been prescribed alternative treatments. Patients who continue using CDK4/6 inhibitors should let their doctors know right away if they have trouble breathing, especially while they are resting. Prescribers should watch patients carefully for any signs of respiratory distress. More information is in patient Medication Guides that are included with each fill of the drugs and also in the FDA’s notice found here.

Raniditine
In a separate alert that also was issued on September 13, 2019, the Food and Drug Administration (FDA) announced that slight amounts of a contaminant, N-nitrosodimethylamine (NDMA), have been detected in samples of ranitidine. NDMA and similar chemicals can cause cancer if consumed in large quantities. An oral histamine-2 (H2) blocker, ranitidine is available both with and without a prescription. Sold under the brand-name, Zantac® (Chattem, a subsidiary of Sanofi-Aventis), and numerous generics, it is widely used to treat gastroesophageal reflux disease (GERD), heartburn and stomach ulcers. Over the last year, several angiotensin receptor blocking (ARB) drugs have been recalled because they contain unacceptably higher amounts of NDMA and chemicals like it than those that have been found in ranitidine, so far. Because the amounts in ranitidine are so small, ranitidine has not been recalled in the U.S. While the FDA continues to investigate, Sandoz, a company that makes it, has stopped distributing the generic. However, any stock currently at stores, pharmacies or wholesalers still can be sold or dispensed. The FDA emphasizes that trace amounts of NDMA naturally are present in foods, tap water and other everyday exposures. Patients who have concerns should discuss changing to another drug in the same class or to a different type of medication with their doctors or pharmacists. Look here for more information about the issue.

Rybelsus Approved to Treat Type 2 Diabetes
On September 20, 20109, Novo Nordisk announced U.S. Food and Drug Administration (FDA) approval for Rybelsus® (semaglutide) oral tablets. It is the first orally-administered glucagon-like peptide (GLP-1) receptor agonist protein for treating adults who have type 2 diabetes. The recommended starting dose is 3 mg/day taken at least 30 minutes before the first food, beverage or other oral medications of the day and with no more than four ounces of plain water. After 30 days, the dose can be increased to 7 mg once daily. The dose may be further increased to the 14 mg tablet once daily if additional glycemic control is needed, but only after at least 30 days on the 7mg daily dose. Launch is planned for early in the fourth quarter of 2019. Complete prescribing information can be found here

 
20Sep
State of Emergency Issued in Texas Due to Severe Flooding

State of Emergency Issued in Texas Due to Severe Flooding

The Governor of Texas has declared a State of Emergency for the following counties due to severe flooding: Brazoria, Chambers, Galveston, Hardin, Harris, Jasper, Jefferson, Liberty, Matagorda, Montgomery, Newton, Orange and San Jacinto.

Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an Emergency Access to Benefits/Refill Too Soon override that allows pharmacies, at the point of sale (POS), to override certain benefit coverage/edits such as an early refill during a government-defined emergency. In addition, if your home delivery of medications is affected by the emergency, you may provide a temporary alternate address (either online at www.express-scripts.com or by calling 1-800-818-6717) or request a local fill as needed.

The Emergency Access to Benefits/Refill Too Soon override process will be implemented with an effective date of September 19, 2019, and expiration date of October 19, 2019.

 
16Sep
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Gvoke Receives Food and Drug Administration Approval
On September 10, 2019, Xeris Pharmaceuticals’ Gvoke™ (glucagon) injection received approval from the U.S. Food and Drug Administration (FDA). It is indicated to treat severe hypoglycemia for patients at least two years old who have diabetes. It will be available in two single-dose subcutaneous (SC) dosage forms – prefilled syringes (Gvoke PFS) and auto-injectors (Gvoke HypoPen™). Each will also be available in two strengths -- 0.5mg/0.1mL for children weighing less than 45Kg (about 100 pounds) and 1mg/0.2mL for heavier children and patients age 12 years and older. Recommended dosing is one injection into the upper arm, lower abdomen or outer thigh as soon as a hypoglycemic event is suspected. Emergency medical help should be called immediately and a second dose of Gvoke may be given if the patient hasn’t recovered within 15 minutes. A carbohydrate, such as chocolate or ice cream, should be given once the patient responds. Unlike other injectable glucagon products, Gvoke does not have to be mixed with sterile water or drawn into a syringe before use. Xeris plans to launch the prefilled syringes by the end of October and the auto-injectors in 2020. Both will be supplied in cartons of one device at a wholesale acquisition cost (WAC) of $280.80 -- or two devices (WAC $561.60). Express Scripts currently is investigating the data around both forms of Gvoke for possible utilization management strategies. They will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete. Prescribing information is here.

Food and Drug Administration Approves Ibsrela
Ibsrela® (tenapanor – Ardelyx) tablets was Food and Drug Administration approved on September 12, 2019. Only slightly absorbed in the gastrointestinal (GI) tract, it blocks sodium/hydrogen exchanger 3 (NHE3) to reduce absorption of sodium and phosphorous in the small intestine and colon. The resulting increase in GI fluid loosens stools, speeds up transit time, promotes bowel movements and lessens abdominal pain for adults who have constipation-dominant irritable bowel syndrome (IBS-C). An estimated 11 million Americans have IBS-C, which causes significant discomfort and loss of productivity. To manage it, the recommended daily dose of Ibsrela is one tablet (50mg) right before breakfast and one tablet right before dinner. Since it may cause possibly severe diarrhea, Ibsrela carries a boxed warning that it should not be used for children. Ardelyx actively is seeking a partner to market it in the U.S. Express Scripts currently is investigating the data Ibsrela for possible utilization management strategies. It also will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete. For its full prescribing information, click here.

New Ofev Indication
A new Food and Drug Administration indication as the first drug to treat systemic sclerosis (scleroderma) associated interstitial lung disease (SSc-ILD) was granted for Ofev® (nintedanib – Boehringer Ingelheim) capsules on September 6, 2019. An autoimmune condition affecting about 100,000 Americans, SSc causes the buildup of fibers and scars in connective tissues. Around one-quarter of patients who have it develop ILD within a few years. As a result, lung function deteriorates, eventually failing completely. In the year-long, phase III SENSCIS® clinical trial of 576 patients who have SSc-ILD, loss of breathing capacity was slowed by 44% for actively treated patients as compared to those using a placebo. Ofev has a previous indication for treating idiopathic pulmonary fibrosis (IPF), another rare and progressive lung disease. For both conditions, the recommended dose is 150mg twice a day with food. Because Ofev may cause liver damage, liver function tests should be conducted prior to initiating treatment and during therapy. To find its complete prescribing information, click here.

Expanded Pediatric Indication for Nucala
The approved age range for GlaxoSmithKline’s Nucala® (mepolizumab) was extended by the Food and Drug Administration on September 12, 2019. Originally approved in November 2015 to be adjunct maintenance treatment of severe eosinophilic asthma for patients at least 12 years of age, it now can be used for children age six years and older. Nucala blocks the action of interleukin-5 (IL-5) to decrease eosinophils, white blood cells that contribute to increased sensitivity of the airways among asthma patients who have an eosinophilic phenotype. For patients between the ages of six years and 12 years, the recommended dose is 40mg once every four weeks. Although the adult dose of Nucala (100mg SC once every four weeks) is available in prefilled syringes and auto-injectors, the 40mg dose has to be administered by a health professional because it currently must be drawn from a 100mg vial. Here is updated prescribing information.

Aczone Gel Indication Extended
Almirall received Food and Drug Administration approval on September 10, 2019, for its topical acne treatment, Aczone® (dapsone) 7.5% gel, to treat children as young as nine years old. Its use originally was limited to patients 12 years of age and older. To treat acne, a small amount of the gel is applied to clean, dry areas of affected skin once a day. Applying it near the eyes and on mucous membranes, such as inside the mouth, should be avoided. Therapy should be evaluated after three months and discontinued if no improvement is seen. Complete prescribing information for Aczone may be found here.

Generic Approved for Amicar Oral Solution
Under a special program, Competitive Generic Therapy (CGT), that accelerates the review of generics for drugs that have “inadequate generic competition”, the Food and Drug Administration approved Amneal Pharmaceuticals’ aminocaproic acid oral solution 0.25g/mL on August 23, 2019. As the first A-rated generic for Amicar® Oral Solution, it will have 180 days of exclusivity before other generics for the liquid dose form can be introduced on the U.S. market. An antifibrinolytic drug, it is used to counteract the effects of other drugs, such as Activase® (alteplase – Genentech), which break down blood clots by blocking the effects of fibrin. However, sometimes they inhibit fibrin too much, resulting in excessive bleeding. Aminocaproic acid helps to restore the fibrin balance and control bleeds. Recommended dosing is four teaspoons in the first hour and then one teaspoon each hour until the bleeding stops – usually within about eight hours. Amneal has not announced launch or pricing plans. IQVIA estimates that U.S. sales for Amicar Oral Solution were $28 million for the fiscal year that ended on June 30, 2019. Both the oral tablet and injectable forms of Amicar already have generics that previously were released in the U.S. 
 

 
9Sep
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

FDA Approval for Orfadin Generic

Novitium Pharma was given U.S. Food and Drug Administration (FDA) approval on Aug. 26, 2019, for nitisinone capsules, an AB-rated generic for Swedish Orphan Biovitrum’s (Sobi’s) Orfadin® (nitisinone) capsules. Used with dietary restrictions, nitisinone prevents the accumulation of tyrosine metabolites for individuals who have hereditary tyrosinemia type 1 (HT-1). Tyrosine is an amino acid that patients with HT-1 cannot break down adequately because they lack the necessary enzyme. Affecting only a few hundred patients, mainly children, HT-1 is a rare and progressive disease that results in potentially fatal kidney, liver and nerve complications if not treated. The generic will be distributed by Par Pharmaceutical, which plans to launch in September 2019. No generics are available for Orfadin Oral Suspension and NITYR™ (nitisinone – Cycle Pharmaceuticals) tablets. According to Sobi, global sales for Orfadin capsules amounted to about $85 million in the most recent four quarters.

New Dosage Form and Expanded Indication for Harvoni and Sovaldi

On August 28, 2019, the U.S. Food and Drug Administration (FDA) approved an oral pellet dosage form for two of Gilead’s hepatitis C (HCV) drugs – Sovaldi® (sofosbuvir) and Harvoni® (ledipasvir/sofosbuvir). The pediatric indications for both were extended to children as young as three years old. For administration, the pellets are mixed with a small amount of a cool, soft, non-acid food, such as ice cream or pudding, and swallowed once a day within one-half hour of being added to the food. Dosing for either drug varies according to the child’s weight. Sovaldi is indicated for children who have genotype 2 or 3 HCV. Children taking Sovaldi also need to take ribavirin. Treatment lasts 12 weeks for children who have genotype 2 HCV, and 24 weeks for children who have type 3. Sovaldi pellets are available in packets of 150mg or 200mg. Harvoni also now comes in two strengths of pellets (ledipasvir 33.75mg/sofosbuvir 150mg and ledipasvir 45mg/sofosbuvir 200mg). It is used for 12 weeks to treat patients at least three years old who have HCV genotype 1, 4, 5, or 6. Some patients who have genotype 1 may need an additional 12 weeks of therapy and some patients may need ribavirin as well. Both have boxed warnings to caution that taking either may worsen or reactivate hepatitis B (HBV), so all patients should have an HBV test before starting therapy and then regular monitoring should be performed during treatment for signs of HBV. Full prescribing information for Sovaldi is available here.  Full prescribing information for Harvoni is available here.

Changes for Addyi

The U.S. Food and Drug Administration (FDA) has approved changes for labeling and dispensing of Addyi® (flibanserin) tablets. First approved in August 2015, it treats acquired, generalized hypoactive sexual desire disorder (HSDD) for premenopausal women. On Sept. 4, 2019, the manufacturer, Sprout Pharmaceuticals issued a press release that Addyi’s boxed warning about the risk of potentially serious low blood pressure when alcohol is used while Addyi is taken has been changed. Its previous directions to stop drinking alcohol while taking Addyi have been modified to drinking no alcohol within two hours of taking Addyi. However, women who have serious liver conditions should not take Addyi at all. Additionally, Addyi can now be prescribed by any healthcare professional licensed to prescribe drugs and it can be dispensed by any pharmacy that carries it. Doctors and pharmacies no longer need certification under its risk evaluation and mitigation strategy (REMS). Recommended dosing is one tablet daily at bedtime. Complete revised prescribing information for Addyi is available here.

 
6Sep
From the CEO

From the CEO

Greetings and Welcome to September 2019! I hope you enjoyed your Labor Day. Traditionally, this holiday marks the end of summer. The warmer season has left and we now are preparing for the cooler fall weather.

Back-to-School

Back-to-school time produces homework for parents – the completion of your child’s standard forms. Most parents must submit immunization records, medication forms, etc. The school may ask for an emergency contact, a sports physical, and/or an authorization form (permission to medically treat your child, if needed). Did you know those with the Foreign Service Benefit Plan (FSBP) can retrieve medical information from the Member Engagement Portal (MEP)? You can print or download medication lists, immunization history, and more through Aetna Navigator.

To access MEP:

  • Log in to Aetna Navigator
  • Look for the Stay Healthy icon
  • Click Discover a Healthier You – you will be directed to MEP
  • Click on Records – access immunizations, medications, etc.
  • Print/download information from the different health categories 

For children with a chronic medical condition such as asthma or diabetes, back-to-school involves even more preparation. Refer to the Medication Adherence Back-to-School Tips from Express Scripts.

Step 2 – Your Biometric Screening

You still can complete Step Two of the Wellness Program – A Biometric Screening – to receive $75 in Wellness Rewards. U.S. members can obtain a Biometric Screening at a Quest Diagnostic Patient Service Center. Register at my.questforhealth.com (registration key - FSBP) to locate a screening center. Or, print a copy of the Biometric Screening Physician Results Form to take to your annual physical exam. Overseas members can choose this option as well. Your results can help you develop a plan and understand your risks. Then, you can decide which FSBP programs are needed to address your individual needs.

To earn the $75 Wellness Reward, you must submit a completed Quest form by December 1. You still have time!  

September Awareness Months

Drug-Free Pain Management Awareness Month – Last month, I wrote about our Pain Management program. However, this important topic warrants repeating. FSBP’s comprehensive program assists you with acute and chronic pain. It offers coaching and support to help you identify non-pharmacologic treatment options. Learn more by calling 800-593-2354. (See page 95 of the 2019 FSBP brochure for details.)

Life Insurance Awareness Month (LIAM) – We celebrate birthdays and anniversaries… September is when we evaluate our life insurance needs. Please ensure your beneficiary information is up to date.

  • Life insurance is important and dependable. Protect your family’s future. Unlike stocks and investments, term life insurance benefits remain unaffected by market fluctuations.
  • Life insurance may be lower than you think. A group plan may cost less than purchasing an individual plan. 
  • Without children, coverage is still important. You have financial responsibilities and don’t want to burden your family with outstanding expenses. 
  • Life changes. Beneficiary designations can change. Outdated contact information may delay a benefit payment.

Let AFSPA help. Learn more at www.afspa.org/life or call 202-833-4910.

CEO Message Archives

My monthly messages are intended to provide current and fluid information about health and wellness. I also share the available FSBP benefits and ancillary programs to address any issues you may have. The messages foster an ongoing dialogue with you that I enjoy. Members have asked for an online library of past CEO Messages. In response, my monthly messages now are archived and available at www.afspa.org/news.


Fall is busy for AFSPA. We finalize the 2020 FSBP brochure and travel for Open Season. Stay informed of what is happening through our website, Facebook, the upcoming Fall newsletter, and our Annual Open Season mailing. Look out for new benefits, at a great 2020 premium! Also, check your mailbox for the 2019 Summer Newsletter.                    

As always, thank you for your loyalty and for giving AFSPA the opportunity to serve you.


To Your Health,
Paula S. Jakub, RHU 
CEO, AFSPA
Executive Director, Senior Living Foundation 

 
5Sep
State of Emergency in Virginia due to Hurricane Dorian

State of Emergency in Virginia due to Hurricane Dorian

The Governor of Virginia has declared a State of Emergency for the following counties due to Hurricane Dorian: Accomack, Chesapeake City, Essex, Gloucester, Hampton City, Isle of Wight, James City, Lancaster, Mathews, Middlesex, Newport News City, Norfolk City, Northampton, Northumberland, Poquoson City, Portsmouth City, Richmond, Richmond City, Suffolk City, Surry, Virginia Beach City, Westmoreland and York.

Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an Emergency Access to Benefits/Refill Too Soon override that allows pharmacies, at the point of sale (POS), to override certain benefit coverage/edits such as an early refill during a government-defined emergency. In addition, if your home delivery of medications is affected by the emergency, you may provide a temporary alternate address (either online at www.express-scripts.com or by calling 1-800-818-6717) or request a local fill as needed.

The Emergency Access to Benefits/Refill Too Soon override process will be implemented with an effective date of August 28, 2019, and expiration date of October 27, 2019.

 
3Sep
International Emergency Due to Hurricane Dorian in Nassau, Bahamas

International Emergency Due to Hurricane Dorian in Nassau, Bahamas

On August 29, 2019, the Department of State approved Ordered [sic] Departure for Embassy staff and their family members from Freeport in The Bahamas through the use of commercially available flights and ferries.

Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an Emergency Access to Benefits/Refill Too Soon override that allows pharmacies, at the point of sale (POS), to override certain benefit coverage/edits such as an early refill during a government-defined emergency. In addition, if your home delivery of medications is affected by the emergency, you may provide a temporary alternate address (either online at www.express-scripts.com or by calling 1-800-818-6717) or request a local fill as needed. The Emergency Access to Benefits/Refill Too Soon override process will be implemented for the attached impacted zip codes with an effective August 28, 2019 and expiration date of October 27, 2019.

 
3Sep
STATE OF EMERGENCY ISSUED IN FLORIDA, GEORGIA, NORTH CAROLINA AND SOUTH CAROLINA DUE TO HURRICANE DORIAN

STATE OF EMERGENCY ISSUED IN FLORIDA, GEORGIA, NORTH CAROLINA AND SOUTH CAROLINA DUE TO HURRICANE DORIAN

The Governors of Florida, Georgia, North Carolina and South Carolina have declared a state of emergency for all counties due to Hurricane Dorian.

Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an Emergency Access to Benefits/Refill Too Soon override that allows pharmacies, at the point of sale (POS), to override certain benefit coverage/edits such as an early refill during a government-defined emergency. In addition, if your home delivery of medications is affected by the emergency, you may provide a temporary alternate address (either online at www.express-scripts.com or by calling 1-800-818-6717) or request a local fill as needed.

The Emergency Access to Benefits/Refill Too Soon override process will be implemented for all the attached zip codes with an effective date of August 28, 2019, and expiration date of Oct 27, 2019.

 
28Aug
State of Emergency Issued in the Commonwealth of Puerto Rico Due to Tropical Storm Dorian

State of Emergency Issued in the Commonwealth of Puerto Rico Due to Tropical Storm Dorian

The Governor of the Commonwealth of Puerto Rico has declared a State of Emergency for all counties due to Tropical Storm Dorian. Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an Emergency Access to Benefits/Refill Too Soon override that allows pharmacies, at the point of sale (POS), to override certain benefit coverage/edits such as an early refill during a government-defined emergency. In addition, if your home delivery of medications is affected by the emergency, you may provide a temporary alternate address (either online at www.express-scripts.com or by calling 1-800-818-6717) or request a local fill as needed.

The Emergency Access to Benefits/Refill Too Soon override process will be implemented with an effective date of Aug. 27, 2019, and expiration date of Sept. 26, 2019.

 
26Aug
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

FDA Approves Xenleta to Treat Community-Acquired Pneumonia

Xenleta™ (lefamulin – Nabriva Therapeutics), the first U.S. Food and Drug Administration (FDA)-approved pleuromutilin, a new class of antibiotics, was given approval on Aug. 19, 2019. Xenleta will be used to treat adults who have community-acquired pneumonia (CAP) caused by bacteria that are proven or believed to be susceptible to a pleuromutilin. The U.S. Centers for Disease Control and Prevention (CDC) estimates that about 40% of the bacteria that cause CAP for approximately 5 million to 6 million American adults annually are at least partially resistant to existing antibacterial drugs. Pleuromutilins work differently than other available antibiotics by blocking two sites bacteria use to manufacture proteins that allow the bacteria to grow. Available in both intravenous (IV) and oral forms, Xenleta is recommended to be used every 12 hours for five to seven days at 150mg administered over one hour for the IV form. Patients who take the oral tablets, or switch to them after starting on an IV, will take one tablet (600mg) once every 12 hours for five days. A mid-September launch is planned at a wholesale acquisition cost (WAC) of approximately $105 per tablet and $140 per 150mg single-dose vial. Full prescribing information is available here.

Extended Pediatric Indications for Asmanex and Dulera

On Aug. 12, 2019, the U.S. Food and Drug Administration (FDA) extended the pediatric indications for Asmanex® HFA (mometasone) and Dulera® (mometasone/formoterol), asthma inhalers that are made by Merck. Both now can be used by children as young as five years old. Asmanex HFA contains a corticosteroid; Dulera adds a long-acting beta2-adrenergic agonist (LABA). Recommended dosing is two sprays of Asmanex HFA 50mcg twice a day to prevent asthma attacks for children between five years old and 12 years old. Patients in the same age range take two inhalations of Dulera 50mcg/5mcg twice daily for maintenance treatment. Neither inhaler is intended to relieve acute asthma attacks. The label for Dulera warns that using LABA drugs, such as formoterol, may increase the chances of asthma-related hospitalizations and other adverse events. Prescribing information for Asmanex HFA is available here. Prescribing information for Dulera is available here.

Generic Launched for EpiPen Jr

Teva Pharmaceutical Industries introduced an AB-rated generic for EpiPen Jr® (epinephrine) Auto-Injector 0.15mg to the U.S. market on Aug. 20, 2019. Indicated for use by children who weigh between 15Kg and 30Kg (about 33 to 66 pounds), it is used for the emergency treatment of allergic reactions, including anaphylaxis. With a wholesale acquisition cost (WAC) of $300/carton, it is dispensed in cartons of two devices that deliver exact amounts of epinephrine. The device is pressed firmly against the outside of the upper thigh to release a dose either intramuscularly (IM) or subcutaneously (SC) through a spring-loaded needle. Teva’s generic for the higher strength EpiPen (0.3mg) launched last November. Other brands, Auvi-Q® (epinephrine auto-injection - Kaléo), and Symjepi™ (Adamis Pharmaceuticals), a prefilled syringe version of self-injected epinephrine, also are available in the U.S., as are authorized generics for both strength auto-injectors. Only Teva’s generics are interchangeable for EpiPens.
 

 
20Aug
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Rozlytrek Approved for Rare Cancers
On Aug. 15, 2019, the U.S. Food and Drug Administration (FDA) approved Rozlytrek™ (entrectinib - Genentech) capsules. It selectively blocks tropomyosin receptor kinases (TRK) A, B and C to treat neurotrophic tyrosine receptor kinase gene fusion-positive (NTRK+) cancers. It is indicated to treat patients who are at least 12 years old and who have solid tumors with NTRK gene fusions, but without known acquired resistance mutation. The tumors also must have metastasized or progressed despite previous treatment. Patients also must risk serious morbidity if the cancer is removed surgically and/or have no other treatment options. Rozlytrek also inhibits the proto-oncogene, ROS1, resulting in its second FDA indication for treating adults who have metastatic ROS1 positive (ROS1+) non-small cell lung cancer (NSCLC). For either indication, recommended adult dosage is 600mg once a day. Doses for pediatric patients range from 400mg to 600mg daily, based on body surface area (BSA). Rozlytrek was launched immediately through a network of specialty pharmacies that includes Accredo with a wholesale acquisition cost (WAC) for an adult dose of about $17,000 a month. Complete prescribing information is available here.

Rinvoq Approved to Treat Rheumatoid Arthritis

The U.S. Food and Drug Administration (FDA) approved AbbVie’s Janus-associated kinase (JAK) inhibitor, Rinvoq™ (upadacitinib) extended-release tablets on Aug. 16, 2019. Indicated to treat adults who have moderate-to-severe rheumatoid arthritis (RA), it will be used after methotrexate has failed to control symptoms or the patient cannot take methotrexate. Recommended dosing is one tablet (15mg) once daily either as monotherapy, along with methotrexate or in combination with other non-biological disease-modifying anti-rheumatic drugs (DMARDs). Rinvoq should not be taken at the same time as biologic DMARDs, immunosuppressants or other JAK inhibitors are being used. A launch is planned for later in August and will be available through a large network of specialty pharmacies that includes Accredo. Complete prescribing information is available here.

New Drug Approved to Treat Narcolepsy

Wakix® (pitolisant – Harmony Biosciences) was approved by the U.S. Food and Drug Administration (FDA) on Aug. 14, 2019. Indicated to treat adults who have excessive daytime sleepiness caused by narcolepsy, it is the first in a new class of drugs known as selective histamine 3 (H?) receptor antagonists/inverse agonists. Although the exact ways that it works are not completely understood, Wakix increases both the production and secretion of histamine, which helps patients stay awake. Wakix will be available as 4.45mg and 17.8mg tablets. The dose should be titrated to the recommended range of 17.8 mg to 35.6 mg taken once daily in the morning upon awakening. It is not a controlled substance that will need to be scheduled by the U.S. Drug Enforcement Administration (DEA) and it does not require a risk evaluation and mitigation strategy (REMS) or Medication Guide. Due to the possibility it can cause liver damage, it should not be used by patients who have serious liver conditions. Launch is planned for the fourth quarter of 2019. It will be available through a limited small network of specialty pharmacies that includes Accredo. Express Scripts currently is investigating the data around Wakix for a possible utilization management strategy. It also will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete. Full prescribing information is available here.

FDA Approves Inrebic to Treat Myelofibrosis

The U.S. Food and Drug Administration (FDA) approved Inrebic® (fedratinib) capsules on Aug. 16, 2019. It selectively inhibits both wild type and mutationally activated Janus-associated kinase 2 (JAK2) for treating adults who have intermediate-2 or high-risk primary or secondary myelofibrosis (MF). One of three similar rare cancers of the blood that all involve over activity of the JAK signaling pathways, MF is caused by mutations in stem cells for blood. With as many as 18,500 patients in the United States, MF usually occurs spontaneously (primary MF), but 10% to 15% of cases have other causes (secondary MF). It is a chronic, incurable condition that develops slowly, so most patients are not diagnosed until they are in their mid-sixties or older. For patients who have it, abnormal cells, fibers and scar tissue accumulate inside bone marrow. Because bone marrow then cannot produce enough normal blood cells, the spleen and liver begin to generate blood cells, which usually causes the organs to enlarge. Symptoms include anemia, fatigue, fever, night sweats and pain below the left ribs. To treat MF, the recommended dose of Inrebic is 400mg (four capsules) taken once daily for patients whose baseline platelet count is 50 X 109 or higher per liter of blood. A boxed warning on the labeling cautions that taking it may be associated with possibly life-threatening encephalopathy. While being treated, patients should be monitored for creatinine and thiamine blood levels, liver function and platelet count. It will be available through a limited large network of specialty pharmacies that includes Accredo. Express Scripts currently is investigating the data around Inrebic for a possible utilization management strategy. It also will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete. Prescribing information is available here.

FDA Approval for Pretomanid

The non-profit group, Global Alliance for TB Drug Development (TB Alliance), received U.S. Food and Drug Administration (FDA) approval for Pretomanid tablets on Aug. 14, 2019. Along with Linezolid and Sirturo® (bedaquiline), it is indicated for the treatment of adult patients who have extensively drug resistant (XDR), treatment-intolerant or nonresponsive multidrug-resistant (MDR) pulmonary tuberculosis (TB). Because TB quickly develops resistance to many available treatment regimens, multiple drugs are used at the same time to treat it. New drugs and new drug combinations also are needed. Although TB is not common in the U.S., the World Health Organization (WHO) estimated that about 10 million cases, resulting in approximately 1.6 million deaths, were diagnosed globally in 2017. Several thousand patients develop XDR-TB and roughly 490,000 have MDR-TB. Pretomanid is the first in the nitroimidazile class of antibiotics, which appears to work against numerous drug-resistant types of TB without causing serious side effects or interactions. Many drug regimens for TB must be used for 12 months or longer. The new combination (abbreviated as BPaL) that includes Pretomanid is indicated for only six months. However, all three drugs should be stopped if the patient experiences jaundice or other symptoms of liver damage Linezolid may need to be reduced or discontinued if anemia or other blood abnormalities indicate the patient may be myelosuppressed or if vision changes might be due to optic nerve injury that it can cause. Both Linezolid and Sirturo may trigger ventricular arrhythmia. Designated as an Orphan Drug, Pretomanid was approved under Priority Review and two other special FDA programs — the Limited Popluation Pathway for Anitbacterial and Antifungal Drugs (LPAD) and the Qualified Infectious Disease Product (QIDP) pathway, which both promote the approval of antibacterial and antifungal drugs to treat serious or life-threatening infections that have limited patient populations. The TB Alliance has licensed distribution of Pretomanid in high-income countries to Mylan, which plans to introduce it to the U.S. market by the end of December. Pricing is not available. Pretomanid’s prescribing information is available here.

Sirturo Approved for Teens

Janssen’s Sirturo was given U.S. Food and Drug Administration (FDA) Accelerated Approval on Aug. 9, 2019, for a new indication to treat patients between the ages of 12 and 18 years old who have MDR pulmonary TB and who weigh 30Kg (66 pounds) or more. Required to be used with at least three other TB drugs, Sirturo is taken as four tablets (400mg) once daily for two weeks and then two tablets (200mg) three times a week for 22 additional weeks. At least 48 hours must be allowed between the 200mg doses. To assure adherence, the drugs should be taken with food and a full glass of water and under the direct supervision of a health professional or caregiver. Heart and liver function should be monitored before beginning treatment and frequently during therapy because Sirturo may cause arrhythmia or liver damage. Further studies are ongoing for its full approval to treat adolescents and for treating younger children, as well. Sirturo will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete. Complete prescribing information is available here.


Eylea Receives FDA Approval for New Dosage Form

On Aug. 13, 2019, the U.S. Food and Drug Administration (FDA) approved single-dose, prefilled syringes for Eylea® (aflibercept - Regeneron) injection. A vascular endothelial growth factor (VEGF) inhibitor, it is injected directly into affected eyes to treat wet age-related macular degeneration (AMD), diabetic retinopathy and macular edema. After a local anesthetic and an anti-infective are applied, it is administered by a specially trained doctor under sterile conditions in a clinic or office. By blocking VEGF receptors, Eylea lessens new blood vessel formation and helps to keep blood from seeping out of leaky vessels. Typically, it is given once every four weeks or once every eight weeks depending on the stage of therapy and the condition being treated. Updated prescribing information is available here.

 
6Aug
Express Scripts News Flash

Express Scripts News Flash

Turalio Approved to Treat Rare Tenosynovial Giant Cell Tumors

On August 2, 2019, the U.S. Food and Drug Administration (FDA) approved Daiichi Sankyo’s colony stimulating factor-1 receptor (CSF-1R) inhibitor, Turalio™ (pexidartinib) capsules. It is the first drug to be FDA indicated for treating adults who have a rare noncancerous joint condition, inoperable tenosynovial giant cell tumor (TGCT), that restricts the patient’s ability to function normally. Recommended dosing is 400mg (two capsules) two times a day at least one hour before or two hours after eating. It will be distributed through an exclusive arrangement with the specialty supplier, Biologics. Accredo will not have access to Turalio. Its possibility of causing liver damage requires a boxed warning and a risk evaluation and mitigation strategy. Complete prescribing information is available here.

  • Brand (Generic) Name: Turalio™ (pexidartinib)
  • Manufacturer: Daiichi Sankyo
  • Date Approved: 2, 2019
  • Indication: to treat adults who have symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery.
  • Dosage Forms Available: 200mg capsules
  • Launch Date: 5, 2019
  • Estimated Annual Cost: The drug will be launched with a wholesale acquisition cost (WAC) of $165 per capsule, or about $240,000 per year of therapy.
  • Specialty Status: Turalio will be added to Express Scripts’ specialty drug list.
  • TGCT causes noncancerous tumors in the tissue of joints and surrounding structures, such as tendons. It does not spread like cancer does, however. With a believed genetic component for some cases, the condition causes the overproduction of colony stimulating factor-1 (CSF-1), which attracts other cells that compose the tumors.
  • At an estimated incidence of 11 cases per million, approximately 2,500 Americans may be affected. This condition is slightly more common for women and diagnosis typically is made in the patient’s 30s or 40s.
  • The two types of TGCT are localized and diffuse. The localized type tends to affect smaller joints, such as the fingers and the wrist. It generally appears as separate lumps that usually can be removed surgically. Tumors of the second type, diffuse TGCT (formerly known as pigmented villonodular synovitis or PVNS), are less defined. They are more common in the knees, harder to remove by surgery and more likely to recur.
  • After 25 weeks in the phase III ENLIVEN Study, tumors for 38% of patients treated with Turalio showed at least partial improvement compared to none of the tumors for participants taking a placebo. Actively treated patients also had greater tumor shrinkage and better movement in the affected joints than the patients taking placebo. Additionally, responses lasted for six months or longer for nearly all who responded to treatment.
  • Turalio will have a boxed warning and a risk evaluation and strategy (REMS) program due to its potential to cause liver damage.
  • Treatment for TGCT currently begins with surgery to remove the tumors, sometimes followed by radiation. Although a number of FDA-approved tyrosine kinase inhibitors (TKI), including imatinib and Tasigna® (nilotinib), have been used to treat TGCT, Turalio is the first drug specifically to be indicated for it.
  • The FDA designated Turalio as a Breakthrough Therapy. It also received Priority Review and Orphan Drug status.
  • Implications: Express Scripts currently is investigating the data around Turalio for a possible utilization management strategy. It also will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete.
 
5Aug
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

New Indication for Keytruda

On July 30, 2019, Merck’s Keytruda® (pembrolizumab) received an additional indication from the U.S. Food and Drug Administration (FDA). Following at least one round of another systemic treatment, it now can be used as a single agent to treat recurrent, locally advanced or metastatic squamous cell esophageal tumors that express human programmed death receptor-1 ligand (PD-L1) and that have progressed. Before treatment begins, PD-L1 status will be verified as a combined positive score of 10 or more by an FDA-approved test. Keytruda, a PD-1-blocking antibody that helps the body’s immune system attack cancer cells, has multiple previous FDA approvals for treating several other kinds of cancer. For its new indication, it will be administered as a 200mg intravenous (IV) infusion once every three weeks for 24 weeks, if the tumors do not progress. Treatment will be stopped earlier if the patient can no longer tolerate the drug or the tumors begin to worsen. Complete revised prescribing information is available here

Extended Approvals for Two Psoriasis Medications

Two topical products made by Leo Pharma have been granted new pediatric indications by the U.S. Food and Drug Administration (FDA). On July 25, 2019, Taclonex® (calcipotriene/betamethasone dipropionate) Topical Suspension got approval to treat plaque psoriasis of the scalp for patients 12 years to 17 years old. A second product, Enstilar® (calcipotriene/betamethasone dipropionate) Foam received a new indication on July 30, 2019, for the treatment of plaque psoriasis for patients at least 12 years old. Previously, both products were approved only for adults age 18 and older. Both contain a vitamin D analog and a corticosteroid, and can be used for psoriasis of the scalp as well as on other areas of the skin. For patients between the ages of 12 years and 17 years, dosing for Taclonex is once daily until psoriasis improves or for up to eight weeks with a limit of 60 grams per week. Enstilar can be applied once a day for four weeks or less, but patients in the 12 to 17 age group should use no more than 60 grams in any four-day period. Neither product should be applied to the face, eyes or mucous membranes, such as the mouth. Prescribing information for Taclonex is available here. Prescribing information for Enstilar is available here

 
5Aug
From the CEO

From the CEO

Greetings and Welcome to August 2019! This means summer is winding down and a new school year is just around the corner. This is a perfect time for parents to ensure their children start the school year healthy by getting an annual physical and recommended vaccinations.

August - National Immunization Awareness Month

Immunizations protect millions of Americans, children and adults. Routine vaccinations prevent the spread of contagious, dangerous, and even deadly diseases. Foreign Service Benefit Plan (FSBP) covers routine and travel immunizations for children and adults at 100% for providers in-network and outside the U.S. Covered adult immunizations include those endorsed by the Centers for Disease Control and Prevention (CDC). This includes the shingles vaccine, Shingrix, approved by the FDA in October 2017. For children, we cover routine childhood and adolescent immunizations. Having your child vaccinated can be important to their long-term health.

August 30 - Opioid Misuse Prevention Day

Opioid addiction remains one of the primary public health crises in the nation. To address this major U.S. epidemic, the American Medical Association (AMA) has set aside August 30, 2019 as Opioid Misuse Prevention Day. The goal is to raise awareness that prescription opioids can be addictive and dangerous. It encourages prevention efforts to combat the opioid crisis. Learn more from the Department of Health and Human Services.

Prescription pain medicines are helpful, when used as directed. Many people suffer from real pain. Last year, nearly 6,000 FSBP members filled almost 13,000 opioid prescriptions for acute and long-term, chronic needs. FSBP offers a pain management program to assist with chronic pain. This comprehensive program offers coaching and support. It also can help you identify non-pharmacologic treatment options to treat your pain. Learn more about this program by calling 800-593-2354. (See page 95 of the 2019 FSBP brochure for details).

Consider Disability Insurance

Many of us have a “rainy day” fund set aside to cover a car repair or to pay to fix a malfunctioning appliance. Few of us have enough money set aside or enough sick days to cover lost wages if an accident or injury renders us unable to work for a substantial period. Disability insurance can help. A disability plan can provide money to cover bills and other immediate expenses while you take the necessary time to recover. AFSPA offers two disability plans to meet the needs of our members worldwide. Depending on the plan you choose, you may be able to receive a lump sum payment after regular monthly payments are exhausted. Or, you may use the regular monthly benefits to cover your inability to work due to maternity – whether it be a routine delivery or with complications (as prescribed by a physician). Learn more at www.afspa.org/disability or call 202-833-4910.


The AFSPA in Action Summer Newsletter should arrive in your mailbox soon. It contains FSBP updates, offers I.T. Summer Safety Tips, and highlights our loyal AFSPA staff. Let us know what you think of the newsletter by emailing [email protected]

I hope you enjoy the rest of your summer. As always, thank you for your trust and for giving AFSPA the opportunity to serve you.

To Your Health,
Paula S. Jakub, RHU 
CEO, AFSPA
Executive Director, Senior Living Foundation 

 
1Aug
Express Scripts News Flash

Express Scripts News Flash

Nubeqa Approved for Prostate Cancer

Under its Priority Review program, the U.S. Food and Drug Administration (FDA) approved Bayer’s Nubeqa® (darolutamide) tablets on July 30, 2019. It is an androgen receptor inhibitor indicated for the treatment of non-metastatic castration-resistant prostate cancer. The recommended dose for Nubeqa is 600mg (two tablets) twice a day. A gonadotropin-releasing hormone (GnRH) analog, such as leuprolide, also should be used for patients who have not had a bilateral orchiectomy (surgical castration). Nubeqa will be available through a large network of specialty pharmacies that includes Accredo. Bayer has not yet announced a launch date. Prescribing information for Nubeqa is available here.

  • Brand (Generic) Name: Nubeqa® (darolutamide)
  • Manufacturer: Bayer
  • Date Approved: July 31, 2019
  • Indication: Treatment of non-metastatic castration-resistant prostate cancer
  • Dosage Forms Available: 300mg tablets
  • Launch Date: Launch date is not known at this time.
  • Estimated Annual Cost: Pricing information is not available at this time.
  • Specialty Status: Nubeqa will be added to Express Scripts’ specialty drug list.
  • According to the American Cancer Society (ACS), about 175,000 cases of prostate cancer are diagnosed in the U.S. annually. Approximately 40% of the estimated 73,000 cases that are castration-resistant have not yet metastasized when they are discovered.
  • In the phase III ARAMIS study, patients taking Nubeqa and using a GnRH analog averaged 40.4 months before the cancer metastasized or the patient died, compared to 18.4 months for patients taking a placebo along with a GnRH analog.
  • Under a priority review program, Nubeqa was approved well ahead of its Oct. 26, 2019, PDUFA date.
  • Nubeqa will be the third androgen receptor inhibitor approved for this indication. Janssen’s Erleada (apalutamide) was the first drug approved in the non-metastatic setting in February 2018. In July of the same year, Astellas/Pfizer’s Xtandi® (enzalutamide) received an expanded indication for patients with non-metastatic castration-resistant prostate cancer.
  • Implications: Express Scripts currently is investigating the data around Nubeqa for a possible utilization management strategy. It also will be evaluated for exclude at launch on the Express Scripts National Preferred Formulary (NPF).
 
30Jul
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

FDA Approval for Second Rituxan Biosimilar

Ruxience™ (rituximab-pvvr), Pfizer’s biosimilar to Rituxan® (rituximab – Celgene), was approved by the U.S. Food and Drug Administration (FDA) on July 23, 2019. It is indicated to treat adults who have non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL) or granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA). A monoclonal antibody, it causes B cells to disintegrate by binding to CD20 proteins on their cell surfaces. Administered as intravenous (IV) infusions, it has to be given by a health professional in a facility equipped to handle emergency treatment of serious side effects that it may cause. A boxed warning lists its potentially fatal adverse effects, including infusion-related reactions, mucocutaneous reactions, progressive multifocal leukoencephalopathy (PML) and reactivation of hepatitis B. Doses vary according to the condition under treatment. Ruxience is not interchangeable with Rituxan or with Rituxan’s other biosimilar, Truxima® (rituximab-abbs – Celltrion/Teva), which was FDA approved in November 2018. Express Scripts currently is investigating the data around Ruxience for a possible utilization management strategy. It also will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete. Launch and pricing information is not yet available for Ruxience, but its full prescribing information is available here.

 

Hadlima, a Biosimilar to Humira, Approved

On July 23, 2019, the U.S. Food and Drug Administration (FDA) approved Hadlima™ (adalimumab-bwwd – Samsung Bioepis), a biosimilar to AbbVie’s Humira® (adalimumab). It is a monoclonal antibody that inhibits tumor necrosis factor (TNF) to reduce inflammation. Its indications are to treat adults who have ankylosing spondylitis (AS), Crohn’s disease, plaque psoriasis, psoriatic arthritis (PsA), rheumatoid arthritis (RA) or ulcerative colitis (UC). Additionally, it is approved for treating children at least four years of age who have polyarticular juvenile idiopathic arthritis (JIA). For most indications, it is given by subcutaneous (SC) injections at maintenance doses of 40mg once every two weeks, after loading doses. A boxed warning on the labels of all TNF blockers outlines the increased risks of cancer and serious infections that may be associated with their use. Prospective patients should be screened for tuberculosis (TB) before starting treatment and periodically while therapy continues. Hadlima is not interchangeable with Humira or with the other Humira biosimilars already FDA approved - Boehringer Ingelheim’s Cyltezo™ (adalimumab – adbm) and Amgen’s Amjevita™ (adalimumab – atto). Under the terms of an agreement with AbbVie, Merck will distribute Hadlima in the U.S. after the end of the second quarter in 2023. Express Scripts currently is investigating the data around Hadlima for a possible utilization management strategy. It also will be excluded at launch on the Express Scripts NPF until our formulary development process is complete. Complete prescribing information is available here.

 

Inhaled Glucagon Approved

Eli Lilly’s new dosage form of glucagon, Baqsimi™ (glucagon) Nasal Powder, 3mg, was U.S. Food and Drug Administration (FDA) approved on July 24. 2019. It will be used to raise dangerously low blood sugar levels (hypoglycemia) for patients four years old and older who have diabetes. Usually considered to be an emergency, hypoglycemia can cause unconsciousness, seizures, coma and death. Although glucagon has been used for decades to treat hypoglycemia, it previously was only available in a powdered form that has to be mixed with sterile water and injected. Expected to be launched within the month, Baqsimi will be dispensed in single-dose inhalation devices. One dose should be given immediately when a hypoglycemic event is suspected. Emergency help should be called and the patient should be given a high sugar drink as soon as possible, followed by a protein-containing food. If the patient is still unconscious 15 minutes after the first dose of Baqsimi, a second one may be used. One device has a wholesale acquisition cost (WAC) of $280.80; a carton of two devices is $561.60. Devices should be kept in their shrink-wrapped tubes until needed. Express Scripts currently is investigating the data around Baqsimi for a possible utilization management strategy. It also will be excluded at launch on the Express Scripts NPF until our formulary development process is complete. Full prescribing information is available here.

 

New Drug Approved to Treat Iron Deficiency

The U.S. Food and Drug Administration (FDA) has approved a new oral treatment for adults who have iron deficiency. On July 25, 2019, Shield Therapeutics was granted approval for Accrufer™ (ferric maltol), which is branded as Feraccru® in Europe. Presently, oral iron products available in the U.S. are derived from iron salts that break apart in the gastrointestinal (GI) system to release the iron. They cause significant side effects such as constipation and nausea for many patients. The alternative, IV iron infusions, must be given in a healthcare facility, making them inconvenient and expensive. Because Accrufer is a non-salt form of iron, it does not cause as much GI disturbance. It is taken as one 30mg capsule twice a day at least one hour before or two hours after eating. Treatment lasts until blood levels of iron are within normal ranges – usually three months or longer. No information about pricing or launch have been made available. Accrufer will be excluded at launch on the Express Scripts NPF until our formulary development process is complete. Accrufer’s prescribing information is available here.

 

Expanded Indication for Otezla

Otezla® (apremilast - Celgene), an oral phosphodiesterase-4 (PDE-4) inhibitor that works inside cells to decrease inflammation, was given a third U.S. Food and Drug Administration (FDA) indication on July 19, 2019. It originally received approvals for psoriatic arthritis and psoriasis in 2014. Now, it is the first drug to be FDA approved for the treatment of mouth sores that are caused by Behçet’s disease. Affecting only about 15,000 to 20,000 patients in the U.S, Behçet’s disease involves inflammation of blood vessels. Usually diagnosed in young adults, it causes recurring sores inside the cheeks and on the lips and tongue. Sores that can look like herpes virus infections or acne also may affect the genital area and the skin. Uveitis (pain and swelling of the eyes) may cause blindness for some patients who have severe forms of the disease. To limit possible diarrhea, nausea and vomiting that it may cause, dosing for Otezla begins at 10mg per day, increased daily to a maintenance dose of 30mg twice a day by the sixth day. Prescribing information is available here.

 
New Dosage Form for Rosuvastatin

After receiving U.S. Food and Drug Administration (FDA) approval on Dec. 18, 2018, Sun Pharmaceuticals released Ezallor Sprinkle™ (rosuvastatin) capsules to the U.S. market on July 15, 2019. It is an HMG-CoA reductase inhibitor that is indicated — along with dietary limitations — to treat primary dysbetalipoproteinemia (type III hyperlipoproteinemia) and hypertriglyceridemia. Either alone or in combination with other drugs that lower cholesterol, it can be used to decrease LDL-C, total cholesterol and ApoB for patients who have homozygous familial hypercholesterolemia. Specifically formulated to treat adult patients who cannot swallow tablets, Ezallor Sprinkle capsules contain extended-release beads of rosuvastatin. Capsules can be swallowed whole or they can be opened, mixed into one teaspoonful of applesauce or another soft, cold food and consumed immediately. Alternately, it can be combined with 40mL of water in a catheter-tipped syringe and given through a nasogastric tube. It is used once a day and is available in 5mg, 10mg, 20mg and 40mg strengths. Express Scripts currently is investigating the data around Ezallor Sprinkle for a possible utilization management strategy. It also will be excluded at launch on the Express Scripts NPF until our formulary development process is complete. Full prescribing information is available  here.

 

Generic Launched for Ery-Tabs

The first generic for Arbor Pharmaceuticals’ Ery-Tabs® has been introduced in the United States by Amneal Pharmaceuticals. It was U.S. Food and Drug Administration (FDA) approved on July 2, 2019, in dose strengths of 250mg, 333mg and 500mg. Amneal’s erythromycin delayed-release tablets is a macrolide antibiotic indicated to treat multiple eye, respiratory, skin, sexually transmitted and urinary infections. For adults, doses of 250mg usually are taken four times a day; 333mg three times a day and 500mg two times a day. For children, doses depend on the child’s age and weight and on the severity of the infection. No more than 4 Gm should be taken by a patient of any age in a single 24-hour period, however. Treatment typically lasts between one week for mild infections and three weeks for severe ones. Although several brands and generics for erythromycin are available, Amneal’s generic is interchangeable only with Ery-Tabs. IQVIA estimated that U.S. sales of Ery-Tabs amounted to approximately $20 million in 2018.


MedWatch Update

Xeljanz/Xeljanz XR

On July 26, 2019, the U.S. Food and Drug Administration (FDA) expanded a Safety Communication it had released in February for Pfizer’s Xeljanz® (tofacitinib) and Xeljanz® XR (tofacitinib extended-release) tablets. Labeling for both drugs now must include a boxed warning that taking 10mg twice a day significantly raises the chance of pulmonary embolisms (blood clots in the lungs) and death. Both drugs already have a boxed warning that taking them can cause lymphoma or other cancers, and that their use has been associated with serious bacterial, fungal and viral infections, including tuberculosis (TB). In preliminary results from a continuing safety study of patients who have rheumatoid arthritis (RA), those taking 10mg of Xeljanz or Xeljanz XR two times a day had more pulmonary embolisms and more of them died for various reasons compared to patients who took two 5mg doses per day. All study participants now are taking only the lower dose. Although the twice-daily 10mg dose has been approved to treat ulcerative colitis (UC), it is not FDA approved for RA or psoriasis. Patients taking the higher dose should get immediate medical help if they suddenly become short of breath, cough up blood, sweat excessively or have other symptoms that might be from pulmonary blood clots. Patients are advised not to stop their Xeljanz or Xeljanz XR, but to talk with their doctors about dose or drug changes. Physicians should be sure that patients are aware of the risks. The twice-daily 10mg dose should be prescribed only for patients who have UC that does not respond to other treatment options and only for as long as needed to resolve the UC episode. For additional information, the FDA notice is available here.

 
23Jul
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Recarbrio Receives FDA Approval

On July 16, 2019, the U.S. Food and Drug Administration (FDA) granted approval for an injectable antibacterial combination drug that includes a new beta lactamase inhibitor. Merck’s Recarbrio™ (imipenem/cilastatin/relebactam) will be used to treat patients who are at least 18 years old and who have complicated infections of the urinary tract or abdomen that are caused by specific types of bacteria. Cilastatin and the new drug, relebactam, do not have antibacterial activity, but they prolong imipenem’s antibiotic effects by keeping it from being attacked by certain enzymes. Recommended dosing is one vial (imipenem 500mg/cilastatin 500mg/relebactam 250mg) given as a 30-minute intravenous (IV) infusion once every six hours for four days to 14 days. To limit possible drug resistance, Recarbrio will be reserved for use by patients who have not responded to or who cannot take other treatments. Merck plans to launch it later in 2019. The FDA approved Recarbrio under its Priority Review program. It also received a Qualified Infectious Disease Product (QIDP) designation, which facilitates approvals for antibacterial and antifungal drugs that treat serious or life-threatening infections. Full prescribing information for Recarbrio is here.

New Dosage Form for AirDuo

Teva Pharmaceuticals’ combination corticosteroid/long-acting beta-adrenergic agonist (LABA) inhaler, AirDuo® (fluticasone/salmeterol) inhalation powder, has been U.S. Food and Drug Administration (FDA) approved for use in a Digihaler™ device. AirDuo is an asthma maintenance treatment for patients who are at least 12 years old. Monitors in the new device communicate with a mobile phone app to track and record data when the inhaler is used. Originally approved in 2017 with a RespiClick® device, AirDuo contains the same active components as Advair® (GlaxoSmithKline), but in different strengths, so it is not interchangeable with Advair. The RespiClick form of AirDuo does have a less expensive authorized generic, however, that can be substituted, but only for the RespiClick version of AirDuo. No authorized generic is available for the Digihaler form. Both AirDuo devices come in three strengths (fluticasone 55mcg/salmeterol 14mcg, fluticasone 113mcg/salmeterol 14mcg and fluticasone 232mcg/salmeterol 14mcg) and either dose form is used two times a day. Launch for the Digihalers is slated for 2020. Express Scripts currently is investigating the data around AirDuo Digihaler for a possible utilization management strategy. It also will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete. Prescribing information for AirDuo Digihaler is available here.

First Avastin and Herceptin Biosimilars Launched in the U.S.

On July 18, 2019, Amgen and Allergan announced the introduction of two previously FDA-approved biosimilars. Each is the first biosimilar released in the U.S. for its originator brand, but neither is interchangeable with the brand or with any other biosimilars. Both are wholesale priced at 15% less than their corresponding brand products.

Mvasi™ (bevacizumab-awwb), a biosimilar to Genentech’s Avastin® (bevacizumab)
Mvasi was approved in September 2017 as combination treatment with chemotherapy (chemo) to treat metastatic colorectal cancer, non-squamous non-small cell lung cancer, glioblastoma and cervical cancer. Along with interferon-alfa, it is indicated for metastatic renal cell carcinoma. It is not approved for three Avastin indications (ovarian, fallopian tube, and primary peritoneal cancers) because they are still protected by Orphan Drug Exclusivity (ODE). Dosing, which varies depending on the indication, ranges from 5mg/kg once every two weeks to 15mg/kg once every three weeks by IV infusion. Wholesale acquisition costs (WAC) for single-use vials of Mvasi are $677.40 for a 100mg vial and $2,709.60 for a 400mg vial. Express Scripts currently is investigating the data around Mvasi for a possible utilization management strategy. It will be excluded at launch on the Express Scripts NPF until our formulary development process is complete. Find its full prescribing information here.

Kanjinti™ (trastuzumab-anns), a biosimilar to Herceptin® (trastuzumab - Genentech)
Kanjinti was FDA approved on June 13, 2019, with the same indications as Herceptin — to treat breast cancer, metastatic gastric cancers and gastroesophageal junction adenocarcinomas that are positive for epidermal growth factor receptor-2 (HER2+). After a loading dose, it is given as an IV infusion at varying doses and on varying schedules according to the cancer being treated. All trastuzumab products have boxed warnings that they may cause birth defects, heart failure, respiratory distress or severe allergic reactions. WAC for Kanjinti is $3,697.26 per 420mg multi-use vial. Express Scripts currently is investigating the data around Kanjinti for a possible utilization management strategy. It will be excluded at launch on the Express Scripts NPF until our formulary development process is complete. Prescribing information is here.

Generics to Lyrica Launched

On July 19, 2019, the U.S. Food and Drug Administration approved the first AB-rated generics to Pfizer’s Lyrica® (pregabalin), a drug approved to treat pain and seizures. Multiple manufacturers received FDA approval to market all eight commercially available capsule strengths: 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg, and 300mg. No company was granted 180 days of generic exclusivity.

 
18Jul
Express Scripts News Flash

Express Scripts News Flash

"Pipeline Update: NASH - Boom or Bust?" Issues Document  Available

Nonalcoholic fatty liver disease (NAFLD) is a widespread, largely asymptomatic condition that results from fat accumulation in the liver. It ranges in severity from essentially harmless simple steatosis (simple fatty liver) to a progressive form, nonalcoholic steatohepatitis (NASH), which damages liver cells and causes inflammation.  NASH can lead to serious liver conditions that include death due to liver failure. Less common than simple steatosis, NASH still is estimated to affect as many as 16 million Americans, including children and teens. However, an invasive diagnostic procedure, limited current treatment options and the delayed availability of outcomes data with pipeline therapies may hinder the uptake of therapies approved to treat NASH, at least initially. This Issues Document summarizes our current thoughts surrounding drugs to treat NAFLD/NASH, a potential blockbuster therapy class. The "Pipeline Update: NASH - Boom or Bust?" Issues Document is available here.

 
16Jul

UPDATE: American Medical Collection Agency (AMCA) Data Security Incident

This is a follow-up to our June 7, 2019 News Feed post concerning the American Medical Collection Agency (AMCA) data security incident. AMCA and Quest Diagnostics have begun to mail notices to individuals whose information was contained on the affected AMCA system.

A dedicated hotline is available for Quest patients to ask questions or learn more information about the AMCA data security incident. The hotline can be reached toll-free at 1-800-491-5304 Monday through Friday from 8:00 a.m. to 5:30 p.m. Central Standard Time. 

For more information, please see the press release issued by Quest Diagnostics at http://newsroom.questdiagnostics.com/press-releases?item=137146.

 
16Jul
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Xembify Approved for Primary Immunodeficiency

Xembify® (immune globulin subcutaneous, human- klhw) was approved by the U.S. Food and Drug Administration (FDA) on July 3, 2019. It is a 20% immune globulin that is injected subcutaneously (SC) through an infusion pump to treat primary immunodeficiency (PI) disorders that include common variable immunodeficiency, congenital agammaglobulinemia, severe combined immunodeficiencies, Wiskott-Aldrich syndrome  and several others. Patients who have a PI usually are at risk for repeated, serious infections. Dosing for Xembify, which may be given weekly or more frequently, depends on the patient’s response to treatment. Once a patient or caregiver is trained in its use, it may be administered at home for patients as young as two years old. Labeling for all immune globulin products includes warnings that they may cause blood clots and kidney damage that could lead to kidney failure. Grifols expects to launch single-dose vials containing 1Gm, 2Gm, 4Gm or 10Gm of Xembify in the fourth quarter of 2019. It will be added to Express Scripts’ specialty drug list. Express Scripts currently is investigating the data around Xembify for a possible utilization management strategy. It also will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete. For its full prescribing information, please go here.


FDA Approves New Dosage Form for Amlodipine

The first commercially available oral liquid form of the calcium channel blocker amlodipine was U.S. Food and Drug Administration (FDA) approved on July 8, 2019. Named Katerzia™ (amlodipine oral suspension - Azurity Pharmaceuticals), it is approved to manage hypertension for patients at least six years old. It has an additional indication for treating adults who have coronary artery disease (CAD), including vasoplastic angina. For pediatric patients and those who are elderly, frail or low weight, the recommended initial dose is 2.5mg (2.5mL) per day, increasing to a maximum of 5mg, if necessary. Adults should be started on 5mg daily, with an upper daily limit of 10mg. Katerzia will be dispensed in bottles containing 150mL of suspension, which should be stored in the refrigerator and shaken well before it is taken. Pricing and launch plans have not been announced. Express Scripts currently is investigating the data around Katerzia for a possible utilization management strategy. It also will be excluded at launch on the Express Scripts NPF until our formulary development process is complete. Check here for its prescribing information.

Ruzurgi Now Available

Ruzurgi (amifampridine – Jacobus Pharmaceuticals), which was approved by the U.S. Food and Drug Administration (FDA) on May 6, 2019, was launched recently. Designated as an orphan drug, Ruzurgi was approved through the FDA’s Fast Track and Priority Review procedures. It is indicated for the treatment of patients between the ages of six years and 17 years who have Lambert-Eaton myasthenic syndrome (LEMS). Diagnosed for only about 400 Americans, LEMS is an autoimmune condition. By damaging voltage-gated calcium channels, LEMS prevents nerves from communicating normally with muscles. It results in fatigue and weakened muscles – especially in the legs. As a potassium channel blocker, Ruzurgi helps to increase calcium concentrations, which improves transmission of nerve signals to muscle cells. Recommended initial dosing for patients who weigh less than 100 pounds is 7.5mg to 15mg per day, gradually increased by 2.5mg to 5mg per day to a maximum daily dose of 50mg divided into up to five doses. For patients weighing 100 pounds or more dosing starts at 15mg to 30mg per day and increases by 5mg to 10mg daily to a maximum daily dose of 100mg divided into up to five doses. Tablets are scored for easy division. Children who have had seizures should not use Ruzurgi. It is exclusively available through PantheRx, a specialty pharmacy. It will be added to Express Scripts’ specialty drug list. Rugurzi’s complete prescribing information is here.

Symjepi Released to Retail Pharmacies

Adamis Pharmaceuticals’ Symjepi™ (epinephrine) injection was U.S. Food and Drug Administration (FDA) approved in June 2017 for the emergency treatment of allergic reactions, including anaphylaxis. The distributor, Sandoz, started introducing it in the U.S. earlier in 2019, beginning with hospitals and clinics. Now, it is available in retail pharmacies. At a wholesale acquisition cost (WAC) of $250 for a package of two, Symjepi is dispensed as single-dose, pre-filled syringes for manual injection. Each syringe contains either 0.3mg/0.3mL of epinephrine (for patients weighing at least 66 pounds) or 0.15mg/0.3mL (for patients who weigh between 33 pounds and 66 pounds). Recommended dosing is one injection, administered intramuscularly (IM) or SC into the thigh. A second injection may be needed, but no more than two should be administered for a single reaction. The patient should receive emergency medical care as well. Syringes should be stored in the original container away from light, used syringes should be discarded in a sharps container and any syringes that contain cloudy, brown or pinkish solution or that have particles in the solution should be returned to the pharmacy for replacement. Its complete prescribing information may be found here.
 

 
11Jul
State of Emergency Issued in Louisiana Due to Potential Tropical Storm Barry

State of Emergency Issued in Louisiana Due to Potential Tropical Storm Barry

The Governor of Louisiana has declared a State of Emergency for all counties due to potential Tropical Storm Barry.

Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an Emergency Access to Benefits/Refill Too Soon override that allows pharmacies, at the point of sale (POS), to override certain benefit coverage/edits such as an early refill during a government-defined emergency. In addition, if your home delivery of medications is affected by the emergency, you may provide a temporary alternate address (either online at www.express-scripts.com or by calling 1-800-818-6717) or request a local fill as needed.

The Emergency Access to Benefits/Refill Too Soon override process will be implemented with an effective date of July 11, 2019, and expiration date of August 11, 2019.

 
9Jul
State of Emergency in California Due to California Earthquake

State of Emergency in California Due to California Earthquake

The Governor of California has declared a State of Emergency for Kern and San Bernardino counties due to the California earthquake.

Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an Emergency Access to Benefits/Refill Too Soon override that allows pharmacies, at the point of sale (POS), to override certain benefit coverage/edits such as an early refill during a government-defined emergency. In addition, if your home delivery of medications is affected by the emergency, you may provide a temporary alternate address (either online at www.express-scripts.com or by calling 1-800-818-6717) or request a local fill as needed.

The Emergency Access to Benefits/Refill Too Soon override process will be implemented with an effective date of July 5, 2019, and expiration date of August 5, 2019.

 
8Jul
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

New Dosage Form Approved for Thiola

Thiola® EC (tiopronin) was approved by the U.S. Food and Drug Administration (FDA) on June 28, 2019, as both 100mg and 300mg delayed-release, enteric-coated tablets. It helps to prevent the formation of cystine kidney stones for patients who have cystinuria. An inherited condition that affects about one American in 7,000 to 10,000, cystinuria is the inability to reabsorb the amino acid, cystine, from food. Symptoms usually develop in the teens or 20s. Cystine crystals deposit in the kidneys and bladder, causing stone formation, blocking urine flow and promoting infections. Thiola EC works by increasing the solubility of cystine. For adults, the recommended daily starting dose is 800mg, with many patients using 1,000mg per day. It also is indicated for children who weigh at least 20Kg (about 45 pounds) at a dose of 15mg/Kg/day and a maximum of 50mg/Kg/day. All therapy should be spread over three doses each day with no restrictions on taking it with food. Immediate-release Thiola currently on the market is available only as 100mg tablets and it must be taken an hour before or two hours after eating, which makes it more difficult to schedule. The patient should continue drinking six to eight full glasses of fluid daily, limiting salt intake and alkalinizing the urine with acetazolamide or potassium citrate. Retrophin expects to launch Thiola EC in July, but no pricing has been made available. Express Scripts currently is investigating the data around Thiola EC for a possible utilization management strategy. Full prescribing information is here.

New Sodium Hyaluronate Product Launched

Teva Pharmaceutical Industries has introduced a new 1% Sodium Hyaluronate to the U.S. market. Also known as hylan, hyaluronan or hyaluronic acid, sodium hyaluronate is a major component of natural synovial fluid, which helps protect joints and keep them flexible. Synthesized sodium hyaluronate derivatives are used after non-drug treatments and pain relievers have failed to reduce pain and stiffness for patients who have osteoarthritis (OA) of the knee. Like similar products, Teva’s sodium hyaluronate is injected intra-articularly (directly into affected knee joints) to help restore lubrication and cushioning. Packaged as three single-use syringes per box, it is given in three weekly injections. Only one knee should be treated at a time. Teva’s product is not a generic, but its effectiveness was comparable to another product already in wide use. It will be added to Express Scripts’ specialty drug list. It also will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete. Prescribing information is available here.

Generics Approved for Uloric

On July 1, 2019, the U.S. Food and Drug Administration (FDA) approved generics for Uloric® (febuxostat – Takeda) from both Alembic Pharmaceuticals and Mylan. Febuxostat is a xanthine oxidase inhibitor that reduces the production of uric acid to help control gout. Available in 40mg and 80mg strength tablets, it is taken once a day. Earlier this year, the FDA required the addition of a boxed warning that patients taking febuxostat had a higher chance of dying from a cardiovascular (CV) problem, such as a heart attack or stroke, than patients taking a different xanthine oxidase inhibitor, allopurinol. Although the relative numbers of non-fatal CV events did not differ significantly between the two groups, the overall risk of death from any reason was increased among those taking febuxostat, as well. Prescribers should consider it only for patients who are unable to use allopurinol. No launch or pricing information presently is available from either generic manufacturer. IQVIA estimated Uloric’s 2018 U.S. market value at $578 million.

Xpovio Approved to Treat Relapsed Multiple Myeloma

The U.S. Food and Drug Administration (FDA) approved Karyopharm Therapeutics’ Xpovio™ (selinexor) tablets on July 3, 2019. To be used in combination with dexamethasone, it is the first in a new class – nuclear export inhibitors. Xpovio works by keeping tumor suppressor proteins (TSP) inside cancer cell nuclei where they cause the cells to disintegrate. It is indicated for adults who have multiple myeloma that has returned despite four or more rounds of treatment with at least two proteasome inhibitors, at least two immunomodulatory agents and one anti-CD38 monoclonal antibody. Although several effective drugs are available to treat multiple myeloma, it develops resistance to many of them, causing relapses. The recommended initial dose of Xpovio is 80mg (four tablets) taken with 20mg of dexamethasone on the first and third days of every week. Launch is planned by July 10, 2019, at an approximate wholesale acquisition cost (WAC) of $22,000 per month. Complete prescribing information is available here.

 
3Jul
Closing early on July 3 & 5- In observance of Independence Day

Closing early on July 3 & 5- In observance of Independence Day

In observance of the Independence Day, AFSPA's phone lines will close at 4:30 pm EDT on Wednesday, July 3rd and Friday, July 5th

Our office will be CLOSED on Thursday, July 4th.

We wish all of our members and their families a safe and fun Independence Day!

 
2Jul
From the CEO

From the CEO

Greetings and Welcome to July 2019! That means summer is in full swing. This warmer season brings picnics, hiking, outdoor sports, and long-awaited vacations. Inevitably, something may occur while traveling that requires a doctor. But how do you address a medical situation when you are away from home? For overseas vacations, you may want to explore Travel Insurance. For medical advice while in the U.S., try using the Foreign Service Benefit Plan’s (FSBP) convenient Telehealth benefit – read more below.

Telehealth

FSBP’s Telehealth benefit is offered through our vendor American Well (Amwell). Their service uses a secure mode of information transmission, between a patient and a medical professional. Telehealth provides 24/7, on-demand, access to health care providers. Patients, physically in the U.S., can connect via phone, mobile, and video.

To learn more or to register:

  1. Download the app by searching for "Amwell" at your mobile device's app store, or
  2. Visit www.Amwell.com or call 844-733-3627.

See page 33 of the 2019 FSBP Brochure for details. Register now to be ready when you need that first visit.

Electronic Funds Transfer (EFT) – Online Enrollment Available Now!

Over 60% of FSBP members receive their payments via EFT. It offers a faster way to get reimbursed for your claims. The payments are deposited directly into your U.S. bank account. Traditionally, enrolling in EFT required printing and mailing a completed EFT/Direct Deposit Authorization Form, with a voided check or bank statement. Our partners at Aetna now have made it simpler to sign up for this convenient service.

Register for EFT online by visiting www.fsbphealth.com. Click on “Member Resources,” and then “Forms Library.” On the “Forms Library” page, click on “EFT/Direct Deposit Authorization form” to complete the fillable form online. Once you “Submit,” your information is sent securely for processing. It is that easy!

Legal Considerations Webinar

In May 2019, AFSPA partnered with the Foreign Service Institute’s Transition Center to present the annual Legal Considerations in the Foreign Service Webinar. Attorneys Jonathan C. Kinney and Lauren Keenan Rote from the law office of Bean, Kinney and Korman, P.C. presented on estate planning including wills, trusts, Powers of Attorney and gifting strategies tailored for foreign affairs employees. Click here to view the recording of this successful webinar.

All members can take advantage of AFSPA’s Legal Services, either stateside or overseas. Four law offices have agreed to assist our members, at preferred rates. Seek legal counsel for estate planning, employment issues, family law, personal injury, and more. For details, click here.

Massage Therapy

July 14 - 20 is Everybody Deserves a Massage Week.  This annual event promotes the benefits of massage – like relieving anxiety, headaches, and bodily injuries. FSBP covers 40 massage therapy visits a year (up to $60, per visit). Our popular massage benefit applies to every covered family member, including children. Visit with any licensed massage therapist – no medical reason required. In addition to your 40 massages annually, FSBP members also receive 40 chiropractic and 40 acupuncture visits. See page 48 of the 2019 FSBP Brochure for details. Start using this year’s 40 massages, before 2019 ends. Click here to learn how to file a massage therapy claim.  

By the way, listen to me on the Federal News Network – For your Benefits show on Monday, July 22 at 10am EST.  I will discuss the 2020 FEHB initiatives, wellness programs, and cost drivers on health care trends. Visit here on July 22 to hear me live.

Have a happy and healthy Independence Day. Many Americans celebrate with fireworks, parades, and picnics; however, we always want to remember the true meaning of the day. The 4th of July represents our nation’s history and heritage. Wherever you are in the world, I hope you take a moment to appreciate the freedoms we have in the United States. Thank you for the work you do to support and protect those freedoms. 

Please enjoy your holiday with friends and family. As always, thank you for your trust and for giving AFSPA the opportunity to serve you.

To Your Health,

Paula S. Jakub, RHU
CEO, AFSPA
Executive Director, Senior Living Foundation

 
1Jul
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Second Biosimilar Approved for Avastin

Pfizer’s Zirabev™ (bevacizumab- bvzr) was U.S. Food and Drug Administration (FDA) approved on June 27, 2019, for treating metastatic or recurring cases of cervical cancer, colorectal cancer, glioblastoma, non-squamous non-small cell lung cancer and renal cell carcinoma. It was not approved for three other Avastin® (bevacizumab – Genentech) indications (ovarian, fallopian tube, and primary peritoneal cancer), because they are protected by Orphan Drug Exclusivity (ODE). It is administered by intravenous (IV) infusion at doses and schedules that differ according to the cancer being treated. Another Avastin biosimilar, Mvasi™ (bevacizumab-awwb – Allergan/Amgen), was FDA approved in September 2017 for the same indications as Zirabev. Although a key Avastin patent expires in July 2019, lawsuits could delay biosimilar launches until 2020 or later. Neither Mvasi nor Zirabev is considered to be a generic and neither is automatically interchangeable with Avastin or each other. According to IMS Health, U.S. sales for Avastin were approximately $3 billion in 2018. It will be evaluated for exclude at launch on the Express Scripts National Preferred Formulary (NPF). Zirabev’s prescribing information is available here.

FDA Approval Extended for Doptelet

Doptelet® (avatrombopag) tablets received a new indication on June 26, 2019. Originally, it was U.S. Food and Drug Administration (FDA) approved in May 2018, only for the short-term, pre-procedure treatment of thrombocytopenia (platelet counts lower than 50,000mcg/Liter of blood) for adult patients with chronic liver disease (CLD) who are scheduled to undergo a procedure. Now it has an additional indication for treating adults who have chronic immune thrombocytopenia (ITP) that is unresponsive to previous treatment. About 60,000 American adults have ITP, an autoimmune condition that increases the risk of bruising and bleeding due to low platelet counts. Doptelet is a thrombopoietin receptor agonist that increases the production of platelets, so taking it may increase the chance of having blood clots. To treat ITP, the recommended initial dose is 20mg once a day with food. Doses and dose schedules can be changed to maintain a more normal platelet count, but no more than 40mg should be taken per day. Revised prescribing information is available here.

Rhinosinusitis Approval for Dupixent

Dupixent® (dupilumab – Regeneron/Sanofi) was approved for a new indication by the U.S. Food and Drug Administration (FDA) on June 26, 2019. It is the first treatment specifically for adult patients who have chronic rhinosinusitis with nasal polyps. As an interleukin-4 alpha receptor (IL-4Rα) and interleukin-13 (IL-13) blocker, it interferes with the inflammatory process. In the clinical studies that led to the new indication, nasal congestion decreased for more than one-half of patients treated with Dupixent as compared to fewer than 20% of patients using a placebo. Nasal polyps were reduced for up to one-third of actively treated study participants. Those using placebo, however, averaged a small (4% to 7%) increase in polyps. Additionally, Dupixent helped to improve lung function for a significant percentage of trial participants who also have asthma, which is common among patients who have rhinosinusitis. All patients continued using a steroid nasal spray during the trials, but around 75% of those using Dupixent no longer needed systemic steroids or nasal surgery to control their rhinosinusitis and polyps. Given by subcutaneous (SC) injection, the recommended dose to treat rhinosinusitis is 300mg once every two weeks. Dupixent also has FDA indications for treating patients age 12 years and older who have resistant eczema, eosinophilic asthma or asthma dependent on oral corticosteroids. Updated prescribing information is available here.

FDA Approves New Indication for Soliris

On June 27, 2019, Alexion Pharmaceuticals received approval from the U.S. Food and Drug Administration (FDA) for Soliris® (eculizumab) to treat patients who have neuromyelitis optica spectrum disorder (NMOSD) that produces antibodies to anti-aquaporin-4 (AQP4). Between 4,000 and 8,000 Americans are estimated to have NMOSD, an autoimmune condition that attacks optic nerves and the spinal cord. It causes eye pain, vision loss, incontinence and paralysis. For many patients, symptoms worsen for unpredictable periods of time and then abate at least partially. In a clinical trial of patients with NMOSD, 98% of the patients using Soliris for 48 weeks did not experience an attack of symptoms, as compared to 63% of patients receiving a placebo. The recommended dose for NMOSD is 900mg (three vials) by IV infusion once a week for four doses, one 1,200mg dose after one more week and then 1,200mg once every two weeks. Soliris also has indications for other rare diseases -- paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS) and generalized myasthenia gravis (gMG). It is available only through a risk evaluation and mitigation strategy (REMS). Its labeling contains a boxed warning about an increased risk of serious meningococcal infections associated with its use. Patients should be vaccinated against meningitis at least two weeks before beginning treatment with Soliris and they should be monitored for signs of meningococcal infections during therapy. Prescribing information is available here.

Darzalex Receives Extended Approval for Multiple Myeloma

Janssen was granted expanded U.S. Food and Drug Administration (FDA) approval for its CD38-directed antibody, Darzalex® (daratumumab) to treat multiple myeloma on June 27, 2019.  In combination with Revlimid® (lenalidomide – Celgene) and dexamethasone, Darzalex now is indicated as first-line treatment for adult patients who have multiple myeloma and who are not candidates for autologous stem cell transplants. After 48 weeks, the Darzalex combination therapy decreased the risk of death or cancer progression by 44% for patients receiving it in a clinical trial -- as compared to patients using Revlimid alone. For use with Revlimid, the recommended dosing schedule for Darzalex is as an IV infusion once a week for eight weeks, once every two weeks for eight additional doses and then once every four weeks until it stops working or the patient can no longer tolerate the side effects. Although infusion rates may vary, the recommended dose for all Darzalex indications is 16mg/Kg of the patient’s body weight given in a healthcare facility staffed and equipped to provide emergency treatment if an infusion reaction occurs. As monotherapy and along with other drugs, Darzalex also has several previous indications as second- or third-line multiple myeloma treatment. Prescribing information is available here.

Updated DrugWatch Document Available

The Emerging Therapeutics department has updated DrugWatch, a document that highlights near-term pipeline drugs as well as potential new generic opportunities. The DrugWatch document is available here.

 
24Jun
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Pediatric Indication for Victoza Approved

On June 17, 2019, the U.S. Food and Drug Administration (FDA) awarded Novo Nordisk’s Victoza® (liraglutide) a new indication. In combination with dietary changes and exercise, it has been available for nearly a decade to improve glycemic control for adults who have type 2 diabetes. Now, it is approved to treat type 2 diabetes for children as young as 10 years old. A glucagon-like peptide-1 (GLP-1) analog, it lowers blood glucose by stimulating insulin release from the pancreas when blood glucose levels are high. Recommended initial dosing for all patients is 0.6mg once a day delivered subcutaneously (SC) through a pre-filled, multi-dose pen-like device. If blood sugar is not controlled adequately after one week, the dose may be increased to 1.2mg/day for at least one week before increasing to a maximum daily dose of 1.8mg. Victoza’s prescribing information included a boxed warning about an increased risk of some types of thyroid tumors. It also warns against its use by patients or close relatives of patients who have medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2). Full prescribing information, which includes a Medication Guide for patients, is available here.

Botox Receives Pediatric Indication

Allergan’s Botox® (onabotulinumtoxinA) was U.S. Food and Drug Administration (FDA) approved on June 20, 2019, to treat patients who are between two years old and 17 years old and who have upper limb spasticity (contractions of the muscles in the hands, wrist and elbow). Cerebral palsy, head injuries, multiple sclerosis (MS), spinal cord injuries or stroke may cause muscle spasms in the limbs. Symptoms may include cramping, pain, shaking or stiffness in the joints of the arms and hands. Botox is a neuromuscular blocker that has been on the market for 30 years. In addition to several cosmetic uses, it has numerous medical indications including bladder dysfunction, blepharospasm (eyelid contractions), cervical dystonia (neck muscle spasms that cause head tilting), chronic migraine, severe axillary hyperhidrosis (excessive underarm sweating) and strabismus (crossed eyes). For treating upper limb spasticity, recommended pediatric dosing depends on the weight of the patient, the affected muscles and the severity of spasticity. Doses are divided into smaller units and injections are given into two or more sites in the affected muscles. For each treatment, doses should not exceed the lesser of six units/Kg or 200 Units. Injections should be given at intervals of at least 12 weeks. All botulinum toxin products, including Botox, carry a boxed warning that they may migrate away from the areas where they are injected and possibly cause widespread side effects, such as serious breathing or swallowing problems. Migration and side effects can happen even several months after the product has been injected. Full prescribing information and a patient Medication Guide for Botox are available here.

FDA Approves New Indication for Dextenza

Dextenza® (dexamethasone ophthalmic insert - Ocular Therapeutix) 0.4mg was approved by the U.S. Food and Drug Administration (FDA) on June 20, 2019, to treat inflammation after ophthalmic surgery, such as cataract removal. Its initial indication, granted last November, is to treat ocular pain related to such procedures. It is placed by the ophthalmic surgeon intracanalicularly — into a small channel in the tear duct. Although the preservative-free insert can be removed if needed, Dextenza is designed to dissolve gradually, releasing dexamethasone for up to 30 days before being cleared from the eye. It replaces corticosteroid eye drops commonly used after eye procedures. Complete prescribing information is available here.

Vertex Gets Pediatric Indication for Symdeko

The U.S. Food and Drug Administration (FDA) announced on June 21, 2019, that — under Priority Review — it has extended the use of Symdeko® (tezacaftor/ivacaftor) to children six years of age and older. First approved in February 2018 as a fixed-dose combination of tezacaftor 100mg/ivacaftor150mg packaged with separate ivacaftor (Kalydeco®) tablets, it was indicated for patients 12 years of age and older. Symdeko treats cystic fibrosis (CF) for patients who either are homozygous for an F508del mutation or who have at least one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that responds to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence. Tezacaftor is a CFTR corrector -- it helps to stabilize CFTR proteins at the correct places for ion channels on cell surfaces. Ivacaftor potentiates CFTR to help keep the ion channels functional, which increases the flow of water and salts into and out of cells. Recommended dosing is one combination tablet in the morning along with a high-fat food and then one ivacaftor tablet about 12 hours later. Additionally, the FDA approved a lower strength combination tablet, tezacaftor 50mg/ivacaftor 75mg that will be used along with a second ivacaftor tablet, 75mg, for patients who weigh 30kg (about 66 pounds) or less. Complete prescribing information is available here.

Sunosi Scheduled

The U.S. Drug Enforcement Agency (DEA) has placed Sunosi™ (solriamfetol – Jazz Pharmaceuticals) into Schedule IV (C-IV) of the Controlled Substances Act. U.S. Food and Drug Administration (FDA) approved in March, Sunosi is the first in its class — dual-acting dopamine and norepinephrine reuptake inhibitors (DNRI). It is indicated to improve wakefulness for adults who have extreme daytime sleepiness related to narcolepsy or obstructive sleep apnea (OSA). A C-IV designation indicates that Sunosi may be misused, but the possibilities of abuse and dependence are small. It will be launched early in July as oral tablets with recommended initial dosing of 75mg/day for narcolepsy and 37.5mg/day for OSA. The maximum dose is 150mg/day. Sunosi will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete. Full prescribing information with a patient Medication Guide is available here.

Vyleesi Approved for Female Sexual Desire Disorder

AMAG Pharmaceuticals received approval from the U.S. Food and Drug Administration (FDA) on June 21, 2019, for Vyleesi™ (bremelanotide). It is a first-in-class melanocortin receptor agonist for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD). It is not intended to treat postmenopausal women or those who have medical or psychiatric conditions, relationship problems or medication use that could interfere with sexual desire. Vyleesi will be available in cartons containing four single-dose auto-injectors to be used on-demand at least 45 minutes in advance of expected sexual activity. Injections should be limited to one in 24 hours and eight per month. Therapy should be re-evaluated if no improvement is seen after eight weeks of treatment. AMAG plans a launch in September through a small network of specialty pharmacies that does not include Accredo. Pricing has not yet been announced. Complete prescribing information is available here.

 
21Jun

Dominion National Data Breach

Notice from Dominion National received today, Friday June 21, 2019: Please read and refer any questions to the Dominion National incident response team at the telephone number bolded below.

On April 24, 2019, through our investigation of an internal alert we received, we determined that an unauthorized party may have obtained access to some of our computer servers. The unauthorized access may have occurred as early as August 25, 2010. After learning of this, Dominion National moved quickly to clean the affected servers and implement enhanced monitoring and alerting software. Dominion National also contacted the FBI and will continue to work with them during their investigation.

Dominion National then undertook a comprehensive review of the data stored or potentially accessible from those computer servers and have determined that the data may include enrollment and demographic information for current and former members of your dental or vision program. The information may include member names, addresses, email addresses, dates of birth, Social Security numbers, member ID numbers, group numbers, and subscriber numbers. We have no evidence that any information was accessed, acquired or misused.

We are in the process of mailing notification letters to potentially affected members. To protect those potentially affected by this incident, Dominion National is offering two-year memberships to ID Experts® MyIDCare™, which include credit monitoring and fraud protection services.

More information about the data security incident, including a copy of the notification Dominion National is providing to potentially affected individuals, can be found on our website, DominionNationalFacts.com. Dominion National has also established a dedicated incident response line for potentially affected individuals to call with any questions they may have. The telephone number for the Dominion National incident response line is 877-503-8923. TTY/TDD users can call 844-261-6819. The incident response line is open Monday through Friday, 8:00 a.m. to 8:00 p.m., Eastern Time.

 
18Jun
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Approval for Slynd, a Progestin-Only Contraceptive

In a press release dated June 6, 2019, Exeltis USA, Inc. announced that the U.S. Food and Drug Administration (FDA) had approved Slynd™ (drospirenone) tablets. FDA approved on May 23, 2019, Slynd is an oral contraceptive that contains only a progestin. Because it does not include estrogen, it is less likely to cause blood clots. Therefore, Slynd may be a safer alternative to contraceptives that contain both estrogen and a progestin for older women, those who smoke and women who are obese. It should not be used by women who have adrenal, kidney or liver diseases because it may raise blood levels of potassium. Exeltis plans a launch in the fall. It will be packaged in cartons of one, three or six 28-day blister cards. Each blister card contains 24 active tablets and four inactive ones. Slynd will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete. Full prescribing information is available here.

Another Herceptin Biosimilar FDA Approved

Kanjinti (trastuzumab-anns – Amgen/Allergan), a biosimilar to Genentech’s Herceptin® (trastuzumab) was U.S. Food and Drug Administration (FDA) approved on June 13, 2019. It is indicated to treat breast cancer, metastatic gastric cancers and gastroesophageal junction adenocarcinomas that are positive for epidermal growth factor receptor-2 (HER2+). Dosing varies according to the condition being treated. All trastuzumab products have boxed warnings that they may cause birth defects, heart failure, respiratory distress or severe allergic reactions. Although its launch and pricing plans have not yet been determined, Kanjinti will compete with four other FDA-approved biosimilars for Herceptin – Herzuma® (trastuzumab-pkrb – Celltrion/Teva), Ogivri® (trastuzumab-dkst – Mylan/Biocon), Ontruzant® (trastuzumab-dttb – Samsung Bioepsis) and Trazimera™ (trastuzumab-qyyp – Pfizer Oncology). None have been launched yet, but at least one could be marketed in the United States before the end of the year. They are not interchangeable with Herceptin, however, or with each other. As estimated by IQVIA, Herceptin’s 2018 sales in the U.S. were around $2.9 billion. Express Scripts currently is investigating the data around Kanjinti for a possible utilization management strategy. It also will be excluded at launch on the Express Scripts NPF until our formulary development process is complete. Full prescribing information is available here.

FDA Expands Approval for Emflaza

A little over two years ago, Emflaza® (deflazacort – PTC Therapeutics) was U.S. Food and Drug Administration (FDA) approved as the only specific treatment of Duchenne muscular dystrophy (DMD) for patients age five and older. The FDA now has extended its use to patients as young as two years old. Emflaza is an oral corticosteroid that decreases both immune and inflammatory activity to relieve symptoms of DMD and also to delay disease progression. It is dosed by weight at 0.9mg/kg/day as either tablets (which can be crushed and mixed with applesauce for administration) or oral suspension. DMD is very rare. Only about 400 to 600 new cases are diagnosed in the United States each year. A condition almost exclusively affecting males, it causes progressive muscle weakening that usually leads to paralysis during the teen years and death in early adulthood. Updated prescribing information is available here.

New Full Indications for Keytruda

On June 10, 2019, Merck’s Keytruda® (pembrolizumab) received full U.S. Food and Drug Administration (FDA) approval for two indications. It is a human programmed death receptor-1 (PD-1)-blocking antibody that helps the body’s immune system attack cancer cells. Keytruda was originally FDA approved in September 2014, for second- or third-line treatment of patients with unresectable or metastatic melanoma. Since then, it has received numerous indications for treating several other types of cancer. Now, it is indicated to be used alone as initial treatment for squamous cell carcinoma of the head and neck (HNSCC) that expresses PD-L1, that is metastatic or recurrent and that cannot be removed surgically. Patients must be tested prior to beginning treatment to verify the presence of PD-L1. The second new indication is independent of PD-L1 status. In combination with fluorouracil (FU) and a platinum-based drug, such as carboplatin, Keytruda can be used as first-line therapy for metastatic, inoperable or recurrent HNSCC. Conversion to full approval from accelerated approval, which was awarded for both indications in 2016, was contingent upon verification of interim results from further clinical testing in the phase III KEYNOTE-048 trial. Keytruda’s recommended dosing for HNSCC is 200mg as a 30-minute intravenous (IV) infusion once every three weeks for up to two years. Revised prescribing information is available here.

Correction
In the June 7, 2019, News and Notes, the dosage for Emgality® (galcanezumab-gnlm) was incorrect. To treat episodic cluster headaches, the actual dose is 300mg (three 100mg injections) at the start of the headache cluster and then an additional 300mg (not 100mg as was stated) once a month until the cluster ends. Apologies for the error

 
12Jun
Express Scripts News Flash

Express Scripts News Flash

Polivy Approved to Treat Diffuse Large B-Cell Lymphoma
Polivy™ (polatuzumab vedotin-piiq), an antibody-drug conjugate immunotherapy from Genentech, received approval from the U.S. Food and Drug Administration on June 10, 2019. To be used as part of a regimen that also includes the chemotherapy (chemo) drugs bendamustine and Rituxan® (rituximab – Genentech/Biogen), it will be used to treat diffuse large B-cell lymphoma (DLBCL) that has recurred or become resistant to therapy for adult patients who have been treated with two or more prior therapies. Polivy sticks to CD79b, a protein released only by B-cells, and its drug component causes the B-cells to disintegrate. Recommended dosing depends on the patient’s weight – 1.8mg/kg infused once every 21 days for six cycles given as an intravenous (IV) infusion. It will be available through open distribution. Complete prescribing information is available here.

  • Brand (Generic) Name: Polivy™ (polatuzumab vedotin-piiq) 
  • Manufacturer: Genentech
  • Date Approved: June 10, 2019
  • Indication: for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, after at least two prior therapies
  • Dosage Forms Available: single-dose vials containing 140mg of Polivy for intravenous (IV) infusion after reconstitution and dilution
  • Launch Date: mid-June 2019
  • Estimated Annual Cost: Pricing information is not yet available.
  • Specialty Status: Polivy will be added to Express Scripts’ specialty drug list.
  • The most common type of non-Hodgkin lymphoma (NHL), DLBCL is expected to be diagnosed for around 22,000 Americans this year. Conventional chemo and stem cell transplants cure many cases, but up to 40% of patients have relapses.
  • Polivy is the first FDA-approved drug that specifically binds CD79b.
  • Its effectiveness was studied in a phase Ib/II clinical trial that included 80 patients. Compared to 18% of patients who were treated only with bendamustine and Rituxan, 40% of patients receiving the triple-drug regimen had a complete response. The overall survival rate averaged 12.4 months for patients using all three drugs versus 4.7 months for those receiving the chemo drugs alone.
  • Several chemo regimens are used to treat relapsed or refractory DLBCL. Appropriate patients also may receive a stem cell transplant after intensive chemo. Additionally, two chimeric antigenreceptor T-cell (CAR-T) therapies, Yescarta® (axicabtagene ciloleucel - Kite Pharma) and Kymriah™ (tisagenlecleucel - Novartis), also are FDA-approved for previously treated DLBCL.
  • The FDA approved Polivy under its Accelerated Approval, Breakthrough Therapy and Priority Review pathways. It also has Orphan Drug status for the treatment of DLBCL. Further clinical study confirming effectiveness and safety will be required before the FDA grants it full approval.

Implications: Express Scripts currently is investigating the data around Polivy for a possible utilization management strategy. It also will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete.

 
10Jun
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

FDA Expands Approval for Zerbaxa

Zerbaxa® (ceftolozane/tazobactam – Merck) was given an additional approval by the U.S. Food and Drug Administration (FDA) on June 3, 2019. The fixed-dose combination of a cephalosporin and a beta lactam inhibitor now is indicated for treating adult patients who have hospital-acquired or ventilator-associated pneumonia caused by susceptible bacteria. As many as 1% of all hospitalized patients develop pneumonia 48 hours or longer either after admission or after needing breathing assistance from a mechanical ventilator. Very difficult to treat, pneumonias acquired in the hospital can prolong in-patient treatment by a week or longer. Zerbaxa is administered as one-hour-long intravenous (IV) infusions. To treat hospital-acquired or ventilator-associated pneumonia, the dose is three grams once every eight hours for eight days to 14 days. The new indication was granted under Priority Review through the FDA’s Qualified Infectious Disease Product (QIDP) program, which prioritizes antibacterial and antifungal drugs that treat serious or life-threatening infections. Prescribing information is available here.


New Indication for Emgality

Eli Lilly’s Emgality® (galcanezumab-gnlm) received a new indication -- to treat adults who have episodic cluster headaches – from the U.S. Food and Drug Administration (FDA) on June 4, 2019. Initially approved in September 2018 to prevent migraine headaches, Emgality belongs to a class known as calcitonin gene-related peptide (CGRP) inhibitors. CGRP is a neuropeptide that promotes vascular changes, inflammation and pain transmission. Blocking it helps prevent or lessen the vasoconstriction that often triggers headaches. In contrast to migraines, cluster headaches occur multiple times a day for relatively short periods (usually lasting for 15 minutes to three hours). Frequently beginning with sudden intense pain that wakes up the patient, they recur daily -- typically for cycles (episodes) that last between three weeks and 12 weeks, but possibly persist for up to a year, and then disappear (remit) for various amounts of time. Chronic cluster headaches do not remit. About 25,000 U.S. patients experience the episodic cluster form, many in roughly predictable cycles. In a clinical trial comparing Emgality to placebo, 71.4% of patients using Emgality had one-half or fewer weekly headache attacks versus 52.6% of patients using the placebo. Patients in both groups averaged about 17.5 weekly attacks at the beginning of the study. At week three, the number was reduced by an average of 8.7 attacks in the actively treated patients and by 5.2 in the group using placebo. Given by subcutaneous (SC) injections, Emgality currently is available as 120mg self-injectors and 100mg and 120mg prefilled syringes. For treating episodic cluster headaches, the dose is 300mg (three successive 100mg injections at the same time) at the start of the cluster cycle and then 100mg once each month until the cycle ends. Emgality’s full prescribing information is available here.

Self-Injectors Approved for Nucala

On June 6, 2019, the U.S. Food and Drug Administration (FDA) approved two new dosage forms for Nucala® (mepolizumab – GlaxoSmithKline). Nucala is a humanized interleukin-5 (IL-5) antagonist monoclonal antibody indicated as adjunct maintenance for treating patients at least 12 years old who have severe eosinophilic asthma. It also is approved for adults who have the rare condition, eosinophilic granulomatosis with polyangiitis (EGPA). Given as a monthly SC injection, it previously had to be administered by a health professional in a healthcare setting. The new forms, prefilled syringes and prefilled auto-injectors, each containing 100mg of Nucala, will allow for at-home dosing by the patient or a caregiver. An exact release date is unclear, but GlaxoSmithKline believes the new dose forms will be available soon. The new formulations of Nuclala will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete. Prescribing information is available here.

 
7Jun

American Medical Collection Agency (AMCA) Breach

American Medical Collection Agency (AMCA), a third-party collections group that works with a number of health care entities in the U.S., revealed earlier this week that it had experienced a data breach of its customer payment site. To date, it is known that as many as 19.6 million records may have been affected due to AMCA’s relationships with Quest Diagnostics and LabCorp. The information accessed by unauthorized entities varies, but it may include name, address, date of birth, Social Security Number, financial information, and medical information. Both LabCorp and Quest have confirmed that no test results were compromised.

AMCA continues to investigate the incident and has released little information at this time. Once more information is available, AFSPA will make it available to our members. Please look for updates on our Facebook page and website.  

 
5Jun
From the CEO

From the CEO

Welcome to Summer 2019! By now, you should have received your Spring AFSPA in Action Newsletter in your mailbox. For Foreign Service Benefit Plan (FSBP) members, it highlights your online Member Engagement tools. Plus, you can learn tips and advice directly from AFSPA staff. The AFSPA Listens column answers our most-asked member questions. Lastly, this newsletter officially begins our year-long celebration of AFSPA’s 90th Anniversary. Please read your Spring Newsletter, as many of the topics address your common concerns.

FSBP’s 24/7 Nurse Advice Line

I want to focus on a somewhat underutilized FSBP benefit – the 24-Hour Nurse Advice Line. Whether you live in the U.S. or overseas, our Health Plan members can speak live to a registered nurse about any medical topic or health concern. As of this year, only a small percentage of members have taken advantage of this 24/7 service. Those who did call in 2019 have asked for advice on visiting an Emergency Room versus an Urgent Care Center. And, several others received self-care guidance and medication information. Some nurses even called to follow-up with members, when the nurse deemed it necessary. This help line allows you to clarify your doctor’s instructions or seek medical advice in the middle of the night. Utilize this FSBP benefit any time by calling 855-482-5750 or 704-834-6782. TDD services are available for the hearing and speech impaired. We also translate foreign languages, if needed.

June is Men’s Health Month

Men’s Health Month heightens the awareness of preventable health problems among men and boys. It encourages early detection and treatment of diseases that affect males.  According to the Center for Disease Control and Prevention:

  • Women are more likely to visit a doctor for annual exams and preventive services than men.
  • For 9 of the top 10 causes of death, men die at higher rates than women.
  • In 1920, women lived an average of one year longer than men. Now men die almost five years earlier than women.
  • Depression in men often goes undiagnosed. Men are 4x more likely to commit suicide than women.

I encourage men to get a routine physical exam and appropriate screenings (colorectal cancer, prostate cancer, etc.). FSBP pays 100% for preventive care when providers are in-network or outside the U.S. If you need help coping with stress, consider using FSBP’s many support programs. Health Coaching, myStrength™ online mental health support, AbleTo online treatment support, and Telehealth Consultations are all available to you at no cost.

Travel Insurance

Summertime usually means visiting family or taking a much-needed vacation. If you are traveling this season, or if family is visiting you, internationally or domestically, consider purchasing travel insurance. An article on page 2 of the 2019 Spring Newsletter shares helpful travel tips and information on AFSPA’s Travel Insurance.

Our plan offers:

  • Referrals to physicians and hospitals
  • Payment of medical claims
  • Emergency evacuation and more

AFSPA’s Travel Insurance can be important for family members visiting you overseas, if their health insurance does not cover services outside the U.S. (like Medicare).

I hope you and your family enjoy a safe, healthy, and fun-filled summer. We will do our part in delivering the level of service you expect. As always, thank you for your trust and for giving AFSPA the opportunity to serve you.

To Your Health,
Paula S. Jakub, RHU
CEO, AFSPA
Executive Director, Senior Living Foundation

 
4Jun
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Extended FDA Approval for Jakafi

On May 24, 2019, the U.S. Food and Drug Administration (FDA) granted approval to Jakafi® (ruxolitinib – Incyte Corp.) tablets for treating acute graft-versus-host disease (aGvHD). It is the first drug indicated to treat patients who are at least 12 years old and who have aGvHD that has not responded to treatment with corticosteroids. Between 35% and 50% of patients who receive a stem cell transplant from a donor develop the potentially life-threatening condition in which immune cells in the donated tissue (the graft) attack organs and tissues of the transplant recipient (the host). Approximately one-half of patients who have aGvHD do not respond to standard treatment with immunosuppression and a corticosteroid, such as methylprednisolone. Acute steroid-resistant aGvHD has a one-year survival rate of only about 30%. To treat it, 5mg of Jakafi will be taken twice daily. A Janus Associated Kinase (JAK) inhibitor that specifically targets JAK1 and JAK2 receptors involved in regulating blood and immune function, it has previous approvals for myelofibrosis and polycythemia vera (rare blood cancers that involve overactivity of JAK signaling pathways). The new indication was approved with both Breakthrough Therapy and Priority Review designations. Jakafi also is an orphan drug for treating aGvHD. Revised prescribing information is available here.


Vraylar Gains New Indication

On May 28, 2019, Allergan and Geodon Richter were given U.S. Food and Drug Administration (FDA) approval for Vraylar® (cariprazine) to treat adults who have depressive episodes associated with bipolar I disorder. An atypical antipsychotic drug, Vraylar now is FDA approved to treat all phases (depressive, manic and mixed) of bipolar I disorder. It also has an indication for schizophrenia. For the new indication, recommended dosing is either 1.5mg or 3mg per day. All atypical antipsychotics carry a boxed warning against using them for elderly or pediatric/adolescent/young adult patients. They may increase the risk of death for older patients and promote suicidal feelings or actions for younger patients. Full prescribing information is available here

New Indication for Revlimid

Celgene’s Revlimid® (lenalidomide) capsules were U.S. Food and Drug Administration (FDA) approved on May 28, 2019, for the treatment of two indolent (slowly progressing) non-Hodgkin’s lymphomas, which together represent about 30% of U.S. lymphoma cases. Along with Rituxan® (rituximab – Genentech), it is indicated to treat adult patients who have follicular lymphoma (FL) or marginal zone lymphoma (MZL) that no longer responds to chemotherapy (chemo) or that recurs after chemo. The treatment protocol is on 28-day cycles that include 20mg of Revlimid once a day for the first 21 days of each cycle and 375mg/m2 of Rituxan once a week for the first cycle followed by once a month for the rest of therapy. Treatments continue for up to 12 cycles if the patient can tolerate it. In the pivotal clinical trial, average progression-free survival (PFS) was nearly three times as long for patients treated with the two-drug combination versus patients receiving Rituxan and a placebo (39.4 months versus 14.1 months). Revlimid also is indicated as monotherapy for mantle cell lymphoma and transfusion-dependent anemia. In combination with dexamethasone, it treats multiple myeloma. However, it has significant risks of causing severe side effects, including blood cell abnormalities and deformity or death of a fetus. Therefore, it is available only through limited distribution under a risk evaluation and mitigation strategy (REMS). Revlimid’s updated prescribing information is available here.

Eagle Pharmaceuticals Renames Its Generic Bendamustine

Eagle Pharmaceuticals received U.S. Food and Drug Administration (FDA) approval in May 2018 under a new drug application (NDA) for a new formulation of bendamustine. Subsequently, the new product was marketed under the generic-looking name of bendamustine. Starting on June 3, 2019, however, it will be known as Belrapzo™ (bendamustine hydrochloride injection). It is FDA approved to treat chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with Rituxan® (rituximab) or a rituximab-containing regimen. No announcement has been made about any possible pricing changes. A unique J-code will be used for it beginning on July 1, 2019. Full prescribing information is available here.

 
3Jun
State of Emergency Issued in Oklahoma Due to Flooding

State of Emergency Issued in Oklahoma Due to Flooding

The Governor of Oklahoma has issued a State of Emergency for all counties due to flooding.  

Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an Emergency Access to Benefits/Refill Too Soon override that allows pharmacies, at the point of sale (POS), to override certain benefit coverage/edits such as an early refill during a government-defined emergency. In addition, if your home delivery of medications is affected by the emergency, you may provide a temporary alternate address (either online at www.express-scripts.com or by calling 1-800-818-6717) or request a local fill as needed.

The Emergency Access to Benefits/Refill Too Soon override process will be implemented with an effective date of May 24th , 2019, and expiration date of June 24th, 2019.

 

 
28May
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Cutaquig Subcutaneous Immune Globulin for Immune Deficiency Launched

Although Octapharma’s Cutaquig® (immune globulin subcutaneous [human] - hipp), 16.5% solution was approved by the U.S. Food and Drug Administration (FDA) in December 2018, it was recently launched. It is indicated to treat primary immunodeficiency diseases, a group of inherited conditions that involves a partial or nonfunctioning immune system. Patients who have the disorders are particularly prone to having serious, chronic and/or recurrent infections. Cutaquig is administered subcutaneously (SC) on a weekly basis to replace immunoglobulin (IG). Doses of Cutaquig depend on the patient’s blood levels IG. A boxed warning that IG can cause blood clots is required on the labeling of all IG products.  Full prescribing information for Cutaquig is available here.


FDA Approves Midazolam Nasal Spray

Nayzilam® (midazolam) nasal spray, a new dosage form for the C-IV benzodiazepine, was FDA approved on May 17, 2019. It is indicated for use as an acute treatment for patients age 12 years and older who have epilepsy and who experience seizure clusters and/or acute repetitive seizures that are different from their usual seizure patterns. The single-dose spray devices, which contain 5mg of midazolam, are intended for immediate use by caregivers when the unusual seizures start. If a second dose is needed, it should be given in the other nostril about 10 minutes after the first spray. No more than two doses should be used for any one episode, and no more than five seizure clusters should be treated with it in any one month. Nayzilam should not be given more often than every three days. It will be dispensed in packages of two sprayers with a Medication Guide and clear instructions for administration. Presently, midazolam is available only in oral syrup and injectable forms. All midazolam products have a boxed warning cautioning about concurrent use with opioids, which increases the risks of respiratory depression, sedation and death. It is also contraindicated for use in patients who have narrow-angle glaucoma. The manufacturer, UCB, has not announced its plans for pricing or launch. Express Scripts currently is investigating the data around Nayzilam for a possible utilization management strategy. It will be excluded at launch on the Express Scripts National Preferred Formulary until our formulary development process is complete. For prescribing information is available here.

Sorilux Approved for Adolescent Psoriasis

Mayne Pharma Group has announced that on May 6, 2019, the FDA approved its 0.005% calcipotriene foam product, Sorilux®, to treat plaque psoriasis for patients between 12 years and 18 years of age. First approved in 2010, Sorilux previously was indicated only for patients at least 18 years old. According to the National Psoriasis Foundation, approximately 8 million patients in the U.S. have psoriasis, with many patients initially diagnosed between 15 years and 25 years of age. Calcipotriene is a vitamin D analog that is believed to decrease the production of psoriasis cells. Directions are to rub a thin layer of the foam into areas of affected skin twice a day, avoiding the face and mucous membranes. Sorilux should not be used around open flames or people who are smoking because the propellant it uses is flammable. Complete prescribing information is available here.

Zolgensma Approved for Spinal Muscular Atrophy

On May 24, 2019, the FDA approved Zolgensma® (onasemnogene abeparvovec-xioi – AveXis). It is a gene therapy that contains a normal copy of the human survival motor neuron 1 (SMN1) gene for patients who have spinal muscular atrophy (SMA) due to bi-allelic mutations in the SMN1 gene. At a dose determined by the patient’s weight, it will be given as one 60-minute intravenous (IV) infusion. A boxed warning on its labeling cautions that Zolgensma may cause damage the liver, so liver function must be monitored before and for three months or longer after treatment. It will be available through a small network of specialty pharmacies that includes Accredo. CuraScript Specialty Distribution will be the sole specialty distributor under a drop ship model. Prescribing information is available here.

Piqray Approved to Treat Certain Breast Cancers

The FDA approved Piqray® (alpelisib – Novartis) on May 24, 2019. To be used along with AstraZeneca’s Faslodex® (fulvestrant), Piqray is a kinase inhibitor indicated to treat patients who have advanced or metastatic hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer that has mutations in phosphoinositide 3-kinase C (PI3KC). The two-drug combination will be second-line therapy when endocrine-based therapy is failing. Piqray’s recommended dose is 300mg (two 150mg tablets) once a day along with Faslodex 500mg intramuscularly (IM) on the first day of each 28-day cycle after one injection each on days 1 and 15 of the first cycle. Qiagen’s therascreen® PIK3CA RGQ PCR companion diagnostic test was approved by the FDA at the same time. Novartis plans an early June launch through open distribution. Full prescribing information for Piqray is available here.

Updated Biosimilar Issues Document Available

The Emerging Therapeutics department has updated the Biosimilars Issues Document to include FDA's revised guidance documents. In 2019, FDA has issued updated draft guidance regarding the naming of biologics, final guidance regarding biosimilar interchangeability and draft guidance regarding quality considerations for developing biosimilars. The Biosimilars Issues Document is available here.

 
24May

AFSPA is closed in observance of the holiday

AFSPA will close at 3:30 PM ET on Friday, May 24, 2019 in observance of the holiday. We will resume our normal business hours at 8:30 AM ET on Tuesday, May 28, 2019.

We wish all of our members and their families a Happy Holiday.

 
21May
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Cyramza Gains New Indication

Eli Lilly’s Cyramza® (ramucirumab) was given an additional U.S. Food and Drug Administration (FDA) approval on May 10, 2019. Its new indication is as monotherapy for patients who have hepatocellular carcinoma (HCC), who have alpha-fetoprotein (AFP) levels of 400ng/mL or higher and who already have been treated with Nexavar® (sorafenib – Bayer HealthCare). Produced by HCC, AFP is a biological marker that can identify patients appropriate for treatment with Cyramza and also track its effectiveness in restricting disease progression. The American Cancer Society estimates about 42,000 new cases of liver cancer will be diagnosed in the U.S. this year. AFP is high for roughly 40% of patients who have advanced HCC, and they have few treatment options. Cyramza is a targeted therapy that inhibits vascular endothelial growth factor receptor 2 (VEGFR2). It works by blocking the formation of new blood vessels, which are needed for tumor growth and survival. To treat HCC, the recommended dose is 8mg/kg once every two weeks as a one-hour intravenous (IV) infusion. In addition to the new indication, the FDA is allowing Lilly to remove a previously required boxed warning about possibly increased risks of hemorrhaging, gastrointestinal (GI) perforation and reduced wound healing for patients receiving Cyramza. Full prescribing information is available here.

Expanded Indication for Xeomin

On May 10, 2019, Xeomin® (incobotulinumtoxinA – Merz Pharmaceuticals) was approved by the U.S. Food and Drug Administration (FDA) as initial treatment for blepharospasm in adult patients. Unintended blinking, also known as blepharospasm, occurs when muscles around the eyes tighten uncontrollably. It is associated with dry or watering eyes, irritation and light intolerance. Xeomin’s other indications are second-line therapy for blepharospasm, and first line for cervical dystonia, chronic sialorrhea and upper limb spasticity. It also has a cosmetic use for temporary smoothing of glabellar lines (frown lines between the eyebrows). For the treatment of blepharospasm, a total of 25 units will be injected into six separate sites around each eye and eyelid. Treatments must be separated by at least three months. All botulinum toxin products carry a boxed warning that they may migrate away from the areas where they are injected and possibly cause widespread side effects, rarely including serious breathing or swallowing problems. Migration and side effects can happen even several months after the product has been injected. A Medication Guide outlining potential risks of Xeomin is provided for patients. Complete prescribing information is available here.

Eylea Approval for Diabetic Retinopathy Expanded

Eylea® (aflibercept - Regeneron) injection was U.S. Food and Drug Administration (FDA) approved on May 13, 2019, to treat all stages of diabetic retinopathy (DR). Previously, it was approved to treat DR only for patients who also have diabetic macular edema (DME). Approximately 4.2 million Americans over 40 years of age have the condition, according to the Centers for Disease Control and Prevention. More that 650,000 of them are at risk of losing their sight. Eylea is a vascular endothelial growth factor (VEGF) inhibitor that is injected directly into affected eyes. After a local anesthetic and an anti-infective are applied, Eylea is administered by a specially trained doctor under sterile conditions in a clinic or office. By blocking VEGF receptors, Eylea lessens new blood vessel formation and helps to keep blood from seeping out of leaky vessels. It has additional indications for wet age-related macular degeneration (AMD) and macular edema. To treat DR, injections are administered once every four weeks for the first five injections, followed by one injection every eight weeks. Full prescribing information is available here.

Bavencio and Inlyta Combination Indicated to Treat Kidney Cancer

U.S. Food and Drug Administration (FDA) approval was granted on May 14, 2019, to EMD Serono (a division of Merck) and Pfizer for combination use of their drugs, Bavencio® (avelumab) injection and Inlyta® (axitinib) tablets, as first-line therapy to treat advanced renal cell carcinoma (RCC). Around 74,000 new cases of kidney cancer will be diagnosed in the U.S. this year, with the majority being RCC. An estimated 20% to 30% of new RCC will not be discovered until it is in advanced stages, which have an average five-year survival rate of 12%. Bavencio, a human programmed death receptor-1 (PD-1)-blocking antibody, enhances the immune system’s ability to destroy cancer cells. It has additional approvals as monotherapy to treat metastatic Merkel cell carcinoma (MCC) and metastatic urothelial (bladder) carcinoma (UC). For RCC, recommended dosing is an 800mg IV infusion once every two weeks. Previously indicated only as second-line therapy for RCC, Inlyta is a tyrosine kinase inhibitor (TKI). It blocks VEGF receptors to reduce the formation of new blood vessels needed by tumors to grow and survive. Incyte is taken orally twice a day at 12-hour intervals. In the phase III clinical trial that lead to the approval, average progression-free survival (PFS) was 13.8 months for patients treated with Bavencio and Inlyta compared to 8.4 months for those taking Sutent® (sunitinib), a current standard treatment for RCC. Revised prescribing information for Bavencio is available here. Inlyta’s prescribing information is available here.

Bivigam Reapproved

The U.S. Food and Drug Administration (FDA) originally approved Biotest AG’s Bivigam® (immune globulin intravenous [human], 10% liquid) in 2012 for the treatment of patients with primary humoral immunodeficiency (PI). Its production was suspended by the company in 2016 due to concerns with the manufacturing process and compliance. Following ADMA Biologicals’ purchase of Biotest, Bivigam was reconformed to use ADMA’s proprietary microneutralization screening method. It now has FDA approval to be remarketed for treating PI. Believed to affect up to 250,000 patients in the United States, PI includes a large group of inherited conditions involving diminished or absent immune function. It makes patients who have it prone to chronic, possibly life-threatening infections. Standard therapy is to replace the missing natural immunoglobulin (IG), usually through IV infusions of products (IVIG) derived from donated human blood plasma. The recommended dose of Bivigam is 300mg/kg to 800mg/kg once every three to four weeks. Frequent dosage and timing adjustments may be needed, based on individual patient response. All IVIG products carry a boxed warning that they may be associated with blood clots and kidney damage that could result in acute kidney failure. ADMA plans to relaunch Bivigam in the second half of 2019. Prescribing information is available here.

Venclexta and Gazyva Combination Granted New Indications

U.S. Food and Drug Administration (FDA) approval was granted on May 16, 2019, for the combination use of AbbVie’s Venclexta® (venetoclax) and Genentech’s Gazyva® (obinutuzumab) to treat people with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). In the phase III clinical trial that led to the approval, fixed 12-month treatment with Venclexta plus Gazyva significantly reduced the risk of disease progression or death by 67% compared to a current standard of care. Gazyva is a CD20-directed monoclonal antibody that targets cancer cells both directly and along with the body’s immune system. Venclexta inhibits B-cell lymphoma-2 (BCL-2), a protein that may interfere with apoptosis (the self-destruction process) in cancer cells. Both drugs have indications for other types of cancer. Revised prescribing information for Venclexta is available here. Gazyva’s prescribing information is available here.

Expanded Indication for Gattex

Takeda Pharmaceuticals received a new indication for Gattex® (teduglutide) on May 17, 2019. It is a glucagon-like peptide-2 (GLP-2) analog that improves intestinal absorption in patients with short bowel syndrome (SBS) who are dependent on parenteral support. SBS can occur after extensive resection of the bowel due to Crohn’s disease, ischemia (lack of blood flow) or other conditions. Patients with SBS often suffer from malnutrition, severe diarrhea, dehydration and fatigue. Treatment typically consists of nutritional support including parenteral nutrition and/or intravenous (IV) fluids. Previously restricted to adult patients, Gattex now can be used for children as young as one year of age. The recommended dose for both adults and pediatric patients is 0.05mg/kg once daily by subcutaneous injection. To ensure that benefits of treatment outweigh its risks, Gattex has a Risk Evaluation and Mitigation Strategy (REMS) that includes a communication plan to inform healthcare providers and patients about risks of developing cancer and polyps (growths) in the intestine, obstructions in the intestine, gallbladder disease, and biliary tract and pancreatic disease. Prescribing information is available here.

Fragmin Approved for Use in Children

On May 16, 2019, the U.S. Food and Drug Administration (FDA) approved the use of Fragmin® (dalteparin sodium) injection to reduce the recurrence of symptomatic venous thromboembolism (VTE) in pediatric patients one month of age and older. VTE can include deep vein thrombosis (blood clot in the deep veins of the leg) and pulmonary embolism (blood clot in the lungs). Fragmin, a type of heparin, was initially approved by the FDA in 1994 for use as an anticoagulant in adults. Full prescribing information can be found on the FDA’s website available here.

 
15May
Emergency Evacuation of Non-Essential Personnel in Iraq

Emergency Evacuation of Non-Essential Personnel in Iraq

The State Department has ordered all non-essential personnel at the U.S. Embassy and consulate in Iraq to leave the country amid rising tensions between the U.S. and Iran.

Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an Emergency Access to Benefits/Refill Too Soon override that allows pharmacies, at the point of sale (POS), to override certain benefit coverage/edits such as an early refill during a government-defined emergency. In addition, if your home delivery of medications is affected by the emergency, you may provide a temporary alternate address (either online at www.express-scripts.com or by calling 1-800-818-6717) or request a local fill as needed. The Emergency Access to Benefits/Refill Too Soon override be active from May 15, 2019 and expiration date June 15, 2019

 
13May
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

 

Generic Launched for Tarceva

On May 10, 2019, Mylan introduced to the U.S. market the first generics for Tarceva® (erlotinib - Genentech) tablets, 25mg, 100mg and 150mg. It is used, along with gemcitabine, for initial treatment of advanced, unresectable or metastatic pancreatic cancer. A second indication is for maintenance or subsequent-line therapy for patients who have metastatic non-small cell lung cancer (NSCLC) that tests positive for epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations and that has progressed following at least one prior chemotherapy (chemo) regimen. For pancreatic cancer, the once-daily recommended dose is 100mg; for NSCLC, the dose is 150mg. IQVIA estimates that sales of Tarceva were about $212 million in the U.S. for the 12-month period ending on March 31, 2019.

Generic Approved for Cuprimine

Amerigen Pharmaceuticals Limited received approval from the U.S. Food and Drug Administration (FDA) on May 7, 2019, for penicillamine capsules, 250mg. The first generic for Bausch Health’s Cuprimine®, penicillamine is a chelator that binds excess copper in the blood of patients who have Wilson’s disease. A hereditary condition, Wilson’s disease affects about 30,000 Americans. Patients who have it cannot process copper correctly into bile. Too much copper in the blood eventually damages the brain, eyes, kidneys and liver. Penicillamine also has indications to reduce cysteine elimination for patients who have cystinuria and to decrease disease activity for patients who have rheumatoid arthritis (RA) that is resistant to other treatments. Dosing depends on the condition being treated as well as on its severity. Amounts above 500mg/day should be divided into two doses. Penicillamine should be taken at least one hour before or two hours after food, milk and any other drugs or supplements. It has a number of possibly serious side effects, including several types of blood abnormalities, kidney damage and myasthenia gravis. Patients using it as maintenance therapy should be monitored closely once a month, following twice weekly lab testing for the first month of treatment and twice monthly testing for the next five months. Pricing and a launch date are uncertain. According to IQVIA, U.S. Cuprimine sales in 2018 amounted to approximately $127 million. Amerigen’s penicillamine is not interchangeable with either Meda Pharmaceutical’s Depen® Titratable tablets, 250mg or Mylan’s D-PENAMINE tablets, 125mg.

Delzicol Generic Available in the U.S.

A generic for Delzicol® (mesalamine – Allergan) delayed-release capsules, 400mg, was released in the United States on May 10, 2019, by Teva Pharmaceutical Industries. It is a type of salicylic acid that acts locally in the intestines to treat ulcerative colitis (UC) for patients five years of age and older. It also is indicated to maintain UC remission for adults. Several other brand and generic mesalamine drugs are FDA approved, but Teva’s generic is substitutable only for Delzicol. Its price and exclusivity status are not yet known. For the 12 months that ended on Feb. 28, 2019, IQVIA set U.S. sales of Delzicol at about $130 million.

Tibsovo Approved for a New Subset of Patients Who Have Acute Myeloid Leukemia

Originally approved by the U.S. Food and Drug Administration (FDA) to treat adults whose acute myeloid leukemia (AML) has returned or become resistant to previous treatment, Tibsovo® (ivosidenib – Agios Pharmaceuticals), was awarded a new indication on May 2, 2019. Newly diagnosed patients who are at least 75 years old or who cannot tolerate intensive induction chemotherapy (chemo) for AML now are candidates for its use. Patients also must test positive for a mutation in isocitrate dehydrogenase-1 (IDH1) enzymes. Normally, IDH1 helps to break down fats from food, regulate glucose levels and protect against oxidative stress. Mutated IDH1 converts normal substances into 2-hydroxyglutarate (2-HG), which promotes cancer cell formation. Approximately 6% to 10% of patients who have AML also have IDH1 mutations. By blocking the production of 2-HG, Tibsovo lessens the creation of AML cells. It is taken as 500mg (two 250mg tablets) once a day along with a low-fat meal or snack. Its label has a boxed warning because nearly one-fifth of patients using it in clinical trials developed differentiation syndrome, a potentially fatal condition caused by very fast production of immature myeloid cells in bone marrow. Other possible results from its use include QT interval prolongation and Guillian-Barre syndrome, so patients need close monitoring during treatment. The new indication was granted under Real-Time Oncology Review (RTOR), an FDA pilot program that accelerates approvals by allowing the FDA to begin analyzing clinical trial results as soon as they are available, but before their formal submission. Its approval also was under Priority Review (the FDA’s plan to approve drugs in six months or less). Full prescribing information is available here.

New Indication for Kadcyla

Genentech’s Kadcyla® (ado-trastuzumab emtansine) got an additional U.S. Food and Drug Administration (FDA) approval on May 3, 2019. It now can be used to treat patients who still have residual invasive  human epidermal growth factor receptor 2 positive (HER2+) early breast cancer after treatment with a taxane agent, such as paclitaxel, and Herceptin® (trastuzumab) followed by surgery. Drug treatment before surgery is known as neoadjuvant therapy; afterward, it is called adjuvant therapy. Previously, Kadcyla was approved only for HER2+ breast cancer that had metastasized following treatment with a taxane and Herceptin. A monoclonal antibody/drug conjugate, Kadcyla’s approval as adjuvant treatment was based on results of the KATHERINE study. After three years, 88.3% of study patients who were treated with Kadcyla were alive and free from a return of invasive breast cancer as opposed to 77.0% of those using Herceptin. The FDA approved the new indication under two of its pilot programs – RTOR and Assessment Aid, a standardized template for data delivery. Both programs accelerate the approval process. In addition, it has an FDA Breakthrough Therapy Designation, which also speeds up the development and review of medicines intended to treat serious or life-threatening diseases. Kadcyla’s extended indication was approved in about three months versus the usual six or 10 month timeframe. For adjuvant therapy of early HER2+ breast cancer, it is given as a 30-minute intravenous (IV) infusion at 3.6mg/kg once every three weeks for 14 treatments. Kadcyla is not interchangeable with any other trastuzumab product. A boxed warning concerns the possibility of embryo, heart or liver damage that it may cause. Complete prescribing information is available here.

 

 

 
 
7May
Express Scripts News Flash

Express Scripts News Flash

Vyndaqel and Vyndamax Approved to Treat Transthyretin-Mediated Amyloidosis Cardiomyopathy

The U.S. Food and Drug Administration (FDA) approved Vyndaqel® (tafamidis meglumine) capsules and Vyndamax™ (tafamidis) capsules on May 3, 2019. They are the first drugs approved in the U.S. to treat cardiomyopathy (CM) caused by transthyretin-mediated amyloidosis (ATTR), a rare heart condition. Accumulations of malformed proteins (amyloid fibrils) in the hearts of patients who have ATTR-CM cause enlargement and thickening of the heart, which eventually leads to heart failure and death. Tafamidis helps to prevent the formation of amyloid fibrils by stabilizing transthyretin (TTR), a transport protein in blood and cerebrospinal fluid. Recommended daily dosing is 80mg (four capsules) of Vyndaqel or 61mg (one capsule) of Vyndamax, which was developed to increase convenience for patients. The two formulations are not interchangeable, however. Vyndaqel is expected to be launched on May 20, 2019, and Vyndamax is expected to be available later in 2019. The annual wholesale acquisition cost (WAC) is reported to be $225,000. Both will be dispensed through a large network of specialty pharmacies that includes Accredo.  Prescribing information for both drugs is available here.

  • Brand (Generic) Name: Vyndaqel® (tafamidis meglumine) and Vyndamax™ (tafamidis)
  • Manufacturer: Pfizer
  • Date Approved: May 3, 2019
  • Indication: to treat cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization
  • Dosage Forms Available: Vyndaqel – 20mg capsules, Vyndamax – 61mg capsules
  • Launch Date: Vyndaqel – May 20, 2019, Vyndamax – later in 2019
  • Estimated Annual Cost: $225,000
  • Specialty Status: Vyndaqel and Vyndamax will be added to Express Scripts’ specialty drug list.
  • The proteins that cause ATTR are folded in ways the body cannot use, so they build up – mostly in the heart and the nerves of the hands, arms, legs and feet. Amyloid deposits in the heart cause cardiomyopathy that may result in fatigue, shortness of breath and swelling in the ankles and legs. Atrial fibrillation and heart failure often follow.
  • Some ATTR is inherited, but most cases in the U.S. are spontaneous or “wild-type”. Symptoms are general and they develop slowly, making diagnosis difficult. Even with a family history of the disease, most cases are not recognized until the patient is an adult. Around 100,000 Americans have ATTR-CM, but only 1% to 2% of those patients have been diagnosed. Once it becomes symptomatic, ATTR-CM limits life expectancy to an average of only about three years.
  • In a new drug class called TTR stabilizers, tafamidis keeps some types of amyloid fibrils from forming, so deposits are decreased or prevented.
  • Following 30 months of treatment in a clinical trial, cardiovascular-related hospitalizations fell by 32% and death from any cause by 30% for patients treated with tafamidis compared to patients taking a placebo. Few adverse events were reported for either group.
  • Vyndaqel received the FDA’s Breakthrough Therapy, Fast Track and Priority Review designations. Both drugs were granted Orphan Drug status.
  • Implications: Express Scripts currently is investigating the data around Vyndaqel and Vyndamax for possible utilization management strategies. They will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete.
 
7May
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

AstraZeneca’s Qternmet XR Approved for Diabetes

Qternmet® XR (dapagliflozin/saxagliptin/metformin) received approval from the U.S. Food and Drug Administration (FDA) on May 2, 2019. The combination of a selective sodium?glucose cotransporter-2 (SGLT-2) inhibitor, a dipeptidyl peptidase?4 (DPP?4) inhibitor and extended-release metformin is indicated to treat adults who have type 2 diabetes, who currently are taking metformin and who need additional glycemic control despite diet limitations and exercise. Qternmet XR will be taken once a day in the morning along with breakfast or a snack. All medications that contain metformin have a boxed warning that taking it may cause lactic acidosis, the buildup of excessive acid in the blood. Qternmet will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete. Prescribing information is available here.

Generics Approved for Tracleer

On April 26, 2019, the U.S. Food and Drug Administration (FDA) approved AB-rated generics to Actelion’s Tracleer® (bosentan) 62.5mg and 125mg tablets. By blocking two types of endothelin receptors, bosentan reduces constrictions in pulmonary arteries to relieve pulmonary arterial hypertension (PAH) for patients age three and older. Dosing for patients under the age of 12 is based on their body weights. Patients at least 12 years old start with 62.5mg twice a day, increasing to 125mg twice a day after four weeks only for patients who weigh more than 40kg (88 pounds). Bosentan has a boxed warning and a risk evaluation and mitigation strategy (REMS) because using it increases the chances of liver damage and, if used during pregnancy, serious birth defects. None of the manufacturers has released launch or pricing plans. According to a March 2019 IQVIA report, Tracleer’s U.S. sales for the previous 12 months were $84.8 million.

Pediatric Indication for Benlysta

The intravenous (IV) form of Benlysta® (belimumab – GlaxoSmithKline) was approved by the U.S. Food and Drug Administration (FDA) on April 26, 2019, to treat systemic lupus erythematosus (SLE) for children as young as five years old, who are being treated with standard therapy. SLE is an autoimmune disease characterized by inflammation in connective tissues. It can affect numerous organs, including the heart, kidneys and skin. With an estimated incidence of 16,000 cases per year and a prevalence of about 1.5 million in the U.S., SLE is believed to affect between 5,000 and 10,000 American children. It strikes many more women than men and SLE is especially prevalent among non-Caucasians. Symptoms of SLE usually are treated with cyclophosphamide, corticosteroids and immunosuppressants. Benlysta is a monoclonal antibody that inhibits B-lymphocyte stimulator (BLyS), a protein elevated in the blood of patients who have SLE. As a result of inhibiting this protein, B cells cannot survive as long and not as many evolve into plasma cells that attack normal tissues. For pediatric patients, it is given as a one-hour IV infusion at 10mg/kg once every two weeks for three doses, then once every four weeks. Benlysta’s subcutaneous (SC) form is not approved for patients under the age of 18 years. Full prescribing information is found on the company’s website available here.

Praluent Receives Indication for Cardiovascular Protection

Praluent® (alirocumab) was U.S. Food and Drug Administration (FDA) approved on April 26, 2019, for decreasing the risk of heart attacks, strokes and unstable angina requiring hospitalizations for adults who have established cardiovascular (CV) disease. The new indication was based on results of the ODYSSEY OUTCOMES clinical trial, which included nearly 19,000 patients who were taking the highest recommended doses of statins to lower LDL cholesterol. Compared to patients taking their regular drugs plus a placebo, risks for participants who received Praluent averaged 27% lower for stroke, 14% lower for non-fatal heart attack, 39% lower for unstable angina requiring hospitalization and 25% lower for death from any cause. Praluent is a proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor jointly developed by Regeneron and Sanofi. Recommended dosing is 75mg injected subcutaneously (SC) from a prefilled syringe or pen device once every two weeks or 300mg (two consecutive 150mg injections) once every four weeks. Its main competitor, Repatha® (evolocumab – Amgen), was FDA approved on Dec. 1, 2017, for an identical indication. Full prescribing information for Praluent is available here.

FDA Approval for Mavyret to Treat Adolescents

The U.S. Food and Drug Administration (FDA) extended the indication for AbbVie’s Mavyret™ (glecaprevir 100mg/pibrentasvir 40mg) on April 30, 2019, to include patients between the ages of 12 and 18 years. A direct-acting antiviral (DAA), it combines an NS3/4A protease inhibitor specific to Hepatitis C virus (HCV) and an NS5A inhibitor. Mavyret is approved as initial treatment of all six genotypes (GT) of HCV for patients who do not have cirrhosis or who have compensated cirrhosis. It also is indicated to treat patients who have HCV GT 1 infection and who previously were treated with either an NS3/4A protease inhibitor or an NS5A inhibitor, but not with both. The recommended dose is three tablets taken together once daily with food. Treatment lasts for eight, 12 or 16 weeks, depending on which other medications the patient has tried and whether or not the patient has compensated cirrhosis. A boxed warning cautions that taking Mavyret may worsen or reactivate hepatitis B (HBV), so all patients should have an HBV test before starting therapy and then regular monitoring should be performed during treatment for signs of HBV. Prescribing information can be found here.

Indication Expanded for Kalydeco

On April 29, 2019, Kalydeco® (ivacaftor – Vertex) was approved by the U.S. Food and Drug Administration (FDA) to treat cystic fibrosis (CF) for children as young as six months old who have at least one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is proven by an FDA-approved diagnostic test to be responsive to ivacaftor treatment. In 2012, Kalydeco was the first medication approved in the U.S. to treat the underlying cause of CF. Later, its indication was extended to children age 12 months and older. It potentiates CFTR to increase the movement of chloride in the body, helping to regulate water and salt in the lungs. Dosing for patients between six months old and six years old varies according to the child’s weight. For administration, packets of powder are mixed with five mL (about one teaspoonful) of soft food or liquid and given orally every 12 hours along with a fat-containing food, such as milk or peanut butter. Updated prescribing information is found on the company’s website available here.

First Vaccine for Dengue Fever FDA Approved

Under Priority Review Dengvaxia® (dengue tetravalent vaccine, live) was approved by the U.S. Food and Drug Administration (FDA) on May 1, 2019. Only for use in areas where dengue fever is endemic, such as Guam and Puerto Rico, it protects children and adolescents ages nine to 16 from all four dengue viruses. An individual’s first experience with dengue fever, which is spread by mosquitoes, may produce only mild effects or none at all. Subsequent infections, however, may cause much more severe symptoms that can include bleeding (dengue hemorrhagic fever), breathing problems, confusion and unrelenting vomiting. Dengvaxia is administered -- only to patients who have a documented history of or who test positive for prior dengue infections -- as three injections at six-month intervals. In trials, it blocked dengue infections for about three-fourths of vaccinated patients. The FDA awarded Dengvaxia a Tropical Disease Priority Review Voucher as part of their program to encourage development of new drugs and biological products for prevention and treatment of neglected tropical diseases. Its manufacturer, Sanofi, can use the voucher to get faster review for a future product or sell to another company. Prescribing information is available here.

 
6May
From the CEO

From the CEO

Greetings and welcome to May 2019! I can’t believe we are in the second quarter of the year. Since January, I personally have met with members in Sarasota, FL, Phoenix, AZ, and Chapel Hill, NC. Participating in Member Meetings throughout the country, remains a favorite part of my job.

Sarasohvisit

When I visit an area, members are glad to see me (usually). They share their AFSPA experiences – both good and bad. I thank you for praising our employees. I bring back your compliments to the team and it truly makes their day. However, I also appreciate your honesty about your challenges. At times, your observations have even alerted us to systemic issues. Your open feedback allows us to improve and get better. I enjoy listening to you and connecting with you at AFSPA’s Regional Member Meetings.


Step 2 - Your Biometric Screening

A few months ago, I began a series featuring the Foreign Service Benefit Plan’s (FSBP) wellness program, the Simple Steps to Living Well Together. I focused on Step One in March 2019, which involves completing a Health Risk Assessment and Physical Exam. This month, I want to highlight Step Two – The Biometric Screening. This short medical exam assesses your overall health and helps answer the question, “Am I really healthy?” The screening evaluates blood pressure, glucose level, cholesterol level, height, weight, and aerobic fitness. These measurements help identify potential risks and underlying medical issues. Follow these steps to register for a Biometric Screening:

  1. Visit https://my.questforhealth.com and enter the registration key, “FSBP”
  2. Locate a PSC locationPrint the Biometric Screening Physician Results Form to take to your physician, or
  3. Call 855-623-9355 to register by phone

Earn a $75 reward by passing three out of five metabolic syndrome criteria. If you don’t pass, you can complete specific wellness programs to receive the $75 reward.

Biometric Screening



FSBP Pain Management Program

The news often features frightening stories about opioid misuse. These drugs can treat chronic pain effectively, which is why many doctors prescribe them. However, overreliance on these medications has resulted in an epidemic. Opioid misuse is ravaging communities across the country.

FSBP’s Pain Management Program helps identify other treatment options. This may include non-pharmacologic modalities, such as injection therapies or medical devices (e.g. nerve stimulators). It could involve alternative treatments like chiropractic, massage therapy, or physical therapy. Learn more on page 95 of the 2019 FSBP Brochure.

To assist, Aetna has expanded its provider database. It now includes information on surgeons who use non-addictive medications, such as EXPAREL.This drug is administered once during surgery – directly at the surgical site. It relieves pain up to three days, with fewer side-effects than opioids. When searching for providers, look at the Plan Information column to learn if the provider offers, “Opioid Alternatives.”

opiod alternative


May - Better Sleep and Mental Health Awareness Months

According to Sleep.org, mental stress impacts your life as well as your sleep quality. Ironically, if you are not well rested, your body actually will boost your stress hormone levels. FSBP offers excellent programs to help reduce stress, which ultimately may improve your sleep. Here are a few Plan services that may assist:

  1. One-on-one health coaching and digital coaching programs
  2. myStrength™- online mental health support program
  3. AbleTo – online treatment support program
  4. Telehealth video visits through Amwell, for members in the U.S.
  5. Special teleheath counseling sessions, for members outside the U.S.

See Section 5(e) of the 2019 FSBP brochure for details.


Please enjoy your Memorial Day. This holiday remembers the sacrifices of the men and women who have served our country. As always, thank you for your loyalty and for giving AFSPA the opportunity to serve you.


To Your Health,

Paula S. Jakub, RHU
CEO, AFSPA
Executive Director, Senior Living Foundation

 

 
30Apr
Product Recall for Losartan

Product Recall for Losartan

 

PRODUCT RECALL: Express Scripts Managing Losartan/Hydrochlorothiazide 100mg/50mg/25mg Recall

 
 

On November 8, 2018, Sandoz Inc. voluntarily recalled one lot of Losartan Potassium Hydrochlorothiazide Tablets, USP 100mg/25mg to the consumer level. This product was recalled due to the trace amount of an impurity, N-nitrosodiethylamine (NDEA), contained in the API Losartan, USP manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd. The Sandoz Inc. Losartan Potassium Hydrochlorothiazide product is manufactured by Lek Pharmaceuticals dd, Ljubljana, Slovenia. This impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution and industrial processes, has been classified as a probable human carcinogen as per the International Agency for Research on Cancer (IARC).

On January 3, 2019, Torrent Pharmaceuticals Limited expanded its voluntary recall from 2 lots of Losartan potassium tablets USP to a total of 10 lots, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. Torrent is only recalling lots of losartan-containing products that contain N-nitrosodiethylamine (NDEA) above the acceptable daily intake levels released by the FDA. As a result an additional 6600 Express Scripts’ patients are impacted.

On February 28, 2019, Camber Pharmaceuticals issued a voluntary recall of 87 lots of Losartan potassium tablets USP to the consumer level due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, Unit – I (API manufacturer). As a result an additional 81,426 Express Scripts’ patients are impacted. Please note, 81,424 of those impacted patients are Department of Defense patients.

On March 1, 2019, Torrent Pharmaceuticals Limited expanded its recall to include 60 lots of Losartan potassium tablets USP and 54 lots of Losartan potassium/hydrochlorothiazide tablets, USP to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. As a result an additional 57,215 Express Scripts patients are impacted.

On April 18, 2019, Torrent Pharmaceuticals Limited expanded its recall to include an additional 36 lots of Losartan potassium tablets USP and 68 lots of Losartan potassium/hydrochlorothiazide tablets, USP to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. As a result an additional 26,485 Express Scripts patients are impacted.

Additional information for the April 18 Torrent recall:

  • Product: Losartan Potassium Tablets 25mg, 50mg, and 100mg AND Losartan Potassium Hydrochlorothiazide Tablets 50mg/12.5mg, 100mg/12.5mg and 100mg/25 mg 
  • Indication: treatment of hypertension
  • Manufacturer: Torrent Pharmaceuticals Limited
  • Lot(s) impacted: for lot info please refer to the FDA alert linked here
  • Type of recall: Voluntary
  • Reason for Recall: due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA).  
  • Return/Replacement information:  Return/replacement is being managed by a third party, Qualanex.  Patients are provided return/replacement instructions in the letter. They are to contact Qualanex (the recall coordinator for Torrent) by email at [email protected] or by calling 888-280-2040 toll free between 8am to 9pm ET to obtain instructions on how to return their recalled product.

Additional information for the Camber recall:

  • Product: Losartan Tablets USP 25 mg, 50 mg, and 100 mg
  • Indication: treatment of hypertension
  • Manufacturer: Camber Pharmaceuticals, Inc.
  • Lot(s) impacted: for lot info please refer to the FDA alert linked here.
  • Type of recall: Voluntary
  • Reason for Recall: due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA).  
  • Return/Replacement information: Stericycle is notifying Camber’s distributors and other customers by recall letter and arranging for return of recalled product of Losartan Potassium Tablets. 

Additional information for the March 1 Torrent recall:

  • Product: Losartan Potassium Tablets 25mg, 50mg, and 100mg AND Losartan Potassium Hydrochlorothiazide Tablets 50mg/12.5mg, 100mg/12.5mg and 100mg/25 mg 
  • Indication: treatment of hypertension
  • Manufacturer: Torrent Pharmaceuticals Limited
  • Lot(s) impacted: for lot info please refer to the FDA alert linked here
  • Type of recall: Voluntary
  • Reason for Recall: due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA).  
  • Return/Replacement information:  Return/replacement is being managed by a third party, Qualanex.  Patients are provided return/replacement instructions in the letter. They are to contact Qualanex (the recall coordinator for Torrent) by email [email protected] or by calling 888-280-2040 toll free between 8am to 9pm ET to obtain instructions on how to return their recalled product.

Additional Information for Sandoz Recall:

  • Product: Losartan Potassium Hydrochlorothiazide Tablets, USP 100mg/25mg
  • Manufacturer: Sandoz, Inc.
  • Lots impacted: Lot number JB8912; Exp. Date 06/2020
  • Type of recall: Voluntary
  • Reason for Recall: due to the presence of an impurity, N-nitrosodiethylamine (NDEA)
  • Return/Replacement information: There is no return/replacement information. Patients will be advised to process a refill. Refills will be filled with non-recalled product or a prescriber outreach for alternative will occur.

 

 

 
     
 
29Apr
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Second Biosimilar Approved for Enbrel

Eticovo (etanercept-ykro - Samsung Bioepis), was approved by the U.S. Food and Drug Administration (FDA) on April 25, 2019. A biosimilar to Enbrel® (etanercept), it is indicated to treat ankylosing spondylitis, plaque psoriasis, polyarticular juvenile idiopathic arthritis (pJIA), psoriatic arthritis (PsA) and rheumatoid arthritis (RA). In clinical studies comparing the effects of Eticovo and Enbrel for patients with methotrexate-resistant RA, both drugs produced similar response, progression and antidrug antibody rates. All drugs in the TNF inhibitor class, including Eticovo, carry a boxed warning that using them may raise the risk of serious infections, including tuberculosis (TB). If used for children or teens, the risk of lymphoma and other cancers may go up, as well. No launch plans for Eticovo have been made public. Erelzi™ (etanercept-szzs - Sandoz) was FDA approved in 2016, but its release to the U.S. market has been delayed by lawsuits from Enbrel’s manufacturer, Amgen. Express Scripts currently is investigating the data around Eticovo for a possible utilization management strategy. It also will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete. Prescribing information is available here.

FDA Approves Duobrii to Treat Psoriasis

On April 25, 2019, the U.S. Food and Drug Administration (FDA) approved Duobrii™ from Bausch Health. It is a topical lotion that combines 0.01% of a high-potency corticosteroid (halobetasol) with 0.045% of a retinoid, tazarotene. Although both drugs have been available separately for several years, Duobrii is the first to contain both. Its indication is for treating adults who have plaque psoriasis. Directions are to apply a thin layer of lotion to dry areas of affected skin once a day with a maximum of 50Gm per week. Pregnant women should not use it; the risk of sunburn is increased by its use; and it may contribute to the development of cataracts or glaucoma. A June launch is planned by Bausch’s subsidiary, Ortho Dermatology, at a wholesale acquisition cost (WAC) of $825 for each 100Gm tube. Express Scripts currently is investigating the data around Duobrii for a possible utilization management strategy. It also will be excluded at launch on the Express Scripts NPF until our formulary development process is complete. Full prescribing information for Duobrii is available here.

Keytruda Gains New Indication

Merck’s Keytruda® (pembrolizumab) was granted another new indication by the U.S. Food and Drug Administration (FDA) on April 19, 2019. In combination with the tyrosine kinase inhibitor (TKI), Inlyta® (axitinib - Pfizer), it is indicated as initial therapy to treat advanced renal cell carcinoma (RCC). As a human programmed death receptor-1 (PD-1)-blocking antibody, it boosts the ability of the immune system to destroy cancer cells. Following its original FDA approval in September 2014 for treating patients who had received prior therapy for unresectable or metastatic melanoma, Keytruda has received multiple new indications for treating various cancer types. Two years ago, it became the first drug approved for treating colorectal cancer (CRC) and any solid tumors that are microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) regardless of the tumors’ primary site of origin. For its RCC indication, Keytruda will be infused once every three weeks at a dose of 200mg, while 5mg of Inlyta will be taken orally twice every day. In the KEYNOTE-426 trial that led to the approval, average progression-free survival (PFS) was four months longer for patients treated with Keytruda and Inlyta compared to those taking Sutent® (sunitinib), a current standard treatment for RCC. Because the combination was approved under the FDA’s Accelerated Approval program, additional confirmatory trials that demonstrate a clinical benefit are needed before full FDA approval is granted. Updated prescribing information for Keytruda is available here.

MedWatch Update

Lartruvo

After results from the phase III ANNOUNCE trial showed no significant differences between treatment with its monoclonal antibody Lartruvo® (olaratumab injection) plus doxorubicin and doxorubicin alone, Eli Lilly is withdrawing Lartruvo from the market. Based on promising phase II study outcomes, it was given Accelerated Approval by the FDA in October 2016 — along with doxorubicin — as initial treatment for adults who have soft tissue sarcomas (STS) that have a histologic subtype for which an anthracycline-containing regimen is appropriate and for which curative treatment with radiotherapy or surgery is not an option. STS, which affects about 13,000 U.S. patients per year, is difficult to diagnose and treat. However, products approved under Accelerated Approval must continue clinical trials to prove their effectiveness before being given full FDA approval. Lartruvo’s preliminary results were not supported. Patients who already are receiving Lartruvo can continue therapy with it, if they and their physicians agree that its risks are outweighed by their response to using it. It will not be offered to new patients, though. More information is in a January Lilly news release available here.

Updated DrugWatch Document Available

The Emerging Therapeutics department has updated DrugWatch, a document that highlights near-term pipeline drugs as well as potential new generic opportunities. The DrugWatch document is available here

 
25Apr
Express Scripts News Flash

Express Scripts News Flash

Skyrizi Approved to Treat Psoriasis
On April 23, 2019, the U.S. Food and Drug Administration (FDA) approved Skyrizi™ (risankizumab-rzaa) for treating moderate-to-severe plaque psoriasis in adults eligible for systemic therapy (oral or injection) or phototherapy (ultraviolet light). Jointly developed by AbbVie and Boehringer Ingelheim, Skyrizi is an interleukin-23 (IL-23) inhibitor that blocks inflammatory processes. Recommended dosing is 150mg -- administered as two separate subcutaneous (SC) injections at the same time. The second dose is one month later than the first and then doses are spaced at 12-week intervals. Patients and caregivers will be able to inject at home once they have been trained in proper technique by a health professional. Injections should be self-administered only in the abdomen or upper thigh, however. A Medication Guide for patients will be dispensed with each prescription. Launch is expected in early May through open distribution. Complete prescribing information is available here.

  • Brand (Generic) Name: Skyrizi™ (risankizumab-rzaa)
  • Manufacturer: AbbVie and Boehringer Ingelheim
  • Date Approved: April 23, 2019
  • Indication: to treat adults who have moderate to severe plaque psoriasis and who are candidates for systemic therapy or phototherapy
  • Dosage Forms Available: Single-dose, prefilled syringes containing 75mg/0.83mL; two SC injections will be used for each dose
  • Launch Date: early May
  • Estimated Annual Cost: Following the first two doses, annual wholesale acquisition cost (WAC) for Skyrizi will be $59,000.
  • Specialty Status: Skyrizi will be added to Express Scripts’ specialty drug list.
  • Psoriasis is an autoimmune disease that results from chronic overactivity of the immune system. It causes an overproduction of skin cells. Plaque psoriasis, which affects approximately eight million patients in the U.S., is characterized by itchy, red, scaly patches on the skin.
  • An interleukin inhibitor, Skyrizi blocks inflammation by sticking to the p19 subunit of IL-23.
  • In clinical trials, skin cleared at least 90% after 16 weeks for 75% of patients receiving Skyrizi. After one year, more than 80% of treated patients had 90% or higher clearance with over 55% having 100% clear skin.
  • Because using Skyrizi may increase the risk of having infections, patients should be tested for tuberculosis (TB) before beginning treatment with it.
  • Tremfya® (guselkumab - Janssen) and Ilumya™ (tildrakizumab-asmn – Sun Pharma) are IL-23 inhibitors previously FDA-approved to treat psoriasis. Stelara® (ustekinumab - Janssen) targets IL-23 and also interleukin-12 (IL-12).

Implications: Express Scripts currently is investigating the data around Skyrizi for a possible utilization management strategy.

 
23Apr
Express Scripts News Flash

Express Scripts News Flash

Generic VESIcare Launched
Today, Teva announced the launch of its AB-rated generics to Astellas Pharma’s VESIcare® (solifenacin succinate) tablets, a muscarinic antagonist approved for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. Teva was allowed to launch generics in April 2019 because of a settlement agreement. Other manufacturers can launch their generics in about a month, after the last patent on VESIcare expires.

  • Brand Drug: VESIcare® (solifenacin - Astellas)
  • Indication: Treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.
  • Generic Manufacturer: Teva Pharmaceutical Industries Ltd.
  • Launch Date: April 22, 2019
  • Dosage Forms Available: 5mg and 10mg tablets
  • Annual U.S. Sales: $955 million for the most recent twelve months ending in February 2019, according to IQVIA data.
  • Multiple additional manufacturers are expected to launch generics on May 20, 2019, following the expiration of the last VESIcare patent listed in FDA’s Orange Book.
  • Other oral medication for treating OAB include Detrol®/LA (tolterodine – Pfizer, generics), Ditropan®/XL (oxybutynin – Janssen, generics), Enablex® (darifenacin – Allergan, generics), Myrbetriq® (mirabegron e.r. - Astellas), Sanctura®/XR® (trospium – Allergan/Indevus, generics), and Toviaz® (fesoterodine – Pfizer).
  • Topical formulations of oxybutynin are also available as Gelnique® (oxybutynin gel – Allergan) and Oxytrol® (oxybutynin transdermal – Allergan).
 
22Apr
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Plenity, Weight Reduction Product, Approved

Gelesis, Inc. received U.S. Food and Drug (FDA) approval on April 14, 2019, for its first product, Plenity™ (Gelesis100). Indicated along with diet and exercise, it promotes weight loss for adults who have body mass indexes (BMI) between 25kg/m2 and 40kg/m2 (overweight and obese individuals). The recommended dosage is 2.25Gm (three capsules) with water before lunch and dinner. It is packaged in boxes that contain seven double blister cards with three capsules on each card section. Capsules contain a hydrogel that cross-links cellulose and citric acid. They should be swallowed 20 to 30 minutes before the meal along with three full glasses of water. The capsules dissolve in the stomach, releasing hundreds of small particles that swell up but do not clump together. The hydrated particles mix with food to fill the stomach, but they provide no nutritional value. The pieces stay intact until they are broken down by enzymes in the large intestines where the water they contain is reabsorbed by the body and the cellulose is eliminated. In five clinical trials, patients taking Plenity reported feeling full faster and longer. In results from one of the studies that included 436 participants, 59% of those taking Plenity for six months lost at least 5% of total body weight (26% lost 10% or more) compared to 42% and 15%, respectively, for those taking a placebo. Even though it is a prescription-only, oral product, Plenity was FDA-approved as a device because it does not have a systemic effect. Unlike some weight-loss drugs that do have chemical actions in the body, Plenity does not have limits on the duration of its use. Additionally, it can be taken by patients who have chronic conditions, such as diabetes. Pricing is not yet available, but Gelesis plans a limited launch of Plenity in the second half of 2019, followed by a nationwide roll-out in 2020. Plenity will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete. Directions for using Plenity are available here.

First Generic for Narcan Nasal Spray

On April 19, 2019, the FDA gave its final approval for Teva’s naloxone nasal spray, the first generic to Narcan® Nasal Spray (Adept Pharma). Naloxone is used outside of medical settings for the emergency reversal of opioid-induced respiratory and central nervous system (CNS) depression. Its nasal form comes in single-dose, ready-to-use inhaler devices. One spray is given immediately before calling for first responders. If the patient does not recover completely or relapses after recovery, additional doses may be administered – in alternate nostrils – once every two to three minutes until medical help arrives. No special training is necessary to use the devices. Other manufacturers have submitted for FDA approval of naloxone generics; they are currently under Priority Review. The FDA is trying to tackle opioid misuse on a number of fronts, including possible approval for nonprescription forms of naloxone and requiring that naloxone be dispensed along with opioid prescriptions. Teva has not yet announced its pricing or launch plans.
 

 
15Apr
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Keytruda Approval Extended

Merck’s human programmed death receptor-1 (PD-1)-blocking antibody, Keytruda® (pembrolizumab), received expanded U.S. Food and Drug Administration (FDA) approval for some previous indications to treat non-small cell lung cancer (NSCLC) on April 11, 2019. It now is indicated as single, initial therapy for patients not previously treated for metastatic NSCLC or stage III NSCLC that cannot be treated by surgery or definitive chemoradiation. Before using it, all the tumors must be confirmed -- through an FDA-approved diagnostic test -- to express PD-1 and they must not have genomic aberrations in epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK). Either alone or in combination with other oncology drugs, Keytruda also is indicated for treating numerous other cancer types. For adults, its recommended dose is 200mg given by a 30-minute intravenous (IV) infusion once every three weeks. Complete, revised prescribing information is available here.

Balversa Approved to Treat Bladder Cancer

Janssen’s Balversa™ (erdafitinib) was approved by the U.S. Food and Drug Administration (FDA) on April 12, 2019. It is a first-in-class kinase inhibitor that targets fibroblast growth factor receptors (FGFR). These receptors can prolong cancer cells' survival and promote their growth. It was approved to treat adults who have locally advanced or metastatic urothelial (bladder) carcinoma that has FGFR2 or FGFR3 mutations and that previously was treated with platinum-based combination chemotherapy (chemo). The recommended starting dose is 8mg orally once a day, increased to 9mg daily if blood phosphate levels stay within acceptable limits. It will be dispensed exclusively through US Bioservices with the launch date still to be determined. Complete prescribing information is here.

MedWatch Updates

Test Strips

On April 8, 2019, the U.S. Food and Drug Administration (FDA) issued a safety communication for patients who use test strips to monitor blood sugar, warfarin levels or other health conditions. Patients and their healthcare providers were cautioned not to use test strips that are not FDA approved or that are pre-owned. Strips that are sold by individuals, through social media or from online retailers may be altered, contaminated, damaged or outdated. Strips sent from other countries may not have FDA approval as effective and safe. Patients are advised to obtain test strips only from reputable sources and to check all refills of their test strips for anything unusual, such as directions in a different language, missing expiration dates, opened containers and old-looking packages. For further details, the FDA’s complete notice is available here.

Additional guidance for patients is available here.

Opioids
In a Safety Announcement dated April 9, 2019, the U.S. Food and Drug Administration (FDA) reminded providers and users of prescription opioids that abruptly stopping the drugs can cause devastating side effects for patients who have become dependent on them. For those who have been taking opioids chronically, doses should be decreased gradually on a schedule tailored to each patient’s characteristics. The plan also should include emotional support and counseling, if necessary. Patients who have or may have an opioid misuse disorder may need medication-assisted treatment and those with chronic uncontrolled pain may need to consult with a pain specialist for different ways to manage their conditions. The FDA is requiring labels for opioids to include how to reduce or discontinue their use, as well as information about their additional side effects and interactions with other drugs. The full FDA communication is available here.

Addyi
A third U.S. Food and Drug Administration (FDA) safety message released this week concerns Addyi® (flibanserin), which was approved in 2015 to treat acquired, generalized hypoactive sexual desire disorder (HSDD) for premenopausal women. On April 11, 2019, the FDA informed the manufacturer, Sprout Pharmaceuticals, that Addyi’s boxed warning about the risk of potentially serious low blood pressure when alcohol is used while Addyi is taken must stay on the labeling. Even though results from post-marketing studies show the risk to be small, some important information may not have been reported in the investigations. The FDA also determined that real-world use of Addyi differs considerably from the conditions in the studies. The current warning to stop drinking alcohol while taking Addyi has been modified, however, to drinking no alcohol within two hours of taking Addyi and avoiding alcohol overnight after taking a dose. If drinking cannot be interrupted, the dose of Addyi can be skipped for the day. The FDA’s full statement is available here.

 
10Apr
Express Scripts News Flash

Express Scripts News Flash

Dovato Approved for First-Line Treatment of HIV

ViiV Healthcare gained U.S. Food and Drug Administration (FDA) approval for a new HIV-1 drug, Dovato (dolutegravir 50mg/lamivudine 300mg), on April 8, 2019. It includes an integrase strand transfer inhibitor (INSTI) and a nucleoside analogue reverse transcriptase inhibitor (NRTI) to treat patients who have HIV-1 that have not been treated previously. In clinical trials, Dovato was as effective and safe as a three-drug combination commonly used for patients newly diagnosed with HIV-1. Dovato is expected to be available later this month with a wholesale acquisition cost (WAC) of about $27,500 per year. Prescribing information is not yet available.

Evenity Approved to Treat Osteoporosis

Evenity™ (romosozumab-aqqg - Amgen) was approved by the U.S. Food and Drug Administration (FDA) on April 9, 2019. A monoclonal antibody to treat osteoporosis, it is specifically indicated for postmenopausal women who have a high risk for breaking bones. Candidates for its use include women who have had previous fractures, who have multiple risk factors and who have not had success with previous treatments. By blocking sclerostin, a protein that helps to regulate bone metabolism, Evenity promotes bone formation and also slows down bone resorption. It will be given by a healthcare professional once a month as two separate injections (totaling 210mg) into the upper arm, abdomen or thigh. No more than 12 doses should be administered, but patients should continue treatment with another osteoporosis agent after the course of Evenity is finished. Launch is planned within the week. It will be available through open distribution. Complete prescribing information is available here.

 
8Apr
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Duaklir Pressair Receives FDA Approval

A new breath-actuated, dry-powder inhaler to treat chronic obstructive pulmonary disease (COPD) was approved by the U.S. Food and Drug Administration (FDA) on March 29, 2019. Duaklir® Pressair® (Circassia Pharmaceuticals) contains aclidinium, a long-acting muscarinic antagonist (LAMA) and formoterol, a long-acting beta2-adrenergic agonist (LABA). Directions are to use one inhalation (400mcg of aclidinium and 12mcg of formoterol) each morning and each evening as maintenance therapy. It will be launched in the U.S. during the second half of 2019. Pricing is not yet available. Duaklir Pressair will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete. Prescribing information is available here.

Approval for Avaclyr Ophthalmic Ointment

Avaclyr™ (acyclovir ophthalmic ointment) 3% was U.S. Food and Drug Administration (FDA) approved on March 29, 2019. It is an antiviral drug indicated to treat acute herpetic keratitis (corneal infection caused by Herpes simplex virus). A thin strip about one cm (approximately one-third of an inch) long will be placed in the pocket underneath  the eye five times a day until the infection clears, and then three times a day for one additional week. The manufacturer, Fera Pharmaceuticals, will announce launch and pricing details after it finds a partner company to market Avaclyr. It will be excluded at launch on the Express Scripts NPF until our formulary development process is complete. Prescribing information is available here.

FDA Approves New Immune Globulin

On April 1, 2019, ADMA Biologics received U.S. Food and Drug Administration (FDA) approval for Asceniv™ (immune globulin intravenous, human – slra 10% liquid). It is indicated to treat primary humoral immunodeficiency disease (PI) for patients who are 12 years old and older. PI includes about 350 rare, chronic conditions, such as common variable immunodeficiency (CVID), severe combined immunodeficiencies (SCID), Wiskott-Aldrich syndrome and X- linked agammaglobulinemia. The immune systems of the estimated 250,000 U.S. patients who have a PI cannot produce antibodies at all or cannot produce enough to prevent recurring infections. Standard therapy is to replace the missing natural immunoglobulin (IG), usually through IV infusions of products (IVIG) derived from donated human blood plasma. Asceniv is manufactured using a unique combination of blood plasma that includes some screened through ADMA’s patented microneutralization process. In the phase III study of Asceniv, all 59 patients treated with it remained free of serious bacterial infections for an entire year. IVIG products carry a boxed warning that they may cause blood clots and/or damage the kidneys. Launch is planned for the second half of 2019. Express Scripts is currently investigating the data around Asceniv IVIG for a possible utilization management strategy. It will be excluded at launch on the Express Scripts NPF until our formulary development process is complete. Prescribing information has not yet been posted.

Wider Use Approved for Zelnorm

Zelnorm™ (tegaserod – Sloan Pharma), which has been restricted to very limited prescribing on the U.S. market, was granted U.S. Food and Drug Administration (FDA) approval for broader use on March 29, 2019. Its availability was severely reduced in 2007 when concerns were raised about its potentially serious cardiovascular risks. After analyzing information from clinical trials and real-world use, the FDA determined that Zelnorm is safe for certain patients to use. Its indication is still narrow, though; for treating irritable bowel syndrome with constipation (IBS-C) only for women who are younger than 65 years old and who have not had gallbladder disease, a heart attack, kidney disease, a stroke or one of several intestinal conditions. Its recommended dose is one 6mg tablet twice daily one-half hour before a meal. If symptoms are not relieved after six weeks, treatment should be stopped. Zelnorm is the only selective serotonin-4 (5-HT4) receptor agonist with an indication for IBS-C. It works differently from other IBS-C medications to promote contraction and relaxation, increase secretions and reduce sensitivity in the gastrointestinal (GI) tract – helping to relieve GI discomfort and normalize bowel movements. It will be excluded at launch on the Express Scripts NPF until our formulary development process is complete. Prescribing information is available here.

Generics Approved for Letairis

Four companies received U.S. Food and Drug Administration (FDA) approval on March 28, 2019, for generic versions of Gilead’s Letairis® (ambrisentan) tablets. Indicated to treat pulmonary arterial hypertension (PAH), ambrisentan is an endothelin receptor antagonist that is taken at a recommended dose of no more than 10mg once a day. It originally was approved by the FDA in 2007 with a risk evaluation and mitigation strategy (REMS), because it may damage the liver and/or cause birth defects. PAH is a rare, aggressive and life-shortening vascular disease that is diagnosed for 500 to 1,000 Americans per year. Resulting from excessively high pressure in the blood vessels leading from the heart into the lungs, it worsens progressively. Up to 20% of patients have a genetic form of PAH, but most cases occur spontaneously. Branded Letairis and the generics from Mylan Pharmaceuticals, Sun Pharma and Watson Laboratories will be dispensed under the original REMS (now called Ambrisentan REMS) by specialty pharmacies. The generic made by Zydus Pharmaceuticals was approved with a “parallel” REMS (PS-Ambrisarten REMS) that allows for retail dispensing. Patients must be enrolled in both REMS programs to receive a generic prescription. In 2018, U.S. sales for Letairis amounted to $943 million.

Ibrance Approved to Treat Breast Cancer in Men

The indication for Ibrance® (palbociclib – Pfizer) was expanded by the U.S. Food and Drug Administration (FDA) on April 4, 2019. It now is specifically indicated, along with an aromatase inhibitor or Faslodex® (fulvestrant), to treat men who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has progressed or metastasized. The American Cancer Society estimates that approximately 2,700 new cases of breast cancer are diagnosed for male patients each year in the United States. Ibrance is a kinase inhibitor that works by blocking cyclin-dependent kinases (CDK4 and CDK6) to limit the growth of cancer cells. It is taken on 28-day cycles, with a recommended dose of one 125mg capsule taken daily, along with food, on days one through 21 followed by seven days without Ibrance. Doses may be lowered for patients who have serious side effects. Full prescribing information is available here.

 
5Apr
From the CEO

From the CEO

Greetings and Welcome to April 2019! As Spring brings new beginnings and thoughtful reflections, I feel privileged to serve more than 82,000 American Foreign Service Protective Association (AFSPA) members every day.


April is Defeat Diabetes Month. The Defeat Diabetes Foundation is on a mission to save children and their families from the pain of diabetes by empowering them with the tools to prevent diabetes or its complications. This month raises awareness of diabetes prevention and treatment. According to www.healthfinder.gov, diabetes is a leading cause of disability and death in the U. S., and it is rising globally. Diabetes increases the risk for heart disease, kidney failure, stroke, and more. You can prevent or delay getting type 2 diabetes by watching your weight, eating healthy, and staying active. Spring is the perfect season to increase the amount of walking you do. Park farther away, use the stairs, or take a 10-minute morning walk. Make small changes to your daily routine to reach the recommended 10,000 steps per day.

Let the Foreign Service Benefit Plan (FSBP) help you manage your diabetes. Try using:

  • Livongo – You and your covered family members with diabetes can join the Livongo program at no cost. Receive a digital meter, unlimited testing strips, and even a support coach. Learn more at FSBP.livongo.com.
  • KidsHealth – A library that provides information and guidance designed specifically for parents, kids, teens and even educators. KidsHealth, provides the entire family age appropriate information and tools to make the best health choices. FSBP members can access this resourceful website by logging into Aetna Navigator. Then select, “Discover a Healthier You,” under the Stay Healthy tab. Finally, select the “KidsHealth Library,” at the bottom of the page (under Important Links).

Of course, my monthly message would not be complete without mentioning wellness. The term wellness means to actively make choices toward living a healthier life. FSBP offers many programs to support you on your personal health journey. If you do have a medical condition, our Wellness Chart may help you identify the best FSBP programs to assist. Review our Wellness Chart to learn how to address your specific condition. This Spring, improve your overall health by using your available FSBP services and resources.


Lastly, believe it or not, April is National Humor Month. Yes, there is such a thing. National Humor Month heightens public awareness of the therapeutic value of humor. Laughter leads to boosted morale, increased communication skills, and an enriched quality of life. Humor lifts ailing spirits, as supported by scientific research. Laughter’s ability to relieve stress may be one of the greatest medical discoveries of our times. We all have hectic lives and busy schedules. Let’s try to take a few minutes a day to bring some laughter back into our lives.


Recently, we mailed out the Senior Living Foundation (SLF) Newsletter to our foreign service colleagues. This charitable Foundation, sponsored by AFSPA, supports retired Foreign Service Personnel and their spouses. If you know someone in need of assistance, call 202-887-8170, to see if SLF can help. Learn more at www.slfoundation.org.

I hope you enjoy this season of fresh starts and new beginnings. As always, thank you for your trust and for giving AFSPA the opportunity to serve you.

To Your Health,

Paula S. Jakub, RHU
CEO, AFSPA
Executive Director, Senior Living Foundation

 

 
2Apr
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

New Oral Testosterone Product Approved

Clarus Therapeutics received approval from the U.S. Food and Drug Administration (FDA) for Jatenzo® (testosterone undecanoate) capsules on March 27, 2019. It is indicated to treat patients who have male hypogonadism (low testosterone blood levels) that are caused by genetic conditions, such as Klinefelter syndrome, and structural problems, such as damage from chemotherapy, injuries or radiation. It is not approved to treat age-related low testosterone levels. Jatenzo is a C-III controlled substance and it has a boxed warning that it may increase blood pressure. Patients should be assessed for risk of heart attacks, strokes and other cardiovascular adverse events before beginning treatment and then monitored regularly during therapy. Recommended dosing ranges from 158mg taken twice a day to 396mg twice daily, depending on testosterone blood levels. It will be available in soft-gel capsules containing 158mg, 198mg or 237mg. Cost and launch plans have not been announced. Express Scripts currently is investigating the data around Jatenzo for a possible utilization management strategy. It also will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete. Full prescribing information is available here.

Teva Introduces Exjade Generic

Generics for Novartis’ Exjade® (deferasirox) tablets for oral suspension were introduced to the U.S. market by Teva on March 22, 2019. Available as 125mg, 250mg and 500mg tablets, they are dissolved in water or fruit juice to drink once a day. Deferasirox treats chronically high blood levels of iron resulting from blood transfusions for patients at least two years old and for patients age 10 years and older who have non-transfusion-dependent thalassemia (NTDT). Doses, which may be adjusted frequently, depend on the patient’s weight and kidney function. A boxed warning about its potential to damage the gastrointestinal system, kidneys and/or liver is required on the labeling for deferasirox. Monthly laboratory tests are required to monitor organ function. Pricing is not known at this time. For 2018, IQVIA estimated that Exjade sales in the U.S. amounted to approximately $134 million.


Generic Launched for Remodulin

Treprostinil, the first generic for Remodulin® injection (United Therapeutics) was launched by Sandoz on March 25, 2019. It decreases exercise-induced symptoms, including shortness of breath, chest pain and fatigue, for patients who have World Health Organization (WHO) Group 1 pulmonary arterial hypertension (PAH). The National Organization for Rare Diseases (NORD) estimates that about 500 to 1,000 new cases of PAH are diagnosed annually for Americans -- mostly for women between 30 and 60 years old. All of its causes are not yet understood, but up to one-fifth of cases are inherited. Others may be caused by exposure to certain drugs or poisons; as many as one-third are associated with other conditions, particularly connective tissue diseases, such as scleroderma. PAH is a progressive disease that causes high blood pressure in the lungs when the arteries in the lungs stiffen and narrow. The right ventricle of the heart, which has to exert more force to push blood through the lungs, becomes enlarged and, if PAH is not treated, the right part of the heart eventually fails. One of the prostaglandins indicated to treat PAH, treprostinil is given by continuous intravenous (IV) or subcutaneous (SC) infusion at doses based on the patient’s weight. Sandoz has 180 days of exclusivity. For 2018, United Therapeutics reported $599 million in global sales for Remodulin, which has several additional dosage forms that are still brand-only.

Cimzia Gains New Indication

UCB Pharmaceuticals’ Cimzia® (certolizumab pegol) injection was U.S. Food and Drug Administration (FDA) approved on March 28, 2019, as the first drug specifically indicated to treat non-radiographic axial spondyloarthritis (nr-axSpA), with objective signs of inflammation. The Spondylitis Association of America estimates that about 2.7 million Americans have axial spondyloarthritis (axSpA), an inflammatory arthritis of the spine that usually is recognized in the late teens to mid forties for patients who have chronic, severe back pain. Up to 35% of those patients have nr-axSpA, which does not show in x-rays, making it difficult to diagnose. All forms of axSpA are painful and progressive and ultimately can deform and/or fuse the spine. After its original 2008 U.S. approval for adult patients with Crohn’s disease, Cimzia has gained additional FDA approvals for ankylosing spondylitis (AS), psoriasis, psoriatic arthritis (PsA) and rheumatoid arthritis (RA). It is given by SC injection at two-week or four-week intervals. All drugs in the TNF inhibitor class carry a boxed warning that using them may raise the risk of serious infections, including tuberculosis. If used by children, the risk of lymphoma and other cancers may go up as well. A Medication Guide that accompanies every Cimzia prescription outlines its potential risks for patients. Updated prescribing information is available here.

Mavenclad Approved to Treat Multiple Sclerosis

Mavenclad®, a new formulation of cladribine, was U.S. Food and Drug Administration (FDA) approved on March 29, 2019, to treat adults who have multiple sclerosis (MS) and who have not been helped by or cannot tolerate other drugs for MS. Developed by EMD Serono, it can be used to treat relapsing-remitting disease (RRMS) and active secondary progressive disease (SPMS), but not for MS with clinically isolated syndrome. Dosing is based on the patient’s weight, with a minimum of 40kg (88 pounds). It is taken in two courses that each include two cycles. For each cycle, the patient takes 10mg or 20mg of Mavenclad once a day for four or five days. After 23 to 27 days, the cycle is repeated until a total dose of 1.75mg/kg is reached for the course. The patient then takes a break of 43 weeks or longer before repeating the two cycles and bringing the total dose to 3.5mg/kg. Further therapy with Mavenclad is not recommended. Tablets should be swallowed whole at least three hours before or after any other oral medications. They should be taken immediately after removal from the blister card and patients should wash their hands carefully after touching them. A boxed warning and patient Medication Guide outline its possible serious risks of causing cancers or birth defects. Starting on or about April 5, 2019, Mavenclad will be dispensed through a limited network of specialty pharmacies that includes Accredo. No pricing plans have been released. Prescribing information is available here.

Updated DrugWatch Document Available

The Emerging Therapeutics department has updated DrugWatch, a document that highlights near-term pipeline drugs as well as potential new generic opportunities. The DrugWatch document is available here.

 

 

 
1Apr
New DBA Partner Announcement

New DBA Partner Announcement

Featured Partner: Tokyo Medical and Surgical Clinic

The Foreign Service Benefit Plan (FSBP) proudly welcomes our newest direct billing partner, Tokyo Medical and Surgical Clinic, located in Tokyo, Japan.

Tokyo Medical and Surgical Clinic was established in 1951 with European and U.S. trained doctors caring for the foreign community. Our direct billing arrangement with Tokyo Medical and Surgical Clinic covers routine annual physical exam/screening.* All examinations include a full medical interview conducted by a doctor in native level English as well as comprehensive blood tests. For more details or to make an appointment, call +81 03-3432-6114.

We strive to simplify your care overseas and are delighted to have this billing arrangement. If you have overseas direct billing questions, please visit our FSBP Overseas Partners page on our website, email us, or call us at 202-833-4910 for assistance.

Thank you for being a valued FSBP member.    

*Routine annual physical exam: Member pays no deductible. FSBP pays 100% of covered services.

 
28Mar
Express Scripts News Flash

Express Scripts News Flash

New Multiple Sclerosis Drug, Mayzent, Approved

Novartis received approval on March 26, 2019, for Mayzent® (siponimod) tablets. Novartis slows down disease progression for adult patients who have relapsing forms of multiple sclerosis (MS), including secondary progressive multiple sclerosis (SPMS) with active disease, relapsing remitting multiple sclerosis (RRMS) and clinically isolated syndrome (CIS). The first drug with a specific indication for SPMS, it reduces inflammation and stimulates remyelination in the central nervous system (CNS). Recommended maintenance dosing for most patients is 2mg daily after gradual dose increases starting at 0.25mg on the first day and reaching 1.25mg on day five. Some patients will be maintained on 1mg/day. Mayzent will be dispensed through a large network of specialty pharmacies that does include Accredo. Complete prescribing information is available here.

  • Brand (Generic) Name: Mayzent® (siponimod) tablets
  • Manufacturer: Novartis
  • Date Approved: March 26, 2019
  • Indication: for the treatment of adults with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome (CIS), relapsing remitting disease, and active secondary progressive disease.
  • Dosage Forms Available: 25mg and 2mg tablets
  • Launch Date: Within the next week
  • Estimated Annual Cost: $88,000
  • Specialty Status: Mayzent will be added to Express Scripts’ specialty drug list.
  • MS is an autoimmune condition that destroys myelin sheaths (protective coverings on nerve cells) in the brain and spinal cord. About two-thirds of patients are women and most patients are diagnosed between 20 years and 50 years of age.
  • The most common form, relapsing-remitting MS (RRMS), affects about 85% of the estimated one million Americans who have the disease. Patients with RRMS have periods of active symptoms alternating with remissions -- periods of little or no disease activity. As many as 80% of patients who have RRMS eventually will progress to SPMS.
  • Mayzent is a more selective successor for Gilenya® (fingolimod – Novartis), which was introduced in 2010 as the first FDA-approved and only other sphingosine 1-phosphate (S1P) receptor modulator in the U.S. Drugs in the class reduce inflammation by preventing lymphocytes from filtering into the central nervous system (CNS) from lymph nodes. They also promote remyelination. 
  • S1P receptor modulators may cause significant side effects, though, including increased risk of infection, macular edema and decreased lung function. Women taking one of them should also use contraception since S1P receptor modulators may cause birth defects.
  • Patients taking their first dose of Gilenya, which binds to four S1P receptors, must have pulse, blood pressure and electrocardiogram monitoring during the following six hours. Its use also has been associated with rare cases of progressive multifocal leukoencephalopathy (PML), a potentially fatal brain infection.
  • Mayzent blocks only two of the five S1P receptors within the CNS. Although it may slow heartbeats, it does not require most patients taking it to be observed after the first dose. Additionally, in clinical trials, no symptoms of PML were reported for any of the patients taking it.
  • In the EXPAND clinical trial of 1,651 patients who have SPMS, the risk of confirmed disability progression over three months was 21% less among patients taking 2mg of Mayzent daily as opposed to those participants who took a placebo.
  • Two other S1P receptor modulators are in late stage development for treating MS. After its first submission was refused by the FDA last year, Celgene’s ozanimod was resubmitted on March 25, 2019, for FDA approval to treat relapsing MS. The first phase III clinical trial for ponesimod (Actelion) reaches its primary completion date in the second quarter of 2019. If results from it and other phase III studies are positive, ponesimod could be approved in 2022.
  • Novartis used a Priority Review Voucher to reduce FDA review time for Mayzent.
  • Implications: Express Scripts currently is investigating the data around Mayzent for a possible utilization management strategy. It also will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete.
 
25Mar
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Pediatric Indication for Avycaz 

Allergan’s fixed-dose antibacterial/beta-lactamase inhibitor, Avycaz® (ceftazidime/avibactam), was approved by the U.S. Food and Drug Administration (FDA) on March 14, 2019, to treat children who are at least three months of age. As monotherapy, it treats complicated (associated with an underlying condition) urinary tract infections. In combination with another antibiotic, metronidazole, it is used for complicated infections within the abdomen. Typically, patients who need it have few or no other options for treatment after other drugs have failed. For patients under the age of 18 years, dosing depends on body weight. It is given as a two-hour intravenous (IV) infusion once every eight hours for five days to 14 days. Avycaz is not approved to treat pneumonia for patients younger than 18 years of age. Full prescribing information is available at here.

Another New Indication for Tecentriq

After it was given a new approval last week for treating triple-negative breast cancer, Tecentriq® (atezolizumab - Roche) was granted another new U.S. Food and Drug Administration (FDA) indication on March 18, 2019. In combination with two chemotherapy (chemo) drugs, carboplatin and etoposide, it now is indicated as initial treatment for patients who have extensive-stage small cell lung cancer (ES-SCLC). According to the American Cancer Society (ACS), approximately 230,000 Americans will be diagnosed with lung cancer in 2019. Between 10% and 15% of the new patients will have SCLC, which tends to metastasize faster. SCLC has only two stages. At diagnosis, about one-third of cases are limited -- generally only in a small part of one lung, with or without lymph node involvement on the same side of the chest. By the time they are found, extensive-stage cases have spread throughout one lung, into both lungs and/or outside of the lungs into other areas of the body. The five-year survival rate for ES-SCLC is low – only about 6% to 15%. In clinical trials for Tecentriq to treat ES-SCLC, overall survival time increased by two months (12.3 vs 10.3) and the time until the disease worsened was extended by about one month (5.2 vs 4.3) for patients receiving Tecentriq with chemo, as compared to participants who were treated with chemo alone. Recommended dosing to treat ES-SCLC is 1,200mg infused IV once every three weeks. It should be given before chemo, if all three drugs are administered on the same day. Revised prescribing information is available here.

New Dosage Form for Prograf

Astellas Pharma, Inc. issued a press release on March 18, 2019, to announce that it has launched Prograf® Granules (tacrolimus for oral suspension). A calcineurin-inhibitor immunosuppressant, it is used along with other immunosuppressants, to prevent organ rejection for patients who have received a heart, kidney or liver transplant. Generally, pediatric patients need higher doses than adults, with dosage depending on the type of transplant and the weight of the patient. Some children and older adults have trouble swallowing Prograf capsules, however. The new dose form may be mixed with one or two tablespoons of water at room temperature to drink or give through an oral syringe. Two oral doses should be taken every day 12 hours apart. The labeling for all tacrolimus products contains a boxed warning concerning an increased risk of infections and cancers that may be associated with its use. Patients using Prograf should not consume any foods or drinks that contain grapefruit. Prograf Granules will be dispensed in boxes holding 50 packets of either 0.2mg or 0.3mg doses. Updated prescribing information is available here.

 
21Mar
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Sunosi Approved to Treat Excessive Daytime Sleepiness

On March 20, 2019, the U.S. Food and Drug Administration (FDA) approved Jazz Pharmaceuticals’ Sunosi™ (solriamfetol). The drug, known as a dual-acting dopamine and norepinephrine reuptake inhibitor, is indicated to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA). The recommended starting dose, which is taken once-daily upon awakening, is 75mg for patients with narcolepsy and 37.5mg for patients with OSA. The dose may be increased every three days to a maximum dose of 150mg once daily. Launch, which depends on the timeline for scheduling as a controlled substance by the U.S. Drug Enforcement Agency (DEA), is planned for late June. Complete prescribing information is available here.

  • Brand (Generic) Name: Sunosi™ (solriamfetol) tablets
  • Manufacturer: Jazz Pharmaceuticals
  • Date Approved: March 20, 2019
  • Indication: to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea
  • Dosage Forms Available: 75mg and 150mg tablets
  • Launch Date: Expected in late June after DEA scheduling
  • Estimated Annual Cost: Pricing information is not available at this time.
  • Narcolepsy is estimated to affect about 200,000 Americans with only about a quarter of these patients being diagnosed and receiving treatment.
  • OSA, on the other hand, impacts approximately 25 million adults. According to Jazz, about 50% of patients with OSA experience excessive daytime sleepiness. While many benefit from the use of continuous positive airway pressure (CPAP) therapy, up to one third of these patients continue to have symptoms.
  • Sunosi is expected to be available after final controlled substance scheduling by the U.S. Drug Enforcement Agency (DEA), which can take up to 90 days after FDA approval.
  • Once available, Sunosi will compete with generically available Nuvigil® (armodafinil - Cephalon) and Provigil® (modafinil - Cephalon), both of which are approved for patients with excessive sleepiness associated with narcolepsy and OSA. They are also approved for use in shift work disorder.

Implications: Express Scripts currently is investigating the data around Sunosi for a possible utilization management strategy. It also will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete.

 
20Mar
The Governor of Iowa has issued a State of Emergency due to flooding

The Governor of Iowa has issued a State of Emergency due to flooding

The Governor of Iowa has issued a State of Emergency due to flooding for the following counties: Butler, Cerro Gordo, Clayton, Hancock, Harrison, Humboldt, Ida, Iowa, Kossuth, Mills, Monona, Montgomery, O'Brien, Pottawattamie, Sioux, Webster, Winnebago, Winneshiek, Woodbury, Worth and Wright. 

Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an Emergency Access to Benefits/Refill Too Soon override that allows pharmacies, at the point of sale (POS), to override certain benefit coverage/edits such as an early refill during a government-defined emergency. In addition, if your home delivery of medications is affected by the emergency, you may provide a temporary alternate address (either online at www.express-scripts.com or by calling 1-800-818-6717) or request a local fill as needed.

The Emergency Access to Benefits/Refill Too Soon override process will be implemented with an effective date of March 14, 2019, and expiration date of April 13, 2019.

 
20Mar
Express Scripts News Flash

Express Scripts News Flash

On March 19, 2019, the U.S. Food and Drug Administration (FDA) approved Zulresso™ (brexanolone – Sage Therapeutics) injection for infusion, the first drug specifically indicated to treat postpartum depression (PPD). It is a neuroactive steroid gamma-aminobutyric acid (GABA)A receptor positive modulator that partially stimulates GABAA receptors in the brain. Zulresso will be given by trained healthcare providers in registered healthcare facilities as an intravenous (IV) infusion over 60 hours at varying dosage rates. Due to the risks of extreme sleepiness and lost or altered consciousness during the infusion, Zulresso has both a boxed warning and a risk evaluation and mitigation strategy (REMS). Patients, who must be enrolled in the REMS before receiving treatment, need continual monitoring during the entire infusion. Full antidepressive effects of Zulresso begin within a few days, however, as compared with the several weeks needed for most oral antidepressants to reach their peak effectiveness. Launch, which depends on the timeline for scheduling as a controlled substance by the U.S. Drug Enforcement Agency (DEA), is planned for late in June. It will only be available through hospitals and clinics; Accredo will not be dispensing Zulresso. Complete prescribing information is available here.

  • Brand (Generic) Name: Zulresso™ (brexanolone) injection
  • Manufacturer: Sage Therapeutics
  • Date Approved: March 19, 2019
  • Indication: Postpartum depression
  • Dosage Forms Available: Single-use 100mg /20mL vials
  • Launch Date: Expected in late June after DEA scheduling
  • Estimated Annual Cost: Wholesale acquisition cost (WAC) will be $34,000 per infusion
  • Specialty Status: Zulresso will be added to Express Scripts’ specialty drug list.
  • Depression is a common complication after childbirth. PostpartumDepression.org estimates that up to 80% of new mothers have “baby blues”, relatively short, mild forms of depression after giving birth.
  • However, approximately 11% of new American mothers (about 400,000 women) experience longer-lasting, more severe PPD. It can cause feelings of guilt or insignificance, impairments in physical functioning, problems with reasoning or even thoughts of suicide. Serious PPD can begin during the pregnancy, shortly after the birth or weeks later. If untreated, symptoms may persist and depression may become chronic.
  • Presently, PPD most commonly is treated with oral antidepressants. They include selective serotonin reuptake inhibitors (SSRIs), such as sertraline; serotonin-norepinephrine reuptake inhibitors, such as duloxetine; and extended-release bupropion. They may take several weeks to reach their full effectiveness. Antidepressants from other classes are not recommended.
  • For administration, Zulresso will be diluted to 100mL of solution and given IV at a recommended dose of 30mcg/kg/hour for the first four hours, increased to 60mcg/kg/hour until hour 24, increased again to 90mcg/kg/hour for hours 24 to 52, decreased back to 60mcg/kg/hour for the next four hours and then reduced back to 30mcg/kg/hour for the final four hours. Once diluted for administration, Zulresso is stable at room temperature for only 12 hours, so at least five IV bags will be used for each patient.
  • In the clinical trials that lead to its approval, patients treated with Zulresso showed more improvement in depression severity scores than those who received a placebo infusion. Treatment effects lasted at least a month after the infusion was completed, as well.
  • Because Zulresso may cause patients using it to become extremely sleepy or lose consciousness during the infusion, it carries a boxed warning and has a REMS program. It will be given to enrolled patients under continual supervision by trained providers and in certified healthcare facilities. It also will be scheduled as a controlled substance.
  • It was approved through the FDA’s Breakthrough Therapy and Priority Review pathways.
  • Implications: Express Scripts currently is investigating the data around Zulresso for a possible utilization management strategy. It also will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete.
 
18Mar
The Governor of Nebraska has issued a State of Emergency due to flooding

The Governor of Nebraska has issued a State of Emergency due to flooding

The Governor of Nebraska has issued a State of Emergency due to flooding. All counties in Nebraska are impacted.

Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an Emergency Access to Benefits/Refill Too Soon override that allows pharmacies, at the point of sale (POS), to override certain benefit coverage/edits such as an early refill during a government-defined emergency. In addition, if your home delivery of medications is affected by the emergency, you may provide a temporary alternate address (either online at www.express-scripts.com or by calling 1-800-818-6717) or request a local fill as needed.

The Emergency Access to Benefits/Refill Too Soon override process will be implemented with an effective date of March 15, 2019 and expiration date of April 14, 2019

 
18Mar
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Rocklatan Approved to Treat Glaucoma

Aerie Pharmaceuticals received approval from the U.S. Food and Drug Administration (FDA) on March 12, 2019, for a new combination eye drop to treat open-angle glaucoma and ocular hypertension. Rocklatan™ (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005% is a fixed-dose combination of  Aerie’s Rhopressa® (netarsudil ophthalmic solution) 0.02%, the only FDA approved Rho kinase (ROCK) inhibitor with a prostaglandin analog. Rhopressa increases filtration of fluid from the eyes through the trabecular mesh, which are small areas of spongy tissue in the front of the eyes. They drain fluids from the eyes into small blood vessels. Rhopressa also may decrease the production of fluid inside the eye and/or prevent fiber buildup in the trabecular regions. The prostaglandin, latanoprost, also promotes fluid drainage, but through a different pathway. Recommended daily dosing is one drop in each eye. A second-quarter 2019 launch is being planned. Analysts expect the wholesale acquisition price (WAC) to be slightly higher than Rhopressa’s WAC of $100 per bottle. Express Scripts currently is investigating the data around Rocklatan for a possible utilization management strategy. It also will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete. Full prescribing information for Rocklatan is available here.


FDA Approves Tecentriq to Treat Triple-Negative Breast Cancer

On March 8, 2019, the U.S. Food and Drug Administration (FDA) granted accelerated approval for Tecentriq® (atezolizumab - Roche), to treat adult patients who have locally advanced or metastatic triple-negative breast cancer (TNBC) that cannot be removed by surgery. TH tumors also must express programmed death receptor-ligand 1 (PD-L1), as verified by an FDA-approved diagnostic test. The first immunotherapy drug approved for breast cancer, it helps the body’s immune system attack cancer cells. Tecentriq will be used in combination with a Celgene chemotherapy drug, Abraxane® (paclitaxel protein-bound particles for injectable suspension [albumin-bound]) for its TNBC indication. About 15% of breast cancers are TNBC. That is, they do not have receptors for estrogen and progesterone and they do not produce excessive amounts of human epidermal growth factor receptor-2 (HER2) protein, which makes them resistant to many targeted drugs. TNBC patients tend to be younger than those who have other types of breast cancer. It is aggressive – likely to spread quickly, recur rapidly and average only about 12 months to 15 months in overall survival time. In the clinical trial that lead to approval, overall survival was 21.3 months for patients treated with Tecentriq and Abraxane compared to 17.6 months for patients using only Abraxane. Recommended dosing is 840mg given by intravenous (IV) infusion over 60 minutes on the first and 15th days of 28-day cycles. Additional trials will be needed to confirm effectiveness before the FDA grants full approval. Tecentriq’s complete prescribing information is available here.

Fourth Herceptin Biosimilar Approved

Trazimera™ (trastuzumab-qyyp), Pfizer’s biosimilar to Herceptin® (trastuzumab – Genentech) was U.S. Food and Drug Administration (FDA) approved on March 11, 2019. It is indicated to treat breast cancer, metastatic gastric cancers and gastroesophageal junction adenocarcinomas that over produce human epidermal growth factor receptor-2 (HER2). Dosing varies according to the condition being treated. All trastuzumab products have boxed warnings that they may cause birth defects, heart failure, respiratory distress or severe allergic reactions. Although Pfizer has not announced launch or pricing plans, Trazimera will compete with three other Herceptin biosimilars that the FDA approved previously – Herzuma® (trastuzumab-pkrb – Celltrion/Teva), Ogivri® (trastuzumab-dkst – Mylan/Biocon) and Ontruzant® (trastuzumab-dttb – Samsung Bioepsis), but that have not yet been launched. None of the biosimilars is interchangeable with Herceptin or any of its other biosimilars. IQVIA estimated Herceptin’s 2018 sales in the U.S. at about $2.9 billion. Express Scripts currently is investigating the data around Trazimera for a possible utilization management strategy. It also will be excluded at launch on the Express Scripts NPF until our formulary development process is complete. Full prescribing information is available here.

New Indication for Dupixent

The U.S. Food and Drug Administration (FDA) approved an additional pediatric indication for Dupixent® (dupilumab) on March 11, 2019. Already indicated to treat adolescents and adults who have eosinophilic asthma and adults who have moderate-to-severe atopic dermatitis (eczema), it now also can be used for treating patients as young as 12 years old who have moderate-to-severe atopic dermatitis that has not responded to prior therapies. Atopic dermatitis is a chronic inflammatory disease that results in cracked, dry, itchy or oozing skin. Jointly developed by Sanofi Genzyme and Regeneron, Dupixent is an interleukin-4 alpha receptor (IL-4Rα) inhibitor that interrupts the inflammatory process. Given as subcutaneous (SC) injections, it can be self-administered or injected by a caregiver. For preteen and teen-aged patients who weigh less than 60Kg (about 130 pounds) the recommended starting dose is 400mg followed by 200mg once every two weeks. The adult dose of a 600mg loading dose and then 300mg every other week is recommended for pediatric patients who weigh 60Kg or more. For prescribing information is available here.

New Valsartan Generic Approved

Under a streamlined review process, the U.S. Food and Drug Administration (FDA) approved Alkem Laboratories’ generic angiotensin receptor blocker (ARB), valsartan, on March 12, 2019. ARBs are used widely to treat high blood pressure and heart disease. Although generic valsartan has been available in the U.S. since 2014, multiple manufacturers recently have had to recall much of it and other generic ARBs due to potentially cancer-causing nitrosamine impurities. The contaminants were introduced when the raw material suppliers changed their refining processes. The FDA collaborated with Alkem to assure that different, safer production methods are used for the new generic. Working with additional manufacturers, as well, the FDA plans to approve more new uncontaminated ARB generics so that the current shortage of them is resolved as quickly as possible.

Two Products Discontinued

After announcing its pending discontinuation last March, CSL Behring stopped shipping Monoclate-P® (antihemophilic factor VIII [human]) in December 2018. As an older therapy that is extracted from human blood plasma to treat hemophilia A, it lost sales to newer, antihemophilic factors that are made by recombinant technologies. The company stated that no effectiveness or safety concerns influenced the decision. It was only for business considerations.
Similar commercial reasons also are prompting the April 1, 2019, market withdrawal for both strengths (5% and 10%) of Flebogamma® DIF (immune globulin intravenous [human] – Grifols USA). Given by IV infusion, Flebogamma 10% is used to treat idiopathic thrombocytopenic purpura (ITP); both strengths treat primary immune thrombocytopenia (ITP), severe combined immunodeficiency, x-linked agammaglobulinemia and other primary immunodeficiencies. Grifols is working with patients and prescribers to switch patients to Gamunex®-C (immune globulin injection [human], 10% caprylate/chromatography purified) as it phases out Flebogamma.

 
12Mar
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Adhansia XR Approved for ADHD
Adlon Therapeutics, a subsidiary of Purdue Pharma, was granted U.S. Food and Drug Administration (FDA) approval on Feb. 27, 2019, for Adhansia XR™ (methylphenidate, extended-release capsules C-II).  It is indicated as a once-daily dose taken in the morning to treat attention deficit hyperactivity disorder (ADHD) for patients at least six years old. Available in six strengths, the capsules may be swallowed or their contents sprinkled onto a soft food and consumed right away. With a recommended starting dose of 25mg, no more than 70mg should be taken daily by children or 85mg by adults. A boxed warning on the labeling cautions that all central nervous system (CNS) stimulants, including methylphenidate, carry risks for abuse and dependence. Launch and pricing plans have not been announced. Adhansia XR is not interchangeable with any other methylphenidate products. Express Scripts currently is investigating the data around Adhansia XR for a possible utilization strategy. It will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete. Full prescribing information is available here.

Lilly to Market Lower-Priced Insulin Lispro
Eli Lilly announced on March 4, 2019, that it will be releasing Insulin Lispro, a half-priced version of its rapid-acting insulin Humalog® (insulin lispro injection 100 Units/mL). Injected subcutaneously (SC) to treat diabetes, Insulin Lispro is used right before or after a meal to manage glucose spikes from food. It also can be used through an insulin pump. Typically, a longer-acting insulin also is used to provide a steady level of insulin that mimics natural insulin production. Insulin Lispro will be launched in the U.S. as soon as distribution agreements are in place. It will be available in 10mL vials at a list price of $137.53 and in packages of five KwikPens at $265.20. Humalog 200 Units/mL currently remains brand-only. Insulin Lispro will be excluded at launch on the Express Scripts NPF until our formulary development process is complete.

 
7Mar
Alabama has issued a State of Emergency due to tornadoes

Alabama has issued a State of Emergency due to tornadoes

The governor of Alabama has issued a State of Emergency due to tornadoes.

Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an Emergency Access to Benefits/Refill Too Soon override that allows pharmacies, at the point of sale (POS), to override certain benefit coverage/edits such as an early refill during a government-defined emergency. In addition, if your home delivery of medications is affected by the emergency, you may provide a temporary alternate address (either online at www.express-scripts.com or by calling 1-800-818-6717) or request a local fill as needed.

The Emergency Access to Benefits/Refill Too Soon override process will be implemented with an effective date of March 5, 2019, and expiration date of April 5, 2019.

 

 
7Mar
Express Scripts News Flash

Express Scripts News Flash

Janssen’s Spravato™ (esketamine) CIII nasal spray received approval from the U.S. Food and Drug Administration (FDA) on March 5, 2019. It will be used, along with an oral antidepressant, for adult patients who have major depression that has not been relieved by two or more appropriate length and dose rounds of treatment with other antidepressants. Spravato will be available in single-use devices containing 28mg (two sprays). For the first four weeks, it will be dosed twice a week beginning at 56mg (two sprays followed by two more approximately five minutes later) for the first time, and then either 56mg or 84mg for the next seven treatments. For maintenance, the recommendation is either 56mg or 84mg once a week for the next four weeks, and then either dosed once a week or once every two weeks. Spravato will be distributed directly to certified treatment centers that have specially trained providers. Patients will administer Spravato, but they will be supervised by a healthcare professional during each treatment and then monitored for a minimum of two hours after. A boxed warning, a risk evaluation and mitigation strategy (REMS) and a patient Medication Guide detail possible sedation, dissociation, suicidal thoughts and misuse associated with using Spravato. It is expected to be launched later this month. It will be available through a small network of specialty pharmacies that includes Accredo. Complete prescribing information is available here.

  • Brand (Generic) Name: Spravato™ (esketamine) CIII Nasal Spray
  • Manufacturer: Janssen Pharmaceuticals
  • Date Approved: March 5, 2019
  • Indication: for treatment-resistant depression in adults, in combination with an oral antidepressant
  • Dosage Forms Available: Single-use nasal spray devices containing a total of 28mg of esketamine delivered in two sprays
  • Launch Date: Launch is expected later this month. The number of certified treatment centers will increase over time.
  • Estimated Annual Cost: The wholesale acquisition cost (WAC) for each dose is between $590 and $885 ($295 per device).
  • Specialty Status: Spravato will be added to Express Scripts’ specialty drug list.
  • Major depression persists for approximately one-third of patients (about 7 million American adults) who have been treated at least twice for sufficient lengths of time with suitable amounts of antidepressant drugs.
  • As a nasal spray, Spravato is absorbed quickly and begins to relieve depression faster than oral antidepressants.
  • Although its exact mechanism of action is not understood completely, Spravato acts differently than other available antidepressant drugs. It is believed to reestablish connections between synapses by blocking N-methyl-D-aspartate (NMDA) receptors in the brain.
  • Five clinical trials tested its use along with an oral antidepressant versus a placebo spray and oral antidepressant. In the long-term study of its use for maintenance, depression returned for about 27% of Spravato-treated patients, but for 45% of patients using a placebo.
  • A REMS, patient Medication Guide and boxed warning caution that Spravato is sedating, that it may cause changes in perception, that it may lead to suicidal thoughts and that it may be abused. Its use will be limited to certified healthcare facilities.
  • Spravato was approved under the FDA’s Fast Track and Breakthrough Therapy programs.
  • Implications: Express Scripts currently is investigating the data around Spravato for a possible utilization management strategy. It also will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete.
 
5Mar
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Approval for Herceptin Hylecta

The U.S. Food and Drug Administration (FDA) approved Genentech’s Herceptin Hylecta™ (trastuzumab/hyaluronidase-oysk) on Feb. 28, 2019. Herceptin is a monoclonal antibody that has been available in the U.S. as an intravenous (IV) form since 1998. This new subcutaneous (SC) formulation is indicated for certain types of HER-2 positive breast cancer. As monotherapy, it will treat patients who have metastatic HER-2 positive breast cancer that has been treated with chemotherapy (chemo) at least twice. In combinations with chemo and other drugs, it can be used first-line or in early stages as treatment for HER-2 positive breast cancers that have other specific genetic characteristics. It can be given over two to five minutes as compared to the 30 to 90 minutes needed for an IV infusion. All trastuzumab products have boxed warnings that they may cause birth defects, heart failure, respiratory collapse or severe allergic reactions. An April launch date is anticipated for Herceptin Hylecta, but its pricing is not yet public. It will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete. Herceptin Hylecta will be added to Express Scripts’ specialty drug list. Prescribing information is available here.

Lotemax SM Approved

The U.S. Food and Drug Administration (FDA) approval for Lotemax® SM (loteprednol etabonate ophthalmic gel – Bausch + Lomb) 0.38% was announced on Feb. 25, 2019. A new strength and formulation of the ophthalmic corticosteroid, it is indicated to reduce inflammation and pain in the eyes after surgical procedures such as cataract removal. For use three times a day in the affected eye(s), it should be used for two weeks beginning on the day after the procedure. Lotemax SM is formulated as sub-micron (SM) sized particles that dissolve into tears much faster and diffuse into the inner eye about twice as well as the previously available Lotemax gel. It is expected to be launched in April 2019. Express Scripts currently is investigating the data around Lotemax SM for a possible utilization management strategy. It will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete. Its full prescribing information is available here.

Generic Launched for Ranexa
Under a settlement agreement, Lupin Pharmaceuticals released AB-rated generics to Ranexa® (ranolazine extended-release - Gilead) tablets in both strengths – 500mg and 1,000mg – on Feb. 27, 2019. Lupin says it will have exclusivity for the generic, which is used to treat chronic angina. No cost information is available. For 2018, U.S. sales of Ranexa were about $945 million, according to IQVIA.

FDA Approves Lonsurf to Treat Gastric Cancers

Taiho Oncology’s Lonsurf® (trifluridine/tipiracil) tablets received U.S. Food and Drug Administration (FDA) approval for a second indication on Feb. 22, 2019. Originally approved in 2015 as second- or third-line treatment for adults who have metastatic colorectal cancer, it now also is indicated for metastatic adenocarcinomas of the stomach or gastroesophageal junction for adults who have had two or more courses of therapy. It combines trifluridine, a nucleoside metabolic inhibitor that interrupts DNA production and cell multiplication, with tipiracil, a thymidine phosphorylase inhibitor that limits the breakdown of trifluridine. Lonsurf is taken along with food twice a day on days one through five and eight through 12 on 28-day cycles. Its recommended dosing is 35mg/m2/dose with an upper limit of 80mg per dose. The American Cancer Society estimates that about 27,500 new cases of gastric cancers will be discovered in the United States in 2019. Almost all are adenocarcinomas, most are in patients age 50 years and older and they are more common for men than women. Because they develop slowly with very few symptoms, many cases are in advanced stages before being diagnosed. Lonsurf’s complete prescribing information is available here.

New Formulation Approved for Colchicine

ROMEG Therapeutics has revealed that Gloperba® Oral Solution, its liquid form of colchicine, was U.S. Food and Drug Administration (FDA) approved on Jan. 30, 2019. Colchicine, which has been used for centuries, treats gout and prevents gout flare-ups. It already is available in oral capsules and tablets and also as a topical gel. Gloperba is indicated to be taken twice every day in doses of 0.6mg (5mL) each to keep adults who have gout from experiencing attacks. Although the daily dose should not be more than 1.2mg, decreasing the dose for patients who have kidney or liver conditions will be easier with the liquid form than with other marketed forms of the drug. Gloperba has not been studied for treating acute flares and it does not relieve pain associated with gout. ROMEG plans to launch it this summer in bottles containing 150mL of solution. Express Scripts currently is investigating the data around Gloperba for a possible utilization management strategy. It will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete. Full prescribing information is available here.

Liquid Form of Levothyroxine Approved

Tirosint®-SOL (levothyroxine oral solution – IBSA Pharma) was launched in the U.S. on March 1, 2019. It is the first oral liquid formulation for a thyroid hormone to be approved by the U.S. Food and Drug Administration (FDA). It replaces natural thyroid hormones for patients who do not produce enough, and limits the activity of pituitary thyrotropin for patients who have surgery and radiation to treat some types of thyroid cancer. To be dispensed in 12 different strengths, it will be packaged in cartons containing 30 individual-dose plastic vials. It can be swallowed directly from the vial or a spoon, mixed with water to drink or delivered through a gastric feeding tube. All oral thyroid products should be taken every morning an hour or more before food and at least four hours before any calcium or iron supplements. Prescribing information is available here.
 

Tremfya Self-Injector Approved

The U.S. Food and Drug Administration (FDA) has approved Tremfya® (guselkumab - Janssen) One-Press injector. Tremfya is a monoclonal antibody that inhibits the action of interleukin 23 (IL-23) for treating adults who have moderate to severe plaque psoriasis and who are candidates for systemic treatment or phototherapy. Previously available only in prefilled syringes, it is given SC in doses of 100mg once every eight weeks after two initial doses four weeks apart. The new injector was easier to use for most patients in a clinical trial that lead to its approval. Disposal was less complicated, as well, since the self-injector needle retracts into the unit after use. Complete prescribing information is available here.

Approval Expanded for Soliqua

On Feb. 27, 2019, the U.S. Food and Drug Administration (FDA) extended the indications for Sanofi’s Soliqua® 100/33 (insulin glargine 100 Units/lixisenatide 33mcg/mL) injection. It originally was approved in July 2016 for adult patients who have type 2 diabetes that is not well controlled by diet, exercise and treatment with Adlyxin™ (lixisenatide - Sanofi) or a long-acting insulin, such as Lantus (insulin glargine - Sanofi). Soliqua 100/33 now can be used, along with diet and exercise, by patients whose type 2 diabetes is not managed by oral antidiabetic medications. Soliqua 100/33 is injected SC once daily one hour or less before the patient’s first meal. Recommended dosing depends on multiple factors that include the patient’s blood sugar monitoring results, physical activity and concurrent medical conditions. No more than 60 Units/20mcg should be used in any one day, however. Soliqua 100/33 is dispensed in disposable pen injectors containing 3mL of drug. Prescribing information is available here.

 
4Mar
State of Emergency issued in California due to Flooding

State of Emergency issued in California due to Flooding

The governor of California has issued a State of Emergency due to flooding caused by winter storms in all counties.

Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an Emergency Access to Benefits/Refill Too Soon override that allows pharmacies, at the point of sale (POS), to override certain benefit coverage/edits such as an early refill during a government-defined emergency. In addition, if your home delivery of medications is affected by the emergency, you may provide a temporary alternate address (either online at www.express-scripts.com or by calling 1-800-818-6717) or request a local fill as needed.

The Emergency Access to Benefits/Refill Too Soon override process will be implemented with an effective date of Feb. 21, 2019 and expiration date of March 23, 2019.

 
19Feb

AFSPA is closed due to inclement weather

Due to inclement weather and following the decision by the Office of Personnel Management, AFSPA will be closed on Wednesday, February 20,  2019. We apologize for the inconvenience.

 

 
19Feb
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

FDA Approves Egaten to Treat Fascioliasis

On Feb. 13, 2019, the U.S. Food and Drug Administration (FDA) approved Egaten® (triclabendazole) tablets. An antiparisitic, Egaten is indicated to treat fascioliasis (liver flukes), a disease caused by flatworms that infect humans and animals through contaminated water or food. In the United States, it is carried mainly by a species of snails. Fascioliasis is rare in the US – with only a few locally acquired human cases reported in California, Florida and Hawaii. Globally, however, it affects over 2 million patients, primarily in tropical areas of Africa, Asia and South America. Residents of the U.S. who travel in areas where it is common may become infected. Acute fascioliasis infection results in abdominal pain, fever, nausea, rash and vomiting. If untreated, the parasites concentrate in the liver, gallbladder and bile ducts, where they produce chronic pain, inflammation and blockages. Indicated for patients as young as six years old, Egaten is taken as two 10mg/kg doses given 12 hours apart to eradicate the flukes. Novartis, which has been supplying it to the World Health Organization (WHO) for about 15 years, has promised to keep contributing an average of 600,000 doses annually at least through 2022. U.S. distribution and pricing plans have not yet been announced. Because fascioliasis is classified as a neglected tropical disease, Egaten qualifies for a Tropical Disease Priority Review Voucher, which Novartis can use to accelerate a future FDA review or sell to another company. Egaten will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete. Prescribing information is available here.

First True Generic Launched for Advair Diskus
Mylan’s Wixela™ Inhub™, the first interchangeable generic for GlaxoSmithKline’s Advair Diskus® (fluticasone propionate/salmeterol inhalation powder) is available on the U.S. market. Inhaled two times daily, it treats asthma for patients age four years and older. It also is used as maintenance treatment for chronic obstructive pulmonary disease (COPD). In the same three strengths available for Advair Diskus, Wixela Inhub was released at wholesale acquisition costs (WAC) approximately 70% below the brand and 67% below the authorized generic, which was introduced Feb. 8, 2019. U.S. sales for Advair Diskus amounted to about $4.2 billion in 2017, as reported by IQVIA.

Mayne Pharma Launches Lexette

Lexette™ (halobetasol) foam, 0.05% was introduced in the U.S. the week of Feb. 10, 2019. It is the first topical foam formulation of the high strength corticosteroid, which is used to treat adults who have plaque psoriasis. Recommended dosing is a thin layer rubbed lightly into affected areas twice a day for no longer than two weeks. It should not be used in the eyes or on the face, genital area, mucous membranes or underarms. Pricing information is not yet available, but it will be dispensed in 50Gm canisters, either singly or in boxes containing two cans. Mayne will have marketing exclusivity until May 2021. Express Scripts currently is investigating the data around Lexette for a possible utilization management strategy. Prescribing information is available here.

New Dosing for Darzalex

Darzalex® (daratumumab – Janssen) was granted U.S. Food and Drug Administration (FDA) approval for a new dosing regimen on Feb.  8, 2019. A CD38-directed antibody, it is indicated alone or combined with other drugs on three-week or four-week cycles to treat multiple myeloma. It is administered as a dose of 16mg/kg in 1,000mL of sodium chloride by intravenous (IV) infusion. Previously, the infusion rate of 50mL to 200mL per hour resulted in infusions lasting up to 20 hours on the first day of treatment since doses are started at the slowest rate. The rate is gradually increased if the patient can tolerate side effects. Now the first dose can be divided into two doses with 8mg/kg given in 500mL of sodium chloride on each of two consecutive days, making the first treatment less stressful for new patients. Subsequent infusions will be at full strength, but they may be able to be given at a faster rate. In a clinical trial comparing the two regimens, no significant differences were found in effectiveness and side effects between the full dose and the divided dose. Prescribing information for Darzalex is available here.

 
17Feb

AFSPA IS CLOSED IN OBSERVANCE OF THE HOLIDAY

AFSPA is closed in observance of the holiday. We will resume our normal business hours at 8:30 am EST on Tuesday, February 19, 2019.
 

 
12Feb
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Jeuveau, New Cosmetic Injection, Approved
Evolus, Inc. received approval from the U.S. Food and Drug Administration (FDA) on Feb. 1, 2019, for Jeuveau™ (prabotulinumtoxinA-xvfs). It is a neuromuscular blocker for temporary improvement in the appearance of moderate to severe glabellar (frown) lines between the eyebrows in adults. Currently, Jeuveau is approved only for cosmetic use; it has no other indications. It will be injected by a healthcare professional intramuscularly (IM) into five separate sites on the forehead no more than once every 90 days. Although the total recommended dose for each treatment is 20 units, it will be supplied only in 100-unit single-use vials. In its clinical trials, results, duration of effectiveness and side effects were comparable to other cosmetic botulinum products available on the U.S. market. None of the products are interchangeable, however. Evolus will release Jeuveau nationwide to physician offices and clinics this spring. Its initial list price is expected to be approximately 70% to 80% of the cost for Botox® Cosmetic (onabotulinumtoxinA - Allergan). All botulinum products carry boxed warnings that their effects may spread to areas far from the injection sites, potentially causing adverse reactions that rarely could include serious breathing and/or swallowing problems. Both mild and severe side effects may occur immediately or be delayed until long after the injections have been administered. Full prescribing information is available here.

FDA Approves Generic for Zovirax Cream
On Feb. 4, 2019, the U.S. Food and Drug Administration (FDA) gave final approval to Perrigo for its AB-rated generic of Zovirax® Cream (acyclovir cream, 5% - Valeant). It is a topical treatment for patients age 12 and older who have cold sores that are caused by herpes simplex virus. Therapy is started as soon as cold sores appear and the recommended dosing is applications to the affected areas of the lips and face five times a day for four days. Perrigo plans to launch acyclovir cream, 5% later in February. Acyclovir ointment, 5% has been available from several generic companies since 2013. Sales for Zovirax Cream, 5% reached about $92 million in 2018, as estimated by IQVIA

 
10Feb

AFSPA is opening late 2/11/2019

Due to inclement weather and following the decision by the Office of Personnel Management, AFSPA will open on a delayed schedule on Monday, February 11,  2019. We will assess staff levels on an ongoing basis with the goal of commencing regular business operations as soon as possible.

Thank you.

 
8Feb
Express Scripts News Flash

Express Scripts News Flash

Cablivi Approved to Treat Acquired Thrombotic Thrombocytopenic Purpura
On Feb. 6, 2019, Sanofi announced the U.S. Food and Drug Administration (FDA) approval for Cablivi® (caplacizumab-yhdp). The first drug that the FDA specifically has approved to treat acquired thrombotic thrombocytopenic purpura (aTTP), it is indicated for use along with both an immunosuppressant and plasma exchange (plasmapheresis). aTTP is a rare disease that causes blood clots in small blood vessels. The first Cablivi treatment is given by a healthcare provider as a single intravenous (IV) injection 15 minutes or more before plasma exchange. A second dose is administered subcutaneously (SC) after the exchange is finished. Then, Cablivi is used as a once-a-day, SC injection that may be administered by the provider, the patient or a caregiver for 30 days beyond the last plasma exchange. If signs of persistent underlying disease remains after this course of therapy, treatment may be extended for a maximum of an additional 28 days. Launch is planned for late in the first quarter of 2019. Complete prescribing information is available here.

  • Brand (Generic) Name: Cablivi® (caplacizumab-yhdp)
  • Manufacturer: Sanofi
  • Date Approved: February 6, 2019
  • Indication: to treat adults who have attacks of acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy
  • Dosage Forms Available: single-dose vials containing 11mg of Cablivi powder for reconstitution and administration as an intravenous or subcutaneous injection
  • Launch Date: late in the first quarter of 2019
  • Estimated Annual Cost: Wholesale acquisition cost (WAC) has been set at $270,000 for an average attack
  • Specialty Status: Cablivi will be added to Express Scripts’ specialty drug list.
  • aTTP is a very rare condition believed to affect fewer than 2,000 adults in the United States. It is caused by antibodies that attack an enzyme (ADAMTS13), which metabolizes von Willebrand Factor (vWF). One of the agents that promotes blood clotting, vWF helps platelets stick to sites of injury. However, if it is not broken down adequately, blood clots can develop in small blood vessels. Results include reduced platelet counts (thrombocytopenia), low red blood cell levels (microangiopathic hemolytic anemia) and decreased local blood supply (ischemia). Eventually, damage to organs such as the brain, heart and kidneys can be fatal.
  • Current treatment for an aTTP episode is once-daily plasma exchange along with high doses of prednisone, or another corticosteroid, to reduce immune response. Plasma exchange filters out vWF particles and the antibodies that destroy ADAMTS13 by replacing the patient’s blood plasma with donated plasma. It continues until platelet counts level off at 150 billion or more per liter of blood for at least two days.
  • A humanized recombinant monoclonal antibody, Cablivi blocks vWF fragments and keeps them from forming blood clots through decreasing its contact with platelets.
  • All patients in clinical trials also received standard plasma exchange and immunosuppression. In one trial, the time to achieve a normal level of platelets was just under three days for patients treated with Cablivi, but almost five days for patients receiving a placebo. Treated patients in a second study were 50% more likely to recover normal platelet levels. Compared to 38.4% of patients given a placebo, 12.7% of patients using Cablivi had a relapse of aTTP. Additionally, fewer deaths, hospitalizations and blood clots occurred among Cablivi-treated patients. Plasma exchange duration averaged 5.8 days for treated patients versus 9.4 days for placebo recipients.
  • Cablivi was approved under the FDA’s Fast Track, Priority Review and orphan programs.
  • Implications: Express Scripts currently is investigating the data around Cablivi for a possible utilization management strategy. It also will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete.
 
6Feb
From the CEO

From the CEO

Greetings and Welcome to February 2019! The new year is well underway, and the December holidays are but a memory. Now it’s time to focus on what we want to accomplish in 2019. I am sure your goals and aspirations are numerous. If any of your goals focus on your health, I hope you will use the Foreign Service Benefit Plan (FSBP)’s services and programs to help you on your health journey.

Your Health Matters

Our new online platform (www.aetnanavigator.com) offers many enhanced functions and services that you can tailor to meet your individual needs. I invite you to log into Aetna Navigator and explore the "Stay Health" options. As health care becomes more personalized, your insurance plan should provide the tools to engage in your own wellness journey.

With this in mind, we have chosen the 2019 theme of “Commitment to Member Engagement.” Throughout the year we will highlight the various programs and services that are available to help you get healthy and stay healthy.

February is American Heart Month

According to the American Heart Association (https://www.heart.org/), cardiovascular disease — including heart disease, stroke, and high blood pressure — is responsible for one out of every three deaths. It is the No. 1 killer of American women and men, and it is a leading cause of serious illness and disability. If you have high blood pressure, I encourage you to take steps to control it. Make sure to complete your routine physical examination, which FSBP covers at 100% when you visit a provider that is in-network or outside the United States. Monitoring your blood pressure is the best form of prevention.

FSBP's 2019 Wellness Program

To assist with managing your blood pressure and other common conditions, FSBP enhanced its wellness program for 2019. The Simple Steps to Living Well Together helps you identify your health risks and achieve your health goals. Plus, you can earn financial rewards to be added to your Wellness Incentive Fund Account.

Step 1 can evaluate your health risks and help detect health conditions early. Step 2 measures certain physical attributes that can identify underlying medical issues. The new Step 3 identifies members with certain conditions who may benefit from our engagement programs.

Every month, the Plan will contact qualified members directly to submit documentation of completion or participate in recommended wellness programs. The initial outreach begins in late April, to allow time for your new-year claims to be assessed for eligibility. Over the next few months, I plan to provide more details about the improved Simple Steps. The program focuses more on rewarding your efforts to achieve and maintain good health.

Tax Documents

FSBP members will receive the IRS Form 1095-B by March 2, 2019, due to an extension from the original January 31 date granted by the IRS. This form confirms that you had minimal essential coverage while you were enrolled in FSBP in 2018. If you have questions about the IRS Form 1095-B, or about lost or incorrect forms, please contact us at 202-833-4910 or at [email protected]. Please note, the 1095-B form is not needed to file your tax return, but it should be kept in your tax file for the year 2018.

We hope your family stays warm and healthy this winter. Please register for AFSPA’s Annual Meeting  to be held online or at AFSPA’s office on Friday, March 1, 2019 at https://www.afspa.org/secureform.cfm?FormName=Annual-Meeting-~-Webinar-RSVP.

As always, thank you for your trust and for giving AFSPA the opportunity to serve you.

To Your Health,

Paula S. Jakub, RHU
CEO, AFSPA
Executive Director, Senior Living Foundation

 
4Feb
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Tosymra Approved to Treat Migraines
Tosymra™ (sumatriptan nasal spray) 10mg was approved by the U.S. Food and Drug Administration (FDA) on Jan. 25, 2019. A new strength of sumatriptan nasal spray that uses a novel formulation, it treats adults who have migraine headaches with or without an aura. The recommended dose is one spray with up to two additional sprays at least one hour apart if pain is not controlled. No more than three doses should be used in any 24-hour period. It should not be used to prevent migraines. Tosymra is packaged in single-dose, disposable spray devices. It is not interchangeable with Imitrex® (sumatriptan nasal spray 5mg and 20mg), generics to Imitrex nasal spray or Onzetra® Xsail® (sumatriptan nasal powder for inhalation). Promius Pharma, the U.S. subsidiary of Dr. Reddy’s Laboratories, has not yet finalized its plans to commercialize Tosymra. Express Scripts currently is investigating the data around Tosymra for a possible utilization management strategy. It also will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete. Full prescribing information is available here.

New Indication for Imbruvica
An oral drug, Imbruvica® (ibrutinib – AbbVie/Pharmacyclics), was U.S. Food and Drug Administration (FDA) approved for a new indication on Jan. 25, 2019. In combination with Gazyva® (obinutuzumab – Genentech) injection, it is approved as initial treatment for adults who have chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). Imbruvica is a Bruton’s tyrosine kinase (BTK) inhibitor and Gazyva is a CD20-directed monoclonal antibody that targets cancer cells both directly and along with the body’s immune system. Recommended dosing is 420mg of Imbruvica each day. After four loading doses in the first 28-day cycle, 1,000mg of Gazyva is infused intravenously (IV) on the first day only of five successive cycles, after the dose of Imbruvica is taken. Gazyva has boxed warnings that it may cause hepatitis B to recur for patients who have or have had hepatitis B and that it rarely may cause progressive multifocal leukoencephalopathy (PML), a potentially fatal brain infection. Both drugs have indications for other types of cancer. Prescribing information for Imbruvica is available here.

 Alimta Receives Expanded Indication
On Jan. 30, 2019, accelerated approval for Eli Lilly’s Alimta® (pemetrexed) injection was converted to full approval by the U.S. Food and Drug Administration (FDA), based on results from an additional clinical trial. In combination with Keytruda® (pembrolizumab – Merck) and platinum-based chemotherapy (chemo), Alimta now is fully approved as initial treatment for patients who have metastatic nonsquamous non-small cell lung cancer (NSCLC) that does not have epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. Dosing is on three-week cycles with Alimta and Keytruda administered on the first day of each cycle. For the first four cycles, a platinum-based drug is given, as well. Alimta works by blocking enzymes that cancer cells need to grow. Keytruda, a programmed death receptor-1 (PD-1)-blocking antibody, is an immunotherapy drug that helps the body’s immune system attack cancer cells. Cancer drugs that contain platinum destroy cancer cells by altering their DNA. In clinical trials, 47% of patients receiving the three-drug regimen responded partially to treatment, as compared to only 18% of those given Alimta, platinum-based chemo and a placebo. Updated prescribing information for Alimta is available here.


FDA Grants Osphena a New Indication
Duchesnay’s Osphena® (ospemifene) was U.S. Food and Drug Administration (FDA) approved to treat moderate to severe vaginal dryness on Jan. 25, 2019. Originally approved in 2013 for treating moderate to severe dyspareunia (painful intercourse), Osphena is not a hormone. It is an oral selective estrogen receptor modulator (SERM) that activates some estrogen receptors and blocks others. Both of its indications result from vulvar and vaginal atrophy (VVA), due to menopause. Recommended dosing is one 60mg tablet daily. Due to its estrogenic effects, Osphena’s labeling has a boxed warning highlighting potential increased risks of uterine cancer, stroke and deep vein thrombosis. Updated prescribing information is available here.

New Dosage Form for Tremfya
A subcutaneous (SC) self-injector device was approved by the U.S. Food and Drug Administration (FDA) on Jan. 29, 2019, for Janssen’s Tremfya® (guselkumab). It previously was available only as prefilled syringes. Tremfya treats plaque psoriasis by inhibiting interleukin (IL)-23, an immune system component that promotes inflammation. After two 100mg loading doses one month apart, 100mg of Tremfya is injected once every two months. Complete prescribing information is available here.

 
1Feb

AFSPA is closing early due to inclement weather

Due to inclement weather AFSPA will be closing at 4:15PM today, Friday, February 1, 2019.
If you have an urgent claim matter, please contact us at [email protected]

We apologize for the inconvenience.

 

 
1Feb
Express Scripts News Flash

Express Scripts News Flash

First Generic to Advair Diskus Approved
On Jan. 30, 2019, the U.S. Food and Drug Administration (FDA) approved Mylan’s Wixela™ Inhub™ (fluticasone propionate / salmeterol inhalation powder). It’s the first A-rated generic to GlaxoSmithKline’s Advair Diskus®. Mylan received approval to market generics for all three currently marketed strengths of Advair Diskus: fluticasone propionate 100mcg/salmeterol 50mcg, 250mcg/50mcg and 500mcg/50mcg. It is unclear if GlaxoSmithKline plans to launch an authorized generic. Mylan is planning to launch Wixela Inhub during the second half of February. Pricing and prescribing information are not yet available.

  • Brand Drug: Advair Diskus® (fluticasone propionate / salmeterol - GlaxoSmithKline)
  • Indication: Twice-daily treatment of asthma in patients four years of age and older, and the maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD).
  • Generic Manufacturer(s): Mylan
  • Launch Date: Second half of February 2019
  • Dosage Forms Approved (fluticasone propionate / salmeterol): 100mcg/50mcg, 250mcg/50mcg and 500mcg/50mcg dosage strengths
  • Annual U.S. Sales: According to IQVIA, U.S. annual sales for Advair Diskus are approximately $4.19 billion.

Other companies developing generics to Advair Diskus include Sandoz, Hikma/Vectura and Teva. However, additional generic competition is not expected until 2020.

 
29Jan

AFSPA IS OPENING LATE

Due to inclement weather and following the decision by the Office of Personnel Management, AFSPA will open on a delayed schedule today, Wednesday, January 30, 2019. We will assess staff levels on an ongoing basis with the goal of commencing regular business operations as soon as possible.

Thank you.

 

 
29Jan

AFSPA IS CLOSING EARLY

Due to inclement weather and following the decision by the Office of Personnel Management, AFSPA will be closing at 2:30PM today, Tuesday January 29, 2019.
If you have an urgent claim matter, please contact us at [email protected]

We apologize for the inconvenience.

Thank you.

 
29Jan
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Ontruzant Approved to Treat Breast Cancer

Ontruzant® (trastuzumab-dttb – Samsung Bioepsis) received approval from the U.S. Food and Drug Administration (FDA) on January 18, 2019. A biosimilar to Herceptin® (trastuzumab - Genentech), it is indicated in combination with other drugs for treating HER2-overexpressing breast cancer, metastatic breast cancer and metastatic gastric cancer or gastroesophageal junction adenocarcinoma in patients who have not received prior treatment for metastatic disease. Recommended doses vary according to the condition being treated. All trastuzumab products have boxed warnings that they may cause birth defects, heart failure, respiratory collapse or severe allergic reactions. It will compete with previously FDA-approved biosimilars for Herceptin – Ogivri® (trastuzumab-dkst – Mylan/Biocon) and Herzuma® (trastuzumab-pkrb – Celltrion/Teva), which have been approved but not yet launched. None of the biosimilars is interchangeable with Herceptin or another biosimilar. Merck will market Ontruzant in the U.S. with a planned launch in the second half of 2019. According to IQVIA, U.S. sales of Herceptin topped $2.8 billion in 2017. Express Scripts currently is investigating the data around Herzuma for a possible utilization management strategy. It also will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete. Complete prescribing information for Ontruzant is available here.


 

 
22Jan
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Cabometyx Approved for Hepatocellular Carcinoma

Exelixis received approval from the U.S. Food and Drug Administration (FDA) on Janauary 14, 2019, for a new Cabometyx® (cabozantinib) indication. Initially the FDA approved in April 2016 to treat advanced renal cell carcinoma (RCC), Cabometyx now also is indicated for treating hepatocellular carcinoma (HCC) after at least one prior therapy with Nexavar® (sorafenib - Bayer). The most common type of liver cancer, HCC is expected to cause about 32,000 deaths this year in the U.S. Affecting approximately twice as many men as women, it is associated with chronic liver diseases such as hepatitis and non-alcoholic steatohepatitis (NASH). The recommended dose of Cabometyx is 60mg once a day at least an hour before or two hours after eating. Full prescribing information is available here.

Generic Sabril Approved

Teva Pharmaceuticals won U.S. Food and Drug Administration (FDA) approval on January 16, 2019, for vigabatrin 500mg tablets, the first generic for Lundbeck’s Sabril® tablets. Vigabatrin is indicated in combination with other drugs to treat complex partial (focal) seizures for patients 10 years and older who have been treated unsuccessfully with multiple other drugs. For patients up to 16 years of age, the recommended dose depends on body weight. Adult dosing begins at 500mg twice a day and increases to a recommended maintenance dose of 1500mg twice a day. Vigabatrin carries a boxed warning that a significant number of patients who use it gradually lose their sight, which does not return. It also has a Risk Evaluation and Mitigation Strategy (REMS). According to IQVIA, U.S. sales of Sabril tablets totaled over $508 million for 2017. Generics for the oral solution dosage form of vigabatrin have been available since May 2018.

 
21Jan

AFSPA is closed in observance of the holiday

AFSPA is closed, today, January 21, 2019 in observance of the holiday. We will resume our normal business hours at 8:30 am EST on Tuesday, January 22, 2019.

 

 
15Jan
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

FDA Approves Additional Strengths for Apadaz

On Jan. 7, 2019, KemPharm announced that Apadaz® (benzhydrocodone/acetaminophen) tablets have been approved by the U.S Food and Drug Administration (FDA) for two new strengths. An immediate-release opioid/acetaminophen combination product, Apadaz is a C-II controlled substance indicated for treating intense, acute pain that has not responded to other therapies. Originally approved last year as benzhydrocodone 6.12mg/acetaminophen 325mg, it also now is approved as tablets with 4.08mg or 8.16mg of benzhydrocodone combined with 325mg of acetaminophen. The recommended dose is one or two tablets every four to six hours as needed. No more than 12 tablets should be taken in any 24-hour period and treatment should last no longer than two weeks. The benzhydrocodone component is a prodrug that is activated by gastrointestinal (GI) enzymes. Crushing it to inhale, inject or smoke will not produce the euphoria associated with misuse of other immediate-release opioids. However, it still can be abused by swallowing. Therefore, the FDA does not consider it to be abuse deterrent and it cannot claim to be in its labeling. All opioids, including Apadaz, have several boxed warnings, including risks for abuse, addiction, overdose and respiratory depression. They caution about neonatal withdrawal syndrome for babies born to women who used opioids while pregnant, as well. Apadaz will be dispensed with a Medication Guide and under a Risk Evaluation and Mitigation Strategy (REMS). Although KemPharm has not yet announced its launch or pricing plans, it has entered into an agreement with KVK Tech to manufacture, market and distribute all three strengths of Apadaz in the U.S. Full prescribing information is available here.
 

 
14Jan

AFSPA will open late 1/15/19

Due to inclement weather and following the decision by the Office of Personnel Management, AFSPA will open on a delayed schedule on Tuesday, January 15, 2019. We will assess staff levels on an ongoing basis with the goal of commencing regular business operations as soon as possible.

Thank you.

 
13Jan

AFSPA is closed due to inclement weather 1/14/19

Following the decision of the Office of Personnel Management, AFSPA's office will be closed Monday, January 14, 2019, due to inclement weather in the Washington metro area. We will resume regular business operations when conditions allow.

We wish everyone a safe (and warm) day!

 
8Jan
From the CEO

From the CEO

Happy New Year! Welcome to all our new enrollees who chose the Foreign Service Benefit Plan (FSBP) during Open Season. And, thank you to our over 32,000 loyal members who stayed with us another year. As this year promises to be interesting and dynamic, we want to keep you informed of all the new developments at the American Foreign Service Protective Association (AFSPA), the sponsor of FSBP. By now, any returning members have received their 2019 Open Season Materials. Read the documents carefully and review your full Plan brochure. Please take the time to utilize the many new services meant to start your 2019 in the right direction.

The In Touch Care (ITC) program offers support for acute or chronic health concerns. This program works behind the scenes to connect you with one-on-one nurse calls, online resources, and even Social Work help. I also want to call attention to a few other featured benefits.

For 2019, FSBP:

  • Added a Pain Management Program that includes biofeedback
  • Added a Personal Medication Coach Program to assist with medication management
  • Removed the dollar limit for orthotics, the devices used to treat the foot or ankle
  • Revamped the Simple Steps to Living Well Together Program, to reward your healthy outcomes

For 2019, your prescription benefits did not change. However, depending on the manufacturer’s rates, your individual drug may have changed tiers. For example, a previous Tier III (Non-Preferred Brand Name Drug) medication may move to a Tier II (Preferred Brand Name Drug), which means the Plan can offer you a lower copay. In contrast, a manufacturer may have increased a Tier II drug price, or a competitor may make available the same equivalent drug for less. This causes that original drug to move to Tier III, thus raising the price. Any members affected by a cost increase were notified by mail.   

For active Federal employees enrolled in the FSAFEDS Program (the government’s Flexible Spending Account), here are a few pointers: 1. FSBP offers paperless reimbursement. This allows us to file the remainder of your claim directly with FSAFEDS. 2. Log into the FSAFEDS website and select a carrier to register for paperless reimbursement. Please choose FSBP (and not Aetna). Your reimbursement may be delayed, until you complete this step correctly. 3. Please contact FSAFEDS directly with FSA reimbursement issues. If the matter involves FSBP, FSAFEDS will reach out to FSBP to investigate. 4. If you were previously enrolled in FSAFEDS, you must re-enroll each Open Season. It does not rollover from year-to-year. We hope this information helps.

If you missed the FEDVIP Open Enrollment for dental or vision plans, AFSPA wants to assist. We offer four excellent dental insurances that are available all year long. And, if you don’t want to pay for full insurance, you can purchase AFSPA’s Discount Care programs. Save money on dental, vision, and LASIK vision correction services. It helps address the “what-if” situations in life. Apply for these plans any time – no open enrollment is needed. Lastly, use TruHearing, to receive discounts on hearing aids and batteries. This complimentary discount program is available to all AFSPA members. When used with FSBP’s hearing aid benefit, those with the health plan can save a lot on out-of-pocket expenses.

We anticipate a wonderful 2019. A New Year means fresh starts and thoughtful resolutions for everyone, including the AFSPA team. We strive to make each year better than the last. And, I personally wish you all a prosperous and healthy New Year. As always, thank you for your trust and for giving us the opportunity to serve you.

 

To Your Health,

Paula S. Jakub, RHU
CEO, AFSPA
Executive Director, Senior Living Foundation

 
8Jan

Department of State New Hire Webinar

his is a recording of a live webinar that AFSPA's COO, Kyle Longton hosted on Monday, January 7, 2019. This video includes an overview on what to consider when selecting a Federal Health Benefit. It includes a brief overview of the enrollment process for the FEHB program, FSAFEDS, FEDVIP and FLTCIP.

**Update for 2019 - HCFSA - up to $2700; (min of $100); spouse can have a separate HCFSA if eligible.

 

 
8Jan
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Pediatric Indication for Sprycel

Bristol-Myers Squibb announced that the U.S. Food and Drug Administration (FDA) approved Sprycel® (dasatinib) tablets for children as young as one year old on Dec. 21, 2018. Sprycel is a tyrosine kinase inhibitor (TKI) that is used, along with chemotherapy (chemo), as initial treatment of Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL). According to the National Institutes of Health (NIH), about one-fifth of U.S. cancer patients under the age of 20 years have ALL and approximately 3,000 children and teens are diagnosed with it annually. Around 3% of pediatric ALL cases involve the Ph+ subtype, a chromosome abnormality responsible for a specific mutation of the BCR-ABL gene. The recommended dose for patients who weigh at least 45kg (about 100 pounds) is 100mg per day. For patients who weigh less, doses are based on body weight. In clinical trials, tablets were dissolved in fruit juice or other liquids for patients who could not swallow whole tablets. Bone growth should be monitored for pediatric and adolescent patients because Sprycel can cause malformations or pain as bones develop. Sprycel has been on the market since 2006 and is also indicated to treat certain adults and children with Ph+ chronic myeloid leukemia and adults with Ph+ ALL with resistance or intolerance to prior therapy. Complete revised prescribing information is available here.

FDA Approvals for 2018 Issues Document Available
In 2018, the U.S. Food and Drug Administration (FDA) approved 62 new medications, known as new molecular entities (NMEs) and therapeutic Biologic License Applications (BLAs), representing a new all-time high number of novel approvals. The Issues Document provides a brief overview of FDA’s approval activity for 2018. The “FDA Approvals for 2018” Issues Document is available here.

 

 
31Dec
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Inbrija Approved for Parkinson’s Disease

Acorda Therapeutics received approval from the U.S. Food and Drug Administration (FDA) on Dec. 21, 2018, for Inbrija™ (levodopa inhalation powder). A new inhaled formulation of levodopa, it is indicated for the intermittent treatment of OFF episodes for patients who have mild-to-moderate Parkinson’s disease that is being treated with carbidopa/levodopa. After levodopa has been used as long-term Parkinson’s treatment, its effectiveness may vary. Many patients experience OFF episodes -- breakthrough symptoms such as tremors and muscle stiffness despite continual treatment. The recommended dose is 84mg (two capsules) inhaled through the Inbrija inhaler device when needed, but no more than five times daily. Capsules should not be swallowed. Patients who also have a lung condition, such as asthma, or who have taken a nonselective monoamine oxidase (MAO) inhibitor, such as phenelzine, within the prior two weeks should not use it. Acorda plans to launch Inbrija during the first quarter of 2019 through a specialty pharmacy network. It will be supplied in boxes containing one inhaler and either 60 or 92 capsules that are individually blister packed. Express Scripts currently is investigating the data around Inbrija for a possible utilization management strategy. It also will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete. Full prescribing information is available here.

FDA Approves ProAir Digihaler to Treat Asthma and COPD

Teva Pharmaceutical Industries announced on Dec. 21, 2018, that the U.S. Food and Drug Administration (FDA) had approved its ProAir® Digihaler™ (albuterol sulfate) Inhalation Powder, 117mcg. It is indicated to prevent and treat bronchospasms for patients who are at least four years old and who have reversible obstructive airway disease. It also is approved to prevent exercise-induced bronchospasms (EIB) for patients aged four years and older. The Digihaler’s sensors not only track when the inhaler is used, they also measure breathing capacity at the same time. The information, which can be transmitted wirelessly to a mobile phone app, can be used to establish patterns of exacerbations. It also may be shared with the patient’s healthcare provider to analyze and determine treatment options. A gradual release is being planned for the devices, with a few “Early Experience” sites opening in limited areas during 2019. A more widespread national introduction will follow in 2020. ProAir Digihaler will be excluded at launch on the Express Scripts NPF until our formulary development process is complete. Prescribing information is available here.

New Combination Vaccine Approved for Children

Vaxelis™ (diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus, Haemophilus B conjugate [meningococcal protein conjugate] and hepatitis B [recombinant] vaccine) was FDA approved on Dec. 21, 2018. Intended to be given as a series of three intramuscular (IM) injections for children at two months, four months and six months of age, the series can be administered to older children, as well, as long as they are under age five. It protects against diphtheria, hepatitis B, invasive Haemophilus influenzae type b (Hib), pertussis (whooping cough), polio and tetanus. A fourth dose of a vaccine against pertussis is needed to complete the recommended primary immunization series. Jointly developed by Merck and Sanofi, Vaxelis will not be marketed in the U.S. until 2020. Complete prescribing information is available here.

Expanded Pediatric Indication for Ravicti

On Dec. 21, 2018, the U.S. Food and Drug Administration (FDA) extended its approval of Ravicti® (glycerol phenylbutyrate – Horizon Pharma) Oral Liquid to include patients of all ages. It is an oral nitrogen-binder used to treat urea cycle disorders (UCD) that are not controlled adequately by dietary changes or supplements. Rare hereditary conditions estimated to affect fewer than 150 new patients per year in the United States, UCDs are caused by shortages of one or more enzymes that eliminate nitrogen (converted into ammonia) from the blood. For patients with a UCD, excess ammonia accumulates — eventually causing brain damage, which could result in death. Ravicti was originally FDA approved to treat patients two years of age and older, later extended to patients at least two months of age and now approved for use in infants. It must be used along with a protein-restricted diet and possibly dietary supplements. The recommended dose range is 4.5mL/m2/day to 11.2mL/m2/day in three equally divided doses that are given by mouth, nasogastric tube or gastrostomy tube, along with breast milk, infant formula or food. Full prescribing information is available here.

Elidel Generic Introduced

Pimecrolimus cream, 1%, a generic for Elidel® (Novartis), was released on the U.S. market by Teva Pharmaceutical Industries on Dec. 27, 2018. A topical immunomodulator, it is indicated for the short-term treatment of eczema (atopic dermatitis) for patients who are two years old or older, who are not immunocompromised and who have tried at least one other topical treatment that hasn’t worked for them. It is applied to affected areas of skin twice a day. After six weeks, treatment should be evaluated for effectiveness. Annual U.S. sales for Elidel amount to over $218 million according to IQVIA.

 
27Dec
AFSPA Expands Direct Billing Arrangement with Westpfalz-Klinikum GmbH

AFSPA Expands Direct Billing Arrangement with Westpfalz-Klinikum GmbH

The Foreign Service Benefit Plan (FSBP) is proud to announce our newly expanded and continued partnership with our direct billing partner, Westpfalz-Klinikum GmbH.

Our direct billing arrangement with Westpfalz-Klinikum GmbH has been expanded to now include coverage for accidental injury*, complete maternity care* and all covered outpatient medical services** in addition to inpatient.

Westpfalz-Klinikum GmbH features 1,354 beds and more than 40 clinics, departments and institutes at the four locations in Kaiserslautern, Kusel, Kirchheimbolanden and Rockenhausen. A wide range of treatment is offered including access to the centers below.

Breast Cancer Center: Founded in 2010, the breast care center in Kaiserslautern is one of 255 centers in Germany certified by the German Association of Senelogy and the German Cancer Association. This well-known certificate states Westpfalz-Klinikum GmbH’s expertise in medical diagnostics and therapy concerning benign and malign breast tumors. Westpfalz-Klinikum GmbH utilizes a network of internal specialists collaboratively in order to find the right individual treatment for each patient. This network includes medical experts from various fields such as: Gynecology; Radiology; Radiation Therapy; Pathology; Psychosomatic medicine; Oncology; Medical genetics.

Comprehensive visceral-oncologic center: This over-regional cancer center treats various types of visceral oncologic cases in a multidisciplinary approach including esophageal, gastric, pancreatic, hepatic, biliary and colorectal cancer as well as orphan forms of abdominal tumors. The main goal of this center is the best possible treatment of cancer in all stages, including diagnosis, staging, surgical, medical therapy and follow-up investigations.

Internal Medicine 2 and Westpfalz Heart Center: The Clinic for Internal Medicine 2 with its Heart Center offers the full range of modern internal medicine diagnostics and treatment, with special emphasis on heart and lung diseases. The subspecialties of cardiology, pneumology, angiology and internal medicine intensive care are offered as well. The center features 128 beds, four catheterization laboratories, a 15-bed intensive care unit and 11-bed specialized chest pain unit.

Pediatric Clinic: The clinic features a capacity of 76 beds and is one the largest pediatric health and medical providers in the region with about 4,000 inbound and 11,000 outbound patients per year. In conjunction with their gynecological clinic, the pediatric clinic is perinatal center level 1, which is the highest level for medical care and therapy to newborn and premature babies. Aside from general pediatric care that encompasses all illnesses of children and teenagers, the following patient-centered care is offered: pediatric cardiology; pediatric electrophysiology; pediatric neurology; pediatric gastroenterology; pediatric diabetology and pediatric gynecology.

We strive to simplify your care overseas and are delighted to have this expanded billing arrangement. If you have overseas direct billing questions, please visit our FSBP Overseas Partners page on our website, email us, or call us at 202-833-4910 for assistance.

Thank you for being a valued FSBP member.    

*Inpatient, Accidental injury and complete maternity care: Member pays no deductible. FSBP pays 100% of covered services.

**Outpatient: Member pays applicable calendar year deductible and 10% coinsurance. FSBP pays 90% of covered services.

 
26Dec
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Herzuma, a Biosimilar to Herceptin, Approved

Herzuma® (trastuzumab-pkrb), jointly developed by Celltrion and Teva Pharmaceutical Industries, was approved by the U.S. Food and Drug Administration (FDA) on Dec. 14, 2018. It is a biosimilar to Genentech’s Herceptin® (trastuzumab). Indicated as part of multi-drug regimens, it treats certain breast cancers, including metastatic cases, that have tested positive for an increased quantity of HER2 receptors on the surface of the tumor cells (HER2+). Herzuma also can be used alone for metastatic HER2+ breast cancer that has been treated previously with chemotherapy (chemo). Herzuma’s launch date has not yet been determined. Mylan and Biocon’s Ogivri™ (trastuzumab-dkst), the first biosimilar to Herceptin, was FDA approved in December 2017, but it has not yet launched in the U.S. All trastuzumab products have boxed warnings that they may cause birth defects, heart failure, respiratory collapse or severe allergic reactions. Express Scripts currently is investigating the data around Herzuma for a possible utilization management strategy. It also will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete. Full prescribing information for Herzuma is available here.

Motegrity Approved for Chronic Idiopathic Constipation

Shire won U.S. Food and Drug Administration (FDA) approval on Dec. 14, 2018, for Motegrity™ (prucalopride). It is the first selective serotonin-4 (5-HT4) receptor agonist approved to treat adults who have chronic idiopathic constipation (CIC). It will be taken orally once a day. In five clinical trials, approximately twice as many patients taking Motegrity regained normal bowel movement patterns as those taking a placebo tablet (19% to 38% for Motegrity versus 10% to 20% for placebo). Although no direct relationship has been established, some trial participants exhibited suicidal tendencies. Patients beginning therapy should report uncharacteristic mood changes to their healthcare providers. Shire has not yet announced its exact launch or pricing plans. Express Scripts currently is investigating the data around Motegrity for a possible utilization management strategy. It also will be excluded at launch on the Express Scripts NPF until our formulary development process is complete. Prescribing information is available here.

Long-Acting Asparagine, Asparlas, Approved

Asparlas™ (calaspargase pegol-mknl), an orphan-designated new version of an asparagine-specific enzyme, was approved by the U.S. Food and Drug Administration (FDA) on Dec. 20, 2018. It is indicated for use in combination with chemotherapy (chemo) to treat acute lymphoblastic leukemia (ALL) for patients between the ages of one month and 21 years. A modified, longer-acting, form of previously available products, it works by decreasing the amounts of an amino acid, asparagine, in the blood. Normal cells can produce asparagine, but ALL cells cannot, so they disintegrate. Asparlas will be administered as an IV infusion once every three weeks as opposed to currently available forms that need to be given more often. Recommended dosing is 2,500 units/m2 of body surface area. It will be dispensed in single-dose vials containing 3,750 units of active drug. The manufacturer, Servier Pharmaceuticals, has not yet released its plans for pricing. Launch is expected in the first quarter of 2019. Express Scripts currently is investigating the data around Asparlas for a possible utilization management strategy. It also will be excluded at launch on the Express Scripts National NPF until our formulary development process is complete. Prescribing information is available here.

Pediatric Indication for Nplate

Under a priority review, the U.S. Food and Drug Administration (FDA) approved Nplate® (romiplostim) on Dec. 14, 2018, to treat chronic immune thrombocytopenic purpura (ITP) for children as young as one year of age. Previously limited to use by adult patients, Nplate works similarly to thrombopoietin, a natural human protein that stimulates platelet production in the bone marrow. Chronic ITP is a rare autoimmune bleeding disorder characterized by low platelet count. It affects an estimated 4,000 U.S. patients who are younger than 18 years of age. If left untreated, ITP can result in anemia, internal bleeding and serious infections. Nplate is given as a once-weekly subcutaneous (SC) injection at one mcg/kg of body weight. An associated Risk Evaluation and Mitigation Strategy (REMS) and Medication Guide for patients outline possible severe side effects of using Nplate, which is available only through a restricted distribution program called Nplate NEXUS (Network of Experts Understanding and Supporting Nplate and Patients). Only healthcare providers and patients registered with the program are able to prescribe and receive Nplate. Revised prescribing information is available here.

Lynparza Receives New Indication

Lynparza® (olaparib) tablets were U.S. Food and Drug Administration (FDA) approved on Dec. 19, 2018, as maintenance treatment for adult patients who have deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube or primary peritoneal cancer and who are in complete or partial response to first-line platinum-based chemo, as detected by an FDA-approved companion diagnostic test. Lynparza is a poly ADP-ribose polymerase (PARP) inhibitor that prevents cancer cells from repairing themselves after being damaged by chemo. It has prior indications for treating other types of ovarian cancer and for metastatic human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has mutations in the BRCA gene. The recommended dose is 300mg twice daily. Lynparza is marketed jointly by AstraZeneca and Merck. Complete prescribing information is available here.

Keytruda Approved for Merkel Cell Carcinoma

On Dec. 19, 2018, Merck’s Keytruda® (pembrolizumab) received accelerated approval from the U.S. Food and Drug Administration (FDA) for the treatment of patients who have recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). Keytruda is a human programmed death receptor-1 (PD-1)-blocking antibody that helps the body’s immune system attack cancer cells. Originally approved on Sep. 4, 2014, to treat patients with unresectable or metastatic melanoma, Keytruda now has numerous indications for treating various kinds of cancer. For MCC, it will be administered once every three weeks as a 30-minute IV infusion. The recommended dose for treating children who have MCC is 2mg/kg up to a maximum of 200mg. For adults, the dose is 200mg. Treatments will be given for 24 months, until the cancer worsens or until the patient can no longer tolerate the drug. Continued approval of Keytruda for MCC depends upon confirmatory trials that demonstrate a clinical benefit. Full prescribing information is available here.

First Generic Launched for Canasa

Mylan announced on Dec. 17, 2018, that it has launched mesalamine rectal suppositories, 1,000mg, the company’s generic for Allergan’s Canasa®. Mesalamine suppositories are used topically to treat mild-to-moderate proctitis (inflammation of the rectal lining), which affects about one-third of patients who have an inflammatory bowel disease, such as ulcerative colitis. It is used once a day at bedtime for between three weeks and six weeks to relieve inflammation. As the first company to file for a generic, Mylan has 180-day exclusivity. IQVIA estimates that Canasa’s American sales amounted to $263 million in the 12 months that ended on Oct. 31, 2018.

Elzonris Approved for Blastic Plasmacytoid Dendritic Cell Neoplasm

Stemline Therapeutics received approval from the U.S. Food and Drug Administration (FDA) on Dec. 21, 2018, for Elzonris™ (tagraxofusp-erzs) injection to treat patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN). Often presenting as leukemia or evolving into acute leukemia, BPDCN is a rare and aggressive disease that can result in tumor cells in the blood, bone marrow, lymph nodes or skin. Following premedication, the recommended dose is 12mcg/kg of body weight, administered intravenously over 15 minutes, once daily on days one to five of a 21-day cycle. Availability and network distribution plans are not known at this time. Complete prescribing information is available here.

Ultomiris Approved for Paroxysmal Nocturnal Hemoglobinuria

On Dec. 21, 2018, the U.S. Food and Drug Administration (FDA) approved Alexion’s Ultomiris™ (ravulizumab-cwvz) injection for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH), a rare blood disorder that causes the destruction of red blood cells (hemolysis). Ultomiris is a long-acting C5 complement inhibitor that prevents hemolysis. It is administered every 8 weeks by intravenous (IV) infusion; the dose depends on the patient’s weight. Ultomiris will be available through open distribution. Launch date and pricing information are not known at this time. Full prescribing information is available here.

 

 

 
18Dec

AFSPA will be closed in observance of the holiday

AFSPA will be closed on  December 24, 2018 and December 25, 2018 in observance of the holiday. We will resume our normal business hours at 8:30 am EST on Wednesday, December 26, 2018

We wish all of our members and their families a Happy Holiday!

 
17Dec
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Tolsura Approved for Systemic Fungal Infections

On Dec. 11, 2018, the U.S. Food and Drug Administration (FDA) approved Mayne Pharma Group’s Tolsura™ (SUBA®-itraconazole) capsules. A new formulation of an existing antifungal drug, it is indicated to treat certain adults who have aspergillosis, blastomycosis or histoplasmosis - serious fungal infections that usually strike patients whose immune systems are  undermined by other medical conditions. Tolsura is manufactured using a technique (SUBA) that improves its soluability and makes its effects more predictable. It will be released in January 2019 as 65mg capsules with directions for doses between 130mg and 260mg per day. Doses of 130mg can be taken once daily; higher amounts should be divided and taken twice per day. A boxed warning on its label cautions that Tolsura can cause or aggravate heart failure and that it should not be taken at the same time as numerous other drugs that can have serious interactions with it. Tolsura will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete. Complete prescribing information for Tolsura is available here.

 
13Dec
New Direct Billing Partner: Tokushukai Group

New Direct Billing Partner: Tokushukai Group

The Foreign Service Benefit Plan (FSBP) proudly welcomes our newest direct billing partner, Tokushukai Group, located in Japan.

Our direct billing arrangement with Tokushukai Group covers inpatient*, accidental injury*, complete maternity care*, routine annual physical exam/screening* and includes the following facilities:

The Tokushukai Group was established in 1973 under the philosophy, “All living beings are created equal.” Under this philosophy, Tokushukai Group aims to provide cutting edge medical care across several regions from not only emergency medical care, but also preventive medical care, chronic medical care to advanced medical care.

We strive to simplify your care overseas and are delighted to have this billing arrangement. If you have overseas direct billing questions, please visit our FSBP Overseas Partners page on our website, email us, or call us at 202-833-4910 for assistance.

Thank you for being a valued FSBP member.

*Inpatient, accidental injury, complete maternity care and routine annual physical exam: Member pays no deductible. FSBP pays 100% of covered services.

 
11Dec

AFSPA will observe changed hours on 12/14/2018

On Friday, December 14, AFSPA will open at 9AM EST and will close at 2:30PM EST.
We apologize for the inconvenience. If you have an urgent claim or benefit matter please contact us at [email protected].

Thank you.

 

 

 
11Dec
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Dextenza Approved for Post-Surgical Eye Pain

Dextenza® (dexamethasone ophthalmic insert) 0.4mg was approved by the U.S. Food and Drug Administration (FDA) on Dec. 3, 2018. It is indicated to treat ocular pain following ophthalmic surgery, such as cataract removal. It will be placed by the ophthalmic surgeon intracanalicularly – into a small channel in the tear duct. Although the preservative-free insert can be removed if needed, Dextenza gradually dissolves, releasing dexamethasone for up to 30 days before being cleared from the eye. It replaces corticosteroid eye drops commonly used after eye procedures. The manufacturer, Ocular Therapeutix, has not yet announced its launch or pricing plans. Dextenza will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete. Prescribing information is available here.

New Indication for Tecentriq 

On Dec. 6, 2018, Tecentriq® (atezolizumab – Genentech) received U.S. Food and Drug Administration (FDA) approval as initial treatment for metastatic non-squamous, non-small cell lung cancer (NSCLC) that does not have EGFR or ALK genomic tumor aberrations. It will be used in a combination that also includes Genentech’s Avastin® (bevacizumab) and chemotherapy (chemo) with paclitaxel and carboplatin. Tecentriq is a programmed death receptor-ligand 1 (PD-L1)-blocking antibody that helps the body’s immune system attack cancer cells. For the new indication, it will be given as a 1,200mg intravenous (IV) infusion once every three weeks. For the first four to six treatment cycles, Tecentriq will be followed by Avastin and chemo, all on the same day. Once chemo ends, Tecentriq and Avastin therapy will continue once every 3 weeks until the cancer progresses or the drug side effects become too harmful for the patient. Updated prescribing information is available here.

 
7Dec
From the CEO

From the CEO

Dear Valued AFSPA Member,

As 2018 ends, I find myself thinking about the past year, and looking forward to the new year. I truly am grateful for our American Foreign Service Protective Association (AFSPA) members. I also appreciate the AFSPA employees who provide the level of service you expect, especially through the challenges we faced this past year. We hope to continue our strong relationship with you in 2019.

To begin, I want to remind you that Open Season ends on Monday, December 10. You have a few days left to review your options and make changes to your:

- Federal Employee Health Benefit (FEHB) Program enrollment - https://www.opm.gov/healthcare-insurance/open-season/

- Federal Employees Dental and Vision Insurance Program (FEDVIP) enrollment - http://www.benefeds.com/

- FSAFEDS enrollment - http://www.fsafeds.com/

Whether you have the Foreign Service Benefit Plan (FSBP), or another Federal health plan, we want you to have all the information you need to make the right decision for you and your family. But please consider AFSPA’s many services when making these important decisions. To assist in your decision making, please review a recording of AFSPA’s Open Season Preparation Webinar. (https://www.youtube.com/watch?v=PHbrNA2ULls&feature=youtu.be)

For those who have the Foreign Service Benefit Plan (FSBP), we are very pleased to offer enriched benefits with our In Touch Care (ITC) Program. ITC provides serious support for acute or chronic health concerns. The program offers one-on-one nurse calls, online resources, Social Work help, and Pain Management, to name a few services. Our new Member Engagement Platform, accessible through Aetna Navigator (http://www.aetnanavigator.com/), creates a gateway to your personal health journey. Our Emmi® Education Programs make complex medical information simple and easy to understand. We have revamped our Simple Steps to Living Well Together Program, to reward you for your healthy outcomes. 

For those facing serious health conditions, we are partnering with PinnacleCare, a health advisory service. Their Connection Health Advisors can help you navigate serious diagnoses, by gathering appropriate medical history and the details of a current diagnosis. The Advisor reviews your case with PinnacleCare’s Medical Team to guide you to the appropriate course of action. This may include connecting you with top-rated specialists who are experienced in your condition and can provide a second opinion and appropriate treatment options. To learn more and be referred to PinnacleCare’s team, please call 800-593-2354.

I wanted to address the Aetna-CVS merger. Many of you may be nervous at this prospect, especially after our most recent claims migration. However, the change will have little immediate impact on the Foreign Service Benefit Plan. These are two complimentary companies combining their strengths to transform the patient health care experience and deliver better care and coordination. Aetna will continue to serve as the Plan’s Administrator, with the same team processing FSBP claims. In addition, the new company created by this merger looks to expand opportunities to bring health care services to consumers. Eventually, CVS Pharmacy locations will include space for wellness, clinical and pharmacy services, vision, hearing, nutrition, beauty, and medical equipment. This will be in addition to the products and services their customers currently enjoy. The new health services will function as a community-based health hub. Many CVS locations will connect you to the pathways needed to improve health. This planned coordination of care can answer patients’ health questions while managing their prescriptions and health coverage. 

Express Scripts will continue to serve as the Plan’s Pharmacy Benefit Manager. That means the same team will serve our account and the same pharmacists will serve our members. CVS is a participating retail pharmacy in Express Scripts’ network; however, members are not required to purchase their short-term (up to a 30-day supply) prescriptions at CVS. You still can choose from hundreds of participating retail pharmacies throughout the country.

As the health care landscape continues to evolve, AFSPA strives to remain at the forefront of benefit design and delivery. We leverage our relationships and work with our partners to create innovative solutions to meet our members’ needs. Our focus remains finding the best way to serve you, wherever you are in the world.

Finally, the holiday season can bring joyful moments, but also stressful ones too. Money worries, travel concerns, or preparing your home for visitors – all can add stress. Depression and stress may hurt your health. FSBP offers many services to support you through this busy time of year, such as telehealth services through Amwell. To learn more, visit Amwell’s website (http://www.amwell.com/) or call 844-733-3627. You are not alone. Regardless of where you are, FSBP is here to help.

As always, it is our honor to provide you with “unparalleled service.” We thank you for entrusting us with your health care needs this past year – and want to continue serving you in 2019. I personally wish you and your loved ones a wonderful and healthy holiday season.

To Your Health,

Paula S. Jakub, RHU
CEO, AFSPA
Executive Director, Senior Living Foundation

 
4Dec
State of Emergency Issued in Alaska Due to Earthquake

State of Emergency Issued in Alaska Due to Earthquake

The governor of Alaska has issued a State of Emergency due to an earthquake in the following counties: Anchorage, Kenai Peninsula, Forest, Valdez Cordova, Cayuga, Bristol Bay, Lake And Peninsula, Aitkin, Rio Grande, Matanuska Susitna, Indiana, Aleutians East, Worcester, Taos, Ulster, Sullivan, Fairbanks North Star, Denali, District of Columbia, North Slope, Southeast Fairbanks, Gove, Northwest Arctic and Johnson. The Emergency Access to Benefits/Refill Too Soon override process will be implemented an effective date of Nov. 30, 2018 and expiration date of Dec. 29, 2018.

 

 
3Dec

Honoring the Life of Former President George H. W. Bush

Dear Members,

AFSPA will be closed on Wednesday, December 5, 2018, in observance of National Day of Mourning for former President George H. W. Bush. We will reopen on Thursday, December 6, 2018 at 8:30AM EST. If you have an urgent claim or benefit matter, please contact us at [email protected].

Thank you

 
3Dec
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Temixys Approved to Treat HIV

On Nov. 16, 2018, Celltrion received approval from the U.S. Food and Drug Administration (FDA) for Temixys (300mg lamivudine/300mg tenofovir disoproxil fumarate). It is a combination of two nucleoside reverse transcriptase inhibitors that will be used once a day along with other HIV drugs to treat HIV-1 infection for patients weighing at least 35kg (about 77 pounds). Its labeling includes a boxed warning that discontinuing the use of lamivudine or tenofovir disoproxil fumarate can activate hepatitis B virus (HBV) for patients who have or who have had HBV. Patients should be monitored for signs of HBV before, during and for several months after treatment with Temixys. Celltrion plans to launch Temixys early in 2019. It will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete. Prescribing information is available here.

New Dosage Form for Actemra

The U.S. Food and Drug Administration (FDA) approved ACTPen™, a prefilled auto-injector for Actemra® (tocilizumab - Genentech) on Nov. 19, 2018. Actemra is an interleukin-6 (IL-6) receptor antagonist approved to treat inflammatory conditions that include rheumatoid arthritis (RA), giant cell arteritis and some types of juvenile arthritis. It also is used to treat cytokine release syndrome, a possible side effect of chimeric antigen receptor (CAR-T) therapy. Each single-dose pen contains 162mg of Actemra in 0.9mL of liquid. Dosage and dose schedules vary depending on the weight of the patient and the condition being treated. A boxed warning for Actemra cautions that its use may make opportunistic bacterial, fungal, viral or other infections more likely for patients using it. Before Actemra is started, prospective patients should be tested for latent tuberculosis (TB). The new prefilled auto-injector is expected to be available in the United States in January 2019. Revised prescribing information is available here.

EpiPen Generics Available 

After an August U.S. Food and Drug Administration (FDA) approval, limited quantities of Teva’s generic to EpiPen® 0.3mg epinephrine auto-injectors now have been released on the U.S. market. Epinephrine (also known as adrenaline) auto-injectors, in both 0.3mg and 0.15mg strengths, are used for the emergency treatment of allergic reactions, including anaphylaxis. They are handheld devices that deliver exact amounts of epinephrine using a spring-loaded needle through intramuscular (IM) or subcutaneous (SC) injection when pressed firmly against the outside of the upper thigh. Manufacturing interruptions, recalls and increased demand have resulted in frequent shortages of epinephrine auto-injectors over the last few years. Teva’s product will help to increase supply. However, it was introduced at $300 for a package of two injectors, which is the same wholesale acquisition cost (WAC) for Mylan’s authorized generic (AG). Two other auto-injectors, Impax Laboratories’ AG to Adrenaclick® (epinephrine injection, USP, auto-injectors) and Auvi-Q® (epinephrine injection - Kaléo), also are available in the U.S. Symjepi™, a prefilled syringe version of self-injected epinephrine, may be launched soon and Teva plans to introduce a 0.15mg strength auto-injector, as well.  

Authorized Generics Planned for Epclusa and Harvoni 

Asegua Therapeutics, a subsidiary of Gilead Sciences, plans to introduce AGs for Gilead’s hepatitis C drugs, Epclusa® (sofosbuvir/velpatasvir) and Harvoni® (ledipasvir/sofosbuvir) in January 2019. Epclusa is approved to treat adults who have any of the six genotypes of the hepatitis C virus (HCV); Harvoni can be used to treat several types of HCV for patients as young as 12 years old. List cost for the most common course of treatment will be $24,000 for either drug, which is what Gilead estimates is comparable to the brand’s costs after rebates and discounts.

 
30Nov
Express Scripts News Flash

Express Scripts News Flash

Truxima, Biosimilar to Rituxan, Approved
On Nov. 28, 2018, the U.S. Food and Drug Administration (FDA) approved Celltrion and Teva’s Truxima® (rituximab-abbs), the first biosimilar to Genentech’s Rituxan®. Truxima is indicated for use alone or in combination with chemotherapy to treat adult patients with CD20-positive, B-Cell non-Hodgkin’s lymphoma (NHL). Celltrion and Teva have yet to release pricing information and a launch date for Truxima. It will be available through open distribution; therefore, Accredo will have access. The complete prescribing information for Truxima is available here.

Firdapse Approved for Lambert-Eaton Myasthenic Syndrome
Catalyst Pharmaceuticals received approval from the U.S. Food and Drug Administration (FDA) on Nov. 28, 2018, for Firdapse® (amifampridine) tablets to treat adults who have Lambert-Eaton myasthenic syndrome (LEMS). A rare autoimmune disease, LEMS interrupts the flow of nerve impulses to muscles. Firdapse blocks potassium channels to keep calcium channels open longer, which enhances nerve signal transmission. The recommended initial dose is 15mg to 30mg daily divided into three or four parts. Doses may be increased by 5mg per day every few days to a maximum of 80mg per day, with no more than 20mg taken in any single dose. It will be dispensed exclusively through a specialty pharmacy other than Accredo. Complete prescribing information is available here.

Xospata Approved for Acute Myeloid Leukemia
On Nov. 28, 2018, the U.S. Food and Drug Administration (FDA) approved Astellas Pharma’s Xospata® (gilteritinib) for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML) with an FLT3 mutation as detected by an FDA-approved test. The recommended dose of Xospata, an oral kinase inhibitor, is 120mg once daily. It will be supplied as 40mg tablets and will be available through a small network of specialty pharmacies that does not include Accredo. Xospata will be launched within a few days. Full prescribing information is available here.

 
29Nov
Express Scripts News Flash

Express Scripts News Flash

The U.S. Food and Drug Administration (FDA) approved Vitrakvi® (larotrectinib – Loxo Oncology) capsules and oral solution on Nov. 26, 2018. A kinase inhibitor, Vitrakvi is the first drug FDA indicated to treat solid tumors that have neurotrophic receptor tyrosine kinase (NTRK) gene fusions. It is “site agnostic”, meaning that it can be used for many different solid tumors, regardless of their site of origin, as long as they have the NTRK abnormality. Dosing is based on body surface area, but most patients will take 100mg twice a day. Vitrakvi was launched immediately through a small network of specialty pharmacies that includes Accredo. Loxo Oncology and Bayer will be co-marketing Vitrakvi. Complete prescribing information is available here.

  • Brand (Generic) Name: Vitrakvi® (larotrectinib)
  • Manufacturer: Loxo Oncology
  • Date Approved: November 26, 2018
  • Indication: for the treatment of adult and pediatric patients who have solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, that are metastatic, that are likely to result in severe morbidity if resected surgically, that have no satisfactory alternative treatments or that have progressed following treatment
  • Dosage Forms Available: 25mg and 100mg capsules; 20mg/mL oral solution
  • Launch Date: Vitrakvi launched upon approval.
  • Estimated Annual Cost: The wholesale acquisition cost (WAC) of Vitrakvi is $393,600 per year.
  • Specialty Status: Vitrakvi will be added to Express Scripts’ specialty drug list.
  • Neurotrophic receptor tyrosine kinase (NTRK) genes produce specific proteins. When they fuse aberrantly with other proteins, tumor growth can be stimulated.
  • Although rare, NTRK fusions are found in many malignancies including some cancers of the appendix, breast, colon, lungs, pancreas or thyroid. Participants in clinical studies also had gastrointestinal stromal tumors (GIST), infantile fibrosarcoma, melanoma, salivary gland tumors or soft tissue sarcoma.
  • The FDA is expected to approve a diagnostic test for NTRK fusions by the end of 2018.
  • In clinical trials, treatment with Vitrakvi resulted in an overall response rate (ORR) of 75%, with 22% of treated patients having a complete response (CR). Response extended for at least six months for 41 of the 55 patients.
  • Under the Vitrakvi Commitment Program, drug costs will be returned if the patient does not show clinical benefit within 90 days.
  • An orphan drug, Vitrakvi also received the FDA’s Accelerated Approval, Breakthrough Designation and Priority Review.
  • Implications: Express Scripts currently is investigating the data around Vitrakvi for a possible utilization management strategy. It also will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete.
 
282018Nov
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Aemcolo Approved to Treat Traveler’s Diarrhea

Aries Pharmaceuticals was granted approval by the U.S. Food and Drug Administration (FDA) on Nov. 16, 2018, for Aemcolo™ (rifamycin) delayed-release tablets, 194mg. Aemcolo is an antibiotic that is indicated for adults who have travelers’ diarrhea due to noninvasive bacteria – primarily Escherichia coli (E. coli). It has been formulated with a proprietary technology to prevent drug release until the tablets are in the colon, so it has very little systemic effect. Recommended dosing is two tablets twice each day for three days. Aries plans to launch Aemcolo in the first quarter of 2019. Approval was given under the FDA’s Fast Track program. It also received Qualified Infectious Disease Product (QIDP) status, which extends its exclusivity through 2028. Aemcolo will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete. Prescribing information is available here.

U.S. Launch for Retacrit

Pfizer released Retacrit™ (epoetin alfa-epbx), its biosimilar for Epogen® (Amgen) and Procrit® (Johnson & Johnson), to the U.S. market on Nov. 12, 2018. Retacrit is approved for treating anemia caused by chronic kidney disease, chemotherapy or the use of zidovudine in patients with HIV infection. It is also approved to reduce the chance that a red blood cell transfusion will be needed in patients undergoing elective, noncardiac, nonvascular surgery. Its dose depends on the indication. Although its indications are the same as those for Epogen and Procrit, Retacrit is not interchangeable with either. All epoetin products have a boxed warning about increased risks of death, myocardial infarction, stroke, venous thromboembolism, thrombosis of vascular access and tumor progression or recurrence with their use. Retacrit will be introduced at a list price approximately two-thirds of Epogen’s and less than one-half of Procrit’s. According to IQVIA, combined annual sales of Epogen and Procrit were approximately $2.4 billion in 2017.

New Indication for Adcetris

The U.S. Food and Drug Administration (FDA) approved Adcetris® (brentuximab vedotin - SeattleGenetics) on Nov. 16, 2018, to treat adults who have not yet been treated for systemic anaplastic large cell lymphoma or other CD30-expressing peripheral T-cell lymphomas. It will be used along with chemotherapy that includes cyclophosphamide, doxorubicin and prednisone. An anti-CD30 monoclonal coupled with a microtubule disrupting agent, Adcetris has several other indications for treating multiple types of lymphoma. For the new use, it is infused intravenously (IV) at 1.8mg/kg (up to a maximum of 180mg/dose) once every three weeks for six to eight doses. Its labeling carries a boxed warning that it may be associated with progressive multifocal leukoencephalopathy (PML), a potentially deadly but rare viral infection of the brain. The new indication was granted under the FDA’s Breakthrough Therapy designation and Priority Review programs. Additionally, it was approved through the FDA’s Real-Time Oncology Review Pilot Program, which allows the drug developer to share information with the FDA before formally submitting the request for FDA action, greatly reducing approval time. Updated prescribing information is available here.

FDA Expands Promacta Indication

The indications for a Novartis drug, Promacta® (eltrombopag), were expanded on Nov. 16, 2018, to include initial therapy for treating severe aplastic anemia. The bone marrow of patients who have severe aplastic anemia does not make adequate numbers of blood cells, including platelets, red blood cells and white blood cells. Patients who have it may experience excessive bleeding and bruising, extreme fatigue and frequent infections. If not treated, potentially life-threatening heart problems, hemorrhages or infections can occur. Promacta works much like a natural protein that promotes platelet production in bone marrow. Patients using it as first-line treatment for severe aplastic anemia will also use immunosuppressants (such as cyclosporine and corticosteroids). It can be used for patients as young as two years old. For patients 12 years of age and older, recommended dosing for Promacta is 150mg daily. Children between six years and 11 years old should take 75mg. Dosing for younger children is based on their weight at 2.5mg/kg. Treatment lasts for six months. A boxed warning and Medication Guide caution that Promacta may cause liver damage, so patients taking it must have their liver enzymes tested regularly. Prescribing information is available here.

Indications Extended for Venclexta

AbbVie/Genentech’s Venclexta ® (venetoclax) tablets received a U.S. Food and Drug Administration (FDA) indication on Nov. 21, 2018, for treating adults who have newly diagnosed acute myeloid leukemia (AML), but who cannot undergo intense chemotherapy. Eligible patients include those age 75 years and older and those who have previous or co-existing conditions that make effective treatment difficult for them to tolerate. Venclexta inhibits B-cell lymphoma-2 (BCL-2), a protein that may interfere with apoptosis (the self-destruction process) in cancer cells. For its new indication, Venclexta will be used along with azacitidine, decitabine or low-dose cytarabine. Dosing is initiated at 100mg on the first day, 200mg on the second and 400mg on the third. Based on which additional agent is being used, maintenance dosing is either 400mg/day or 600mg/day until AML worsens or the patient can no longer continue therapy. Complete revised prescribing information is available here.

 
26Nov
Express Scripts News Flash

Express Scripts News Flash

Gamifant Approved to Treat Primary Hemophagocytic Lymphohistiocytosis

Gamifant® (emapalumab-lzsg) was approved by the U.S. Food and Drug Administration (FDA) on Nov. 20, 2018, to treat an extremely rare hereditary condition, primary hemophagocytic lymphohistiocytosis (HLH). It is an antibody that inhibits interferon gamma, which is overproduced by patients who have HLH. It will be administered intravenously (IV) at a starting dose of 1mg/kg per day every three or four days. Doses may be increased over the first few treatments to a maximum of 10mg/kg if symptoms and lab values do not improve on smaller doses. Patients will continue receiving Gamifant along with dexamethasone, until the patient undergoes a stem cell transplant or treatment with the drug is no longer tolerable. Cost information is not yet available. The manufacturer, Swedish Orphan Biovitrum (Sobi), expects to begin shipping Gamifant to treatment centers in the first quarter of 2019. Complete prescribing information is available here.

Daurismo Approved for Acute Myeloid Leukemia
On Nov. 21, 2018, the U.S. Food and Drug Administration (FDA) approved Pfizer’s Daurismo™ (glasdegib) for the first-line treatment of acute myeloid leukemia (AML) in adult patients who are 75 years or older or who have comorbidities that preclude use of intensive induction chemotherapy. It is used in combination with low-dose cytarabine (LDAC), a type of chemotherapy. The recommended dose of Daurismo is 100mg orally, once daily. Launch is expected in early December. It will be available through a large network of specialty pharmacies that includes Accredo. Full prescribing information is available here.

 
21Nov

Happy Thanksgiving

In observance of the Thanksgiving holiday, AFSPA will close at 1PM ET on Wednesday, November 21. We will remain closed on Thursday and Friday, November 22 and 23, and we will resume normal business hours at 8:30 am ET on Monday, November 26.

Thank you for trusting us to serve you and your family. We wish each of you a very Happy Thanksgiving!

 
19Nov
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Hepatocellular Carcinoma Indication Approved for Keytruda

Merck’s Keytruda® (pembrolizumab) received accelerated approval from the U.S. Food and Drug Administration (FDA) for an additional indication on November 9, 2018. It now is approved to treat patients who have hepatocellular carcinoma (HCC) that have previously been treated with Nexavar® (sorafenib). Keytruda is a human programmed death receptor-1 (PD-1)-blocking antibody that helps the body’s immune system attack cancer cells. It originally was FDA approved on September 4, 2014, for the second- or third-line treatment of patients with unresectable or metastatic melanoma. Since then, it has received multiple new indications for treating various cancer types. In May 2017, Keytruda became the first drug approved for treating colorectal cancer and any solid tumors that are microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) regardless of the tumors’ primary site of origin. For its HCC indication, Keytruda will be infused once every three weeks at a dose of 200mg. Continued approval of Keytruda for HCC is contingent upon confirmatory trials that demonstrate a clinical benefit for patients. Revised prescribing information is available here.

 
12Nov

STATE OF EMERGENCY IN CALIFORNIA DUE TO WILDFIRES

The Governor of California has declared State of Emergency in Butte, Los Angeles and Ventura due to wildfires.

Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an Emergency Access to Benefits/Refill Too Soon override that allows pharmacies, at the point of sale (POS), to override certain benefit coverage/edits such as an early refill during a government-defined emergency. In addition, if your home delivery of medications is affected by the emergency, you may provide a temporary alternate address (either online at www.express-scripts.com or by calling 1-800-818-6717) or request a local fill as needed. The Emergency Access to Benefits/Refill Too Soon override process will be implemented with an effective date of November 9, 2018 and expiration date of December 9, 2018.

 
6Nov
From the CEO

From the CEO

Welcome to November 2018! As the year comes to an end, this season calls for planning and preparation for the upcoming year. Open Season starts this month, which is a great time to take a look at all your benefits. Think about adding dental coverage, life insurance, or a disability plan from AFSPA. For stateside members, you even might want to consider our Discount Care Programs to save on dental, vision and even hearing aids. Please look for the 2018 Fall Newsletter in your mailbox, which highlights these programs and more.


New! Group Enhanced Life (GEL) Insurance Plan

Please review AFSPA’s new term life insurance plan, Group Enhanced Life (GEL). I know you have many insurance choices – but I hope you look into the GEL plan. It includes a feature that enables you to receive a portion of your total coverage amount, if you become chronically ill. These funds can be used to assist with home care, assisted living, and nursing home expenses. 

Take advantage of the 2018 GEL Open Enrollment, which ends December 31. During this period, members age 19 to 59 can enroll for up to $200,000 of coverage without medical underwriting or a review of one’s health status. Click here to learn more about GEL. Please view a recording of our Life Insurance Webinar that was held September 2018, in recognition of Life Insurance Awareness Month.


Open Season Activities

Open Season is approaching fast. This year’s enrollment period is from November 12 to December 10, 2018. AFSPA staff travel to various regions of the globe in preparation for Open Season. Any direct hire Federal employee who is enrolled or is eligible to enroll in the Federal Employee Health Benefits (FEHB) Program can attend. These briefings offer valuable information on FEHB, FEDVIP, and FSAFEDS to make informed decisions. AFSPA staff also will attend over 60 domestic agency Open Season health fairs this year. If you are in the area overseas or in the states, please plan to attend an Open Season event.


November Diabetes Awareness Month

Diabetes by the numbers:

  • Over 30 million U.S adults have diabetes—1 out of 4 don’t know it.
  • 1 out of 3 people will develop diabetes in their lifetime.
  • Medical costs are 2x as high as for people without diabetes.
  • Risk of death is 50% higher than for adults without diabetes. 

FSBP provides several programs for members with diabetes:

  • In Touch Care – personal support to help manage chronic conditions, including one-on-one calls with a nurse and digital support resource
  • Virtual Lifestyle Management – an internet-enabled self-management education program with trained coaches to assist you\
  • Mediterranean Wellness Program – an interactive on-line, 8-week program that assists you in maintaining a desirable weight and keeping healthy
  • Livongo – a diabetes monitoring program that provides support through a cellular enabled meter, mobile app, and personalized interventions 

Other available resources: HealthfinderCenter for Disease Control and Prevention


Thanksgiving Trivia!

Thanksgiving is approaching – a time to be with family, reflect on our good fortune and how lucky we are to celebrate this truly American holiday.

True or False? Chowing down for one day on Thanksgiving is no big deal. 

False. Overeating on Thanksgiving has become a national pastime. But the traditional foods that we love so much are extremely high in fat and calories. Worse, Thanksgiving often is the kickoff to an entire six weeks of overeating that ends on New Year’s Day. So if you want to be heart-healthy this Thanksgiving – and beyond — consider preparing lighter versions of your favorite dishes. Reduce your salt intake and load your plate with vegetables. By making these changes, watching your portion size, and burning a few calories with a long walk after dinner, you may start a healthy new Thanksgiving family tradition. I plan to enjoy the holiday celebrations, but will try to do so in moderation – and maybe take a walk after that 2000 calorie meal. 


As Thanksgiving approaches, I want to express my gratitude for your patience and loyalty this year. As always, thank you for your trust and for giving us the opportunity to serve you. 

To Your Health, 

Paula S. Jakub, RHU
CEO, AFSPA 
Executive Director, Senior Living Foundation

 
13Nov
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Ortho Dermatologics Gains Approval for Bryhali

Bryhali™ (halobetasol propionate) Lotion, 0.01%, received U.S. Food and Drug Administration (FDA) approval on Nov. 6, 2018, for the treatment of adults who have plaque psoriasis. A widely used high-potency corticosteroid, halobetasol is available in a number of other topical dosage forms, some as generics. Bryhali uses a proprietary lotion formula, however, that allows it to be used for up to 8 weeks as compared with a 2-4 week limit for most other high-potency steroids. Ortho Dermatologics, a division of Bausch Health, plans to launch it in November. Bryhali will be marketed in 60Gm and 100Gm tubes with directions to apply a thin layer to the affected areas once a day. Bryhali will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete. Full prescribing information for Bryhali may be found here.

Yupelri Approved for COPD

On Nov. 9, 2018, the U.S. Food and Drug Administration (FDA) approved Theravance and Mylan’s Yupelri™ (revefenacin) inhalation solution. It is a long-acting muscarinic antagonist (LAMA) nebulization solution for the once-daily maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Yupelri, which can be used with a standard jet nebulizer, will be available as single-dose vials containing 175mcg/3mL of solution. Pricing and availability information is not yet known. Yupelri will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete. Full prescribing information can be found here.

Empliciti Approved for Multiple Myeloma

The U.S. Food and Drug Administration (FDA) approved a new indication for Bristol-Myers Squibb’s Empliciti® (elotuzumab) on Nov. 6, 2018. It now can be used, along with Pomalyst® (pomalidomide – Celgene) and dexamethasone, to treat adults who have multiple myeloma that has relapsed or become resistant after two or more previous treatments with Revlimid® (lenalidomide – Celgene) and a proteasome inhibitor, such as Velcade® (bortezomib – Millennium/Takeda) or Kyprolis® (carfilzomib – Amgen). Empliciti is an antibody that activates the immune system and also seeks out a specific protein on myeloma cells. In the clinical study that led to the approval, 53.3% of patients treated with all three drugs responded to therapy compared to 26.3% of patients receiving only Pomalyst and dexamethasone. Additionally, progression-free survival (PFS) averaged 10.3 months for patients using all three drugs versus about 4.7 months for Pomalyst/dexamethasone-treated participants. For its new indication, Empliciti will be infused intravenously (IV) once a week for two 28-day cycles, and then once every four weeks. Dosing is weight based at 10mg/kg for the first eight infusions and at 20mg/kg thereafter. Complete, revised prescribing information is available here.

 
New Indication for Restylane Lyft

Galderma announced on Nov. 5, 2018, that a new indication – to correct age-related midface (cheek) contour deficiencies for adults age 21 and older – had been U.S. Food and Drug Administration (FDA) approved for Restylane Lyft® (hyaluronic acid/lidocaine) gel. The Restylane line of products includes dermal fillers that have indications for various cosmetic uses in the face and hands. For use in the cheeks, Restylane Lyft will be inserted through cannulas (thin, flexible tubes) with blunt tips and small, side openings, rather than with sharp needles. Using a cannula is believed to reduce bruising, swelling and recovery time after procedures.


Primatene Mist Re-Introduced in the United States

Amphastar Pharmaceuticals received U.S. Food and Drug Administration (FDA) approval on Nov. 7, 2018, to re-market its non-prescription product, Primatene® Mist (epinephrine inhalation aerosol bronchodilator suspension) 0.125mg/spray in the U.S. It is used for temporary relief of mild, intermittent asthma for patients age 12 years and older. The original Primatene Mist was taken off the market in 2011 because the propellant it contained contributed to the reduction of Earth’s ozone layer. The newly approved version uses a different, safer propellant and it also will be packaged in metal containers with mouthpieces and dose counters rather in the glass containers previously used. Before each inhalation, the canister must be shaken and one dose sprayed into the air to assure the correct dose. Patients using it are advised to contact a doctor if their symptoms worsen after using Primatene Mist, if symptoms do not improve within 20 minutes, if more than eight sprays are needed in any 24-hour period or if more than two asthma attacks occur in one week. Launch is expected in early 2019 at most retail pharmacies. Pricing has not yet been released.

 

 

 

 

 

 
92018Nov
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Bijuva Approved to Treat Menopausal Symptoms

Bijuva™ (estradiol, 1mg/progesterone, 100mg – TherapeuticsMD) capsules were approved by the U.S. Food and Drug Administration (FDA) on Oct. 28, 2018. Bijuva is indicated to be taken once every evening along with food to relieve moderate-to-severe vasomotor symptoms due to menopause for women who have not had hysterectomies. “Bio-identical” hormone replacement has been available from compounding pharmacies and as single component (estradiol and progesterone) commercial products for decades. However, Bijuva is the first to use them in an FDA-approved commercial combination. Bio-identical hormones chemically duplicate natural ones to help manage symptoms, which include facial flushing, hot flashes and night sweats. Labeling has a boxed warning, common to all female-hormone replacements, that using an estrogen/progestin combination may raise the risk of blood clots, dementia, breast cancer or strokes. Taking estrogen alone may contribute to developing cardiovascular conditions, dementia and endometrial cancer. Hormone replacement should not be used to prevent cardiovascular disease or dementia. No cost information currently is available for Bijuva, but launch is planned for the second quarter of 2019. Express Scripts currently is investigating the data around Bijuva for a possible utilization management strategy. It also will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete.

New Opioid, Dsuvia, Approved

On Nov. 2, 2018, AcelRx Pharmaceuticals was given U.S. Food and Drug Administration (FDA) approval for Dsuvia™ (sufentanil sublingual tablets, 30mcg), C-II. For use only in certified healthcare facilities, it is indicated for treating adults who have intense, acute pain that requires an opioid. It will be available in the first quarter of 2019 as prefilled, single–tablet dispensers that a health professional will use to insert one tablet under the patient’s tongue. Doses must be separated by at least one hour and no more than 12 tablets should be given in any 24-hour period. In clinical studies, Dsuvia began to work within 15 minutes. Compared to 65% of study patients given a placebo, only 22% of Dsuvia-treated participants needed rescue treatment with morphine within the first 12 hours after abdominal surgery. A Risk Evaluation and Mitigation Strategy (REMS) limits distribution to certified heathcare facilities. Boxed warnings on its label caution that opioids can cause potentially severe breathing problems, that they can be life-threatening if swallowed by children and that neonatal withdrawal syndrome is possible for babies born to women who used opioids while pregnant. It will be excluded at launch on the NPF until our formulary development process is complete.

FDA Approval for Sympazan to Treat Lennox-Gastaut Syndrome

The U.S. Food and Drug Administration (FDA) approved Sympazan™ (clobazam) oral film on Nov. 2, 2018. Made by Aquestive Therapeutics, it is a new dosage form of clobazam that is indicated in combination with other anti-seizure drugs to treat patients at least two years old who have Lennox-Gastaut syndrome (LGS). A rare form of epilepsy, LGS is believed to affect fewer than 20,000 patients in the U.S. It is difficult to treat because it causes multiple different types of seizures, some lasting for several minutes and/or repeating rapidly. Multi-drug therapy generally is required throughout the patient’s life. With a planned launch in November, Sympazan will be available in foil pouches each containing one 5mg, 10mg or 20mg berry-flavored film. Recommended daily dosing is 5mg to 20mg per day for children weighing 30kg (66 pounds) or less and 10mg to 40mg for children heavier than 30kg. Doses of 10mg or more should be divided into two equal parts. Clobazam also is available as Aquestive’s brand, Onfi® and generic oral tablets and oral suspension. Labeling for all clobazam products carries a boxed warning that taking it at the same time as an opioid could result in extreme sleepiness, breathing problems, coma or even death. They are C-IV controlled substances. Express Scripts currently is investigating the data around Sympazan for a possible utilization management strategy. It also will be excluded at launch on the NPF until our formulary development process is complete.
 

Third Biosimilar to Humira Approved

Sandoz has announced that Hyrimoz™ (adalimumab-adaz), a biosimilar to AbbVie’s Humira®, was U.S. Food and Drug Administration (FDA) approved on Oct. 30, 2018. It is indicated to treat ankylosing spondylitis (AS), Crohn’s disease (CD) for adults, juvenile idiopathic arthritis (JIA) for patients at least four years old, plaque psoriasis (Ps), psoriatic arthritis (PsA), rheumatoid arthritis (RA) and ulcerative colitis (UC) for adults. It blocks the activity of tumor necrosis factor (TNF), a protein that is overproduced in certain autoimmune conditions causing inflammation and tissue damage. Under the terms of a patent settlement, Sandoz will release Hyrimoz in the United States on Sept. 30, 2023. Amgen’s Amjevita™ (adalimumab – atto), approved in September 2016, is expected to be introduced on Jan. 31, 2023. Boehringer Ingelheim has not yet announced a release date for Cyltezo™ (adalimumab – adbm), which was FDA approved in August 2017. Hyrimoz will be excluded at launch on the NPF until our formulary development process is complete.
 

Udenyca Biosimilar to Neulasta Approved

Udenyca™ (pegfilgrastim-cbqv – Coherus BioSciences) a biosimilar to Amgen’s Neulasta®, was U.S. Food and Drug Administration (FDA) approved on Nov. 2, 2018. A leukocyte growth factor, it reduces the risk of infection for patients who have non-myeloid malignancies being treated with anti-cancer drugs that are associated with bone marrow suppression and clinically significant febrile neutropenia. As an adverse effect of some chemotherapy (chemo), the drugs that kill cancer cells also destroy normal cells, including neutrophils – white blood cells that protect against infections. As a result, infections are more likely and usually more serious among cancer patients receiving chemo. Pegfilgrastim is a PEGylated form of the granulocyte colony-stimulating factor (G-CSF) analog filgrastim, giving it a longer duration of action. G-CSF causes cells in bone marrow to produce more neutrophils. The approval of Udenyca follows that of Fulphila™ (pegfilgrastim-jmdb – Mylan/Biocon) on June 4, 2018. Neither biosimilar is interchangeable with Neulasta. Launch plans and pricing for Udenyca are expected to be announced by the company on Nov. 8. According to IQVIA, U.S. annual sales of Neulasta were approximately $4.3 billion in 2017. Express Scripts currently is investigating the data around Udenyca for a possible utilization management strategy. It also will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete.

Xyrem Now Indicated for Children

Jazz Pharmaceuticals received a new indication for Xyrem® (sodium oxybate) on Oct. 26, 2018. It is an oral solution containing 0.5mg/mL that is taken at bedtime to treat cataplexy (random, sudden loss of muscle strength) due to narcolepsy and excessive daytime sleepiness. Previously restricted to adult patients, Xyrem now can be used for children as young as seven years old. After small starting doses, which are weight-based for children, it must be increased gradually to a recommended daily range of 6mg to 9mg. The total dose is divided into two equal parts that each are diluted with about one-fourth cup of water. Following two hours or more without eating, the first dose is taken as soon as the patient is in bed; and the second between two-and-one-half and five hours later. A C-III controlled substance, it carries a boxed warning that taking it while drinking alcohol and/or using central nervous system (CNS) depressants (such as antipsychotics, benzodiazepines, opioids or sedating antidepressants) can significantly affect consciousness and can lead to severe breathing problems. Additionally, it has a Risk Evaluation and Mitigation Strategy (REMS) that requires it to be prescribed only by certified providers, dispensed only through a single specialized and certified pharmacy and sent only to patients registered with the program.

Cardiovascular Indication for Invokana

On Oct. 29, 2018, the U.S. Food and Drug Administration (FDA) approved a new indication for Janssen’s Invokana® (canagliflozin) tablets, Invokamet® (canagliflozin/metformin) tablets and Invokamet®  XR (canagliflozin/metformin) extended-release tablets. Invokana is a sodium-glucose co-transporter 2 (SGLT2) inhibitor, first approved in 2013 to treat adults who have type 2 diabetes. It and its metformin combinations now are indicated to decrease the risk of a heart attack, stroke or cardiovascular (CV) related death for adults who have both type 2 diabetes and diagnosed CV disease. Although other diabetes drugs, such as Novo Nordisk’s Victoza® (liraglutide) injection, are approved for the same indication, the Invokana line currently includes the only oral drugs to have the indication.

Keytruda Gains New Indication

Merck’s Keytruda® (pembrolizumab) injection was granted a new indication as first-line treatment for metastatic squamous non-small cell lung cancer (NSCLC) on Oct. 30, 2018. It will be used along with carboplatin and either paclitaxel or Abraxane® (nab-paclitaxel) and given at an intravenous (IV) dose of 200mg once every three weeks until the cancer begins to progress or until the patient can no longer take the drug. Keytruda is a human programmed death receptor-1 (PD-1)-blocking antibody that has previous indications for treating multiple types of cancer. As an immuno-oncology (I/O) drug, it increases the ability of the body’s immune system to destroy cancer cells. Its new indication does not depend on PD-L1 expression and patients will not need pharmacogenomic testing before it can be used.

Levitra Generic Launched

Lannett Company released vardenafil, an AB-rated generic for Bayer Healthcare’s Levitra®, on the U.S. market on October 31, 2018. Vardenafil is a phosphodiesterase-5 (PDE-5) inhibitor indicated to treat erectile dysfunction (ED), which is estimated to affect about 18 million American men. According to IQVIA, Levitra’s sales amounted to approximately $127 million in 2017. Other ED drugs, sildenafil (Viagra® - Pfizer) and tadalafil (Cialis® - Eli Lilly) also are available as generics.

Lorbrena Approved to Treat Metastatic Non-Small Cell Lung Cancer
The U.S. Food and Drug Administration (FDA) approved Lorbrena® (lorlatinib - Pfizer) on Nov. 2, 2018. It is a third-generation anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI), which will be used to treat patients who have ALK-positive metastatic non-small cell lung cancer (NSCLC) that has worsened despite treatment with Xalkori® (crizotinib - Pfizer) and at least one other ALK inhibitor for metastatic disease. It also is indicated for NSCLC that was treated with Alcensa® (alectinib - Genentech) or Zykadia® (ceritinib - Novartis) as the first ALK inhibitor therapy for metastatic disease. Recommended dosing is one 100mg tablet per day, but doses may be decreased to 50mg or 75mg/day if the patient has serious side effects from the drug. Pfizer has not yet released a launch date. Lorbrena will be dispensed through a large network of specialty pharmacies that includes Accredo.

Generic Trisenox 10mg/10mL Launched

After an August 31 U.S. Food and Drug Administration (FDA) approval, arsenic trioxide injection, 10mg/10mL was introduced to the U.S. market by Fresenius Kabi on Oct. 26, 2018. It is given via IV to treat acute promyelocytic leukemia (APL) that has t(15;17) translocation or PML/RAR-alpha gene expression. Only a few hundred Americans are diagnosed with APL annually. Arsenic trioxide is administered when APL has recurred or resists previous therapy with retinoids and anthracyclines (such as doxorubicin). It is used in combination with oral tretinoin. Dosing for induction therapy is 0.15mg/Kg every day until bone marrow is suppressed, but no longer than 60 days. Between three weeks and six weeks after the end of induction, dosing resumes for 25 more daily doses over no more than five weeks for the consolidation phase of treatment. The Fresenius Kabi product is the only generic currently available in the U.S. However, the brand, Trisenox® - Teva, now is available only in 12mg/6mL vials since Teva’s withdrawal of its 10mg/10mL strength in November 2017. Labeling has a boxed warning that differentiation syndrome, which can be life-threatening, may be associated with using arsenic-based drugs. Differentiation syndrome is caused by the rapid production of immature myeloid cells. Its symptoms include fever, difficult breathing, low blood pressure, swelling and rapid weight gain. Patients also should be evaluated for ventricular arrhythmias and other heart conditions before starting treatment, because arsenic trioxide also can cause potentially fatal heart problems. IQVIA estimates U.S. sales of the 10mg/10mL version of Trisenox at over $67 million in 2017.

 

 
29Oct
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

New Levoleucovorin Approved

Spectrum Pharmaceuticals’ Khapzory® (levoleucovorin) for injection was approved by the U.S. Food and Drug Administration (FDA) on Oct. 19, 2018. It is a folate analog with three FDA approved indications: for rescue after high doses of methotrexate are used to treat osteosarcoma, to reduce toxicity from overdoses or inadequate elimination of folic acid antagonists (such as methotrexate) and, along with fluorouracil, to treat metastatic colorectal cancer. Khapzory is given by intravenous (IV) infusion at varying doses depending on the condition that is being treated. Although other levoleucovorins, including generics, are available in the U.S., they have a slightly different formulation, so they are not interchangeable with Khapzory. Spectrum plans a January 2019 launch of vials containing either 175mg or 300mg of powdered Khapzory for reconstitution. It will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete. Full prescribing information is available here.

Generics Launch for Onfi

Several generic companies launched AB-rated generics for Lundbeck’s Onfi® (clobazam) tablets and Onfi oral suspension after orphan exclusivity for the brand expired on Oct. 21, 2018. A C-IV controlled substance, clobazam is a benzodiazepine that is used with other antiepileptic drugs to manage seizures for patients as young as two years old who have Lennox-Gastaut syndrome (LGS). Affecting up to 24,000 children in the United States, LGS causes different types of seizures. It includes cognitive impairments and a distinctive electroencephalogram (EEG) pattern, as well. Patients with LGS may have frequent injuries from falls associated with “drop” seizures, which cause sudden, unpredictable losses of muscle tone. It is hard to manage -- needing multi-drug therapy that generally is required throughout the patient’s life. Labeling for clobazam carries a boxed warning that taking it at the same time as an opioid could result in extreme sleepiness, breathing problems, coma or even death. As estimated by IQVIA, U.S. sales for Onfi tablets and oral suspension together amounted to around $849 million in the 12-month period that ended on Aug. 31, 2018.

 
25Oct
Express Scripts News Flash

Express Scripts News Flash

Xofluza Approved to Treat Flu

On Oct. 24, 2018, the U.S. Food and Drug Administration (FDA) approved Genentech and Shionogi and Company’s Xofluza™ (baloxavir marboxil) for the treatment of acute uncomplicated influenza (flu) in patients 12 years of age and older who have been symptomatic for no more than 48 hours. It blocks influenza cap-dependent endonuclease, an enzyme involved in the replication of the flu virus. Recommended dosing for Xofluza is a single 40mg dose for those weighing 40kg (about 88 pounds) to less than 80kg (about 175 pounds). Patients weighing 80kg or more should receive a single dose of 80mg. Genentech plans on making Xofluza available within the coming weeks. Full prescribing information is available here

  • Brand (Generic) Name: Xofluza™ (baloxavir marboxil)
  • Manufacturer: Genentech/Shionogi and Company
  • Date Approved: October 24, 2018
  • Indication: Treatment of acute uncomplicated influenza in patients at least 12 years old who have been symptomatic for no more than 48 hours
  • Dosage Forms Available: 20mg and 40mg tablets
  • Launch Date: According to the manufacturers, Xofluza will be available within the coming weeks.
  • Estimated Annual Cost: The wholesale acquisition cost (WAC) will be approximately $150 per treatment.
  • While the impact of the flu varies, the Centers for Disease Control and Prevention (CDC) estimates that the flu has resulted in between 9.2 million and 35.6 million illnesses, between 140,000 and 710,000 hospitalizations and between 12,000 and 56,000 deaths annually since 2010.
  • Xofluza is a selective inhibitor of influenza cap-dependent endonuclease, an enzyme that is involved in viral replication. Blocking this enzyme interferes with the ability of influenza virus to reproduce.
  • Early treatment with antiviral drugs can lessen symptoms and shorten the time patients who have flu feel sick. In clinical trials, starting Xofluza within 48 hours from the onset of flu symptoms reduced the duration of symptoms by about one-third (from an average of 80 hours to around 54 hours). These results are similar to those from Tamiflu® (oseltamivir – Genentech, generics).
  • Neuraminidase inhibitors, which inhibit an enzyme involved in the virus budding from the host cell, include Rapivab® (peramivir - BioCryst), Relenza® (zanamivir - GlaxoSmithKline) and Tamiflu® (oseltamivir - Genentech/generic).
  • No antiviral, including Xofluza, replaces the need for an annual flu vaccination, which remains the single best way to help protect against the flu.
  • Xofluza was approved under FDA’s priority review program.
  • Implications: Xofluza will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete.

 

 
23Oct
Express Scripts News Flash

Express Scripts News Flash

Dupixent Approved to Treat Eosinophilic Asthma

Dupixent® (dupilumab) was granted a second indication by the U.S. Food and Drug Administration (FDA) on Oct. 19, 2018. Originally FDA approved in March 2017 to treat atopic dermatitis, Dupixent now also is approved to treat patients who have eosinophilic asthma or who have asthma that is managed only by taking corticosteroids orally. It will be added to their usual maintenance therapy for patients at least 12 years old. Jointly developed by Sanofi and Regeneron, Dupixent is an interleukin-4 alpha receptor (IL-4Rα) blocker  ?  an antibody that disrupts the inflammatory process. Given as subcutaneous (SC) injections, it can be self-administered or injected by a caregiver. After the first Dupixent dose of 400mg or 600mg (two injections at the same time but at different injection sites), recommended dosing for its asthma indication is either 200mg or 300mg once every two weeks. Available through open distribution, it is dispensed in pre-filled, single-dose syringes. Revised prescribing information is available here.

  • Brand (Generic) Name: Dupixent® (dupilumab)
  • Manufacturer: Sanofi and Regeneron
  • Date Approved: October 19, 2018
  • Indication: as an add-on maintenance treatment in patients with moderate-to-severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid-dependent asthma
  • Dosage Forms Available: single-dose, pre-filled syringes, each containing 200mg or 300mg of Dupixent
  • Estimated Annual Cost: The wholesale acquisition cost (WAC) for either dose of Dupixent is about $37,000
  • Specialty Status: Dupixent is on Express Scripts’ specialty drug list.
  • According to the U.S. Centers for Disease Control and Prevention (CDC), more than 22 million Americans have asthma. Between 5% and 10% of patients with asthma have severe asthma and approximately 50% of patients with severe asthma have an eosinophilic phenotype.
  • Dupixent is an antibody that deactivates a specific interleukin receptor (IL-4Rα), blocking IL-4 and IL-13 cytokine-induced responses and lessening the inflammatory process.
  • Cinqair® (reslizumab – Teva), Fasenra™ (benralizumab – AstraZeneca) and Nucala® (mepolizumab – GlaxoSmithKline) are IL-5 inhibitors that are FDA approved for treating severe eosinophilic asthma. Cinqair is infused intravenously (IV); Fasenra and Nucala are given SC. They all are administered once-monthly by a healthcare professional.
 
22Oct
EXPRESS SCRIPTS CLINICAL NEWS AND NOTES

EXPRESS SCRIPTS CLINICAL NEWS AND NOTES

Yutiq Implant Approved for Uveitis

The U.S. Food and Drug Administration (FDA) approved Yutiq™ (fluocinolone acetonide intravitreal implant) 0.18mg on Oct. 12, 2018. Indicated to treat noninfectious uveitis affecting the posterior segment of the eye, it is placed in the back of the eye by a physician using a preloaded device. Posterior uveitis is inflammation in a layer of tissue in the eye’s back wall. It can be associated with an injury or an autoimmune disease, but it frequently has no apparent cause. If not treated, uveitis can result in blindness. Yutiq releases 0.25mcg of fluocinolone acetonide per day for three years to reduce the inflammation and lessen damage inside the eye. In clinical trials, a much smaller percentage of patients treated with Yutiq experienced a recurrence of uveitis after six months and 12 months as opposed to patients who had an inactive insert. The most common side effects were cataract development and increased intraocular pressure (IOP). EyePoint Pharmaceuticals plans a first quarter 2019 launch. Yutiq will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete. Complete prescribing information for Yutiq is available here.

 

Liletta Use Extended to Five Years

Allergan announced that the U.S. Food and Drug Administration (FDA) expanded the indication for Liletta® (levonorgestrel-releasing intrauterine system) 52mg on Oct. 15, 2018. Liletta is an intrauterine device (IUD) that originally was approved in 2015 to prevent pregnancy for three years by continuously releasing small amounts of a progestin, levonorgestrel. It later was reapproved with a different type of inserter for four-year use. Based on ongoing clinical trials, the FDA now has approved it for up to five years. A new system may be inserted to continue contraception after five years or it can be removed at any time, if pregnancy prevention is no longer required. Updated prescribing information for Liletta is available here.

 

Panzyga Immunoglobulin Approved in August

Octapharma’s Panzyga® (intravenous immunoglobulin 10%) was approved by the U.S. Food and Drug Administration (FDA) on Aug. 2, 2018. It is indicated for the treatment of primary humoral immunodeficiency in patients 2 years of age and older and chronic immune thrombocytopenic purpura in adults. Panzyga was recently added to the drug file. It is expected to be launched in early 2019. Panzyga will be added to Express Scripts’ specialty drug list. Distribution information is not known at this time. Express Scripts currently is investigating the data around Panzyga for a possible utilization management strategy. It also will be evaluated for exclude at launch on the National Preferred Formulary (NPF). Prescribing information is available here.

 
22Oct

Website Maintenance

Please be advised we will be processing critical website maintenance on Friday, October 26, 2018, from 8:00PM EST until 4:00AM EST. The website may not be available during this time. We apologize for the inconvenience.

 

 
17Oct
Express Scripts News Flash

Express Scripts News Flash

Talzenna Approved for Breast Cancer

The U.S. Food and Drug Administration (FDA) approved Pfizer’s Talzenna™ (talazoparib) capsules on Oct. 16, 2018. A poly (ADP-ribose) polymerase (PARP) inhibitor, Talzenna blocks an enzyme cancer cells use to restore their DNA. It is indicated to treat deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2?negative locally advanced or metastatic breast cancer in adults. Recommended dosing is 1 mg daily after the genetic mutation has been verified by an FDA-approved diagnostic test, such as BRACAnalysis CDx™ (Myriad Genetics Laboratories). Pfizer plans to launch Talzenna in October. It will be available through a large network of specialty pharmacies that includes Accredo. Complete prescribing information is available here.

  • Brand (Generic) Name: Talzenna™ (talazoparib)
  • Manufacturer: Pfizer
  • Date Approved: October 16, 2018
  • Indication: for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) HER2-negative locally advanced or metastatic breast cancer
  • Dosage Forms Available: 25mg and 1 mg oral capsules
  • Launch Date: By the end of October
  • Estimated Annual Cost: Wholesale acquisition cost (WAC) for 1 mg Talzenna capsules is $177,980/year
  • Specialty Status: Talzenna will be added to the Express Scripts specialty drug list.
  • According to the American Cancer Society (ACS), approximately 250,000 cases of invasive breast cancer are diagnosed annually; and up to 10% of breast cancer patients have BRCA mutations. An estimated 150,000 U.S. patients presently have metastatic disease.
  • In a clinical study, average progression-free survival (PFS) was 8.6 months for participants taking Talzenna compared with 5.6 months for patients using a standard-of-care chemotherapy (chemo). All patients in the study had been treated up to three times previously with cytotoxic chemo.
  • Talzenna will compete with Lynparza® (olaparib – AstraZeneca), which was FDA approved in January to treat BRCA-mutated, HER2-negative breast cancer. Lynparza also is indicated to treat advanced ovarian cancer that has deleterious or suspected deleterious gBRCAm and certain patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer.
  • The FDA approved Talzenna under its Priority Review pathway.

Implications: Express Scripts currently is investigating the data around Talzenna for a possible utilization management strategy. It also will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete

 
16Oct
Express Scripts News Flash

Express Scripts News Flash

Generic AndroGel 1.62% Topical Gel Launched
Perrigo announced the launch of its AB-rated generic to AbbVie’s AndroGel® (testosterone) 1.62% topical gel, CIII, a product approved for treating men who have deficiencies or absences of natural (endogenous) testosterone. AndroGel is applied topically once daily in the morning to clean, dry, intact skin of the shoulders and upper arms. Perrigo will receive 180 days of generic exclusivity. While the launch of an authorized generic is expected, additional generics will be delayed until at least April 2019.

  • Brand Drug: AndroGel® (testosterone 1.62% topical gel - AbbVie)
  • Indication: Replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone.
  • Generic Manufacturer(s): Perrigo
  • Launch Date: October 15, 2018
  • Dosage Forms Available: Testosterone 1.62% topical gel is available as 1.25g and 2.5g unit dose packets, and an 88g (1.25g per actuation) pump.
  • Annual U.S. Sales: $1 billion for the most recent twelve months ending in August 2018, according to IQVIA.

Perrigo received approval for its AB-rated (interchangeable) generics to AndroGel 1.62% gel pump and packets in 2015 and 2017, respectively. However, a settlement agreement resulted in a delay in generic availability.

 
15Oct

STATE OF EMERGENCY DUE TO TROPICAL STORM MICHAEL

The Governor of Virginia has declared a State of Emergency for all counties due to Tropical Storm Michael.

Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an Emergency Access to Benefits/Refill Too Soon override that allows pharmacies, at the point of sale (POS), to override certain benefit coverage/edits such as an early refill during a government-defined emergency. In addition, if your home delivery of medications is affected by the emergency, you may provide a temporary alternate address (either online at www.express-scripts.com or by calling 1-800-818-6717) or request a local fill as needed. The Emergency Access to Benefits/Refill Too Soon override process will be implemented with an effective date of October 11, 2018 and expiration date of November 11, 2018.

 
15Oct
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Indication Extended for Gardasil 9

On Oct. 5, 2018, the U.S. Food and Drug Administration (FDA) approved Merck’s Gardasil® 9 (human papillomavirus 9-valent vaccine, recombinant) for individuals between 27 and 45 years old. It has been available in the U.S. since 2014 for use in patients between nine and 26 years of age. Gardasil 9 provides protection against nine strains of human papilloma virus (HPV), but it does not treat any HPV infection the patient already has. Additionally, Gardasil 9 offers no protection against HPV strains the patient was exposed to before being vaccinated. For adults between the ages of 15 and 45 years old, it is given in a series of three shots over six months. The U.S. Centers for Disease Control and Prevention (CDC) estimates that approximately 14 million Americans are infected with HPV each year. Many individuals are not even aware of the infections and most clear up without treatment. However, some HPV strains may cause genital warts and some may develop into cancers of the anus, cervix, penis, throat or vagina. Prescribing information is available here.

Xarelto Gains New Indication

Janssen received a new indication for its oral anticoagulant, Xarelto® (rivaroxaban) on Oct. 11, 2018. Taken along with aspirin, Xarelto now is approved to reduce the risk of major cardiovascular (CV) events, such as heart attacks, strokes and CV-related death, for patients who have chronic coronary artery disease (CAD) or peripheral artery disease (PAD). Xarelto has several previous U.S. Food and Drug Administration approvals, including to prevent and treat deep vein thromboses (DVT) and pulmonary embolisms (PE). It works by blocking blood clotting factor Xa, thereby reducing the ability of the blood to form clots. In the clinical trial that led to the most recent approval, patients taking 2.5mg of Xarelto twice a day and a once-daily 100mg aspirin experienced 14% fewer heart attacks, 42% fewer strokes and 22% fewer CV deaths than patients taking only aspirin. No increases were seen in bleeding into the brain or fatal bleeding among study participants. Xarelto carries a boxed warning that stopping an anticoagulant abruptly increases the risk of blood clots. Additionally, undergoing a spinal procedure, such as spinal anesthesia or a spinal puncture, while taking Xarelto may cause blood to accumulate in the spine, potentially damaging the spinal cord and leading to impairments in movement. Revised prescribing information is available here.

Correction
The title for the September 14 News and Notes piece on GamaSTAN should be “New GamaSTAN Formulation Approved.” Its indications have not changed.

 
15Oct

STATE OF EMERGENCY DUE TO HURRICANE MICHAEL

The Governor of Georgia has expanded a State of Emergency due to Hurricane Michael to include the following counties: Butts, Clarke, Columbia, Elbert, Greene, Jasper, Lamar, Lincoln, McDuffie, Monroe, Morgan, Oconee, Oglethorpe, Putnam, Taliaferro and Wilkes.

Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an Emergency Access to Benefits/Refill Too Soon override that allows pharmacies, at the point of sale (POS), to override certain benefit coverage/edits such as an early refill during a government-defined emergency. In addition, if your home delivery of medications is affected by the emergency, you may provide a temporary alternate address (either online at www.express-scripts.com or by calling 1-800-818-6717) or request a local fill as needed. The Emergency Access to Benefits/Refill Too Soon override process will be implemented with an effective date of October 9, 2018 and expiration date of October 16, 2018.

 
11Oct

STATE OF EMERGENCY DUE TO HURRICANE MICHAEL

The Governor of South Carolina has extended the statewide State of Emergency currently in effect to cover anticipated impact due to Hurricane Michael.

Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an Emergency Access to Benefits/Refill Too Soon override that allows pharmacies, at the point of sale (POS), to override certain benefit coverage/edits such as an early refill during a government-defined emergency. In addition, if your home delivery of medications is affected by the emergency, you may provide a temporary alternate address (either online at www.express-scripts.com or by calling 1-800-818-6717) or request a local fill as needed. The Emergency Access to Benefits/Refill Too Soon override process will be implemented with an effective date of October 10, 2018 and expiration date of November 9, 2018.

 
11Oct

STATE OF EMERGENCY DUE TO HURRICANE MICHAEL

The Governor of North Carolina has declared a State of Emergency due to Hurricane Michael in the following counties: Alamance, Anson, Beaufort, Bertie, Bladen, Brunswick, Camden, Carteret, Caswell, Chatham, Chowan, Columbus, Craven, Cumberland, Currituck, Dare, Davidson, Davie, Duplin, Durham, Edgecombe, Forsyth, Franklin, Gates, Granville, Greene, Guilford, Halifax, Harnett, Hertford, Hoke, Hyde, Johnston, Jones, Lee, Lenoir, Martin, Montgomery, Moore, Nash, New Hanover, Northampton, Onslow, Orange, Pamlico, Pasquotank, Pender, Perquimans, Person, Pitt, Randolph, Richmond, Robeson, Rockingham, Sampson, Scotland, Stokes, Surry, Tyrrell , Vance, Wake, Warren, Washington, Wayne, Wilson, and Yadkin.

Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an Emergency Access to Benefits/Refill Too Soon override that allows pharmacies, at the point of sale (POS), to override certain benefit coverage/edits such as an early refill during a government-defined emergency. In addition, if your home delivery of medications is affected by the emergency, you may provide a temporary alternate address (either online at www.express-scripts.com or by calling 1-800-818-6717) or request a local fill as needed. The Emergency Access to Benefits/Refill Too Soon override process will be implemented with an effective date of October 10, 2018 and expiration date of November 9, 2018.

 
11Oct

STATE OF EMERGENCY DUE TO HURRICANE MICHAEL

The Governor of Georgia has declared a State of Emergency due to Hurricane Michael in the following counties: Appling, Atkinson, Bacon, Baker, Baldwin, Ben Hill, Berrien, Bibb, Bleckley, Brantley, Brooks, Bryan, Bulloch, Burke, Calhoun, Camden, Candler, Charlton, Chatham, Chattahoochee, Clay, Clinch, Coffee, Colquitt, Cook, Crawford, Crisp, Decatur, Dodge, Dooly, Dougherty, Early, Echols, Effingham, Emanuel, Evans, Glascock, Glynn, Grady, Hancock, Houston, Irwin, Jeff Davis, Jefferson, Jenkins, Johnson, Jones, Lanier, Laurens, Lee, Liberty, Long, Lowndes, Macon, Marion, Mcintosh, Miller, Mitchell, Montgomery, Muscogee, Peach, Pierce, Pulaski, Quitman, Randolph, Richmond, Schley, Screven, Seminole, Stewart, Sumter, Talbot, Tattnall, Taylor, Telfair, Terrell, Thomas, Tift, Toombs, Treutlen, Turner, Twiggs, Upson, Ware, Warren, Washington, Wayne, Webster, Wheeler, Wilcox, Wilkinson and Worth.

Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an Emergency Access to Benefits/Refill Too Soon override that allows pharmacies, at the point of sale (POS), to override certain benefit coverage/edits such as an early refill during a government-defined emergency. In addition, if your home delivery of medications is affected by the emergency, you may provide a temporary alternate address (either online at www.express-scripts.com or by calling 1-800-818-6717) or request a local fill as needed. The Emergency Access to Benefits/Refill Too Soon override process will be implemented with an effective date of October 9, 2018 and expiration date of October 16, 2018.

 
11Oct

STATE OF EMERGENCY DUE TO HURRICANE MICHAEL

The Governor of Alabama has declared a State of Emergency for the entire state of Alabama.

Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an Emergency Access to Benefits/Refill Too Soon override that allows pharmacies, at the point of sale (POS), to override certain benefit coverage/edits such as an early refill during a government-defined emergency. In addition, if your home delivery of medications is affected by the emergency, you may provide a temporary alternate address (either online at www.express-scripts.com or by calling 1-800-818-6717) or request a local fill as needed. The Emergency Access to Benefits/Refill Too Soon override process will be implemented with an effective date of October 7, 2018 and expiration date of November 7, 2018.

 
11Oct

STATE OF EMERGENCY DUE TO HURRICANE MICHAEL

UPDATE:

The Governor of Florida has declared a State of Emergency due to Hurricane Michael. The following counties have been added to the State of Emergency: Baker, Union, Bradford, Alachua, Hernando, Pasco, Pinellas,  Hillsborough, and Manatee.

Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an Emergency Access to Benefits/Refill Too Soon override that allows pharmacies, at the point of sale (POS), to override certain benefit coverage/edits such as an early refill during a government-defined emergency. In addition, if your home delivery of medications is affected by the emergency, you may provide a temporary alternate address (either online at www.express-scripts.com or by calling 1-800-818-6717) or request a local fill as needed. The Emergency Access to Benefits/Refill Too Soon override process will be implemented with an effective date of October 7, 2018 and expiration date of December 6, 2018.

 
9Oct

STATE OF EMERGENCY DUE TO HURRICANE MICHAEL

The Governor of Florida has declared a State of Emergency due to Hurricane Michael for the following counties: Escambia, Santa Rosa, Okaloosa, Walton, Holmes, Washington, Bay, Jackson, Calhoun, Gulf, Gadsden, Liberty, Franklin, Leon, Wakulla, Jefferson, Madison, Taylor, Hamilton, Suwannee, Lafayette, Dixie, Columbia, Gilchrist, Levy and Citrus.

Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an Emergency Access to Benefits/Refill Too Soon override that allows pharmacies, at the point of sale (POS), to override certain benefit coverage/edits such as an early refill during a government-defined emergency. In addition, if your home delivery of medications is affected by the emergency, you may provide a temporary alternate address (either online at www.express-scripts.com or by calling 1-800-818-6717) or request a local fill as needed. The Emergency Access to Benefits/Refill Too Soon override process will be implemented with an effective date of October 7, 2018 and expiration date of December 6, 2018

 
10Oct
Express Scripts News Flash

Express Scripts News Flash

Revcovi Approved to Treat Adenosine Deaminase Severe Combined Immune Deficiency
On Oct. 5, 2018, the U.S. Food and Drug Administration (FDA) approved Leadiant Biosciences’ Revcovi™ (elapegademase-lvlr) injection. It is a pegylated recombinant product that replaces adenosine deaminase (ADA), an enzyme that is deficient in patients who have adenosine deaminase severe combined immune deficiency (ADA-SCID). Recommended initial dosing for previously untreated patients is 0.2mg/kg of ideal body weight given by intramuscular (IM) injection twice weekly for a minimum of 12 to 24 weeks until immune reconstitution is achieved. For those changing from a prior enzyme treatment, one dose of 0.2mg/kg is administered once a week. After immune function has been reestablished, doses may be reduced to maintain blood levels of ADA. Revcovi is expected to be launched by the end of 2018. It will be available through a limited network of specialty pharmacies that is currently being established. Complete prescribing information is available here.

  • Brand (Generic) Name: Revcovi™ (elapegademase-lvlr) injection
  • Manufacturer: Leadiant Biosciences, Inc.
  • Date Approved: Oct. 5, 2018
  • Indication: to treat adenosine deaminase severe combined immune deficiency (ADA-SCID) in pediatric and adult patients.
  • Dosage Forms Available: single-dose vials containing 2.4mg/1.5mL for intramuscular injection
  • Launch Date: by the end of 2018
  • Estimated Annual Cost: Pricing information is not yet available.
  • Specialty Status: Revcovi will be added to Express Scripts’ specialty drug list.
  • ADA-SCID is an ultra-rare condition diagnosed for only about 40 to 100 patients in the United States each year – mostly at birth. Patients who have it are partially or totally deficient in an essential enzyme that metabolizes deoxyadenosine, which is poisonous to T-lymphocytes. If untreated, children who have ADA-SCID rarely live longer than two years because their impaired immune systems cannot protect against infections, even from microorganisms that usually do not cause most people to become sick.
  • However, diagnosis is delayed – sometimes into adolescence – for approximately 10% to 15% of patients who have partial ADA-SCID.
  • Before an enzyme replacement became available in the early 1990s, treatment for ADA-SCID (often called “Bubble-Boy Disease”, at the time) was to severely limit the child’s environment to avoid exposure to possible sources of infection.
  • Currently, Leadiant also markets Adagen® (pegademase bovine) injection, a replacement enzyme that is derived from cattle. Its dosing has to be determined individually for each patient. Other therapies include bone marrow transplants and a gene therapy that is investigational in the U.S.
  • Once all patients are converted to Revcovi, Leadiant plans to discontinue Adagen.
  • In clinical trials, both ADA activity and the numbers of functioning lymphocytes were increased by Revcovi. Using it decreased the amounts of deoxyadenosine, as well.
  • Approval was granted under the FDA’s Priority Review and Fast Track designations. Revcovi also has Orphan status for ADA-SCID.
  • Implications: Express Scripts currently is investigating the data around Revcovi for a possible utilization management strategy. It also will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete.
 
9Oct
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

New Testosterone Replacement Product Approved

Xyosted™ (testosterone enanthate – Antares Pharma) injection was approved by the U.S. Food and Drug Administration (FDA) on Sept. 28, 2018, for the replacement of testosterone in men who have primary or hypogonadotropic hypogonadism resulting from genetic or structural reasons. It is not intended to treat low testosterone due to aging, and its safety and efficacy have not been tested in patients younger than 18 years of age. Self-injected subcutaneously (SC) once a week, it will be available before the end of the year in 50mg, 75mg, and 100mg strengths. Like all testosterone products, it is a Schedule III (C-III) controlled substance and it carries a boxed warning that using testosterone can raise blood pressure, possibly raising the risk of a heart attack or stroke. Patients using Xyosted should be checked frequently for hypertension. Express Scripts currently is investigating the data around Xyosted for a possible utilization management strategy. It also will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete. Full prescribing information is available here.

Seysara Approved to Treat Acne

On Oct. 1, 2018, Paratek Pharmaceuticals’ Seysara™ (sarecycline) tablets, a tetracycline-derived antibiotic, was granted U.S. Food and Drug Administration (FDA) approval to treat acne. Specifically, it is indicated for once-daily use to treat inflammatory lesions of non-nodular moderate-to-severe acne vulgaris in patients who are at least 9 years old. Recommended dosing is 60mg (for patients who weigh between about 73 pounds and 119 pounds (33kg to 54kg), 100mg for patients between 120 pounds and 185 pounds (55kg to 84kg) and 150mg for patients between 186 pounds and 300 pounds (85kg to 136kg). If acne has not lessened after three months of treatment, continued use may not provide additional benefit. Seysara will be marketed in the U.S. by Almirall, which plans a January 2019 launch. Express Scripts currently is investigating the data around Seysara for a possible utilization management strategy. It also will be excluded at launch on the Express Scripts NPF until our formulary development process is complete. Full prescribing information is available here.

New Antibacterial, Nuzyra, Approved

Paratek’s second tetracycline derivative, Nuzyra™ (omadacycline), was approved by the U.S. Food and Drug Administration (FDA) on Oct. 2, 2018, to treat community-acquired bacterial pneumonia (CABP) and acute skin and skin structure infections (ABSSSI). It is indicated to be used once daily for one week to two weeks -- either infused intravenously (IV) at a dose of 100mg, taken orally at 300mg or a combination of both. If tablets are taken, only water should be consumed for at least four hours before and two hours after oral doses of Nuzyra. Additionally, antacids, dairy products and vitamins should be avoided, or at least separated by four hours or more from oral doses of Nuzyra. It should not be used by pregnant women or children younger than 12 years old. Nuzyra will be excluded at launch on the Express Scripts NPF until our formulary development process is complete. Prescribing information is available here.

Hemlibra’s Indication Extended

Hemlibra® (emicizumab-kxwh - Genentech) was U.S. Food and Drug Administration (FDA) approved on Oct. 4, 2018, for routine prophylaxis to prevent or reduce bleeding episodes for patients who have hemophilia A without factor VIII inhibitors. It was originally approved in November 2017 for patients with hemophilia A with factor VIII inhibitors. Approximately 16,000 individuals in the U.S. have hemophilia A, a congenital deficiency of coagulation factor VIII. About two-thirds of patients do not have inhibitors, which are antibodies to factor VIII replacements. Hemlibra is a bispecific monoclonal antibody that replaces the activity of factor VIII by sticking to both activated coagulation factor IXa and factor X to prevent bleeding episodes. It is self-administered subcutaneously once a week, once every two weeks or once every four weeks. A boxed warning on its labeling cautions that some patients have experienced thrombotic microangiopathy or thromboembolism (severe blood clots) after using activated prothrombin complex concentrate (rescue treatment) to treat bleeds for 24 hours or more while receiving Hemlibra therapy. The new indication was granted as a Breakthrough Therapy. Express Scripts currently is investigating the data around Hemlibra for a possible utilization management strategy. Prescribing information is available here.

Expanded Indication Approved for Kyprolis

Under Priority Review and the U.S. Food and Drug Administration's (FDA) Real-Time Oncology Review and Assessment Aid Pilot Programs, Amgen’s Kyprolis® (carfilzomib) was given approval for a new dosing alternative on Sept. 28, 2018. A proteasome inhibitor that interferes with cellular proteins, Kyprolis is given on 28-day cycles to treat patients who have multiple myeloma and who have received at least one prior course of treatment. First FDA approved in July 2012, Kyprolis was originally indicated as monotherapy for patients who have received at least two prior therapies, but whose disease worsened within 60 days after completion of the latest one. Later, it was approved for use in combination with dexamethasone or Revlimid® (lenalidomide – Celgene) plus dexamethasone. For both earlier indications, recommended maintenance dosing of Kyprolis is 56mg/m2 infused on the first two consecutive days of three consecutive weeks and then withheld for 12 days. The new indication is for a once-weekly IV infusion of Kyprolis at 70mg/m2, along with dexamethasone, for three weeks followed by a 13-day rest period. Prescribing information is available here.

Fycompa Gains Expanded Indication

With a Priority Review, Fycompa® (perampanel – Eisai) was U.S. Food and Drug Administration (FDA) approved on Sept. 27, 2018, to treat patients at least 4 years old who have partial-onset seizures (also known as focal seizures). In combination with other anti-epileptic drugs, it has additional indications for other types of seizures, including primary generalized tonic-clonic seizures for patients 12 years of age and older. A selective, non-competitive ionotropic alpha-amino-3-hydroxy-5-methyl-4-isoxazoleproprionic acid (AMPA) receptor antagonist, Fycompa is the only FDA-approved drug in its class. Available as both oral tablets and oral suspension, it is taken once a day at bedtime. The starting dose is 2mg/day increasing to maintenance doses of 8mg to 12mg per day. A Medication Guide and a boxed warning on Fycompa’s labeling caution that taking it has been associated with behavioral, mood or personality changes and/or psychiatric effects, such as aggression, anger, anxiety, irritability or hallucinations. Some Fycompa patients think about or attempt to hurt themselves or other people. A C-III controlled substance, it also has the potential for dependence and/or abuse. Prescribing information is available here.

New Dosage Form for Xolair

Genentech was given U.S. Food and Drug Administration (FDA) approval on Sept. 28, 2018, for a single-dose, prefilled syringe version of Xolair® (omalizumab). First approved in 2003, Xolair has an indication for treating patients at least 6 years old who have moderate-to-severe persistent asthma, who test positive for year-round allergies and who have allergy symptoms that are not managed sufficiently by inhaled corticosteroids. In March 2014, it received an additional approval for treating patients 12 years and older who have hives from chronic idiopathic urticaria (unexplained intense itching) that are not controlled with antihistamine therapy. Xolair is a monoclonal antibody dosed as an SC injection given by a healthcare provider either once every two weeks or once every four weeks. The new dosage form, expected to be available by the end of 2018, eliminates the need for clinicians to reconstitute Xolair doses, making administration easier and quicker. A boxed warning and Medication Guide caution that Xolair may cause anaphylaxis (severe allergic reactions), so patients should stay under observation at the healthcare facility for enough time after each injection to be sure no reaction will occur. Prescribing information for Xolair is available here.

Tegsedi Approved for Hereditary Transthyretin-Mediated Amyloidosis
Ionis Pharmaceuticals received approval from the U.S. Food and Drug Administration (FDA) for Tegsedi™ (inotersen) on Oct. 5, 2018. It is indicated for the treatment of adults who have polyneuropathy caused by hereditary transthyretin-mediated amyloidosis (hATTR). The recommended dose for Tegsedi is 284mg administered as a once-weekly subcutaneous (SC) injection. It decreases the amounts of TTR proteins in the blood by blocking the mutated RNA that produces them. A boxed warning on its labeling cautions that using it may cause thrombocytopenia (possibly sudden and dangerous drops in platelet count) and/or glomerulonephritis (kidney inflammation that may cause kidney failure). Due to its potentially severe side effects, Tegsedi was approved with a risk evaluation and mitigation strategy (REMS). Akcea Therapeutics, a subsidiary of Ionis, will be marketing Tegsedi. It will be available exclusively through Accredo Specialty Pharmacy. Akcea plans to launch Tegsedi single-dose prefilled syringes within the next one to three weeks. Complete prescribing information is available here.
 

 
5Oct
From the CEO

From the CEO

Greetings and welcome to Fall 2018! I am pleased to announce the 2019 Premiums for the Foreign Service Benefit Plan (FSBP):

Foreign Service Benefit Plan 2019 Premiums

Bi-Weekly Premium

 

Monthly Premium

Self Only            Code 401

Self Plus One Code 403

Self & Family Code 402

 

Self Only Code 401

Self Plus One Code 403

Self & Family     Code 402

   $ 67.04

$164.59

$165.86

 

$145.26

    $356.61

   $359.37

We continue to offer a comprehensive benefit package, at very competitive rates. The Plan is committed to providing unparalleled services that our unique worldwide membership requires. We strive to demonstrate that daily through our programs and through our premiums – which only increased around 1.5% from 2018.


October is “Talk About Your Medicines” Month. We encourage you to talk to your health care provider about all your medicines. Focus on learning the expected outcomes, possible side effects, benefits, and potential risks. Click here to learn 10 questions to ask about the medicines you take. Use this checklist to guide the conversations with your health professional. Asking these questions can help you maximize the benefits of your medicine and minimize the risks.

Express Scripts, FSBP’s Pharmacy Benefit Manager, offers several resources to help guide you:

  • Cobranded website
    • Live chat with a Patient Care Advocate
    • Send secure messages online
    • Contact a Specialist Pharmacist
  • Express Scripts app
    • Use “Medicine Cabinet” to set medication reminders
    • Track your prescription deliveries
    • Price medications and compare drug prices

October is also National Chiropractic Health Month. Back pain remains a prevalent and disabling condition worldwide. It is one of the most common reasons that patients visit doctors. Providers often prescribe opioid pain medications for back pain. The overuse and abuse of prescription opioids in the U.S. remains a top public health problem. It’s essential to understand the various treatments available. This includes spinal manipulation to safely address musculoskeletal conditions such as lower back pain.

FSBP offers generous chiropractic, acupuncture, and massage therapy benefits. Each covered family member receives 40 visits for each alternative service every year (up to $60/visit). Chiropractic care can help with headaches, back aches, arm pain, leg pain, etc. This awareness month offers a great time to explore these services. With 40 annual visits included in your health plan, why not try it today?


We are excited to introduce a new term life insurance plan, Group Enhanced Life (GEL). I know you have many insurance choices – but I hope you look into the GEL plan. It includes a feature that enables you to receive a portion of your total coverage amount if you become chronically ill. These funds can be used to assist with home care, assisted living, and nursing home expenses. Take advantage of the 2018 GEL Open Enrollment Period that started October 1 and ends on December 31. Click here to learn more about the new GEL plan.


Open Season is approaching fast. This year’s enrollment period is from November 12 to December 10, 2018. AFSPA staff travel to various regions of the globe in preparation for Open Season. Any Direct Hire Federal employee who is enrolled in or eligible for the Federal Employees Health Benefits (FEHB) Program can attend.  

We will send out notices throughout the fall to alert members when we will be in your area. For the latest list of AFSPA’s Open Season visits, check our website and Facebook page regularly. If you’re in the area, please attend one of our Open Season briefings.


Don’t forget your flu shot! FSBP covers flu vaccinations at 100%, when obtained at an in-network provider or a provider outside the U.S. Many agencies offer onsite flu shots. With AFSPA’s ongoing commitment to “Walking the Walk,” our staff received in-office vaccines on September 24. If we can do it, you can too!

As always, thank you for your trust and loyalty. We truly appreciate you giving us the opportunity to serve you.

To Your Health,

Paula S. Jakub, RHU
CEO, AFSPA
Executive Director, Senior Living Foundation


 

 
3Oct

International Emergency: Indonesia Quake, Tsunami and Volcanic Eruption

International Emergency: Indonesia Quake, Tsunami, and Volcanic Eruption.

Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an Emergency Access to Benefits/Refill Too Soon override that allows pharmacies, at the point of sale (POS), to override certain benefit coverage/edits such as an early refill during a government-defined emergency. In addition, if your home delivery of medications is affected by the emergency, you may provide a temporary alternate address (either online at www.express-scripts.com or by calling 1-800-818-6717) or request a local fill as needed. The Emergency Access to Benefits/Refill Too Soon override process will be implemented with an effective date of September 28, 2018 and expiration date of October 28, 2018.

 
3Oct

International Emergency: Evacuation of Basra Consulate

The U.S government announced on Friday, September 28, 2018 that the U.S. Consulate in the Southern Iraqi city of Basra is being temporarily closed amid violence.

Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an Emergency Access to Benefits/Refill Too Soon override that allows pharmacies, at the point of sale (POS), to override certain benefit coverage/edits such as an early refill during a government-defined emergency. In addition, if your home delivery of medications is affected by the emergency, you may provide a temporary alternate address (either online at www.express-scripts.com or by calling 1-800-818-6717) or request a local fill as needed. The Emergency Access to Benefits/Refill Too Soon override process will be implemented with an effective date of September 28, 2018 and expiration date of October 28, 2018.

 
2Oct
Express Scripts News Flash

Express Scripts News Flash

 

Arikayce Approved to Treat Mycobacterium Avium Complex
The U.S. Food and Drug Administration (FDA) approved Arikayce® (amikacin liposome inhalation suspension – Insmed, Inc.) on Sept. 28, 2018. Also abbreviated as ALIS, Arikayce is an aminoglycoside antibiotic that is inhaled into the lungs once daily through a specialized device, the Lamira™ Nebulizer System. It is indicated for use in combination with other antibacterial drugs to treat adult patients who have few or no options to treat a rare lung disease caused by Mycobacterium avium complex (MAC) despite six months or longer of standard multi-drug treatment. Product labeling carries a boxed warning that Arikayce may raise the risk of adverse respiratory effects. It will be available in the coming weeks through a small network of specialty pharmacies that does not include Accredo. Complete prescribing information is available here.


Libtayo Approved for Cutaneous Squamous Cell Carcinoma
Libtayo® (cemiplimab-rwlc) was U.S. Food and Drug Administration (FDA) approved on Sept. 28, 2018. Jointly developed by Regeneron Pharmaceuticals and Sanofi, it is a monoclonal antibody that is indicated to treat metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC), a type of skin cancer. It will be given as 30-minute intravenous (IV) infusions once every three weeks for patients who cannot have surgery or radiation. It will be dispensed with a Medication Guide that warns of possible immune-related adverse effects, including colitis, hepatitis, nephritis and pneumonitis that it may cause. Libtayo was launched upon approval. It is available exclusively through Onco360 Specialty Pharmacy; therefore, Accredo will not have access. Prescribing information is available here.

 

 

 
1Oct
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Lower Strength Approved for Symjepi

On Sept. 27, 2018, the U.S. Food and Drug Administration (FDA) approved a new, lower strength of Symjepi™ (epinephrine) injection, a single-dose prefilled syringe for use as an emergency treatment for type I allergic reactions, including anaphylaxis. The new 0.15mg strength can be used in patients who weigh between 33 pounds and 66 pounds. A higher strength (0.3mg/dose) was FDA approved in June 2017 to treat patients weighing 66 pounds or more. Although the product has not yet been launched, the manufacturer, Adamis Pharmaceuticals, recently entered into an agreement with Sandoz to bring Symjepi to market. Pricing information is not yet available. Full prescribing information is available here.

 

Epidiolex Scheduled

The U.S. Drug Enforcement Administration (DEA) has determined that GW Pharmaceutical’s Epidiolex® (cannabidiol) oral solution is a Schedule V (C-V) controlled substance. Epidiolex is indicated to treat patients at least two years old who have seizures related to Lennox-Gastaut syndrome (LGS) and Dravet syndrome (DS). Schedule V, the least restrictive class of controlled substances, includes drugs with little potential for abuse, but proven medical uses. Other antiepileptic medications, such as Briviact® (brivaracetam) and Vimpat® (lacosamide) are C-V drugs, as well. GW plans to launch Epidiolex as soon as the company is licensed for distribution -- likely within the next six weeks. Prescribing information is available here.

 

Bendamustine Hydrochloride Injection NDA Approved

On May 15, 2018, Eagle Pharmaceuticals was awarded approval to its New Drug Application (NDA) for bendamustine 100mg/4ml (25mg/ml) solution for injection to treat chronic lymphocytic leukemia and indolent B-cell non-Hodgkin lymphoma. Although the same drug and concentration are found in the company’s Bendeka®, it was approved with its own unique NDA. Availability and pricing information are not known at this time. Full prescribing information is available here.

 

Vizimpro Approved for Non-Small Cell Lung Cancer
On Sept. 27, 2018, the U.S. Food and Drug Administration (FDA) approved Pfizer’s Vizimpro® (dacomitinib) tablets as a first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test. Recommended dosing is 45mg orally once daily, with or without food. Pfizer plans to launch Vizimpro within the next few weeks. It will be available through a large network of specialty pharmacies that includes Accredo. Complete prescribing information is available here.


Generic to Cialis Launched
Teva’s A-rated generic to Cialis® (tadalafil – Eli Lilly) was launched in the United States on Sept. 27, 2018. Cialis is a phosphodiesterase 5 (PDE5) inhibitor indicated for use as a once daily treatment of erectile dysfunction (ED), signs and symptoms of benign prostatic hyperplasia (BPH) and both (ED/BPH). Teva will have 180 days of exclusivity before other companies can launch their generics. IQVIA estimates that U.S. sales of Cialis amounted to over $1.9 billion for the 12-month period ending July 31, 2018.   


Emgality Approved for Migraine Prevention

Eli Lilly’s Emgality™ (galcanezumab-gnlm) was approved by the U.S. Food and Drug Administration (FDA) on Sept. 27, 2018. The third calcitonin gene-related peptide (CGRP) inhibitor to enter the U.S. market, it is indicated to prevent migraine headaches for adults. Following a single loading dose of 240mg (two self-injections at the same time), one dose (120mg) will be self-injected subcutaneously (SC) each month. Emgality will be available through open distribution in the near future. Complete prescribing information is available here.


Updated Issues Document Available
The “Medical Marijuana Issues Document” has also been updated to reflect the approval and DEA scheduling of Epidiolex. This issues document is available here.

Correction
The September 14, issue of News and Notes incorrectly identified Xelpros™ (latanoprost ophthalmic emulsion – Sun Pharma) 0.005%, as the only benzalkonium-free prostaglandin eye drop. In fact, other ophthalmic prostaglandins, including Travatan Z® (travoprost ophthalmic solution - Novartis) 0.004% and Zioptin® (tafluprost ophthalmic solution - Akorn) 0.0015%, also are preservative-free. Xelpros is the only latanoprost eye drop without a benzalkonium preservative.

 
27Sep
Express Scripts New Flash

Express Scripts New Flash

Epinephrine Auto-Injector Market Summary
Despite negative publicity over pricing, Mylan’s EpiPen® (epinephrine injection 0.3mg) and EpiPen Jr® (epinephrine injection 0.15mg) Auto-Injectors continue to lead the U.S. market for self-injectable epinephrine products. However, recent events, including the re-introduction of Auvi-Q® (epinephrine injection - Kaléo), approval of AB-rated EpiPen generics (Teva), manufacturer agreements and the pending launch of a prefilled syringe version of epinephrine (Symjepi – Adamis/Sandoz) may result in a shift of market share from EpiPen. This document summarizes our current understanding of the market dynamics surrounding the epinephrine auto-injector market.

2018-2019 Influenza Season Issues Document Available
The best way to keep from getting influenza (flu) is to get an influenza vaccination before the start of the flu season each year. The U.S. Centers for Disease Control and Prevention (CDC) recommends getting vaccinations in September or October of each year. However, since the flu season lasts until spring, getting vaccinated even after it is well underway still offers protection. This document provides a general update for the 2018?2019 flu season and highlights Express Scripts program offerings.

 
25Sep
Express Scripts News Flash

Express Scripts News Flash

Copiktra Approved for Leukemia and Lymphoma

On Sept. 24, 2018, Verastem received approval from the U.S. Food and Drug Administration (FDA) for Copiktra™ (duvelisib) for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies. It also received accelerated approval for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. Copiktra is an oral phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma inhibitor. The recommended dose is 25mg twice daily. The dose can be modified based on toxicity. Verastem launched Copiktra upon approval. It is available through a limited network of specialty pharmacies that does not include Accredo. Full prescribing information can be found here.

  • Brand (Generic) Name: Copiktra™ (duvelisib)
  • Manufacturer: Verastem
  • Date Approved: September 24, 2018
  • Indication: Adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies and adult patients with relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies
  • Dosage Forms Available: 15mg and 25mg capsules
  • Launch Date: Copiktra was launched upon approval.
  • Estimated Annual Cost: Pricing information is not yet available.
  • Specialty Status: Copiktra will be added to Express Scripts’ specialty drug list.
  • CLL/SLL and FL, which affect approximately 350,000 patients in the U.S., are common types of blood cancers known as indolent non-Hodgkin lymphomas. Patients oftentimes relapse and become refractory to currently-available therapies.
  • Dosage Forms Available: 15mg and 25mg capsules
  • Launch Date: Copiktra was launched upon approval.
  • Estimated Annual Cost: Pricing information is not yet available.
  • Specialty Status: Copiktra will be added to Express Scripts’ specialty drug list.
  • CLL/SLL and FL, which affect approximately 350,000 patients in the U.S., are common types of blood cancers known as indolent non-Hodgkin lymphomas. Patients oftentimes relapse and become refractory to currently-available therapies.
  • The labeling for Copiktra contains a boxed warning concerning the risk of four fatal and/or serious toxicities including: infections, diarrhea or colitis, cutaneous reactions and pneumonitis. It was also approved with a Risk Evaluation and Mitigation Strategy (REMS) to help physicians manage these risks.
  • Copiktra, an orphan-designated drug, was approved under FDA’s priority review program. The FL indication was approved under FDA’s accelerated approval program based on overall response rate. Confirmatory trials that demonstrate a clinical benefit are required for continued approval for this indication.
  • Implications: Express Scripts currently is investigating the data around Copiktra for a possible utilization management strategy. It also will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete.
 
25Sep
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Authorized Generic Launched for Ampyra

Mylan launched an authorized generic for Ampyra® (dalfampridine – Acorda Therapeutics) on Sept. 21, 2018. Dalfampridine is indicated to improve walking for patients who have multiple sclerosis (MS). Approximately 1 million patients in the U.S. have MS, a chronic central nervous system (CNS) condition that can cause a variety of symptoms including paralysis, loss of vision and cognitive impairments. Up to 85% of patients with MS experience difficulty with walking. At a recommended dose of 10mg twice daily, dalfampridine can be taken alone or used along with other drugs that treat MS. IQVIA estimated that U.S. sales for Ampyra were about $553 million for the 12-month period that ended on June 30, 2018. While no generic manufacturer has announced the launch of its A-rated generic to Ampyra, several have been approved according to the FDA’s website.

 
17Sep
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Cassipa Approved to Treat Opioid Dependence

Teva Pharmaceuticals USA received approval from the U.S. Food and Drug Administration (FDA) on Sept. 7, 2018, for Cassipa® (buprenorphine 16mg/naloxone 4mg) sublingual film, a C-III controlled substance. It is indicated for maintenance treatment of opioid misuse disorder. Buprenorphine is an opioid agonist-antagonist, which partially blocks opioid receptors. It provides pain relief up to a certain level, but does not produce euphoria. Naloxone, a full opioid antagonist, has very little activity when taken sublingually, but it blunts the euphoric effects of buprenorphine if the drug is crushed and inhaled or dissolved and injected. Used once daily, Cassipa is intended to be part of a comprehensive treatment plan that includes counseling and psychosocial support. It should be used only after a patient is stabilized on 16mg or less of buprenorphine after using another product for induction therapy. A Medication Guide and product labeling warn that buprenorphine can be abused. As with all opioids, Cassipa also can cause potentially severe breathing problems and it can be life-threatening if swallowed by children. It can be prescribed only by clinicians who are certified under the Drug Addiction Treatment Act (DATA). No launch or price plans have been announced. Cassipa will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete. Prescribing information may be found here.

 

New Ophthalmic Drug, Xelpros, Approved

Xelpros™ (latanoprost ophthalmic emulsion – Sun Pharma) 0.005% was U.S. Food and Drug Administration (FDA) approved on Sept. 14, 2018. It is a prostaglandin analogue that reduces elevated intraocular pressure (IOP) and is indicated for treatment of open-angle glaucoma and ocular hypertension. One drop will be used in each affected eye once a day in the evening. Although other prostaglandin eye drops, including generics, are available, Xelpros is the first one that does not include benzalkonium chloride (BAK), a common preservative. Instead, a proprietary formulation technology makes it dissolve better. As with all ophthalmic prostaglandins, using it may cause changes in eye and eyelid color. Eyelash properties, including length and thickness, also may be affected. In the U.S., Xelpros will be distributed by Sun Ophthalmics. Express Scripts currently is investigating the data around Xelpros for a possible utilization management strategy. It also will be excluded at launch on the NPF until our formulary development process is complete. Prescribing information is available here.

 

New GamaSTAN Indications Approved

On Sept. 4, 2018, Grifols announced that a new formulation of its GamaSTAN® (immune globulin [human]) has been U.S. Food and Drug Administration (FDA) approved as prevention for hepatitis A and measles. Specifically, it is indicated to prevent hepatitis A within two weeks after exposure for individuals who are younger than one year old or older than 40 years old, who are immunocompromised or who have cancer, chronic kidney disease or chronic liver disease. It also can be administered to prevent or modify measles when used for individuals who have not had measles, who have not been vaccinated against it and who were exposed to measles no more than six days previously. For exposure to hepatitis A, the recommendation is 0.1mg/kg given as a single intramuscular (IM) dose. To prevent or modify measles, most patients will need one 0.25mg/kg IM dose, but 0.5mg/kg IM is recommended for pediatric patients who are immunocompromised. Although highly effective hepatitis A vaccines are available in the U.S., they may take weeks to reach full effectiveness. GamaSTAN is the only immune globulin product currently approved in the U.S. for post-exposure prevention. Its labeling carries a boxed warning that immune globulins may cause blood clots. Full prescribing information is available here.


Pediatric Indication Expanded for Subcutaneous Actemra

The subcutaneous (SC) form of Actemra® (tocilizumab - Genentech) was given U.S. Food and Drug Administration (FDA) approval on Sept. 13, 2018, to treat active systemic juvenile idiopathic arthritis (SJIA) for children as young as two years of age. SJIA, believed to affect about 30,000 America children, is an uncommon subtype of juvenile idiopathic arthritis. In general, it causes painful joint inflammation and a fever that peaks every day for two weeks or more. Actemra is a monoclonal antibody that inhibits interleukin-6 receptors, which promote inflammation. Its intravenous (IV) form also is approved to treat SJIA for children two years old and older, but it must be given in a doctor’s office or clinic. The SC form is packaged in prefilled syringes that caregivers or older patients can give at home. For children weighing 30kg (about 66 pounds) or less, the recommended SC dose is one injection (162mg) once every two weeks. For patients who weigh more than 30kg, injections increase to one per week. The label for Actemra cautions that its use may predispose patients to having opportunistic bacterial, fungal, viral or other infections. Before treatment with it begins, patients should be tested for latent tuberculosis (TB). A Medication Guide is provided for patients and caregivers. Complete prescribing information is available here.

Lumoxiti Approved to Treat Hairy Cell Leukemia
AstraZeneca’s immunotoxin, Lumoxiti™ (moxetumomab pasudotox-tdfk) injection for intravenous (IV) use, was approved by the U.S. Food and Drug Administration (FDA) on Sept. 13, 2018. It is indicated to treat adults who have hairy cell leukemia that recurs or resists treatment despite two or more rounds of systemic treatment, including therapy with a purine nucleoside analog. It will be infused over one-half hour at a recommended dose of 0.04mg/kg on the first, third and fifth days of 28-day cycles for a maximum of six cycles. A boxed warning cautions that it may cause capillary leak syndrome and/or hemolytic uremic syndrome, which both may be fatal. AstraZeneca plans on launching Lumoxiti within the next four to six weeks. It will be exclusively available through CVS Specialty Pharmacy; Accredo will not have access. Complete prescribing information currently is available here.


Ajovy Approved to Prevent Migraines
Teva Pharmaceuticals received approval on Sept. 14, 2018, from the U.S. Food and Drug Administration (FDA) for its migraine prevention drug, Ajovy™ (fremanezumab-vfrm). It is the second drug to be approved in its class, calcitonin gene-related peptide (CGRP) inhibitors. CGRP is a protein produced by nerve cells and involved in constricting blood vessels. Baseline levels of CGRP may be unusually high for individuals who have migraines. By blocking it, Ajovy helps prevent or lessen the vasoconstriction that often triggers migraines. Recommended dosing is one self-administered, subcutaneous (SC) injection (225mg) once a month or three injections (675mg) given at the same time once every three months. Ajovy will be available through open distribution in approximately two weeks. It will be priced at about $575 per month -- similarly to Aimovig™ (erenumab-aooe – Amgen/Novartis), the only other CGRP inhibitor currently available on the U.S. market. It is not approved for the acute treatment of migraine. Complete prescribing information is available here.

 
12Sep

AFSPA's Phone System is Back Online

As of 12:00pm EST, AFSPA's phone system is now back online. Thank you for your patience.
 

 
12Sep

STATE OF EMERGENCY DUE TO HURRICANE FLORENCE

The Mayor of the District of Columbia has declared a State of Emergency due to Hurricane Florence.

Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an Emergency Access to Benefits/Refill Too Soon override that allows pharmacies, at the point of sale (POS), to override certain benefit coverage/edits such as an early refill during a government-defined emergency. In addition, if your home delivery of medications is affected by the emergency, you may provide a temporary alternate address (either online at www.express-scripts.com or by calling 1-800-818-6717) or request a local fill as needed. The Emergency Access to Benefits/Refill Too Soon override process will be implemented for the attached impacted zip codes with an effective September 10, 2018 and expiration date of October 10, 2018.

 
12Sep

AFSPA System Currently Down

Dear Valued Members,

Please be advised we are currently experiencing technical difficulties with our phone systems. We are working to restore services as soon as possible. 

Thank you for your patience and we apologize for any inconvenience.


Thank you,
Kyle Longton
COO

 
11Sep

STATE OF EMERGENCY DUE TO HURRICANE FLORENCE

The Governor of Maryland has issued a State of Emergency in all counties due to Hurricane Florence.

Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an Emergency Access to Benefits/Refill Too Soon override that allows pharmacies, at the point of sale (POS), to override certain benefit coverage/edits such as an early refill during a government-defined emergency. In addition, if your home delivery of medications is affected by the emergency, you may provide a temporary alternate address (either online at www.express-scripts.com or by calling 1-800-818-6717) or request a local fill as needed. The Emergency Access to Benefits/Refill Too Soon override process will be implemented for the attached impacted zip codes with an effective September 10, 2018 and expiration date of October 10, 2018.

 
11Sep

STATE OF EMERGENCY DUE TO TYPHOON MANGKHUT

States of Emergency Issued in Guam and the Commonwealth of the Northern Mariana Islands due to Typhoon Mangkhut.

Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an Emergency Access to Benefits/Refill Too Soon override that allows pharmacies, at the point of sale (POS), to override certain benefit coverage/edits such as an early refill during a government-defined emergency. In addition, if your home delivery of medications is affected by the emergency, you may provide a temporary alternate address (either online at www.express-scripts.com or by calling 1-800-818-6717) or request a local fill as needed. The Emergency Access to Benefits/Refill Too Soon override process will be implemented for the attached impacted zip codes with an effective September 8, 2018 and expiration date of October 8, 2018.

 
10Sep

STATE OF EMERGENCY DUE TO HURRICANE FLORENCE

The Governors of  North Carolina, South Carolina and Virginia have issued a State of Emergency for all counties in each state due to the Hurricane Florence.

Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an Emergency Access to Benefits/Refill Too Soon override that allows pharmacies, at the point of sale (POS), to override certain benefit coverage/edits such as an early refill during a government-defined emergency. In addition, if your home delivery of medications is affected by the emergency, you may provide a temporary alternate address (either online at www.express-scripts.com or by calling 1-800-818-6717) or request a local fill as needed. The Emergency Access to Benefits/Refill Too Soon override process will be implemented for the attached impacted zip codes with an effective Sept. 7, 2018 and expiration date of Oct. 7, 2018.

 
10/2018Sep

"Express Clinical News and Notes"

Tiglutik Approved to Treat Amyotrophic Lateral Sclerosis

The U.S. Food and Drug Administration (FDA) approved ITF Pharma’s Tiglutik™ (riluzole) oral suspension on Sept. 5, 2018. It is indicated to treat patients who have amyotrophic lateral sclerosis (ALS). In the United States, about 20,000 individuals have ALS, a progressive disease that destroys nerve cells in the brain and spinal cord. Patients who have it gradually lose the abilities to move, speak and even breathe. Because many patients who have ALS cannot swallow easily, Tiglutik is a thickened liquid form of the medication that is given by oral syringe. The few other treatments for ALS are either injections or oral tablets that have to be compounded into an oral liquid form. Recommended dosing is 50mg (10mL or about two teaspoons) once every 12 hours at least one hour before or two hours after a meal. Because Tiglutik can damage the liver, hepatic transaminase levels for patients taking it should be checked once a month for the first three months and then at regular intervals during therapy. To be dispensed in 300mL bottles, its launch is planned for mid-October. It will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete. Pricing information has not yet been announced, but complete prescribing information is available here.

 

 

 
7Sep
From the CEO

From the CEO

Greetings and Welcome to September 2018! Summer is leaving, and fall is coming. Many have started a new school year or moved to a different post. Changes in our routine can cause changes in our eating habits. As we enter a new season, be aware of your meal options and make the healthier food choices.


Back-to-school time produces homework for parents – the completion of your child’s standard forms. Most parents must submit immunizations records, medication forms, etc. The school may ask for an emergency contact, a sports physical, and/or an authorization form (permission to medically treat your child, if needed). Did you know those with the Foreign Service Benefit Plan (FSBP) can retrieve medical information from the Member Engagement Portal (MEP)? This means you can print or download medications, immunization history, and more through Aetna Navigator.

How to access MEP:

  • Log in to Aetna Navigator 
  • Look for the Stay Healthy icon
  • Click Discover a Healthier You – you will be directed to MEP 
  • Click on Records – access immunizations, medications, etc.  
  • Print/download information from the different health categories

The ability to access and print/download this important information is just one of the many great tools now available to you on the new Member Engagement Portal as a result of migration to the new platform.


September is Healthy Aging® Month. This annual health observance focuses national attention on the positive aspects of growing older. Now in its second decade, this month provides practical ideas for adults over 45 to improve their well-being. Click here for 10 Tips for Rein­vent­ing Your­self dur­ing Healthy Aging Month.


Believe it or not, the effects of the Aetna Migration are receding somewhat. Claims processing time is returning to normal service levels of 10-15 calendar days. The number of calls received has decreased, and wait time are improving. It is taking longer, but we are making progress with our backlog of emails. Many messages are duplicates or follow-ups to previous matters. Our team must examine every email and works to address all your concerns. Please know that we are do value your feedback and are responding as quickly as possible.


Lastly, September is Life Insurance Awareness Month. This is a perfect time to look at ways to better protect your family’s future. Funeral expenses and outstanding bills can create an added burden on loved ones. To assist, AFSPA is offering a webinar called Life Insurance 101 on Friday, September 28, 12pm to 1pm EST. It will give you the basic information on how to choose a policy and how much coverage is needed. Click here to learn about the webinar and to register for this online event. For those who cannot attend that day, a recording of the live presentation will be available after the event.


This remains a busy time of year for AFSPA. We are managing the Migration process, preparing the 2019 FSBP brochure, and getting ready for Open Season travel. We will keep you informed through our website, on Facebook, in the Fall newsletter, and our Open Season mailing. Look for new benefits and programs at a great 2019 premium! Also, check your mailbox for the 2018 Summer Newsletter.

As always, thank you for your loyalty and for giving AFSPA the opportunity to serve you.

To Your Health,

Paula S. Jakub, RHU
CEO, AFSPA
Executive Director, Senior Living Foundation

For those in the DC area, consider attending the Senior Living Foundation’s Planning for Change seminar on Thursday, September 27, 2018. Attendees of this half-day event will learn about advances in medicine, estate planning, transitioning to home care, and more. Visit SLF’s website for more details and to register.
 
5Sep

STATE OF EMERGENCY DUE TO TROPICAL STORM GORDON

Tropical Storm Gordon is expected to make landfall tonight as a hurricane and is currently located about 145 miles east-southeast of the mouth of the Mississippi River with maximum sustained winds of 65 miles per hour.

The governors of Alabama, Louisiana and Mississippi have declared States of Emergency in the following counties due to Tropical Storm Gordon.

  • Alabama: Baldwin, Choctaw, Clarke, Conecuh, Escambia, Mobile, Monroe and Washington
  • Louisiana: all counties
  • Mississippi: George, Hancock, Harrison, Jackson, Pearl River and Stone

Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an Emergency Access to Benefits/Refill Too Soon override that allows pharmacies, at the point of sale (POS), to override certain benefit coverage/edits such as an early refill during a government-defined emergency. In addition, if your home delivery of medications is affected by the emergency, you may provide a temporary alternate address (either online at www.express-scripts.com or by calling 1-800-818-6717) or request a local fill as needed. The Emergency Access to Benefits/Refill Too Soon override process will be implemented with an effective date of September 3, 2018 and expiration date of October 3, 2018.

 
5Sep

STATE OF EMERGENCY DUE TO FLOODING

The governor of Wisconsin has issued a State of Emergency for the entire state due to flooding.

Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an Emergency Access to Benefits/Refill Too Soon override that allows pharmacies, at the point of sale (POS), to override certain benefit coverage/edits such as an early refill during a government-defined emergency. In addition, if your home delivery of medications is affected by the emergency, you may provide a temporary alternate address (either online at www.express-scripts.com or by calling 1-800-818-6717) or request a local fill as needed. The Emergency Access to Benefits/Refill Too Soon override process will be implemented with an effective date of August 30, 2018 and expiration date of September 30, 2018.

 
5Sep

STATE OF EMERGENCY DUE TO HURRICANE LANE

The governor of Hawaii has issued a State of Emergency for the Hawaiian Islands due to Hurricane Lane.

Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an Emergency Access to Benefits/Refill Too Soon override that allows pharmacies, at the point of sale (POS), to override certain benefit coverage/edits such as an early refill during a government-defined emergency. In addition, if your home delivery of medications is affected by the emergency, you may provide a temporary alternate address (either online at www.express-scripts.com or by calling 1-800-818-6717) or request a local fill as needed. The Emergency Access to Benefits/Refill Too Soon override process will be implemented with an effective date of Aug. 23, 2018 and expiration date of Sept. 22, 2018.

 
4Sep
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Xerava Approved to Treat Abdominal Infections

The U.S. Food and Drug Administration (FDA) approved Xerava™ (eravacycline) on Aug. 27, 2018, to treat complicated (extensive) intra-abdominal infections in patients at least 18 years of age. It is a tetracycline antibiotic administered as an intravenous (IV) infusion. Recommended dosing is one mg/kg of body weight every 12 hours for four days to 14 days. It can be used to treat multiple infection types, including appendicitis, cholecystitis and peritonitis, that are caused by bacteria known or believed to be sensitive to Xerava’s effects. The manufacturer, Tetraphase Pharmaceuticals, plans a launch in the fourth quarter of 2018. Xerava will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete. Prescribing information is available here.


Hemophilia A Drug, Jivi, Approved

Bayer’s Jivi® (antihemophilic factor [recombinant] PEGylated-aucl) was U.S. Food and Drug Administration (FDA) approved for hemophilia A on Aug. 30, 2018. It is a coagulation factor VIII replacement indicated for use to prevent bleeds in patients who are at least 12 years old and who have had previous treatment. Jivi also has FDA indications to treat active bleeding and to manage bleeding associated with dental and surgical procedures. For bleeding prevention, the recommended dosing is based on the patient’s weight at 30IU to 40IU/kg two times per week. Doses and dose intervals may be adjusted according to the patient’s response, and acute doses may be added to control bleeds. Bayer plans to begin shipping Jivi this week. It will be added to Express Scripts’ specialty drug list. Express Scripts currently is investigating the data around Jivi for a possible utilization management strategy and it also will be excluded at launch on the NPF until our formulary development process is complete. Full prescribing information for Jivi is available here.

 

FDA Approves Delstrigo and Pifeltro for HIV

Merck received U.S. Food and Drug Administration (FDA) approval for Delstrigo™ (doravirine/lamivudine/tenofovir disoproxil fumarate) tablets and Pifeltro™ (doravirine) tablets on Aug. 30, 2018. Both are once-daily treatments for adults who have HIV, but who have not had prior treatment with an antiretroviral medication. Delstrigo, which combines Pifeltro, a new non-nucleoside reverse transcriptase inhibitor (NNRTI), with two nucleoside reverse transcriptase inhibitors (NRTIs), will be taken alone. Its labeling includes a boxed warning that discontinuing the use of lamivudine or tenofovir disoproxil fumarate can activate hepatitis B virus (HBV) for patients who have or who have had HBV. Patients should be monitored for signs of HBV before, during and for several months after treatment with Delstrigo. Pifeltro must be used along with other antiretrovirals. Merck expects that both drugs will be available within the month. Both will be excluded at launch on the NPF until our formulary development process is complete. Full prescribing information for Delstrigo is available here. Full prescribing information for Pifeltro is available here.

 

Imbruvica Plus Rituxan Approved for Waldenström’s Macroglobulinemia

On Aug. 24, 2018, the U.S. Food and Drug Administration (FDA) approved Imbruvica® (ibrutinib – Pharmacyclics/Janssen) together with Genentech’s Rituxan® (rituximab) to treat Waldenström’s macroglobulinemia (WM), a rare type of non-Hodgkin lymphoma. Imbruvica is a Bruton’s kinase inhibitor that works by blocking a specific enzyme needed by the cancer to multiply and spread. For WM, its recommended dose is 420mg once a day. Rituxan, a CD20-directed cytolytic antibody approved to treat several different cancers, is used off-label for several other cancers, including WM. It is given as an IV infusion at 375mg/m2 once each week for four weeks followed by a three-month break and then infused for four more weekly doses. When both drugs are used on the same day, Imbruvica should be taken first. In the iNNOVATE Study, progression-free survival (PFS) lasted at least 30 months for 82% of dual therapy patients, but for only 28% of those treated with Rituxan and a placebo. Imbruvica’s complete prescribing information is available here.

 
27Aug
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Oxervate Approved for Neurotrophic Keratitis

On Aug. 22, 2018, the U.S. Food and Drug Administration (FDA) approved Oxervate™ (cenergermin-bkbj ophthalmic solution) for the treatment of neurotrophic keratitis. It is a rare, degenerative disease of the cornea resulting from the loss of corneal sensitivity. This can lead to progressive damage to the top layer of the cornea, including ulcerations and perforations in severe cases. The recommended dose is one drop into the affected eye(s) six times a day, at two-hour intervals, for a total of eight weeks. The FDA granted approval of Oxervate to Dompé farmaceutici SpA. Oxervate will be made available in the United States by early 2019. Pricing is not available at this time. Express Scripts currently is investigating the data around Oxervate for a possible utilization management strategy. It also will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete. Complete prescribing information is available here.


Inveltys, New Ophthalmic Corticosteroid, Approved

Also on Aug. 22, Kala Pharmaceuticals received U.S. Food and Drug Administration (FDA) approval for Inveltys™ (loteprednol etabonate ophthalmic suspension) 1%. It is indicated to treat pain and inflammation after eye surgery. Starting one day after the surgery and for the following two weeks, one or two drops should be put into the affected eye(s) two times a day. A proprietary technology, mucus-penetrating particles, helps Inveltys infiltrate better into the eyes than other corticosteroid eye drops, which usually are needed four times a day. Because extended use of an ophthalmic corticosteroid can cause glaucoma or damage optic nerves, intraocular pressure (IOP) should be checked if the drug is used for 10 days or longer. Express Scripts is currently investigating the data around Inveltys for a possible utilization management strategy. It also will be excluded at launch on the Express Scripts NPF until our formulary development process is complete. Kala plans an early 2019 launch. Full prescribing information is available here.


Altreno Approved to Treat Acne

Altreno™ (tretinoin 0.05% - Ortho Dermatologics) lotion was approved by the U.S. Food and Drug Administration (FDA) on Aug. 24, 2018. It is the first tretinoin lotion approved to treat patients who have acne and who are at least nine years old. Recommended use is a thin layer applied to affected areas once a day. Patients who use Altreno should minimize exposure to sunlight and they should not apply it close to their eyes, mouth or mucous membranes. Like all retinoids, Altreno may cause dry, irritated or reddened skin, even though it contains moisturizers. It will be introduced to the U.S. market in the fourth quarter of 2018. Express Scripts is currently investigating the data around Altreno for a possible utilization management strategy. Altreno will also be excluded at launch on the Express Scripts NPF until our formulary development process is complete. Prescribing information is available here.

New Indication for Keytruda

Merck announced on Aug. 20, 2018, that Keytruda® (pembrolizumab) has been U.S. Food and Drug Administration (FDA) approved, in combination with Alimta® (pemetrexed – Eli Lilly) and platinum-based chemotherapy (chemo) to treat some forms of metastatic non-small cell lung cancer (NSCLC). The drug combination will be used as initial therapy for patients who have NSCLC that does not have epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) tumor aberrations. Keytruda is a human programmed death receptor-1 (PD-1)-blocking antibody. As an immuno-oncology (I/O) drug, it increases the ability of the body’s immune system to destroy cancer cells. In the clinical trial that supported the new indication, 48% of patients using the regimen that included Keytruda responded to treatment, as compared to 19% of participants receiving only Alimta and chemo. Response times averaged about three months longer in the triple-therapy group, as well (11.2 months vs 7.8 months, respectively). Since its initial FDA approval in 2014, Keytruda has received indications for several other cancer types. Updated prescribing information is available here.

Fibryna Added to Drug File
Octapharma’s Fibryga® (fibrinogen [human]), which was U.S. Food and Drug Administration (FDA) approved in June 2017, has been added to the Express Scripts’ Drug File. It is a human fibrinogen concentrate indicated for the treatment of acute bleeding episodes for adults and adolescents who have a congenital fibrinogen deficiency. It is given by IV infusions with the dose and the frequency of dosing determined by the patient’s weight, the extent of the bleeding and the required fibrinogen blood levels. Dispensed in one-gram, single-use vials, Fibryga must be reconstituted before use. Complete prescribing information is available here.


Extended Expiration Dates for EpiPens

To help relieve the current shortage of epinephrine auto-injectors, the U.S. Food and Drug Administration (FDA) is allowing Mylan to delay the expiration dates for some of its EpiPen® (epinephrine) Auto-Injectors 0.3mg and their authorized generic, by four months. The devices are used as emergency treatment for anaphylaxis (severe, systemic allergic reactions), for adults and children who weigh at least 66 pounds. Recommended use is one injection into the middle of the outer thigh (through clothing, if necessary) at the onset of the reaction, with a second dose after a few minutes if the patient does not improve. Ordinarily, each injector expires 20 months after its manufacture, but the FDA evaluated the drug’s stability and determined that the devices are useable for an additional four months. Expiration dates for EpiPen Jr® (epinephrine) Auto-Injectors) 0.15mg are NOT being extended at this time. Specific EpiPen and authorized generic lot numbers that are included are available here. More information about the FDA’s action is available here.

 
Takhzyro Approved to Prevent Hereditary Angioedema Attacks
Shire received U.S. Food and Drug Administration approval for Takhzyro™ (lanadelumab -flyo) on Aug. 23, 2018. Takhzyro is indicated to treat hereditary angioedema (HAE) for patients at least 12 years old. The first monoclonal antibody to be approved for HAE therapy, it blocks plasma kallikrein to prevent swelling caused by HAE. Recommended initial dosing is one 300mg subcutaneous (SC) self-injection every two weeks, which may be reduced to once every four weeks if the patient has no attacks for six months. It will be dispensed through a small network of specialty pharmacies that includes Accredo. Complete prescribing information is here.
 

 

 
22Aug
EXPRESS SCRIPTS CLINICAL NEWS AND NOTES

EXPRESS SCRIPTS CLINICAL NEWS AND NOTES

Diacomit Approved to Treat Dravet Syndrome

Biocodex received U.S. Food and Drug Administration (FDA) approval for Diacomit (stiripentol) on Aug. 20, 2018. It is indicated to treat seizures for patients who have Dravet Syndrome (DS), who take Onfi® (clobazam - Lundbeck) and who are at least two years old. Recommended dosing is 50mg/kg daily, divided into two or three doses and taken along with a meal. Capsules should be swallowed whole; powder packets should be mixed into 100mL (about three ounces) of water to drink. Because Diacomit may cause neutropenia and/or thrombocytopenia, the patient’s blood counts should be checked before they begin treatment and then every six months during therapy. It will be dispensed with a Medication Guide. Launch date, pricing and distribution plans are not known at this time. Complete prescribing information is available here.

  • Brand (Generic) Name: Diacomit (stiripentol)
  • Manufacturer: Biocodex
  • Date Approved: Aug. 20, 2018
  • Indication: for the treatment of seizures associated with Dravet syndrome in patients 2 years of age and older taking clobazam
  • Dosage Forms Available: 250mg and 500mg oral capsules; 250mg and 500mg packets of powder for oral suspension
  • Launch Date: Launch date is unknown.
  • Estimated Annual Cost: Pricing information is not available at this time.
  • According to the Centers for Disease Control and Prevention (CDC), about 470,000 U.S. children have some form of epilepsy. However, DS is very rare, affecting around 8,000 patients.
  • DS causes multiple different types of seizures; some may last for several minutes and/or repeat rapidly. It is difficult to manage, usually needing multidrug therapy that is required throughout the patient’s life.
  • In two very small Phase III clinical trials, between 67% and 71% of children taking Diacomit plus clobazam or another antiepileptic drug experienced at least a 50% reduction in seizure activity as compared to 5% to 9% of participants using a placebo along with other seizure medications.
  • About two-thirds of patients taking Diacomit in studies had greater than expected sleepiness. More than one-half had decreased appetite and around one-quarter lost weight.
  • Ending treatment with it requires a gradual tapering to decrease the risk of seizures.
  • Epidiolex® (cannabidiol – GW Pharmaceuticals), the only other drug specifically FDA-indicated to treat DS, was approved on June 25, 2018. It is expected to launch later this year, depending on the timing of Drug Enforcement Agency (DEA) scheduling.
  • Diacomit has been available for use in certain countries outside of the U.S. for several years. Since Biocodex did not release information to the public regarding its plan to seek FDA approval of Diacomit, Express Scripts had not been tracking this product while in the pipeline.

Implications: Express Scripts currently is investigating the data around Diacomit for a possible utilization management strategy. It also will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete.

 
23Aug
FSBP Partners with Meditar in Buenos Aires, Argentina

FSBP Partners with Meditar in Buenos Aires, Argentina

Featured Partner: Meditar

The Foreign Service Benefit Plan (FSBP) proudly welcomes our newest direct billing partner, Meditar, located in Buenos Aires, Argentina.

Our direct billing arrangement with Meditar covers inpatient*, accidental injury* and all covered outpatient care**.

  • Meditar is one of the first, largest and advanced managed healthcare companies in Latin America.
  • Meditar’s provider network is comprised of over 100 facilities throughout Argentina.
  • Meditar is a member of the International Society for Quality in Health Care (ISQua), a leading international health care evaluation and accreditation program.

To arrange care through Meditar, you must contact their Administrative Offices for assistance with scheduling appointments and coordinating your admissions and tell them you are a member of the FSBP. You may contact Meditar’s offices located in the city Buenos Aires at +54 11 4327-2434, Monday-Friday, 9am-6pm, local time or in the city of Rosario at +54 341 440-8379, Monday-Friday, 8am-4pm, local time. You also may contact Meditar via e-mail at [email protected] For urgent matters that occur outside of Meditar’s normal business hours you may contact Dr. Mario L. Domínguez at +54 9 11 4173-8814 or Dr. Gustavo Pla at +54 9 11 4424-4222 for assistance with coordinating care.

After arranging your admissions, Meditar will coordinate your care with their provider network facilities and will make payment up front for covered services under the FSBP. You are responsible for any balance after Meditar’s payment, which should be paid directly to Meditar.

As always, you can see any covered provider anywhere in the world and receive in-network level of benefits. If you elect to receive services from a facility in Argentina outside of Meditar’s provider network, you may be required to pay up front for services according to that facility’s rules. Please note this direct billing arrangement does not take the place of your normal benefits. Benefit coverage is subject to the provisions of the FSBP Brochure.

We strive to simplify your care overseas and are delighted to have this direct billing arrangement. If you have overseas direct billing questions, please visit our FSBP Overseas Partners page on our website, email us, or call us at 202-833-4910.

Thank you for being a valued FSBP member.

*Inpatient and accidental injury: Member pays no deductible. FSBP pays 100% of covered services. Please see the FSBP Brochure for more details.

**Outpatient care: Member pays applicable calendar year deductible and 10% coinsurance. FSBP pays 90% of covered services. Please see the FSBP Brochure for more details. Members should be prepared to show proof of calendar year deductible status at time of service using the Aetna Mobile App on their smart phone or bring a copy of the most recent Explanation of Benefits that shows the deductible status.

 
21Aug
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Cequa Approved to Treat Dry-Eye Disease
Sun Pharmaceuticals’ Cequa™ (cyclosporine ophthalmic solution) 0.09% received approval from the U.S. Food and Drug Administration (FDA) on Aug. 14, 2018. An immunosuppressant in the calcineurin inhibitor class, it is indicated for topical use to increase the production of tears for patients who have keratoconjunctivitis sicca (dry eyes). It is a preservative-free formulation that uses unique nanomicelles to improve solubility and increase diffusion into the eye. Cequa also is a higher strength than other cyclosporine eye drops. Recommended dosing is one drop in each eye twice a day at 12-hour intervals. It will be dispensed in boxes of 60 single-use vials containing 0.25mL (one dose for each eye). Sun Pharmaceuticals has not disclosed its launch or pricing plans. Express Scripts currently is investigating the data around Cequa for a possible utilization management strategy. It also will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete. Prescribing information is available here.

New Indication for Lenvima
Lenvima® (lenvatinib – Eisai/Merck) was U.S. Food and Drug Administration (FDA) approved on Aug. 15, 2018, as initial treatment for patients who have hepatocellular carcinoma (HCC) that cannot be removed by surgery. It is a receptor kinase (RTK) inhibitor that selectively blocks activity of several enzymes needed for cancers to grow. Recommended dosing for HCC is once a day at 8mg (two 4mg capsules) or 12mg (three 4mg capsules) depending on the patient’s weight. In the REFLECT clinical study, Lenvima was comparable to the standard of care, Nexavar® (sorafenib - Bayer), for average overall survival time (OS) -- 13.6 months vs. 12.3 months. However, progression-free survival (PFS) doubled (7.3 months vs 3.6 months) and the overall response rate (ORR) more than tripled (41% vs 12%) for those treated with Lenvima. It has previous indications for treating some types of thyroid and kidney cancers and it currently is in multiple clinical trials for treating several other cancers. Updated prescribing information for Lenvima is available here.
 
Kalydeco’s Indication Expanded
Vertex Pharmaceuticals’ Kalydeco® (ivacaftor) was approved by the U.S. Food and Drug Administration (FDA) on Aug. 15, 2018, to treat children as young as one year old and who weigh at least 7kg (approximately 15 pounds). Previously, its use was limited to children age two years and older. Kalydeco treats cystic fibrosis (CF) caused by mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Before treatment begins, patients must test positive for susceptible mutations. For children who weigh less than 14kg (around 30 pounds), recommended dosing is one 50mg dose every 12 hours with a food that contains fat. The dose increases to 75mg twice a day for children weighing more than 14kg. Kalydeco is available in 50mg and 75mg single-dose pouches of granules to mix with about a teaspoonful of liquid or soft food for administration. It is also supplied as 150mg tablets for adults and older children. Its prescribing information is available here.
 
Opdivo Gains New Indication
Under the U.S. Food and Drug Administration's (FDA) Accelerated Approval and Priority Review processes, Bristol-Myers Squibb received a new approval for Opdivo® (nivolumab) injection for intravenous (IV) use on Aug. 16, 2018. The monoclonal antibody is a programmed death receptor-1 (PD-1) checkpoint inhibitor. Its new indication is to treat patients who have metastatic small cell lung cancer (SCLC) that has worsened even after treatment with platinum-based chemotherapy (chemo) and one or more additional therapies. Opdivo enhances the ability of the immune system to attack and destroy cancer cells. It is given as 30-minute IV infusions once every two weeks (240mg) or once every four weeks (480mg). Originally, the FDA approved Opdivo in December 2014 as a breakthrough therapy for advanced melanoma. It now has several additional indications, both alone and in combination with other drugs, to treat various types of cancer. Complete prescribing information may be found here.

Eylea Labeling Revised
On Aug. 16, 2018, the U.S. Food and Drug Administration (FDA) approved a 12-week dosing schedule for Eylea® (aflibercept) Injection. Eylea is a vascular endothelial growth factor (VEGF) inhibitor that is injected into the eye to treat wet age-related macular degeneration (AMD), macular edema and diabetic retinopathy. For AMD, it is given once every four weeks for three doses and then reduced to once every eight weeks for most patients. Some patients continue on a four-week schedule, however. Now, some patients are eligible for dosing once every 12 weeks after they have been treated successfully for at least one year. Eylea’s revised prescribing information is available here.

First True Generic to EpiPen Approved
Teva Pharmaceutical Industries was granted U.S. Food and Drug Administration (FDA) approval on Aug. 16, 2018, for its AB-rated generic versions of Mylan’s EpiPen® (epinephrine) Auto-Injector 0.3mg and EpiPen, Jr® (epinephrine) Auto-Injector 0.15mg. Used as emergency treatment for anaphylaxis (severe, systemic allergic reactions), they are indicated for adults and children who weigh at least 33 pounds. Recommended use is one auto-injection into the middle of the outer thigh (through clothing, if necessary) at the onset of the reaction. A second injection may be needed before emergency personnel arrive, but no more than two doses should be self-injected for one episode. Teva is expected to launch its generic epinephrine auto-injector in the coming months. Pricing information is not yet available. U.S. sales for EpiPen and EpiPen, Jr totaled approximately $763 million in 2017.

Corrections

The August 13 Clinical News and Notes incorrectly states that the Annovera contraceptive is inserted into the uterus. It is vaginal. Complete prescribing information is available here. In addition, the email identifies Galafold's indication for patients age 16 years and older, it actually is indicated for adults. Full prescribing information is available here.

 

 
13Aug
EXPRESS SCRIPTS CLINICAL NEWS AND NOTES

EXPRESS SCRIPTS CLINICAL NEWS AND NOTES

Arakoda Approved to Prevent Malaria

The U.S. Food and Drug Administration (FDA) approved Arakoda™ (tafenoquine) tablets on Aug. 8, 2018. Developed by 60 Degrees Pharmaceuticals in partnership with the U.S. Army, Arakoda is indicated to prevent malaria infections for adults. Tablets should be taken with food at a dose of 200mg (two tablets) once a day for the three days immediately before traveling to the location where malaria is present. While at the location, each patient should take two tablets together once a week with the last dose taken one week after leaving the place of malaria exposure. The FDA approved another tafenoquine product (Krintafel – GlaxoSmithKline/Medicines for Malaria Venture) on July 20, 2018. However, it is indicated only for one-time dosing to prevent the relapse of malaria caused by Plasmodium vivax (P. vivax). Full prescribing information for Arakoda is available here.

FDA Approves Jornay PM to Treat ADHD

On Aug. 9, 2018, the U.S. Food and Drug Administration (FDA) approved Jornay PM™ (methylphenidate) extended-release capsules to treat attention deficit hyperactivity disorder (ADHD). Indicated for use by children age six and older, it utilizes Ironshore Pharmaceuticals’ patented Delexis® technology, which slows down drug absorption. Like all methylphenidates, it is a C-II controlled substance. Unlike other methylphenidate products, however, Jornay PM is not taken in the morning. The recommended initial dose is 20mg taken once a day at about 8:00 p.m. Gradual overnight release of the drug manages morning ADHD symptoms and then lasts throughout the day.  Doses may be adjusted on a weekly basis to a maximum of 100mg per day. Timing also may be changed to between around 6:30 and 9:30 in the evening, depending on the child’s response. A boxed warning on the labeling cautions that all central nervous system (CNS) stimulants, including methylphenidate, carry risks for abuse and dependence. Express Scripts currently is investigating the data around Journay PM for a possible utilization strategy. It will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete. Complete prescribing information is available here.

Annovera Vaginal Birth Control Approved

The Population Council, Inc. received U.S. Food and Drug Administration (FDA) approval for Annovera™ (segesterone acetate/ethinyl estradiol vaginal system) on Aug. 10, 2018. It combines a new progestin (segesterone acetate) with a commonly used estrogen to provide hormonal contraception for one year. A ring-shaped vaginal insert, it is placed in the uterus by the user. It remains in place, releasing low levels of both hormones, for 21 days, then it is removed, washed and stored in a special case for one week. It can be used for up to 13 cycles (one year). The Population Council is a nonprofit, international organization that promotes public health solutions in developing countries. Through a partnership with TherapeuticsMD, Annovera will be available in the United States. However, it will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete. Prescribing information is available here.

 Extended Indication and Vial Form for Granix

Granix® (tbo-filgrastim), Teva’s alternative for Neupogen® (filgrastim - Amgen), was granted a pediatric indication by the U.S. Food and Drug Administration (FDA), which also approved it for sale in vials – both on July 31, 2018. Granix is a leukocyte growth factor that was first introduced in the U.S. in November 2013 to help limit the length of neutropenia for patients who are being treated for nonmyeloid cancers with drugs that have a high chance of causing neutropenia with fever. In neutropenia, the numbers of neutrophils, which are the white blood cells mainly responsible for fighting blood borne bacteria, are seriously reduced, increasing the risk for infections. Granix is injected subcutaneously (SC) once daily beginning at least 24 hours after the administration of a myelosuppressive drug and continuing until neutrophil counts are in normal ranges. Recommended dosing is 5mcg/kg of the patient’s body weight. Its extended indication means that Granix can be used to treat infants as young as one month old. In addition to the previously available pre-filled syringes, which contain either 300mcg/0.5mL or 480mcg/0.8mL, it also will be launched in 300mcg/mL and 480mcg/1.6mL vials shortly, according to a Teva press release. Prescribing information is available here.

First Generic for Adcirca Approved

Mylan Pharmaceuticals received U.S. Food and Drug Administration (FDA) approval on Aug. 3, 2018, for tadalafil, the first generic for Adcirca® (United Therapeutics). A phosphodiesterase type 5 (PDE5) inhibitor, tadalafil is taken once a day to treat pulmonary arterial hypertension (PAH). Affecting about 50,000 Americans, PAH is a rare, serious vascular disease that results from dangerously high pressure in the blood vessels leading from the heart to the lungs. Launch is planned before the end of August and Mylan will have six months of exclusivity before other generics can be marketed in the U.S. Adcirca is on Express Scripts’ specialty drug list; therefore, generics to Adcirca will be included as well. Annual U.S. sales for Adcirca are approximately $483 million.

 Kapspargo Sprinkle Launched

An extended-release, sprinkle form of metoprolol succinate was released to the U.S. market on Aug. 6, 2018. Kapspargo™ Sprinkle capsules (Sun Pharma) was U.S. Food and Drug Administration (FDA) approved in January 2018, to treat angina, heart failure and high blood pressure. It is a beta blocker usually taken at doses between 25mg and 200mg once a day. Indicated for children as young as six years old, the capsules can be swallowed whole or opened and the contents mixed with about a teaspoonful of a soft food, such as pudding, and then consumed. Pediatric doses are based on the child’s weight. Capsule contents can be dissolved in about a tablespoonful of water for administration through a nasogastric (NG) tube, as well. Kapspargo will be dispensed in 25mg, 50mg, 100mg and 200mg strengths. Express Scripts currently is investigating the data around Kapspargo for a possible utilization strategy. It will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete. Complete prescribing information is available here.

Orkambi Granted Expanded Indication and New Dose Form

On Aug. 6, 2018, Orkambi® (lumacaftor/ivacaftor), which previously was approved to treat children age six and older, received U.S. Food and Drug Administration (FDA) approval for children as young as two years of age. Additionally, it will be available as oral granules -- making dosing easier for children who may not be able to swallow a tablet. The combination works in two ways to correct cystic fibrosis-causing mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Lumacaftor is a CFTR corrector, which helps CFTR proteins reach the cell surface. Ivacaftor is a CFTR potentiator, which helps keep the CFTR protein channels on the cell surface open longer to increase the flow of salt and water into and out of the cell. Granule packets will be marketed in two strengths, lumacaftor 100mg/ivacaftor 125mg (for children between two and six years old and who weigh less than 14 kg or about 30 pounds) and lumacaftor 150mg/ivacaftor 188mg (for children in the same age group who weigh more than 14 kg). One packet of granules will be mixed with one teaspoonful of a liquid or a soft food and given along with food that contains a high amount of fat. Doses are given 12 hours apart. Vertex, which plans to launch the granule packets within the next month, estimates that about 1,300 more children may now be eligible for Orkambi treatment. Complete, revised prescribing information is available here.

Onpattro Approved for Hereditary Transthyretin-Mediated Amyloidosis

The U.S. Food and Drug Administration (FDA) approved Alnylam’s Onpattro™ (patisiran) lipid complex injection on Aug. 10, 2018, for the treatment of adults with peripheral nerve disease (polyneuropathy) caused by hereditary transthyretin-mediated amyloidosis (hATTR). Onpattro works by blocking (silencing) mutated ribonucleic acid (RNA) that causes hATTR, a rare disease that produces disability, pain and organ damage. Given by intravenous (IV) infusion once every three weeks, Onpattro is dosed at 0.3mg/kg for patients weighing less than 100kg (about 220 pounds). Patients weighing more will receive a fixed dose of 30mg. Alnylam plans an immediate launch. The only specialty pharmacies with access will include Orsini and US BioSciences. Accredo will not have access. Complete prescribing information is available here.

Galafold Approved to Treat Fabry Disease

Galafold™ (migalastat – Amicus Therapeutics) was approved by the U.S. Food and Drug Administration (FDA) on Aug. 10, 2018. It is indicated to treat patients 16 years of age and older who have Fabry disease identified by a diagnostic test as resulting from one or more of multiple abnormalities in the galactosidase alpha (GLA) gene. The first oral treatment for Fabry disease, it also is the first FDA-approved alpha-galactosidase A (α-Gal A) chaperone (enhancer). It boosts the activity of the patient’s existing α-Gal A, an enzyme that is lacking and/or dysfunctional in Fabry disease. Previously available treatment replaces missing α-Gal A. Recommended dosing is one oral capsule every other day at least two hours before and two hours after any food. Galafold was launched upon approval and is available through a small network of specialty pharmacies that includes Accredo. Complete prescribing information for Galafold is available here.

 
13Aug

State of Emergency Due to Wildfires in California

The governor of California has issued a State of Emergency for Orange and Riverside counties due to wildfires.

Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an Emergency Access to Benefits/Refill Too Soon override that allows pharmacies, at the point of sale (POS), to override certain benefit coverage/edits such as an early refill during a government-defined emergency. In addition, if your home delivery of medications is affected by the emergency, you may provide a temporary alternate address (either online at www.express-scripts.com or by calling 1-800-818-6717) or request a local fill as needed. The Emergency Access to Benefits/Refill Too Soon override process will be implemented with an effective date of Aug. 10, 2018 and expiration date of Sept. 9, 2018.

 

 
13Aug
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Poteligeo Approved for Rare Non-Hodgkin Lymphomas

 

Poteligeo® (mogamulizumab-kpkc) injection for intravenous (IV) use was approved by the U.S. Food and Drug Administration (FDA) on Aug. 8, 2018. It is a monoclonal antibody that attaches to CC chemokine receptor type 4 (CCR4), a protein on the surfaces of some cancer cells. Its indications are for adults who have had one or more systemic treatments for mycosis fungoides (MF) or Sézary syndrome (SS), but whose cancers have returned or have resisted therapy. MF and SS are rare variants of non-Hodgkin lymphoma that affect the skin. Poteligeo is dosed by weight at 1mg/kg and given as intravenous (IV) infusions on 28-day cycles. For the first cycle, it will be administered four times at one-week intervals; then treatments are reduced to one infusion every two weeks for the following cycles. Dosing continues until the cancer worsens or the patient cannot tolerate the drug’s side effects. Kyowa Kirin is planning a fourth quarter 2018 launch. When it is launched, CVS will be the only specialty pharmacy with access. Complete prescribing information is available here.

  • Brand (Generic) Name: Poteligeo® (mogamulizumab-kpkc)
  • Manufacturer: Kyowa Kirin
  • Date Approved: 8, 2018
  • Indication: for the treatment of adult patients with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy
  • Dosage Forms Available: single-dose vials containing 20mg/5mL
  • Launch Date: Fourth quarter 2018
  • Estimated Annual Cost: Pricing information is not yet available.
  • Specialty Status: Poteligeo will be added to Express Scripts’ specialty drug list.
  • MF and SS are slowly progressing cutaneous T-cell lymphomas that affect about one American in 200,000. Men are more likely to have them and they are more common among adults in their 50s and 60s.
  • Current therapies include topical treatments with corticosteroids, retinoids or chemotherapy. Ultraviolet light (with or without associated drugs), skin surface radiation and total skin electron beam therapy also may be used.
  • If systemic therapy is needed, methotrexate and oral retinoids are used; as are interferons. Adcetris® (brentuximab vedotin – Seattle Genetics), Istodax® (romidepsin - Celgene) and Zolinza® (vorinostat – Merck) all are FDA approved to treat cutaneous T-cell lymphomas, as well.
  • In a clinical trial of 372 patients, progression-free survival (PFS) time averaged more than twice as long (7.6 months) for those receiving Poteligeo as for patients using Zolinza (3.1 months).
  • Poteligeo was approved under the FDA’s Breakthrough and Priority Review programs. It also has an Orphan Drug designation.
  • Implications: Express Scripts currently is investigating the data around Poteligeo for a possible utilization management strategy. It also will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete.
 
7Aug
From the CEO

From the CEO

Greetings and Welcome to August 2018! This means summer is winding down and a new school year is coming quickly. For those with children, this is a good time to visit the pediatrician and the dentist to ensure a successful and healthy school year.

Along the same lines, August is National Immunization Awareness Month. Immunizations aren’t just for babies and children at their well-child visits. They are necessary for preteen/teens, adults, as well as pregnant women. FSBP provides comprehensive benefits for child and adult immunizations – payable at 100% for providers in-network and outside the U.S.  Adult immunizations include those endorsed by the Centers for Disease Control and Prevention (CDC). For children, we cover routine childhood and adolescent immunizations. Having your child vaccinated can be important to their long-term health.

For those with the Foreign Service Benefit Plan (FSBP), I encourage you to explore the great resources available on Aetna Navigator. I like the Health Decision Support Tool, powered by Emmi. This interactive web-based program makes complex medical information easy to understand. The short online videos can educate you or your children on various health topics, treatment options, and chronic conditions. The presentations can be viewed anywhere with Internet access.

Just follow these steps to get started:

1. Log into Aetna Navigator 

2. Select “Stay Healthy”

3. Select “Health Decision Support from Emmi.”  

Each Emmi program takes about 20 minutes to watch. You can view the videos multiple times or pause it to finish later. As you watch the videos, you can write printable notes to bring to your next doctor’s appointment. Try it today!

Lastly, summer is an active Transfer/Permanent Change of Station (PCS) time. As you prepare to leave one post for another, please send us your new address. Your employing agency/retirement office does not notify FSBP when you change your contact information with them. Please send a note  with your updated mailing address, telephone number(s), and email address. You also can change your contact information via the Member Portal.

As always, thank you for your trust and for giving AFSPA the opportunity to serve you.

To Your Health,

Paula S. Jakub, RHU
CEO, AFSPA
Executive Director, Senior Living Foundation

 
7Aug
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Long-Acting Antipsychotic, Perseris, Approved

Indivior announced on July 27, 2018, that Perseris™, an extended-release version of injectable risperidone, had been approved by the U.S. Food and Drug Administration (FDA). Indicated to treat adults who have schizophrenia, Perseris is formulated for once-a-month, subcutaneous (SC) dosing. Healthcare providers will administer injections of either 90mg or 120mg. As with all atypical antipsychotic drugs, Perseris will have a boxed warning that using it increases the risk of death for elderly patients who have psychosis due to dementia. Perseris will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete. Prescribing information for Perseris is available here.

 

New Delivery System for Remodulin

On July 30, 2018, United Therapeutics and Medtronic received U.S. Food and Drug Administration (FDA) approvals for a new dosage form and delivery device for Remodulin® (treprostinil). A prostacyclin vasodilator, Remodulin relaxes blood vessels to relieve blood pressure for adult patients who have Class I, II or III pulmonary arterial hypertension (PAH). Presently, it is given either SC or intravenously (IV) through a surgically implanted catheter. Both use an external device similar to an insulin pump to provide continuous dosing. Since the IV route is more prone to infections, most patients and prescribers choose the SC route. The new delivery system uses Medtronic’s SynchroMed™ II pump, which is implanted under the skin, and a specially adapted catheter that remains within a blood vessel. In clinical studies, patients used the implant for four years or longer with only 10% having pump failures or other device-related problems. Filling the pump’s drug reservoir will be done through injections given by healthcare providers. Refills may last as long as four months -- depending on the patient’s dose. Launch for the Implantable System for Remodulin is expected in the first quarter of 2019. It will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete. The manual for the pump is not yet available, but Remodulin’s prescribing information is available here.

 
2Aug
Express Scripts News Flash

Express Scripts News Flash

Mulpleta® Approved for Pre-Procedure Thrombocytopenia

 

On July 31, 2018, the U.S. Food and Drug Administration (FDA) approved Mulpleta® (lusutrombopag) for the treatment of thrombocytopenia (platelet counts lower than 50,000mcg/L) in adult patients who have chronic liver disease (CLD) and who are scheduled to undergo a medical or dental procedure. The recommended dose is one 3mg tablet orally once daily for seven consecutive days. Dosing should begin eight to 14 days prior to the procedure and the procedure should be two to eight days after the last dose. Shionogi plans to launch Mulpleta® in early September. It will be available through specialty pharmacies including Accredo. Full prescribing information is available here.

  • Brand (Generic) Name: Mulpleta® (lusutrombopag)
  • Manufacturer: Shionogi Inc.
  • Date Approved: July 31, 2018
  • Indication: thrombocytopenia in adult patients who have chronic liver disease (CLD) and who are scheduled to undergo a procedure
  • Dosage Forms Available: 3mg tablets
  • Launch Date: early September 2018
  • Estimated Annual Cost: Pricing information is not available at this time.
  • Specialty Status: Mulpleta® will be added to Express Scripts’ specialty drug list.
  • Mulpleta® is a thrombopoietin receptor agonist that increases the production of platelets.
  • About 70,000 patients in the U.S. have CLD and thrombocytopenia; undergoing a procedure increases the risk of bleeding in these patients.
  • Doptelet® (avotrombopag – Dova Pharmaceuticals) is another oral thrombopoietin receptor agonist approved in May 2018 for the same indication.
  • Other thrombopoietin receptor agonists on the market include Nplate® (romiplostim – Amgen; subcutaneous) and Promacta® (eltrombopag – Novartis; oral). Both are approved to treat chronic immune (idiopathic) thrombocytopenia (ITP). Promacta® also has indications to treat thrombocytopenia in patients who have chronic hepatitis C as well as for those who have severe aplastic anemia.
  • Implications: Express Scripts currently is investigating the data around Mulpleta® for a possible utilization management strategy. It will be evaluated for exclude at launch on the Express Scripts National Preferred Formulary (NPF).
 
1Aug
Express Scripts News Flash

Express Scripts News Flash

July 31, 2018

Azedra Approved to Treat Adrenal Tumors

 

On July 30, 2018, the U.S. Food and Drug Administration (FDA) approved Azedra® (iobenguane I 131 – Progenics Pharmaceuticals, Inc.) under its Breakthrough, Fast-Track, Orphan and Priority Review designations. Azedra, a radiopharmaceutical, is the first drug to be FDA approved for treating patients who have rare neuroendocrine cancers – either a pheochromocytoma (tumor of the adrenal gland) or a paraganglioma (tumor in similar tissue outside the adrenals). Additionally, patients must be at least 12 years old and they must need systemic therapy for inoperable tumors that have spread. Radiopharmaceuticals give off low levels of radiation to diagnose or treat diseases. Recommended dosing for Azedra® is based on the patient’s weight, with one dose given by intravenous (IV) infusion to determine the required level likely to produce results. Two therapeutic doses then are infused at least 90 days apart. It will be administered by physicians who are trained to give radiopharmaceuticals and in facilities that are equipped to minimize exposure to radiation. Although it will be added to Express Scripts’ specialty drug list, Azedra will not be dispensed through Accredo. Its complete prescribing information is available here.

  • Brand (Generic) Name: Azedra® (iobenguane I 131)
  • Manufacturer: Progenics Pharmaceuticals, Inc.
  • Date Approved: July 30, 2018
  • Indication: for the treatment of adults and pediatric patients 12 years and older with iobenguane scan-positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma who require systemic anticancer therapy
  • Dosage Forms Available: single-dose 2mL and 30mL vials containing 555MBq/mL
  • Launch Date: Launch date is not known at this time.
  • Estimated Annual Cost: Pricing information is not yet available.
  • Specialty Status: Azedra® will be added to Express Scripts’ specialty drug list.
  • Adrenal tumors are extremely rare. The American Cancer Society estimates that just 200 or fewer cases are diagnosed in the United States each year. However, the five-year survival rate is only about 12%.
  • A major symptom of pheochromocytoma and paraganglioma is high blood pressure.
  • In the clinical study that lead to its approval, Azedra was effective in achieving a 50% reduction, lasting six months or longer, in the use of drugs that 17 of the 68 trial participants needed to control blood pressure. Azedra® also decreased tumor size for 15 patients (22%) who received it. Cancer worsened for only 4.7% of patients over the year after treatment.
  • Azedra® carries a warning about radiation exposure for the patient, healthcare providers and caregivers. Other side effects may include bone marrow suppression, kidney damage, low thyroid function and secondary cancers.
  • No other drug is approved to treat adrenal tumors; the standard of care is surgery.
  • Implications: Azedra® will be evaluated for exclude at launch on the Express Scripts National Preferred Formulary (NPF).
 
1Aug

AFSPA Phone System is back online

AFSPA's phone system is back online. Thank you for your patience.
 

 

 
1Aug

AFSPA Phone Systems Currently Down

AFSPA currently is experiencing issues with its phone system. We apologize for the inconvenience. We are working to resolve it and return to providing service to our members as soon as possible.

 
31Jul
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Nivestym, Second Neupogen Biosimilar, Approved

On July 20, 2018, the U.S. Food and Drug Administration (FDA) approved Nivestym™ (filgrastim-aafi) injection, made by Pfizer. It is the second FDA-approved biosimilar to Neupogen® (filgrastim – Amgen), and has the same FDA approved indications as Zarxio™ (filgrastim-sndz – Sandoz), the first biosimilar to Neupogen which was introduced to the U.S. in the fall of 2015. All are indicated for treating patients undergoing myelosuppressive chemotherapy (chemo) for cancer, patients receiving induction or consolidation chemo for acute myeloid leukemia (AML), patients having bone marrow transplantation to treat cancer, patients going through autologous peripheral blood progenitor cell collection/therapy and patients with severe chronic neutropenia. Doses, which differ according to the condition being treated, may be injected intravenously (IV) or given subcutaneously (SC). A launch date and pricing are still uncertain. Express Scripts currently is investigating the data around Nivestym for a possible utilization management strategy. It also will be evaluated for exclude at launch on the National Preferred Formulary (NPF). Complete prescribing information for Nivestym is available here.  

 

Krintafel Approved to Prevent Malaria Relapse

Using its Priority Review process, the U.S. Food and Drug Administration (FDA) approved Krintafel (tafenoquine) on July 20, 2018. Jointly developed by GlaxoSmithKline (GSK) and the Medicines for Malaria Venture (MMV), it will be given in one dose to prevent the relapse of malaria. It is indicated for patients who are at least 16 years old and who are being treated for malaria caused by Plasmodium vivax (P. vivax). Because P. vivax stays inactive and accumulates in the liver after the initial infection has been cleared, malaria can recur multiple times without re-exposure after the first instance. Krintafel eliminates the hidden forms of the parasite, preventing re-activation of earlier cases. The recommended dose is a 300mg (two 150mg capsules), along with standard malaria treatment, on the first or second day that treatment begins. The FDA awarded Krintafel a tropical disease priority review voucher as part of their program to encourage development of new drugs and biological products for prevention and treatment of neglected tropical diseases. GSK/MMV can use the voucher to get faster review for a future product or sell to another company. Express Scripts currently is investigating the data around Krintafel for a possible utilization management strategy. It also will be evaluated for exclude at launch on the NPF, if it is launched in the United States. Prescribing information is available here

 
30Jul

STATE OF EMERGENCY DUE TO WILDFIRES IN CALIFORNIA

The governor of California has issued a State of Emergency for Riverside and Shasta Counties in California due to Wildfires.

Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an Emergency Access to Benefits/Refill Too Soon override that allows pharmacies, at the point of sale (POS), to override certain benefit coverage/edits such as an early refill during a government-defined emergency. In addition, if your home delivery of medications is affected by the emergency, you may provide a temporary alternate address (either online at www.express-scripts.com or by calling 1-800-818-6717) or request a local fill as needed. The Emergency Access to Benefits/Refill Too Soon override process will be implemented with an effective date of July 27, 2018 and expiration date of August 27, 2018.

 
27Jul
Product Recall Valsartan and Valsartan HCTZ Recall

Product Recall Valsartan and Valsartan HCTZ Recall

 

 

On July 13, the U.S. Food and Drug Administration (FDA) announced a recall of medications containing valsartan, a generic medication used to treat high blood pressure and heart failure, from some manufacturers due to an impurity detected in the recalled products. However, not all products containing valsartan are being recalled. Other manufacturers are also recalling their products out of a sense of extra caution. Only those in the original FDA notice are recalled to the patient level. Others are recalled to the pharmacy level only. However, the number of manufacturers recalling products is reducing market supplies of valsartan-containing products. There is an expectation that over the next few months a shortage situation may occur.

 

The companies below are recalling all lots of non-expired products that contain the ingredient valsartan supplied by a third party:

 

Medicine

Company

Recall Information

Recall Level

Valsartan

Major Pharmaceuticals

Major Pharmaceuticals recall

Consumer/Patient

Valsartan

Solco Healthcare

Solco Healthcare recall

Consumer/Patient

Valsartan

Teva Pharmaceuticals Industries Ltd.

Teva Pharmaceuticals recall

Consumer/Patient

Valsartan/Hydrochlorothiazide (HCTZ)

Solco Healthcare

Solco Healthcare recall

Consumer/Patient

Valsartan/Hydrochlorothiazide (HCTZ)

Teva Pharmaceuticals Industries Ltd.

Teva Pharmaceuticals recall

Consumer/Patient

 

 

 
 
24Jul
EXPRESS SCRIPTS CLINICAL NEWS AND NOTES

EXPRESS SCRIPTS CLINICAL NEWS AND NOTES

Orilissa Approved to Treat Endometriosis

The U.S. Food and Drug Administration approved Orilissa™ (elagolix – AbbVie/Neurocrine Biosciences) tablets on July 24, 2018. It is an orally-administered gonadotropin-releasing hormone (GnRH) receptor antagonist indicated to relieve moderate to severe pain for women who have endometriosis. Recommended dosing is 150mg once a day for up to 24 months or 200mg twice a day for up to six months. AbbVie plans to launch Orilissa in early August 2018. Full prescribing information is available here.

  • Brand (Generic) Name: Orilissa™ (elagolix)
  • Manufacturer: AbbVie/Neurocrine Biosciences
  • Date Approved: July 24, 2018
  • Indication: for the management of moderate to severe pain associated with endometriosis
  • Dosage Forms Available: 150mg and 200mg oral tablets
  • Launch Date: early August 2018
  • Estimated Annual Cost: Based on wholesale acquisition cost (WAC), Orilissa will cost approximately $11,000 per year.
  • Endometriosis results when small fragments of the endometrium (the lining of the uterus) dislocate outside the uterus. This tissue responds to menstrual cycles in the same way that the uterus does -- filling with blood and then bleeding each month.
  • Affecting 11% or more of women during their child-bearing years, endometriosis causes pain, inflammation and swelling – usually in the abdomen.
  • Pharmaceutical management for it currently includes danazol, oral contraceptives, progestins, nonsteroidal anti-inflammatory drugs (NSAIDs) and opioids. GnRH agonists, such as leuprolide, also are used, but none of them is available as an oral medication and not all of them are approved to treat endometriosis.

Implications: Express Scripts currently is investigating the data around Orilissa for a possible utilization management strategy. It also will be evaluated for exclude at launch on the Express Scripts National Preferred Formulary (NPF).

 
23Jul
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Symtuza Approved to Treat HIV-1
Janssen’s Symtuza ™ was approved by the U.S. Food and Drug Administration (FDA) on July 17, 2018. It combines 800mg of darunavir (a protease inhibitor), 150mg of cobicistat (a CYP3 inhibitor), 200mg of emtricitabine and 10mg of tenofovir alafenamide (both are nucleoside analog reverse transcriptase inhibitors) to treat adults who have HIV-1. It can be used for initial treatment and also for certain patients who have maintained an HIV-1 RNA viral load of less than 50 copies per mL for at least six months on a stable antiretroviral regimen. Recommended dosing is one tablet daily. The labeling for Symtuza includes a boxed warning that discontinuing the use of emtricitabine or tenofovir disoproxil fumarate (a drug similar to tenofovir alafenamide) can activate hepatitis B virus (HBV) for patients who have or who have had HBV. Patients should be monitored for signs of HBV before, during and for several months after treatment with Symtuza. Full prescribing information is available here.

Symtuza will be added to Express Scripts’ specialty drug lists that contain HIV medications. Express Scripts currently is investigating the data around Symtuza for a possible utilization management strategy. It will also be evaluated for exclude at launch on the Express Scripts National Preferred Formulary (NPF).

First Drug to Treat Smallpox Approved
TPOXX ® (tecovirimat – SIGA Technologies, Inc.) was U.S. Food and Drug Administration (FDA) approved on July 13. An orthopoxvirus VP37 envelope wrapping protein inhibitor, it interferes with the ability of smallpox virus to spread and infect body cells. Although smallpox essentially was eliminated from the world nearly 40 years ago, samples of it exist in laboratories. It could be spread through bioterrorism or an accident and vaccines for it are no longer given routinely. Through an agreement with the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA), SIGA will supply TPOXX to the U.S. government’s Strategic National Stockpile of drugs and medical supplies to be used in the event of an emergency. The safety of TPOXX was confirmed for over 350 healthy individuals in human clinical trials. However, its effectiveness for preventing smallpox after exposure was tested only in laboratory animals because deliberately exposing humans to smallpox is unethical. Between 80% and 100% of test animals survived smallpox exposure when TPOXX treatment was started within four days. Recommended dosing for adults is 600mg (three capsules) twice a day. Doses for children weighing at least 13Kg (about 29 pounds) are based on weight. Capsules should be taken within 30 minutes after a meal containing high or moderate amounts of fat and treatment lasts for 14 days. TPOXX is an orphan drug that was fast-tracked and given priority review by the FDA. It also is the first drug to receive a new Material Threat Medical Countermeasure Priority Review Voucher, which provides additional incentives for certain medical products intended to treat or prevent harm from specific chemical, biological, radiological and nuclear threats. Prescribing information is available here.

Express Scripts currently is investigating the data around Tpoxx for a possible utilization management strategy.

Xtandi Indication Expanded
The indication for Xtandi ®  (enzalutamide - Astellas Pharma/Pfizer) was extended by the U.S. Food and Drug Administration (FDA) on July 13, 2018. Xtandi is an androgen receptor inhibitor that originally was approved in 2012 to treat men who have metastatic castration-resistant prostate cancer (CRPC) that previously was treated with docetaxel. Its new approval, which was granted under a priority review, allows its use to treat patients whose cancer has not yet metastasized. Xtandi is used along with an androgen-deprivation therapy (ADT), such as Eligard ® (leuprolide – Tolmar Pharmaceuticals) or Zoladex ® (goserelin – TerSera Therapeutics). In the clinical trials leading to the approval, participants who took Xtandi in addition to receiving ADT survived without developing metastases for an average of 36.6 months compared to 14.7 months for participants on ADT alone. Prescribing information for Xtandi is available here.
 
Kisqali Label Expanded under FDA’s First Real-Time Oncology Review Program
The U.S. Food and Drug Administration (FDA) has approved the first expanded indication under its pilot Real-Time Oncology Review program. Novartis’ Kisqali ® (ribociclib) also was given breakthrough and priority designations for the two new indications it received on July 18, 2018. Real-Time Oncology Review speeds up the approval process by allowing manufacturers to submit data from cancer clinical trials to the FDA for evaluation before filing a complete application. Originally approved by the FDA on March 13, 2017, Kisqali already was indicated as first-line treatment for postmenopausal women who have metastatic or advanced hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) breast cancer. Kisqali is now approved for use in combination with any aromatase inhibitor for initial endocrine-based treatment of pre-, peri- or postmenopausal women who have advanced or metastatic HR+/HER2- breast cancer and in combination with fulvestrant to treat patients with postmenopausal HR+/HER2- breast cancer following disease progression on endocrine therapy. Kisqali is taken on 28-day cycles with one 600mg dose (three 200mg tablets) every day for 21 consecutive days and then no treatment for the remaining seven days. It selectively inhibits cyclin-dependent kinase (CDK) 4 and 6 (CDK4/6), enzymes that promote the growth and spread of cancer cells. Revised prescribing information is available here.

Pediatric Indication Extension for Intelence
The labeling for Intelence ® (etravirine – Janssen) tablets was revised by the U.S. Food and Drug Administration (FDA) on July 16, 2018, to include children as young as two years old who weigh 10Kg (22 pounds) or more. Previously indicated only for patients age six years and older, Intelence is a non-nucleoside reverse transcriptase inhibitor (NNRTI) for treating HIV-1. It is taken in combination with a ritonavir-boosted protease inhibitor, such as atazanavir, and either one or two nucleoside reverse transcriptase inhibitors (NRTIs), such as lamivudine and zidovudine. Dosing for children depends on their weight and doses are taken twice a day. For patients who cannot swallow tablets, Intelence can be dissolved in a teaspoonful of water and given directly or the dissolved tablet can be mixed with a small glass of milk or orange juice. Prescribing information is available here.

Tibsovo Approved to Treat Acute Myeloid Leukemia
The U.S. Food and Drug Administration (FDA) announced on July 20, 2018, that it had approved Agios Pharmaceuticals’ Tibsovo ® (ivosidenib) oral tablets. It is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation, as determined by an FDA-approved test. The recommended dosing is 500mg orally once daily until the patient can no longer tolerate the drug or the cancer spreads. A boxed warning cautions that differentiation syndrome, which can be life-threatening, may be associated with taking Tibsovo. Availability and network distribution plans are not known at this time. Prescribing information is available here.
 

 
19JUL

AFSPA IS CLOSING EARLY

AFSPA will close at 12:00 PM EST on Friday, July 20, 2018 for a staff training.
We will resume normal business hours at 8:30 AM EST on Monday, July 23, 2018.

If you have an urgent claim or benefit matter, please contact us at [email protected]  

Thank you.

 
16Jul
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Opdivo/Yervoy Combination Approved to Treat a Rare Cancer Type

Bristol-Myers Squibb received approval from the U.S. Food and Drug Administration (FDA) on July 11, 2018, to use Opdivo® (nivolumab) and Yervoy® (ipilimumab) for approximately 5% of patients who have colorectal cancer. Specifically, the two drugs will be used together to treat patients who are at least 12 years old and whose metastatic or inoperable colorectal cancer (mCRC) is microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR). Additionally, the cancer must have advanced despite treatment with a chemotherapy (chemo) regimen containing fluoropyrimidine, irinotecan or oxaliplatin. For the new indication, the recommended doses are given on one day --  3mg/kg of Opdivo infused intravenously (IV) over one-half hour followed by 1mg/kg of Yervoy over one-half hour -- once every three weeks for four cycles. Yervoy then is discontinued and Opdivo is given IV once every two weeks at a dose of 240mg for as long as the patient can tolerate taking it or until the cancer worsens. Product labeling for Yervoy carries a boxed warning that it can cause immune-mediated adverse reactions potentially involving any organ system and possibly life-threatening. Patients should be tested for adrenal, hormone, liver and thyroid functions before Yervoy is initiated and before each dose. Full prescribing information for Opdivo is available here. Full prescribing information for Yervoy is available here.

 
10Jul
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Aristada Initio Approved

In a press release dated July 2, 2018, Alkermes reported that the U.S. Food and Drug Administration (FDA) has approved Aristada Initio® (aripiprazole lauroxil). It is an extended-release formulation of the antipsychotic, using proprietary technology to reduce particle size, intended to simplify the start of Aristada treatment for adults who have schizophrenia. A single IM dose (675mg in a pre-filled syringe) will be administered along with one 30mg oral dose of aripiprazole. Aristada Initio is only to be used as a single dose and is not for repeated dosing. Long-term treatment with regular Aristada, which is given once every four, six or eight weeks, can begin on the same day or anytime within 10 days. The previous regimen requires a 21-day course of oral aripiprazole before the injectable form of the drug is started. Although they both are long-acting injectables, Aristada Initio is not interchangeable with Aristada, which takes longer to achieve effective blood levels. Alkermes plans a U.S. launch for Aristada Initio in mid-July. The labeling for all antipsychotic drugs contains a boxed warning noting that elderly patients who have dementia-related psychosis and who are treated with antipsychotic drugs are at an increased risk of death. Prescribing information for Aristada Initio is available here.


Generic Launched for Makena

American Regent launched hydroxyprogesterone caproate injection 250mg/mL on June 25, 2018. It is the first preservative-free AP-rated (interchangeable) generic for Makena® (AMAG Pharma USA), a drug indicated to reduce the risk of preterm birth for women who are pregnant with one baby and who previously delivered one preterm baby spontaneously. Intramuscular (IM) injections must be given once a week by a healthcare provider. At a recommended dose of 250mg, the injections begin between weeks 16 and 21 of the pregnancy, and then continue until week 37 or the birth of the child. The generic is available in single-dose vials, but pricing information is not available. According to the AMAG annual report, worldwide net sales for Makena were approximately $387 million in 2017.


Sialorrhea Indication for Xeomin

Xeomin® (incobotulinumtoxinA) was granted a new indication on July 3, 2018, for treating adults who experience sialorrhea (excessive drooling). Xeomin is a nerve toxin with previous approvals to treat upper limb spasticity (ULS), muscle spasms associated with cervical (neck muscle) dystonia and blepharospasm (involuntary closing of the eyelids). It also has a cosmetic indication for temporarily improving glabellar lines (frown lines between the eyebrows). Although other botulinum toxins have similar indications, Xeomin is the first one approved for sialorrhea. Associated with strokes and conditions such as Parkinson’s disease, excess drooling can cause skin and tooth problems, as well as embarrassment for the patient. To reduce drooling, Xeomin will be injected by a health professional into two sets of the patient’s salivary glands (four injections per treatment). Treatments must be separated by 16 weeks or longer. Updated prescribing information is available here.

 
5Jul
From the CEO

From the CEO

Greetings and Welcome to July 2018! That means summer is in full swing. This warmer season brings picnics, hiking, other outdoor activities and long-awaited vacations. Inevitably, something may occur while traveling that requires a doctor. Where do you go if you need medical advice without going to an emergency room or an Urgent Care Center? And, is the facility in-network? How do I even know how to get there?


telehealthThese questions all can be answered by the Foreign Service Benefit Plan’s (FSBP) convenient Telehealth benefit. This program, offered through our vendor American Well (Amwell), uses a secure mode of information transmission between a patient and a medical professional. Telehealth provides 24/7, on-demand, access to health care providers. Patients physically in the U.S. can connect via phone, mobile, and video. These doctors can treat and prescribe medications (if necessary) for common health issues such as: colds, flu, fever, rash, ear infections, and migraines. In addition, you can participate in online mental health counseling to address depression, anxiety, stress, etc. Telehealth even allows you to meet with a trained dietician for guidance on proper diet and nutrition.

I recently attended a conference and one of the workshop topics specifically focused on Telehealth. The common theme was twofold:

  • When infrastructure breaks down; i.e, geography, weather, etc., Telehealth picks up
  • Once a patient uses a Telehealth provider, it often becomes preferred to a live visit.

See pages 33 - 34 of the 2018 FSBP Brochure for details on the Telehealth Benefit. Register now to be ready when that first visit is needed.

It is easy to sign-up for Telehealth:

  1. Download the iOS or Android App by searching for "Amwell" at your mobile device's app store, or
  2. Sign-up online at www.Amwell.com or by phone, 844-733-3627.

To learn more about Telehealth consultations, visit Amwell’s website or call 844-733-3627.


Also, July 15-21 is EveryBody Deserves a Massage Week – a perfect reason to schedule a personal massage. woman getting massage

While more research is needed, some studies have found massage may help with:

  • Anxiety
  • Digestive disorders
  • Fibromyalgia
  • Headaches
  • Insomnia related to stress
  • Myofascial pain syndrome (muscle pain)
  • Soft tissue strains or injuries
  • Sports injuries
  • Temporomandibular joint pain (jaw pain)

FSBP covers 40 massage therapy visits a year (up to $60 per visit). Our wildly popular massage benefit applies to each family member on your health plan. In addition to 40 massages every year, FSBP members receive 40 chiropractic and 40 acupuncture visits as well. See page 49 of the 2018 FSBP Brochure for details on all three of these alternative benefits. You still have time to get in your 40 massages before 2018 ends. Click here to learn how to file a massage therapy claim.  


I hope you enjoyed a happy and healthy Independence Day. Every year, this holiday commemorates the adoption of the Declaration of Independence on July 4, 1776. Many Americans celebrated with fireworks, parades, and picnics; however, we always want to remember the true meaning of the day. The Fourth of July represents our nation’s history and heritage. Wherever you are in the world, I hope you took a moment to appreciate the freedoms we have in the United States. Thank you for the work you do to protect those freedoms. 

Please enjoy your friends and family this summer. As always, thank you for your trust and for giving AFSPA the opportunity to serve you.

To Your Health,

Paula S. Jakub, RHU

CEO, AFSPA

Executive Director, Senior Living Foundation

 
4Jul

AFSPA is closed today

AFSPA is closed, today, July 4, 2018 in observance of the holiday. We will resume our normal business hours at 8:30 am EST on Thursday, July 5, 2018. 

 
3Jul
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Zemdri Approved to Treat Urinary Tract Infections

The U.S. Food and Drug Administration (FDA) approved Zemdri™ (plazomicin - Achaogen, Inc.) on June 25, 2018. An antibacterial drug in the aminoglycoside class, Zemdri is indicated to treat complicated (associated with predisposing conditions) urinary tract infections (cUTI) for patients age 18 and older. A second indication, to treat blood infections, was not approved because the number of participants in the clinical trial was too small to reach a definite conclusion on its effectiveness. Aminoglycoside antibacterials all have boxed warnings that they may injure the kidneys, damage hearing, interfere with nerve-to-muscle impulses and hurt developing fetuses. Additionally, to help decrease the development of bacterial resistance, Zemdri should be used only after other antibiotics have failed to control infections that are caused by susceptible bacteria. Its recommended dose is 15mg/Kg given by intravenous (IV) infusion once a day for four to seven days. Express Scripts is currently investigating the data around Zemdri for a possible utilization management strategy. It will be evaluated for exclude at launch on the Express Scripts National Preferred Formulary (NPF). Full prescribing information is available here.


FDA Approves Qbrexza to Treat Hyperhidrosis

On June 28, 2018, the U.S. Food and Drug Administration (FDA) approved Dermira’s Qbrexza™ (glycopyrronium) cloth. It is indicated for treating patients age nine years and older who have primary axillary hyperhidrosis (excessive underarm sweating). Dermatologists estimate that around 10 million Americans have the condition. Beginning in October, Qbrexza will be available in boxes of 30 single-use pouches each containing one cloth saturated with 2.4% glycopyrronium, a drug that reduces the activity of sweat glands. Directions are to use one cloth to rub each armpit only one time, once a day. It should not be used on skin that is irritated. After disposing of the used cloth, patients are advised to wash their hands thoroughly and to avoid touching their eyes. Among its common side effects are dry mouth, blurry vision and dilated pupils that could increase light sensitivity. Express Scripts is currently investigating the data around Qbrexza for a possible utilization management strategy. It will be evaluated for exclude at launch on the Express Scripts NPF. Prescribing information is available here.

 

Invanz Generic Approved

Aurobindo Pharma Limited received U.S. Food and Drug Administration (FDA) approval on June 25, 2018, for ertapenem injection, the generic for Invanz® (Merck). Ertapenem is an antibacterial drug that is either infused or injected intramuscularly (IM) to treat several types of complicated infections for patients as young as three months old. Aurobindo plans to launch the generic in July. According to IQVIA, the global market for Invanz was approximately $387 million for the twelve-month period that ended on April 30, 2018.


New Strength and Dosage Form for Nuplazid

Acadia Pharmaceuticals announced on June 29, 2018, that U.S. Food and Drug Administration (FDA) approved a new strength (10mg tablets) and a new dose form (34mg capsules) for Nuplazid® (pimavanserin). An atypical antipsychotic known as a selective serotonin inverse agonist (SSIA) that targets 5-HT2A receptors, Nuplazid treats hallucinations and delusions that are associated with Parkinson’s disease psychosis. Recommended dosing is 34mg daily, but only 17mg tablets were available previously. The 10mg tablet will allow for dose adjustments when patients take other drugs that interfere with Nuplazid. Its labeling contains a boxed warning that elderly patients with dementia-related psychosis are at an increased risk of death if treated with antipsychotic drugs. Although Acadia expects to launch both products by the middle of August, no pricing plans have been released. Both will be evaluated for exclude at launch on the Express Scripts NPF.

 
29Jun
Espress Scripts News Flash

Espress Scripts News Flash

Braftovi and Mektovi Approved to Treat Melanoma


On June 27, 2018, the U.S. Food and Drug Administration (FDA) approved Array BioPharma’s two new drugs, Braftovi™ (encorafenib) capsules and Mektovi® (binimetinib) tablets. They are kinase inhibitors that will be used together to treat unresectable or metastatic melanoma for patients who test positive for BRAF V600E or BRAF V600K mutations. Braftovi’s recommended dose is 450mg once a day. It will be available in capsules containing 50mg or 75mg to allow for dosage adjustments if patients experience side effects. Mektovi is taken twice a day at doses of 45mg (three tablets) each. They will be dispensed through a limited network of specialty pharmacies that does not include Accredo. Complete prescribing information for Braftovi™ is available here. Complete prescribing information for Mektovi is available here.

     

  • Brand (Generic) Name: Braftovi™ (encorafenib) + Mektovi® (binimetinib)
  • Manufacturer: Array BioPharma
  • Date Approved: June 27, 2018
  • Indication: for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or BRAF V600K mutations, as detected by an FDA-approved test.
  • Dosage Forms Available: Braftovi – 50mg and 75mg oral capsules, Mektovi – 15mg oral tablets.
  • Launch Date: Braftovi and Mektovi will be available within one week.
  • Estimated Annual Cost: Pricing information has not yet been announced.
  • Specialty Status: Braftovi and Mektovi will be added to Express Scripts’ specialty drug list.
  • Melanoma is a rare, but destructive form of skin cancer. Each year in the United States, approximately 74,000 new cases of melanoma are diagnosed and nearly 10,000 patients will die from the disease. Approximately half of patients with melanoma skin cancer have a BRAF gene mutation.
  • The approval of Braftovi + Mektovi was based on the COLUMBUS clinical study. The overall survival period for patients treated with the combination averaged 33.6 months as compared to 16.9 months for those receiving a standard of care, Zelboraf® (vemurafenib – Genentech).
  • Braftovi + Mektovi will compete with Cotellic™ (cobimetinib – Genentech/Exelixis) + Zelboraf and GlaxoSmithKline’s Mekinist® (trametinib) + Tafinlar® (dabrafenib) that also are approved for combination use to treat patients with advanced BRAF V600 mutation-positive melanoma.
 
28Jun
FSBP Partners with Herzliya Medical Center in Israel

FSBP Partners with Herzliya Medical Center in Israel

Featured Partner: Herzliya Medical Center         HMCIsrael-logo

The Foreign Service Benefit Plan (FSBP) proudly welcomes our newest direct billing partner, Herzliya Medical Center, located in Herzliya, Israel.

Our direct billing arrangement with Herzliya Medical Center covers inpatient*, accidental injury*, complete maternity care*, routine annual physical exam* and all covered outpatient medical services**.

  • Herzliya Medical Center provides individualized treatment to its patients. As part of the hospital’s uniquely personalized service, each patient is assigned a case manager to handle all administrative, logistical and medical issues.
  • Herzliya Medical Center employs many multilingual healthcare professionals, including: native Russian speakers; native English speakers; and additional interpreters as needed.
  • Herzliya Medical Center features 5 hospitalization wards, 9 operation rooms and 101 standard hospitalization beds.

We strive to simplify your care overseas and are delighted to have this billing arrangement. If you have overseas direct billing questions, please visit our FSBP Overseas Partners page on our website, email us, or call us at 202-833-4910 for assistance.

Thank you for being a valued FSBP member.    

*Inpatient, accidental injury, complete maternity care and routine annual physical exam: Member pays no deductible. FSBP pays 100% of covered services.

**Outpatient: Member pays applicable calendar year deductible and 10% coinsurance. FSBP pays 90% of covered services.

 
27Jun

STATE OF EMERGENCY DUE TO THE PAWNEE WILDFIRE IN CALIFORNIA

The Governor of California has issued a State of Emergency for Lake County due to the Pawnee Wildfire.

Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an Emergency Access to Benefits/Refill Too Soon override that allows pharmacies, at the point of sale (POS), to override certain benefit coverage/edits such as an early refill during a government-defined emergency. In addition, if your home delivery of medications is affected by the emergency, you may provide a temporary alternate address (either online at www.express-scripts.com or by calling 1-800-818-6717) or request a local fill as needed. The Emergency Access to Benefits/Refill Too Soon override process will be implemented with an effective date of June 25, 2018 and expiration date of July 25, 2018.

 
27Jun
Express Scripts News Flash

Express Scripts News Flash

 

Epidiolex Approved for Rare Types of Epilepsy

 

Epidiolex® (cannabidiol) oral solution was approved by the U.S. Food and Drug Administration (FDA) on June 25, 2018. The first FDA-approved derivative of Cannabis sativa (marijuana), it is believed to modulate several transporters and receptors involved in epilepsy. It is indicated to treat two rare forms of the condition, Lennox-Gastaut syndrome (LGS) and Dravet syndrome (DS), for patients as young as two years old. Recommended initial dosing is 2.5mg/kg twice a day (5mg/kg/day). After one week, doses may be increased by 2.5mg/kg per dose (5mg/kg/day) at weekly intervals, if needed. The maximum dose is 10mg/kg twice daily (20mg/kg/day). As a controlled substance, Epidiolex will be scheduled through the Drug Enforcement Agency (DEA), which the manufacturer, GW Pharmaceuticals, has estimated will take approximately three months. It will be distributed through a small network of specialty pharmacies that includes Accredo. Complete prescribing information is available here.   

 

  • Brand (Generic) Name: Epidiolex® (cannabidiol)
  • Manufacturer: GW Pharmaceuticals
  • Date Approved: June 25, 2018
  • Indication: for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients two years of age and older.
  • Dosage Forms Available: oral solution containing 100mg/mL in 100mL bottles.
  • Launch Date: Dependent on DEA action, but expected in Fall 2018.
  • Estimated Annual Cost: Pricing information is not yet available.
  • Specialty Status: Epidiolex will be added to Express Scripts’ specialty drug list.
  • According to the Centers for Disease Control and Prevention (CDC), about 3.4 million people in the U.S., including approximately 470,000 children, have some form of epilepsy. However, DS and LGS are very rare. Between 14,000 and 18,500 patients in the US have LGS; about 8,000 have DS.
  • Both LGS and DS cause multiple different types of seizures, some lasting for several minutes and/or repeating rapidly. Both syndromes are hard to manage, with both needing multiple-drug therapy that generally is required throughout the patient’s life.
  • Epidiolex is the first drug that the FDA approved specifically to treat DS.
  • Cannabidiol (CBD) is a highly refined substance that does not contain tetrahydrocannabinol (THC), the chemical responsible for marijuana’s psychoactive effects. Although its precise activity is not known, CBD is likely to include multiple effects on nerve channels and calcium inside cells.
 
26Jun
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Nocdurna Approved for Nocturnal Polyuria

Nocdurna® (desmopressin acetate) was approved by the U.S. Food and Drug Administration (FDA) on June 21, 2018. The first sublingual form of the drug, it is dissolved under the tongue without water. Nocdurna is indicated to treat adults who have nocturnal polyuria – the need to urinate at least twice during the night. It is taken once daily about one hour before bedtime. Women will take a lower dose (27.7mcg) than men (53.3mcg). A boxed warning cautions that using it may cause hyponatremia (low sodium levels in the blood). Sodium levels should be checked before treatment begins, within one week after starting Nocdurna, about a month later and then at regular intervals. It should not be used by individuals who are taking loop diuretics or corticosteroids. Ferring Pharmaceuticals plans to launch it in the second half of 2018. Express Scripts is currently investigating the data around Nocdurna for a possible utilization management strategy. It also will be evaluated for exclude at launch on the Express Scripts National Preferred Formulary (NPF). Full prescribing information is available here.

 Cinryze Label Expansion

On June 21, 2018, Shire announced that the U.S. Food and Drug Administration (FDA) had approved Cinryze® (C1 esterase inhibitor [human]) for children as young as six years old. Originally approved in October 2008, it previously was indicated only to help prevent attacks of hereditary angioedema (HAE) for patients 12 years of age and older. HAE is an orphan disease with fewer than 10,000 patients in the U.S. A genetic disorder due to a deficiency of C1 inhibitor, it causes painful, recurrent, unpredictable and potentially life-threatening swelling of the abdomen, arms, face, legs, throat and urogenital tract. Its pediatric indication is based on a study of 12 patients between the ages of seven years and 11 years who received Cinryze every three or four days for 12 weeks. It is infused intravenously (IV) over a 10-minute period. Compared to the number of HAE attacks in the 12 weeks before being treated, children who received 500 units of Cinryze  averaged a 71.1% decrease in attacks and those receiving 1,000 units had a 84.5% decrease. Additionally, attacks not only tended to be milder, less acute treatment was needed, as well. Cinryze is not indicated to treat acute HAE attacks. Updated prescribing information is available here.

 

 

 

 
20Jun
AFSPA's CEO, Paula S. Jakub, RHU discusses Wellness in the FEHB on Federal News Radio

AFSPA's CEO, Paula S. Jakub, RHU discusses Wellness in the FEHB on Federal News Radio

On Monday, June 18, 2018, Paula S. Jakub, RHU, CEO of AFSPA, sponsor of the Foreign Service Benefit Plan (FSBP), was featured as a guest on the "For Your Benefit" show on Federal News Radio. She talked about Population Health and Wellness in the FEHB Program.

As healthcare becomes more complex and expensive, the FEHB Program offers programs that help get enrollees healthy and keep them healthy.  Paula is a Subject Matter Expert in Federal Health Insurance and serves on the adjunct faculty of the Foreign Service Institute.

Paula discussed the following topics:

  • What does wellness look like?
  • OPM’s Strategic Goal for your health
  • Where to start – Consider your health plan to be a partner in your wellness
  • How to get the most out of your plan’s wellness incentives
  • Working with your chronic condition

Click here to listen to a recording of the show.

 
5Jun
From the CEO

From the CEO

Welcome to Summer 2018! By now, you should have seen the Spring AFSPA in Action Newsletter in your mailbox. It highlights some of our new 2018 Foreign Service Benefit Plan (FSBP) benefits and provides helpful Migration updates. The center spread contains a detailed website chart to assist you with navigating our most used online tools and services. This newsletter also discusses how to manage chronic conditions like back pain and diabetes. It even explains Virtual Lifestyle Management, our online nutrition and weight management program. As always, COO Kyle Longton answers some of your most difficult questions in his ongoing AFSPA Listens column. Please take the time to read your Spring Newsletter. It promises to cover a variety of topics and address many of your common concerns.

According to the American Diabetes Association, diabetes affects over 30 million Americans every day. FSBP’s new Livongo health benefit makes living with diabetes easier, at no-cost to you. We have seen a high response to this remote diabetes monitoring program. Since launching in January 2018, it has been embraced by almost 550 eligible members. This demonstrates an extremely high participation rate. Livongo provides a free monitor, test strips, and lancets to enrollees. Members also can communicate with a Certified Diabetes Educator, whenever support is needed. Click here to register or to learn more about the Livongo program.

June is National Great Outdoors Month a perfect time to get out into nature and participate in your favorite activity – hiking, biking, swimming, boating, fishing, softball, tennis, or camping. The National Safety Council has tons of information on keeping safe while exploring the great outdoors. And, if you are going to eat outdoors during these activities, please make sure to keep your food safe. Foodborne illnesses can occur when food is not handled correctly. Click here for food safety tips from the U.S. Department of Agriculture. Proper planning can ensure that you and your family stay happy, healthy, and free from harm.

Lastly, summertime usually means visiting family or looking forward to a much-needed vacation. If you are traveling this season or if family is visiting you, internationally or domestically, consider applying for AFSPA’s Travel Insurance. This plan can provide protective services and medical coverage in case anything goes wrong. AFSPA’s Travel Insurance offers benefits including: referrals to physicians and hospitals, payment for medical claims, emergency evacuation, and more. This plan is especially important for family members visiting you overseas, if their health insurance does not cover services outside the U.S. (like Medicare).  Click here to learn more about AFSPA’s Travel Insurance.

I hope you and your family enjoy a safe, healthy, and fun-filled summer. We will do our part in delivering the level of service you have come to expect. As always, thank you for your trust in us and for giving AFSPA the opportunity to serve you.

To Your Health,

Paula S. Jakub, RHU

CEO, AFSPA

Executive Director, Senior Living Foundation

 
19Jun
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Moxidectin Approved for River Blindness

On June 13, 2018, the U.S. Food and Drug Administration (FDA) approved moxidectin, an antiparasitic drug to treat onchocerciasis (river blindness) in patients aged 12 years of age and older. This tropical disease is caused by the parasitic worm, Onchocerca volvulus. Infection can result in severe inflammation of the skin, enlarged lymph nodes and, in some patients, visual disturbances that can ultimately lead to blindness. It is estimated that nearly 200 million people are at risk for the disease. While it occurs in Yemin and small areas of South and Central America, more than 99% of people infected live in sub-Saharan Africa. Recommended dosing is 8mg, administered as four 2mg tablets, as a single dose. The drug was developed by Medicines Development for Global Health, a non-profit bio-pharmaceutical company that develops medicines to address unmet needs in low- and middle-income countries. Pricing and availability are not known at this time. Full prescribing information is available here.

New Indication Approved for Venclexta

On June 8, 2018, AbbVie announced the U.S. Food and Drug Administration (FDA) approval of Venclexta® (venetoclax) for use in combination with rituximab for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy. It was approved under FDA’s breakthrough therapy and priority review programs. Venclexta is an oral B-cell lymphoma 2 (BCL-2) inhibitor that was originally approved in April 2016 for the second-line treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion, as detected by an FDA approved test. Full prescribing information is available here.

Keytruda Label Expanded

This week, the U.S. Food and Drug Administration (FDA) approved two additional indications for Keytruda® (pembrolizumab - Merck), an infused human programmed death receptor-1 (PD-1)-blocking antibody. Under its accelerated approval program, the FDA approved Keytruda to treat adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after two or more prior lines of therapy. PMBCL is a type of non-Hodgkin lymphoma. Also under accelerated approval, the FDA approved Keytruda for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 as determined by an FDA approved test. Originally approved in 2014 to treat advanced melanoma, Keytruda also has indications for several other cancer types. Full prescribing information for Keytruda is available here.

New Indication for Avastin

On June 13, 2018, Genentech announced that the U.S. Food and Drug Administration (FDA) approved Avastin® (bevacizumab) in combination with chemotherapy (carboplatin and paclitaxel), followed by Avastin as a single agent, for the treatment of women with advanced (stage III or IV) ovarian cancer following initial surgical resection. Avastin is an infused monoclonal antibody that blocks vascular endothelial growth factor (VEGF), a protein that helps tumors grow and spread. Avastin was originally approved in 2004 and is indicated to treat several different cancer types. Full prescribing information is available here.

Generic Advair Diskus Delayed

Earlier this week, Mylan announced that the company is now expecting a Complete Response Letter (CLR) for its application for generic Advair Diskus® (fluticasone propionate/salmeterol inhalation powder – GlaxoSmithKline). According to Mylan, the U.S. Food and Drug Administration (FDA) has identified “minor deficiencies” in the application that will likely result in a CRL on June 27, 2018. Once the official rejection letter is received, Mylan will provide updated guidance for possible FDA approval. Mylan also noted that because the application was previously granted a priority review, it could receive approval before the standard 90-day review period that follows resubmission of a generic application. As a result, it’s still possible for Mylan’s generic Advair Diskus to receive approval before the end of 2018. We will provide updates as soon as more information becomes available.

Carimune IVIG Nanofiltered to Be Discontinued

CSL Behring announced that the company has decided to discontinue production of Carimune® Immune Globulin Intravenous (Human), Nanofiltered, in the third quarter of 2018. This product was first introduced to the U.S. market in 1984. Since then, more advanced immune globulin options have been made available. Given the preference among healthcare professionals and patents for these newer products, the company has decided to discontinue Carimune NF, which will allow CSL Behring to dedicate more resources to its newer IVIG products.

Generics to Suboxone Sublingual Film Approved

On June 14, 2018, the U.S. Food and Drug Administration (FDA) approved the first AB-rated generics to Indivior’s Suboxone® (buprenorphine and naloxone) sublingual (SL) film (CIII), a product approved for the maintenance treatment of opioid dependence. Two manufacturers, Dr. Reddy’s and Mylan, announced approval of their generics. Dr. Reddy’s also announced plans for an “at risk” launch.

 
12Jun
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Extended Indication for Alimta

On June 4, 2018, the U.S. Food and Drug Administration (FDA) fully approved Alimta® (pemetrexed for injection) as first-line treatment of patients who have metastatic nonsquamous non-small cell lung cancer (NSCLC). It is approved for use along with Keytruda® (pembrolizumab - Merck) and carboplatin in a regimen called “triplet therapy”. Although Keytruda is a PD-L1 inhibitor, the three drugs work together whether or not the cancer expresses PD-L1. The combination had been given accelerated approval in May 2017. Results of a continuing clinical study, KEYNOTE-021, Cohort G1, confirmed that both overall response and progression-free survival were improved for the patients receiving triplet therapy as compared to those receiving only Alimta and carboplatin. For the new indication, Alimta is given as a 10-minute intravenous (IV) infusion of 500mg/m2 on the first day of each 21-day treatment cycle. Up to four cycles of triplet therapy may be administered and they may be followed by maintenance doses of Alimta alone or Alimta with Keytruda. When they are used on the same day, Alimta should be given after Keytruda, but before carboplatin. Full prescribing information for Alimta is available here.

Leukine Approved to Treat Acute Radiation Sickness

In a press release dated June 6, 2018, Partner Therapeutics announced that Leukine® (sargramostim) has been approved by the U.S. Food and Drug Administration (FDA) as treatment for Hematopoietic Syndrome of Acute Radiation Syndrome (exposure to radiation that suppresses bone marrow). Since exposing humans to radiation is unethical, the approval is based on studies in laboratory animals. A human granulocyte-macrophage colony stimulating factor (GM-CSF), Leukine has been on the U.S. market nearly 30 years with indications in oncology and transplants. Recommended adult dosing is 7mcg/Kg/day given as a subcutaneous (SC) injection. It can be used for patients of any age, including infants. Treatment can start as late as 48 hours after the exposure to radiation and still be effective. Updated prescribing information for Leukine is available here.

Rituxan Approved to Treat Pemphigus Vulgaris

On June 7, 2018, Genentech announced that the U.S. Food and Drug Administration (FDA) approved Rituxan® (rituximab) for the treatment of adults with moderate to severe pemphigus vulgaris (PV). PV is an autoimmune disease that affects between 30,000 and 40,000 Americans. It is a painful and potentially life-threatening condition that is associated with progressive blistering of the skin and mucous membranes. Rituxan is a CD20-directed monoclonal antibody that is also approved to treat certain patients with non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis. The recommended dose for PV is two 1000 mg IV infusions separated by 2 weeks in combination with a tapering course of glucocorticoids, then a 500mg IV infusion at month 12 and every 6 months thereafter or based on clinical evaluation. Full prescribing information is available here.

 
6Jun
Express Scripts News Flash

Express Scripts News Flash

Fulphila, Biosimilar for Neulasta, Approved

The U.S. Food and Drug Administration (FDA) approved Fulphila™ (pegfilgrastim-jmdb – Mylan/Biocon) on June 4, 2018. The first biosimilar for Neulasta® (pegfilgrastim - Amgen) to be approved in the U.S. It is indicated to decrease the risk of infections for patients who are receiving cancer drugs that interfere with the bone marrow’s production of blood cells and that are associated with a clinically significant incidence of febrile neutropenia. Fulphila will be given as one subcutaneous (SC) dose during each round of chemotherapy (chemo). It is administered at least one day after chemo is completed and at least 14 days before the next treatment. Its complete prescribing information is available here.

  • Brand (Generic) Name: Fulphila™ (pegfilgrastim-jmdb)
  • Manufacturer: Mylan/Biocon
  • Date Approved: June 4, 2018
  • Indication: to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
  • Dosage Forms Available: single-use, prefilled syringes containing 6mg/0.6mL
  • Launch Date: Mylan anticipates launching Fulphila in the coming weeks.
  • Estimated Annual Cost: Pricing information is not yet available.
  • Specialty Status: Fulphila will be added to Express Scripts’ specialty drug list.
  • Febrile neutropenia is an adverse effect of some chemotherapy (chemo). The drugs that kill cancer cells also destroy normal cells, including neutrophils. As a result, infections are more likely and usually more serious among cancer patients receiving chemo.
  • Symptoms of febrile neutropenia include a fever of about 100 degrees and a neutrophil count of under 500/mm3 (normal values are between 1,500/mm3 and 8,000/mm3).
  • Although multiple variables are involved in febrile neutropenia, an estimated 60,000 Americans being treated for cancer develop it annually.
  • Pegfilgrastim is a PEGylated form of the granulocyte colony-stimulating factor (G-CSF) analog filgrastim, giving it a longer duration of action. G-CSF causes cells in bone marrow to produce more neutrophils – white blood cells that protect against infections.
  • Fulphila is not interchangeable with Neulasta. However, the two products have no clinically significant differences in safety, purity or effectiveness.
  • Coherus has a biosimilar version of Neulasta under FDA review with an FDA Action Date of Nov. 3, 2018.
  • According to IQVIA, U.S. annual sales of Neulasta were approximately $4.3 billion in 2017.
 
4Jun
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Imvexxy Approved to Relieve Symptoms of Menopause

On May 29, 2018, the U.S. Food and Drug Administration (FDA) approved Imvexxy™ (estradiol vaginal inserts), which is made by TherapeuticsMD, Inc. The applicator-free inserts provide low doses (either 4mcg or 10mcg) of estradiol to treat moderate-to-severe dyspareunia (vaginal pain associated with sexual activity) that is caused by vaginal dryness and thinness after menopause. Recommended dosing is one insert daily for 14 days, then one insert twice a week thereafter. Launch will be in July at a price similar to the cost of vaginal estradiol products that currently are available on the U.S. market. Labeling for Imvexxy carries boxed warnings that are common to all estrogens, which includes an increased risk of breast or endometrial cancers, blood clots or strokes. When used along with a progestin, they may also contribute to cardiovascular (CV) conditions and possibly to dementia. Express Scripts is currently investigating the data around Imvexxy for a possible utilization management strategy. It also will be evaluated for exclude at launch on the Express Scripts National Preferred Formulary (NPF). Imvexxy’s complete prescribing information is available here.

Combination Drug Approved to Treat Osteoarthritis Pain and High Blood Pressure

Kitov Pharmaceuticals received U.S. Food and Drug Administration (FDA) approval on May 31, 2018, for Consensi™, which combines 2.5mg, 5mg or 10mg of the calcium channel blocker, amlodipine, with 200mg of celecoxib, a cyclooxygenase-2 (COX-2) inhibiting non-steroidal anti-inflammatory drug (NSAID). It will be taken one time a day to treat both high blood pressure and pain caused by osteoarthritis. The amlodipine component lowers blood pressure. NSAIDs have a boxed warning that they may cause potentially serious CV and/or gastrointestinal (GI) side effects. Presently, no launch or pricing plans have been announced. Express Scripts is currently investigating the data around Consensi for a possible utilization management strategy. It also will be evaluated for exclude at launch on the Express Scripts National Preferred Formulary (NPF). Prescribing information is available here.

Cimzia Approved for Psoriasis

The U.S. Food and Drug Administration (FDA) has approved an additional indication for UCB’s pegylated tumor necrosis factor (TNF) inhibitor, Cimzia® (certolizumab pegol). On May 24, 2018, its use was expanded to treat moderate-to-severe plaque psoriasis for adults who are eligible for phototherapy or systemic treatments. In three phase III clinical trials that involved more than one thousand patients, Cimzia showed effectiveness both for patients who had not used a biological therapy before and also for those who had. Recommended dosing is two subcutaneous (SC) injections of 200mg each, given at the same time, once every 14 days. Cimzia is already approved for several other inflammatory conditions, including ankylosing spondylitis (AS), Crohn's disease, psoriatic arthritis (PsA) and rheumatoid arthritis (RA). All drugs in the TNF inhibitor class carry a boxed warning that using them may raise the risk of serious infections, including tuberculosis. If used by children, the risk of lymphoma and other cancers may go up, as well. Prescribing information is available here.

Ulcerative Colitis Indication for Xeljanz

Pfizer’s Xeljanz® (tofacitinib) was U.S. Food and Drug Administration (FDA) approved on May 30, 2018, to treat adult patients who have moderate-to-severe forms of ulcerative colitis (UC). It is an inflammatory condition believed to affect about 900,000 Americans. Xeljanz, known as a Janus kinase (JAK) inhibitor, blocks JAK pathways that relay inflammatory signals within cells. Originally approved in November 2012, Xeljanz also has indications for PsA and RA. Its labeling includes a boxed warning about its potential risk of causing serious infections and cancers. Treatment with Xeljanz may also increase cholesterol levels, increase liver enzymes and decrease blood counts. To inform healthcare providers and patients about the serious risks associated with Xeljanz, it is dispensed under a risk evaluation and mitigation strategy (REMS) and with a Medication Guide. Updated prescribing information is available here.

Olumiant Approved for Rheumatoid Arthritis

Olumiant® (baricitinib), a Janus kinase (JAK) inhibitor, was approved by the U.S. Food and Drug Administration (FDA) on June 1, 2018. It is indicated to treat adults who have moderately to severely active rheumatoid arthritis (RA) that has not been well managed by treatment with one or more tumor necrosis factor (TNF) inhibitors. Recommended dosing is one tablet daily either alone or along with a non-biologic disease-modifying anti-rheumatic drug (DMARD), such as methotrexate. Lilly plans to launch Olumiant by the end of June. Full prescribing information is available here.

Taytulla Recall

One lot (number 5620706) of Taytulla® (norethindrone/ethinyl estradiol/ferrous fumarate) was recalled by the manufacturer, Allergan, on May 29, 2018. The four inactive capsules incorrectly were placed at the beginning of the packs instead of at the end. Taking the oral contraceptive out of order could fail to prevent a pregnancy. The recalled capsules were not sold in pharmacies, however. They all are samples that were distributed only through physician offices and clinics. Individuals who have questions about the recall should contact their physicians or they can call Allergan at 800.678.1605 on weekdays from 8 a.m. to 8 p.m. Eastern.

Kynamro Discontinued

Because Kastle Therapeutics is closing in mid-June, sales of its high cholesterol drug, Kynamro® (mipomersen), ended on May 31, 2018. Kynamro,  an oligonucleotide inhibitor of apolipoprotein B-100 synthesis, was FDA approved in 2013 to reduce low density lipoprotein-cholesterol (LDL-C), apolipoprotein B (apoB), total cholesterol (TC) and non-high density lipoprotein-cholesterol (non-HDL-C) for patients who have homozygous familial hypercholesterolemia (HoFH). Patients who used Kynamro are being moved to alternative therapies.

 
1Jun

AFSPA is Currently Experiencing Technical Difficulties

Dear Valued Members,

Please be advised we are currently experiencing technical difficulties with our systems. We are working to restore services as soon as possible. 

Thank you for your patience and we apologize for any inconvenience.


Thank you,
Kyle Longton
COO

 
31May

STATE OF EMERGENCY DUE TO SEVERE STORMS AND FLOODING IN MARYLAND

The Governor of Maryland has declared a State of Emergency due to Severe Storms and Flooding.

Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an Emergency Access to Benefits/Refill Too Soon override that allows pharmacies, at the point of sale (POS), to override certain benefit coverage/edits such as an early refill during a government-defined emergency. In addition, if your home delivery of medications is affected by the emergency, you may provide a temporary alternate address (either online at www.express-scripts.com or by calling 1-800-818-6717) or request a local fill as needed. The Emergency Access to Benefits/Refill Too Soon override process will be implemented with an effective date May 27, 2018 and expiration date of June 26, 2018.

 
30May
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

New Potassium-Lowering Agent Approved

On May 18, 2018, the U.S. Food and Drug Administration (FDA) approved AstraZeneca’s Lokelma™ (sodium zirconium cyclosilicate) for oral suspension to treat adults who have hyperkalemia (blood potassium levels of 5 mEq/L or higher). Hyperkalemia is associated with chronic kidney disease, diabetes, heart failure and the use of certain heart medications. Lokelma sticks to potassium and, since it cannot be absorbed by the body, pulls potassium out with it. In a clinical trial, potassium levels returned to normal ranges within 48 hours for 92% of the patients treated with Lokelma (previously known as ZS-9). Recommended initial dosing is 10Gm three times a day until potassium levels normalize, but for no longer than two days. Doses then are reduced to 10Gm once a day for maintenance of optimal potassium levels. Doses can be adjusted if potassium falls too low or begins to rise. Lokelma will be dispensed in packets containing either 5Gm or 10Gm of granules that are mixed with water for administration. Launch and pricing plans have not yet been released. Express Scripts is currently investigating the data around Lokelma for a possible utilization management strategy. It also will be evaluated for exclude at launch on the Express Scripts National Preferred Formulary (NPF). Complete prescribing information is available here.

Arnuity Ellipta Approved for Younger Children

Arnuity® Ellipta® (fluticasone furoate inhalation powder) has been U.S. Food and Drug Administration (FDA) approved for children as young as five years old. The FDA granted GlaxoSmithKline approval for the expanded indication on May 17, 2018. Arnuity Ellipta is a corticosteroid inhaler, used once daily as prophylactic therapy for asthma. For patients between the ages of five and 11 years, recommended dosing is one 50mcg inhalation per day as maintenance therapy. The recommended dose for patients 12 years of age and older is higher. Updated prescribing information is available here.

Prolia Gains New Indication

Amgen’s Prolia® (denosumab) has a new indication to treat glucocorticoid-induced osteoporosis. On May 18, 2018, the U.S. Food and Drug Administration (FDA) approved Prolia for both men and women who take a glucocorticoid and who also have had an osteoporotic fracture, have multiple risk factors for fracture and/or have failed on or are intolerant to other available osteoporosis treatments. It has previous indications for other types of osteoporosis, as well. Typically, glucocorticoids are used as maintenance therapy for inflammatory conditions such as asthma and rheumatoid arthritis (RA). They cause bones to become thin and fragile, however; resulting in fractures for a high percentage of patients who need long-term therapy with them. Prolia blocks key components of the bone resorption process, thereby helping to strengthen bones. Its recommended dosing is one 60mg subcutaneous (SC) injection given by a healthcare provider twice a year. Additionally, patients should take calcium and vitamin D supplements, daily. A Medication Guide for patients warns that Prolia may have some major adverse effects, including serious allergic reactions, low blood calcium levels, infections and erosion of the jawbone. Prescribing information is available here.
 

Palynziq Approved for Phenylketonuria

BioMarin Pharmaceuticals received approval from the U.S. Food and Drug Administration (FDA) on May 24, 2018, for Palynziq™ (pegvaliase-pqpz). It is indicated to lower blood levels of phenylalanine (Phe) for adult patients who have phenylketonuria (PKU). A rare, inherited disorder, PKU affects approximately 20,000 Americans, who lack the specific enzyme that processes Phe. Palynziq, the first drug to treat the cause of PKU, is a pegylated synthetic replacement for the missing enzyme. Recommended dosing is 2.5mg given subcutaneously (SC) once a week for four weeks, then raised gradually over five weeks or longer to a maintenance dose of 20mg once a day. Some patients may need to use 40mg/day, if Phe levels are not reduced adequately. Due to the chance that Palynziq may cause anaphylaxis (severe allergic responses), it has both a boxed warning and a risk evaluation and management strategy (REMS). It is expected to be available by the end of June through a limited network of specialty pharmacies that includes Accredo. Prescribing information is available here

 
24May
Express Scripts News Flash

Express Scripts News Flash

Yonsa Approved for Prostate Cancer

Sun Pharma’s Yonsa® (abiraterone acetate) was approved by the U.S. Food and Drug Administration (FDA) on May 22, 2018, to treat patients who have metastatic castration-resistant prostate cancer. It will be used along with methylprednisolone. Recommended dosing is 500mg, administered as four 125mg tablets, once daily in combination with methylprednisolone 4mg administered orally twice daily. Launch and pricing plans have not yet been announced. Yonsa will be available through open distribution; therefore, Accredo will have access. Complete prescribing information is available here.

  • Brand (Generic) Name: Yonsa® (abiraterone acetate)
  • Manufacturer: Sun Pharma
  • Date Approved: May 22, 2018
  • Indication: Metastatic castration-resistant prostate cancer
  • Dosage Forms Available: 125mg tablet
  • Launch Date: Launch date isn’t known at this time.
  • Estimated Annual Cost: Pricing information is not known at this time.
  • Specialty Status: Yonsa will be added to Express Scripts’ specialty drug list.
  • The National Cancer Institute (NCI) estimates that about 161,000 new cases of prostate cancer are diagnosed annually in the U.S., with up to 20% of them resistant to surgical or chemically induced castration.
  • Approximately 90% of patients with castration-resistant prostate cancer eventually will develop metastases in their bones.
  • Yonsa inhibits CYP17, an enzyme found in prostate tumors and needed for the production of androgens. Blocking CYP17 lowers levels of testosterone.
  • As the brand Zytiga® (Janssen Biotech), abiraterone acetate has been FDA approved to treat metastatic prostate cancer since 2011. However, Yonsa’s manufacturing uses SoluMatrix Fine Particle Technology, a proprietary process that results in much smaller particles of drug that can be given in lower doses. It was approved as a new drug that will be marketed as a branded product.
  • In the STARR and STARR-E clinical trials, patients taking methylprednisolone and Yonsa at half the dose of abiraterone acetate had similar results for effectiveness and safety as study participants who took prednisone and Zytiga.

Implications: Express Scripts currently is investigating the data around Yonsa for a possible utilization management strategy. It also will be evaluated for exclude at launch on the Express Scripts National Preferred Formulary (NPF).

 
22May
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Generic Launched for Welchol Tablets

On May 16, 2018, Amneal Pharmaceuticals announced the launch of its AB-rated generic to Welchol® (colesevelam) 625mg tablets. It is a bile acid sequestrant approved to treat high blood cholesterol. Shortly after, Sun announced the launch of an authorized generic to compete in the market. The recommended dose is six tablets taken all at once or three tablets twice daily. Doses should be taken at the same time as a meal and with a full glass of water or other beverage. The powdered form of Welchol currently remains brand-only. According to IQVIA, sales for Welchol were approximately $526 million for the 12 months ending February 2018. 

Briviact Gains Pediatric Indication

Oral forms of Briviact® (brivaracetam – UCB) were approved by the U.S. Food and Drug Administration (FDA) on May 10, 2018, to treat partial-onset seizures for patients who are at least four years old. It can be used alone or in combination with other epilepsy drugs. According to the Centers for Disease Control and Prevention (CDC) about 470,000 children and teens in the U.S. have some form of epilepsy, with around 60% of all patients with epilepsy having the partial-onset type. Also called focal seizures, partial-onset seizures begin in only one area of the brain and they usually last just a few minutes. Dosing of Briviact for patients up to the age of 16 years is based on their body weight. Doses are taken, either as oral solution or tablets, twice a day and patients can start on the recommended dose right away -- gradually increasing the dose is not needed. Tapering down the dose when patients stop taking the drug is necessary, though. A Medication Guide that accompanies each Briviact prescription warns that patients taking it may have suicidal thoughts, mood shifts, fatigue or other side effects. Complete prescribing information is available here.

Approval Expanded for Gilenya

Novartis received priority and breakthrough approval from the U.S. Food and Drug Administration (FDA) on May 11, 2018, for Gilenya® (fingolimod) to treat children as young as 10 years old. Gilenya is an oral, disease-modifying drug indicated for treating relapsing forms of multiple sclerosis (MS). The drug is a sphingosine 1-phosphate receptor modulator, which keeps white blood cells from reaching the central nervous system (CNS) where they could damage myelin, the protective covering around nerve fibers. Even though most cases of MS are diagnosed among young adults, between 20 and 40 years of age, the National MS Society estimates that between 8,000 and 10,000 American children have it. In general, MS progresses more slowly among children and teens. However, they may have more relapses than adults do. Recommended dosing for patients weighing at least 40Kg (88 pounds) is one 0.5mg capsule daily. Patients who weigh less should take 0.25mg per day. A Medication Guide given to patients outlines the side effects that may be associated with taking Gilenya. They include slow heart rate, higher risk of infections and vision problems. Full prescribing information is available here.

Extended Indication for Truvada

The U.S. Food and Drug Administration (FDA) approved Gilead’s Truvada® (emtricitabine/tenofovir disoproxil fumarate) on May 15, 2018, as pre-exposure prophylaxis (PrEP) for teens who are at risk for acquiring HIV-1 and who weigh at least 35 Kg (77 pounds). The company sought the expanded indication based on a study from the Centers for Disease Control and Prevention (CDC), which found young adults between 13 and 24 years of age made up 21% of new HIV infection cases in 2016. In the company’s trial conducted by the Adolescent Medicine Trials Network for HIV/AIDS, which included young men who have sex with men 15 to 17 years of age, once daily PrEP with Truvada demonstrated a similar safety profile as in the adult Truvada trials. The labeling does carry boxed warnings that patients taking Truvada to prevent HIV-1 must be tested as negative for the virus before treatment starts and at least once every three months during therapy. Additionally, discontinuing it may rekindle the hepatitis B virus for patients who have or have had hepatitis B. A Medication Guide describing its use and potential side effects will be dispensed to every patient who receives a Truvada prescription. Updated prescribing information is available here.

Aimovig Approved for Migraine Prevention

On May 17, 2018, the U.S. Food and Drug Administration (FDA) approved Amgen and Novartis’ Aimovig™ (erenumab-aooe), a calcitonin gene-related peptide (CGRP) inhibitor for the preventive treatment of migraine in adults. The recommended dose is 70mg, as a self-administered subcutaneous (SC) injection, once monthly. Some patients may benefit from monthly doses of 140mg administered as two consecutive SC injections of 70mg each. Amgen and Novartis plan to launch Aimovig within one week. Complete prescribing information is available here

Lucemyra Approved to Alleviate Opioid Withdrawal Symptoms

Under a priority review and a fast track designation, US WorldMeds received U.S. Food and Drug Administration (FDA) approval on May 16, 2018, for Lucemyra™ (lofexidine). Indicated to lessen the symptoms of opioid withdrawal for adults who stop taking opioids, it should be integrated into a comprehensive treatment plan that also includes behavioral components. A centrally acting alpha-2 adrenergic agonist, it is the first non-opioid drug to be FDA approved for managing withdrawal. Recommended dosing is three tablets taken every five to six hours each day for about a week and then tapered down as symptom severity decreases. No more than 16 tablets should be taken in any 24-hour period and Lucemyra should not be used for longer than two weeks. US WorldMeds plans to launch Lucemyra in August. Complete prescribing information is available here.   

 

 

 
14May
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Bowel Cleanser Plenvu Approved 

Valeant Pharmaceuticals announced that its subsidiary, Salix, received U.S. Food and Drug Administration (FDA) approval for Plenvu® (polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride and potassium chloride for oral solution) on May 4, 2018. Used to prepare the bowels for colonoscopies, Plenvu requires less active solution (one liter or slightly over one quart) per dose compared to other bowel prep products that need larger volumes to work. The patient still must drink an equal amount of water or other clear liquid after each dose, however. In contrast to other bowel cleansers that usually need as much as four liters to be taken at a rate of eight ounces every 15 minutes until the entire amount is consumed, Plenvu is separated into two doses that are dispensed in three packets to be mixed with water and taken in order. The first can be used between 4 p.m. and 8 p.m. on the day before the colonoscopy or it can be taken the morning of the procedure. The remaining two packets are mixed together in one liter of water to be used between two hours and 12 hours after the first. Plenvu and all other fluids must be finished at least two hours before the colonoscopy is scheduled. Patients can drink water or other clear fluids (such as broth) after each dose of Plenvu; but they should not eat food or drink alcohol, milk or colored beverages once Plenvu is started. Salix plans to launch Plenvu in the U.S. during the third quarter of 2018. Although pricing is not yet available, prescribing information is available here.

Combination of Drugs Approved for Treating Overactive Bladder 

According to Astellas Pharma, two of its drugs, Myrbetriq® (mirabegron) and VESIcare® (solifenacin), were U.S. Food and Drug Administration (FDA) approved in late April 2018, to be used in combination to treat overactive bladder (OAB). Although each already is indicated as a single agent for OAB, they work in different ways. Myrbetriq eases tone in the bladder’s detrusor muscle, allowing more urine to be stored. VESIcare helps prevent incidents of incontinence and urinary urgency by keeping the bladder from contracting suddenly. Three clinical studies included over 10,000 patients who had OAB for at least three months, urinated an average of at least eight times per day and experienced incontinence three times or more per week. Combination therapy resulted in better control across all three parameters than placebo or either drug alone. Recommended once-daily dosing is one 25mg or 50mg extended-release tablet for Myrbetriq and one 5mg or 10mg tablet for VESIcare. Prescribing information for Myrbetriq is available here. VESIcare’s prescribing information is available here.

Lyrica Indication Expanded

On May 3, 2018, the U.S. Food and Drug Administration (FDA) approved the use of Lyrica® (pregabalin) as adjunctive treatment for patients as young as four years old who have partial onset seizures. Lyrica has prior indications for various types of pain, including fibromyalgia and postherpetic neuralgia, and it previously was approved to treat seizures among adults. Doses for pediatric patients (up to 17 years of age) are based on the patient’s weight and they are spread over two or three times daily. Because Lyrica may cause side effects that include allergic reactions, dizziness, suicidal thoughts or swelling, it is dispensed with a Medication Guide for patients and caregivers. Prescribing information is available here.

New Indication for Darzalex

Darzalex® (daratumumab), a human IgG1k monoclonal antibody marketed by Janssen Biotech, was given a new indication by the U.S. Food and Drug Administration (FDA) on May 7, 2018. Together with Velcade® (bortezomib - Takeda), melphalan and prednisone (VMP), it is approved as initial treatment for patients who are newly diagnosed with multiple myeloma, but who are not appropriate candidates for autologous stem cell transplants. Treatment with VMP will be for nine 42-day cycles in combination with Darzalex, followed by Darzalex alone. In the phase III ALCYONE study, patients received 16mg/Kg of Darzalex every week for the first cycle, once every three weeks for eight additional cycles; then as a single agent once a month until it no longer kept the cancer from getting worse. Revised prescribing information is available here.

 
8May
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Andexxa Approved to Reverse Anticoagulation

Portola Pharmaceuticals’ Andexxa® [coagulation factor Xa (recombinant), inactivated-zhzo] was approved by the U.S. Food and Drug Administration (FDA) on May 3, 2018. It is the first drug indicated to reverse anticoagulation effects of the direct factor Xa inhibitors, Eliquis® (apixaban – Bristol-Myers Squibb) and Xarelto® (rivaroxaban – Janssen), when patients have bleeding that cannot be controlled or that is life-threatening. It will be infused intravenously (IV) as a 400mg or 800mg dose targeted to 30mg/minute and then followed by 4mg/minute or 8mg/minute infusions for as long as two hours. In two clinical studies, Andexxa (also known as andexanet alfa) restored an average of at least 90% of normal coagulation for patients who received it. A boxed warning on its label cautions that it may cause blood clots, strokes, heart failure or death. Andexxa received accelerated approval, orphan drug status and a breakthrough therapy designation from the FDA. Its full approval depends on the results of a post-marketing study scheduled to end in 2023. Launch will be in two phases, with a small initial release in early June and wider distribution planned for early in 2019 after the FDA approves manufacturing changes. Andexxa will be evaluated for the “Exclude at Launch” program of the National Preferred Formulary (NPF). Its prescribing information is available here

New Indications for Tafinlar and Mekinist

In the past few days, the U.S. Food and Drug Administration (FDA) has approved the Novartis drugs, Tafinlar® (dabrafenib) and Mekinist® (trametinib), to treat two different types of cancer that have mutations in the same gene, BRAF V600. Although both Mekinist and Tafinlar are kinase inhibitors, they affect different parts of the same pathway. The first new indication, granted on April 30, 2018, is to treat melanoma that has tested positive for a BRAF V600 mutation, that has involved lymph nodes and that has been completely removed. In the phase III COMBI-AD study, melanoma patients taking the drugs had a 53% lower chance of relapse or death than those taking placebos. The second new indication, as the first treatment for inoperable or metastatic anaplastic thyroid cancer (ATC), was approved on May 4. ATC is a rare, but aggressive, cancer with average expected survival of only five to twelve months at diagnosis. In a trial for ATC patients, more than one-half of those treated with the drug combination had at least partial shrinkage of their thyroid tumors. Some tumors disappeared completely and others remained at the same size for six months or longer. Both approvals were as breakthrough therapies and under priority reviews. For ATC, Tafinlar/Mekinist therapy has Orphan Drug status, as well. Recommended dosing for Mekinist is 2mg once a day; for Tafinlar, it is 150mg (two 75mg capsules) twice a day. They can be used separately, but together, they have previous indications for metastatic forms of BRAF V600-mutated melanoma and non-small cell lung cancer (NSCLC). Tafinlar is dispensed with a medication guide due to the possibility that taking it may cause other types of cancer, including cutaneous squamous cell carcinoma. Prescribing information for both drugs is available here.   

Kymriah Receives New Indication

Kymriah™ (tisagenlecleucel) suspension for IV infusion was U.S. Food and Drug Administration (FDA) approved on April 30, 2018, to treat adults who have large B-cell lymphoma that has relapsed or recurred despite being treated two or more times. Specifically, it now is indicated to treat high grade B-cell lymphoma, diffuse large B-cell lymphoma (DLBCL) and DLBCL arising from follicular lymphoma (FL). Kite Pharma’s Yescarta™ (axicabtagene ciloleucel) was approved last October with similar indications. Novartis plans to set the wholesale acquisition cost (WAC) for the adult dose of Kymriah at $373,000, the same as Yescarta’s list price and about $100,000 lower than the WAC for Kymriah’s acute lymphoblastic leukemia (ALL) indication. A chimeric antigen receptor T cell (CAR-T) therapy, Kymriah originally was approved on August 30, 2017, for treating patients under the age of 25 years who have B-cell ALL that has relapsed at least two times or that no longer responds to standard treatments. It is administered as a one-time infusion at a certified treatment center that has staff members trained to give it and to recognize its possible side effects. Adverse events, such as acute kidney injury, bleeding episodes, encephalopathy; and/or cytokine release syndrome (CRS), which is an overreaction to T-cell activation, may be associated with Kymriah infusions. Because some may be fatal, labeling carries a boxed warning and Kymriah also has a risk evaluation and mitigation strategy (REMS). Revised prescribing information is available here

 
4May
From the CEO

From the CEO

Greetings and welcome to May 2018! I can’t believe we already are in the second quarter of 2018. The first quarter was a rough one with all the Migration related challenges. However, the processing time for claims is starting to improve as we become more familiar with new system. 

Here are some domestic numbers from the first quarter:

  • 81.3% of domestic claims were processed within 15 days
  • 99% of domestic claims were processed within 30 days

Foreign claims took a bigger hit due to extensive quality checks:

  • 40.8% of foreign claims were processed within 15 days
  • 90% of foreign claims were processed within 30 days

However, if your claim was either delayed or processed incorrectly, these numbers mean nothing to you. And, you had every reason to be disappointed. Thank you for your patience as we continue to adapt to the new system. We hope to return to our normal 10 to 15-day average processing time by early summer.

Several health-related themes are highlighted in May – Women’s Health Month, Mental Health Awareness Month, and High Blood Pressure Awareness Month. The Foreign Service Benefit Plan (FSBP) provides excellent benefits and programs that focus on all three of these conditions and more. Here is a quick overview of our related services:

Women’s Health

  • Well woman care based on current recommendations
  • Breast and cervical cancer screenings
  • Healthy Pregnancy Program
  • Express Scripts Specialist Pharmacists are specially educated and trained in women’s health issues. They stand ready to help you with any questions about medicines, at no cost to you. To learn more about women’s health and other medical conditions (asthma, diabetes, etc.), call ESI at 800.818.6717 and ask for a specialist pharmacist. 

See pages 35 – 40 of the 2018 FSBP brochure for details.

Mental Health

  • One-on-one health coaching and digital coaching programs
  • myStrength™- on-line mental health support program
  • AbleTo – on-line treatment support program
  • Telehealth video visits through Amwell for members in the U.S.
  • Special Teleheath consultation benefit for members outside the U.S.

See Section 5(e) of the 2018 FSBP brochure for details.

High Blood Pressure 

High Blood Pressure Education Month encourages people to look at various lifestyle factors which may be contributing to high blood pressure. Lifestyle changes can help reduce blood pressure such as: maintaining a healthy body weight (check the BMI Calculator), regular exercise, quitting smoking, and following a healthy low sodium diet rich in fruit and vegetables. FSBP programs include:

  • One-on-one health coaching and digital coaching programs
  • Mediterranean Wellness Program
  • Virtual Lifestyle Management

Controlling Blood Pressure is one of our 15 Healthy Actions for which you can earn a Wellness Incentive. Why not start on a better path by taking the Simple Steps today?

  • Step One :    Taking your Health Risk Assessment
  • Step Two:    Getting your Biometric Screening
  • Step Three:  Controlling Your Blood Pressure (Step three can be completed at any time)

See Section 5(h) of the 2018 FSBP brochure for details.

I truly hope you enjoy your Memorial Day holiday with your family, as we remember the sacrifices of the men and women who gave their lives in service to our country. As always, thank you for being a valued member and for your continued confidence in our ability to serve you.

To Your Health,

Paula S. Jakub, RHU
CEO, AFSPA
Executive Director, Senior Living Foundation


 

 
1May
Join our 2018 Legal Considerations in the Foreign Service Webinar

Join our 2018 Legal Considerations in the Foreign Service Webinar

Legal Considerations in the Foreign Service Webinar (MQ854)
Wednesday, May 9, 2018
10:00 am ET - 11:15 am ET

The Protective Association is delighted to once again host the annual Legal Considerations Webinar with the Transition Center at the Foreign Service Institute. The mobile foreign affairs lifestyle gives rise to unique legal implications for foreign affairs  employees and their family members. We feel it is extremely important for our members to have access to quality legal service. This webinar will focus on estate planning, specifically on wills, trusts, powers of attorney, and gifting.

Guest Presenters:
Attorney Jonathan C. Kinney (bio) and Attorney Lauren Keenan Rote( bio) of the law firm Bean, Kinney and Korman.

Who May Attend:
Open to all foreign affairs agency employees (active and retired) and adult eligible family members (EFMs). There is no charge to participate.

How to Register: 
To register, please fill out the Survey Monkey registration form: https://www.surveymonkey.com/r/MQ854May2018

Questions:
For questions, please contact the Foreign Service Institute (FSI) Transition Center at [email protected]

 
1May
2018 AFSPA In Action Spring Newsletter

2018 AFSPA In Action Spring Newsletter

Hot off the press! The 2018 AFSPA In Action Spring Newsletter has been uploaded to our website. You should also expect a physical copy in your mailbox soon. Thanks for being a valued member!

 
30Apr

AFSPA is online

AFSPA is online. We apologize for the inconvenience this may have caused.

Regards,

Yancy Meiller
IT Manager

 
30Apr

AFSPA is currently experiencing technical difficulties

Dear Members,

Please be advised we are currently experiencing technical difficulties with our systems. We are working to restore services as soon as possible. 

Thank you,


Yancy Meiller
IT Manager

 
30Apr
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

New Dosage Form for Akynzeo

The U.S. Food and Drug Administration (FDA) approved an intravenous (IV) formulation of Helsinn Healthcare’s Akynzeo® (fosnetupitant 235mg/palonosetron 0.25mg) single-dose vials on April 19, 2018. A combination of two anti-nausea agents, it is administered along with dexamethasone to prevent cancer chemotherapy (chemo)-induced nausea and vomiting (CINV). Palonosetron, first approved as Aloxi™ injection in 2008, is a serotonin-3 (5-HT3) receptor antagonist. It prevents CINV during the acute phase, which is within the first 24 hours after chemo is started. Fosnetupitant dissociates into netupitant, a drug in the substance P/neurokinin 1 (NK1) receptor antagonist class. It also prevents acute CINV, but it continues working for up to five days to prevent delayed phase CINV, as well. Akynzeo also is available as oral capsules. Recommended dosage for the IV form is one vial mixed with 50mL of fluid and given over one-half hour before the start of each chemo treatment. It will be launched in May, but pricing for the new form has not yet been released. Prescribing information is available here.

Extended Indication for Trelegy Ellipta

On April 24, 2018, the original indication for Trelegy™ Ellipta®, the first inhaler to include three medications for maintenance treatment of chronic obstructive pulmonary disease (COPD) was expanded by the U.S. Food and Drug Administration (FDA). Jointly developed by GlaxoSmithKline and Innoviva, it contains a corticosteroid (fluticasone furoate), a long-acting muscarinic antagonist (umeclidinium) and a long-acting beta2-adrenergic agonist (vilanterol) in a dry-powder inhaler. Trelegy Ellipta originally was indicated for patients who already were using some of the included drugs, but who needed additional control of airway obstruction or worsening COPD. While it cannot be used to treat acute attacks of COPD, it is now approved to help relieve worsening COPD and airway obstruction associated with the condition. Dosing is once daily. Like other products that contain a beta2-agonist such as vilanterol, the labeling includes a boxed warning that Trelegy Ellipta may increase the chances of death if it is used by an asthma patient. Complete prescribing information is available here

 

 
27Apr
Express Scripts News Flash

Express Scripts News Flash

On April 23, 2018, the U.S. Food and Drug Administration (FDA) approved Otsuka Pharmaceutical’s Jynarque™ (tolvaptan) tablets to slow the decline in kidney function for adults who are at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD). An inherited condition, ADPKD, which affects about 140,000 Americans, involves the development and enlargement of cysts in the kidneys. It leads to end-stage renal disease, dialysis and/or kidney transplants. Jynarque, the first drug approved to treat it, will be taken orally twice a day. Recommended initial dosing is 45mg each morning and 15mg eight hours later. Doses are increased weekly to 60mg/30mg and then to a maintenance dose of 90mg/30mg. Jynarque will be available to patients in late May, but its distribution will be limited through a risk evaluation and mitigation strategies (REMS) program because it may cause liver damage. Accredo will not have access to Jynarque. Prescribing information is available here.

  • Brand (Generic) Name: Jynarque™ (tolvaptan)
  • Manufacturer: Otsuka Pharmaceutical Co
  • Date Approved: April 23, 2018
  • Indication: to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD).
  • Dosage Forms Available: 7-day and 28-day blister packages of 15mg and 45mg, 30mg and 60mg or 30mg and 90mg tablets
  • Launch Date: Late May 2018
  • Estimated Annual Cost: The wholesale acquisition cost (WAC) for a 28-day dose pack is $13,041.10
  • Specialty Status: Jynarque will be added to Express Scripts’ specialty drug list.
  • Autosomal dominant polycystic kidney disease (ADPKD) is an inherited disorder that causes the kidneys to enlarge. Cysts, which develop and expand as they fill with fluid, progressively reduce kidney function. Although the damage may be slower for some patients, eventually the kidneys fail.
  • In the United States, approximately 140,000 patients have ADPKD
  • Jynarque is a selective vasopressin V2-receptor antagonist, which also is approved under the brand-name Samsca® to treat hyponatremia (low sodium levels). Essentially, it works by decreasing the amount of fluid available in the kidneys.
  • Product labeling includes a boxed warning that Jynarque can cause severe liver damage. Liver function testing will be required before treatment begins, two weeks later, every month for 18 months and every three months after that.
 
24Apr
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Opdivo-Yervoy Combination Approved

Bristol-Myers Squibb announced on April 16, 2018, that the U.S. Food and Drug Administration (FDA) had approved two of its monoclonal antibody drugs to be used in combination for patients who have previously untreated advanced renal cell carcinoma (RCC). Opdivo® (nivolumab) is a programmed death receptor-1 (PD-1) blocker that also has numerous indications to treat melanoma and several other cancer types. Yervoy® (ipilimumab), which blocks cytotoxic T-lymphocyte antigen 4 (CTLA-4), has previous indications for melanoma. Together, they increase T-cell activity to improve anti-tumor effects against advanced RCC. In the CheckMate-214 clinical trial, 41.6% of patients using Opdivo plus Yervoy had an objective response (OR) as compared to 26.5% of patients using Sutent® (sunitinib). Objective response means that tumor size decreased by a specified amount of size for a predetermined amount of time. Sutent currently is a standard of care for the initial treatment of advanced RCC. Fewer serious adverse events were reported among patients treated with Opdivo/Yervoy than the Sutent-treated participants, as well. Recommended dosing is 1mg/Kg of Opdivo infused intravenously (IV) over 30 minutes followed by a 3mg/Kg IV infusion of Yervoy over 90 minutes. Treatments using both drugs are given once every three weeks up to four times. Then, Yervoy is discontinued and Opdivo is administered as 240mg once every two weeks or 480mg once every four weeks. Patients can stay on Opdivo therapy until they no longer tolerate its side effects or it stops working. Yervoy has a boxed warning about the possibility it may cause severe immune-related reactions that potentially could involve the intestines, liver, nerves, skin and other organs. Full prescribing information for both drugs is available here

Full FDA Approval for Praxbind

An accelerated approval, which was granted for Praxbind® (idarucizumab – Boehringer Ingelheim) in 2015, was converted by the U.S. Food and Drug Administration (FDA) to a full approval on April 12, 2018. Accelerated approvals are given to speed up availability of drugs that fill previously unmet needs. They are based on intermediate clinical trial results and fully approved only when further study results show clinical benefits. Praxbind is a reversal agent for Boehringer Ingelheim’s oral anticoagulant, Pradaxa® (dabigatran). It is used when a patient taking Pradaxa must have emergency surgery or experiences uncontrolled bleeding. The RE-VERSE AD study showed that coagulation returned to normal limits for most patients within four hours of receiving Praxbind. It is given either as two 2.5Gm IV infusions or as 5Gm injected into an IV line that is not being used for any other drugs. Praxbind is stocked at hospitals throughout the U.S. Its prescribing information is available here.

New Indication for Vonvendi

The U.S. Food and Drug Administration (FDA) approved Shire’s Vonvendi® [von Willebrand factor (recombinant)] on April 18, 2018, to manage perioperative bleeding for adult patients who have von Willebrand disease (VWD). Vonvendi was first FDA approved in 2015 to treat and control bleeding episodes for patients with VWD. Administered by IV infusion, doses are determined by the patient’s weight. For planned procedures, it is given between 24 hours and 12 hours before the surgery, blood levels are checked at about three hours before the scheduled time and additional Vonvendi is infused, if necessary. Its revised prescribing information is available here

 Tagrisso Receives New Indication

Under U.S. Food and Drug Administration's (FDA’s) priority review and breakthrough therapy programs, Tagrisso® (osimertinib - AstraZeneca) tablets were given a new indication on April 18, 2018. It was approved for first-line treatment of patients who have epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC). Before beginning treatment, patients will be verified -- through an FDA-approved diagnostic test -- to have exon 19 deletions or exon 21 L858R mutations. Tagrisso is a tyrosine kinase inhibitor (TKI) that blocks the activity of both EGFR-sensitizing and EGFR T790M-resistance mutations. It is taken as one daily 80mg dose. When compared in a clinical trial to two other TKIs, Iressa® (gefitinib) and Tarceva® (erlotinib), that also are used for initial therapy of EGFR-mutated NSCLC, Tagrisso produced better results. The average length of progression-free survival (PFS) for patients using Tagrisso was nearly twice as long as for patients using one of the other drugs (18.9 months vs. 10.2 months. A higher percentage of Tagrisso-treated patients had an OR, as well; and their responses lasted an average of 17.6 months as opposed to 9.6 months for those using a comparator drug. Complete prescribing information is available here

Generic Approved for Zavesca

Amerigen Pharmaceuticals received U.S. Food and Drug Administration (FDA) approval on April 17, 2018, for miglustat capsules, the first generic for Actelion’s Zavesca®. An inhibitor of the enzyme glucosylceramide synthase, miglustat is taken one to three times daily by patients who have type 1 Gaucher disease. Approximately 6,000 patients in the U.S. have the genetic condition, which causes the accumulation of fat molecules in the spleen, liver, bone marrow and other parts of the body. Miglustat use is limited because it can cause severe diarrhea and weight loss. Amerigen has not yet announced its launch or pricing plans, although the generic has been added to Express Scripts' drug file. According to information from Actelion, sales of Zavesca amounted to nearly $107 million in 2016.

Since Zavesca is on Express Scripts’ specialty drug list, the generic will be included as well.

Imbruvica Tablets Replacing Capsules

A tablet formulation of once-daily Imbruvica® (ibrutinib – Pharmacyclics/Janssen) was U.S. Food and Drug Administration (FDA) approved on Feb. 16, 2018. The manufacturers will discontinue the current 140mg capsule form in mid-May. Imbruvica works by blocking Bruton's tyrosine kinase (BTK), an enzyme needed by cancer to multiply and spread. Its initial FDA approval was in November 2014 to treat mantle cell lymphoma (MCL). Since then, it has gained indications for other cancer types and for graft-versus-host disease. Unlike the capsules, which were manufactured only in 70mg and 140mg strengths, Imbruvica tablets are available in 140mg, 280mg, 420mg and 560mg strengths. Although dosage differs according to the indication, most patients take one of the higher doses. Previously, they had to take more than one capsule at a time. However, doses change often and adjustments may not be as easy since the tablets are dispensed only in 28-day blister packages containing only one strength. All four strengths of Imbruvica have the same list cost. Prescribing information is available here

Olysio Discontinued

Due to a significant drop in sales, Janssen Therapeutics is withdrawing Olysio® (simeprevir) from the U.S. market. Olysio is a protease inhibitor approved in 2013 for use in combination with other antiviral drugs to treat hepatitis C. The subsequent approval and widespread adoption of more effective drugs that have less complicated dosing effectively has made Olysio obsolete. Its marketing will formally end on May 25, 2018, but supplies may be exhausted before then. Patients using it should work with their doctors to ensure that they have enough Olysio to finish the complete 12-week course of therapy.

Tavalisse Approved for Chronic Immune Thrombocytopenia

On April 17, 2018, the U.S. Food and Drug Administration (FDA) approved Rigel Pharmaceutical’s Tavalisse™ (fostamatinib disodium hexahydrate), a drug to treat thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. The recommended initial dose is 100mg taken orally twice daily. After four weeks, the dose can be increased to 150mg twice daily, if needed, to achieve a target platelet count of at least 50 x 109/L as necessary to reduce the risk of bleeding. Rigel is planning on making Tavalisse available in late May 2018. It will be available through a limited network of specialty pharmacies that does not include Accredo. Pricing plans have not yet been announced. Complete prescribing information is available here

Crysvita Approved to Treat X-linked Hypophosphatemia

On April 17, 2018, the U.S. Food and Drug Administration (FDA) approved Ultragenyx’ Crysvita® (burosumab-twza) to treat X-linked hypophosphatemia (XLH) in adults and pediatric patients 1 year of age and older. XLH is a rare inherited disease that causes low phosphorous levels in the blood. Symptoms can include rickets (weak bones), bone and tooth pain, shortness and hearing loss. Recommended initial pediatric dosing is 0.8mg/Kg (rounded to the nearest 10mg) as a subcutaneous (SC) injection once every two weeks. For adults, the dose is 1mg/Kg (rounded to the nearest 10mg) once every four weeks. The single-dose upper limit for both children and adults is 90mg. Ultragenyx plans on launching Crysvita on May 1, 2018. It will be available through a limited network of specialty pharmacies that includes Accredo. Complete prescribing information is available here.

 
16Apr
Express Scripts Clinincal News and Notes

Express Scripts Clinincal News and Notes

Second Indication Approved for Rubraca

Rubraca® (rucaparib – Clovis Oncology) was approved by the U.S. Food and Drug Administration (FDA) for an additional indication on April 6, 2018. It now can be used as maintenance treatment for recurrences of epithelial ovarian, fallopian tube or primary peritoneal cancer for patients who are in a complete or partial response to platinum-based chemotherapy. At the same time, the FDA converted to full approval of its original accelerated approval for ovarian cancer that has progressed despite at least two chemotherapy treatments and that has a deleterious BRAC genetic mutation as confirmed by an FDA-approved diagnostic test. Rubraca is an oral poly (ADP-ribose) polymerase (PARP) inhibitor that has recommended dosing of 600mg twice a day until the cancer worsens or the patient cannot take the drug any longer. It is available in 200mg, 250mg and 300mg tablets. Prescribing information is available here

Exparel Receives an Expanded Indication

On April 6, 2018, Pacira Pharmaceuticals received U.S. Food and Drug Administration (FDA) approval for a new indication of its injected local anesthetic, Exparel® (bupivacaine liposome injectable suspension). Exparel is now approved to produce postsurgical regional analgesia when given through an interscalene brachial plexus block. The brachial plexus includes the nerves in the shoulders; scalenes are muscle groups at the sides of the neck. Temporarily numbing the area stops nerve signals to the spine and lessens pain after an upper-arm surgery, such as a rotator cuff repair. For its new indication, Exparel is given as one 133mg dose (10mL), administered before the procedure as several one or two mL injections into the tissue surrounding the brachial plexus. Due to its unique formulation, it releases bupivacaine slowly, relieving pain for as long as 120 hours after injection. Exparel is not interchangeable with other injected local anesthetics, which must be injected in larger volumes or given through a catheter. Complete prescribing information for Exparel is available here

 Afinitor Disperz Approved for New Indication

A new indication was approved by the U.S. Food and Drug Administration (FDA) for Afinitor Disperz® (everolimus tablets for oral suspension - Novartis) on April 10, 2018. It is the first adjunctive therapy to treat children as young as two years old who have partial-onset seizures related to tuberous sclerosis complex (TSC). Behavioral and learning problems result, along with physical effects such as distinctive skin manifestations. Afinitor is a kinase inhibitor indicated to treat several types of cancer. The Disperz form, tablets that dissolve in small amounts of water, was first was approved in August 2012 to treat a rare brain tumor called subependymal giant cell astrocytoma (SEGA) that also is associated with TSC. Caused by a genetic mutation, TSC is a rare disease that causes non-cancerous tumors in the brain and other organs. For TSC-related seizures, recommended initial dosing for Afinitor Disperz is 5mg/m2 once a day until TSC gets worse or the drug’s side effects become too severe. Doses may have to be adjusted often after blood concentrations are checked at frequent intervals. Full prescribing information is available here

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
11Apr
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Symfi Approved for HIV

Mylan will launch Symfi™ (efavirenz 600mg/lamivudine 300mg/tenofovir disoproxil fumarate 300mg) tablets in the second quarter of 2018. Approved for once-daily treatment of HIV-1, it can be used by patients weighing 40 Kg (88 pounds) or more. A slightly different version, Symfi Lo™ (efavirenz 400mg/lamivudine 300mg/tenofovir disoproxil fumarate 300mg) tablets, was introduced in March. A third recently approved Mylan antiretroviral combination, Cimduo™ (lamivudine 300mg/tenofovir disoproxil fumarate 300mg) tablets, also is expected to be released on the U.S. market in the second quarter. All three are similar to, but not generics for, brand-name antiretrovirals. However, they will be priced at significant discounts to other branded HIV drugs. Labeling for Symfi includes a boxed warning that discontinuing the use of lamivudine or tenofovir disoproxil fumarate can activate hepatitis B virus (HBV) for patients who have or who have had HBV. Patients should be tested for HBV before, during and for several months after treatment with Symfi.  Complete prescribing information is available here.

New Indication for Bydureon

On April 2, 2018, Bydureon® (exenatide extended release) injectable suspension received approval from the U.S. Food and Drug Administration (FDA) as adjunct therapy with basal insulin. It can be used along with insulin glargine to manage type 2 diabetes for adults whose blood sugar is not controlled by other medications. In the DURATION-7 clinical study, average hemoglobin A1c (HbA1c) levels decreased by more than one-half of a percentage point for patients adding Bydureon to their insulin glargine compared to patients using a placebo and insulin glargine. Some patients in each group also took metformin. Nearly one-third of Bydureon-treated participants achieved HbA1cs at or below 7%, but only 7% of those on placebo did. Bydureon is a glucagon-like peptide-1 (GLP-1) receptor agonist that may increase the risk of hypoglycemia when used with insulin. Labeling for it includes a boxed warning for patients who have medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2), because GLP-1 agonists may cause some types of thyroid tumors. Pancreatitis also is possible during its use. Prescribing information is available here.

 
6Apr
From the CEO

From the CEO

Greetings and Welcome to April 2018! During this season of new beginnings and reflection, I feel privileged to play a role in serving more than 73,000 AFSPA members every day.

We are continuing to improve the many Migration related issues and operational challenges. I know it has caused extreme frustration and I want to extend my sincerest apologies for the delays in response times, claims payment, and overall inconvenience this migration may have caused you. We are working every day to resolve every issue. For our long-time members, you know this is not how AFSPA standardly operates. Please remain patient as we strive to return to the service levels you deserve. To our newer members, please don’t let this first impression cloud your opinion about us. I know it is not what you expected or what you were promised, but we are committed to restoring the excellent service you have heard about us from your colleagues. We are working harder than ever for the privilege to continue to serve you.

Several years ago, we moved the AFSPA Annual Member Meeting from January to March to avoid the DC area winter weather. This year’s meeting was scheduled for Friday, March 2, 2018. However, mother nature had other ideas and hit the region with a Nor’easter. This major wind storm caused the Federal government, and thus our AFSPA office, to close for the day.   Although we could not hold the onsite meeting, almost 300 members participated in the live webinar offered that day. Click here to view the recording of the Annual Meeting presentation and to learn the latest AFSPA/FSBP updates.

Since 1987, April has been designated as Alcohol Awareness Month. It is meant to increase public understanding and reduce the stigma of alcoholism. The National Council on Alcoholism and Drug Dependence, Inc. has chosen, “Changing Attitudes:  It’s not a ‘rite of passage.” as their 2018 theme. It emphasizes education on treatments and prevention of alcoholism. Youth particularly need this information. Parents play an important role in helping kids understand the impact of alcohol. FSBP offers support programs for both adults and children. Treatment services range from outpatient detoxification to Telehealth. See Section 5(e) Mental health and substance misuse disorder benefits for the 2018 FSBP Brochure for a full description of available services.

For our FSBP members living with diabetes, I want to remind you of our new program called Livongo that is available to you at no additional cost.  This is a remote diabetes monitoring program that provides support through a cellular enabled meter, mobile app and personalized interventions.  The program includes:

  • Unlimited blood glucose test strips and lancets
  • Connected glucometer
  • Real-time interventions by Certified Diabetes Educators

For more information, please refer to page 95 of the 2018 FSBP Brochure. If you would like to register for Livongo, click here or contact 800-945-4355. Registration code is FSBP.

Lastly, we are required to maintain and provide you with our Notice of Privacy Practices (NPP), which was last updated on April 1, 2017. The Notice of Privacy Practices describes the following information:

  1. How your confidential medical information (i.e., Protected Health Information [PHI]) may be used and disclosed;
  2. How you can get access to your PHI; and
  3. FSBP's responsibilities. 

Click here to review FSBP’s NPP.

It also appears:

  • On FSBP’s website footers;
  • On Member Portal;
  • On My Online Services (MOS - the shared Aetna and FSBP website);
  • In new FSBP member packets; and
  • In other FSBP member communications, where applicable.

For questions on FSBP's NPP, please call a Health Benefits Officer at 202-833-4910.

As a reminder, please look for your 2018 AFSPA in Action Spring Newsletter in your mailboxes soon. I hope you enjoy this new season of fresh starts and new beginnings. As always, thank you for your trust and for giving AFSPA the opportunity to serve you.

 

To Your Health,

Paula S. Jakub, RHU

CEO, AFSPA

Executive Director, Senior Living Foundation


 

 
3Apr
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

 

Generics Launched for Aloxi 0.25mg/5mL

Immediately after it received U.S. Food and Drug Administration (FDA) approval on March 23, 2018, Teva Pharmaceutical Industries, Inc. launched its generic for Eisai/Helsinn’s Aloxi® (palonosetron) injection for intravenous use, 0.25mg/5mL. One authorized generic and other generics have also been introduced – at least one under a settlement agreement. However, the brand co-manufacturers are considering further legal action after their patents were invalidated by a U.S. federal appeals court. Palonosetron is a 5-HT3 receptor antagonist used to prevent nausea and vomiting associated with cancer chemotherapy (chemo) and for patients undergoing surgery. It is approved for patients as young as one month old. For children and teens up to 18 years old, doses are calculated by weight. The recommended adult dose is 0.25mg through a 30-second IV infusion about one-half hour before chemo starts. A much lower dose, 0.075mg, is given right before anesthesia for patients having surgery. Single-dose vials containing 0.075mg/1.5mL remain brand-only. According to IQVIA, global sales for Aloxi 0.25mg/5mL were around $452 million during 2017.

 Toujeo Max SoloStar Approved

A larger pre-filled pen device for Toujeo® (insulin glargine 300 Units/mL) was approved by the U.S. Food and Drug Administration (FDA) on March 26, 2018. Called the Toujeo Max SoloStar®, it holds 3mL (900 units), which is twice the amount in the previously available device. Toujeo is injected subcutaneously (SC) once a day to control diabetes for adults who have either type 1 or type 2. Individual doses of Toujeo can be as high as 160 units through the Max device, as opposed to 80 units previously. Sanofi plans to introduce the larger pens in the third quarter of 2018 at the same cost as the original, smaller one. Prescribing information is available here

New Labeling Language for Tresiba

On March 26, 2018, the U.S. Food and Drug Administration (FDA) agreed that Novo Nordisk can revise the label for Tresiba® (insulin degludec). A long-acting insulin, it is used to control blood sugar levels for patients who are at least one year old. Based on results from the DEVOTE safety outcomes trial, Tresiba’s label can now indicate that it does not increase the chance of adverse cardiovascular (CV) effects compared to treatment with insulin glargine. Additionally, labeling can state that the rates of severe hypoglycemia (extremely low blood sugar) decreased by about 40% with Tresiba versus insulin glargine. Updated prescribing information for Tresiba is available here

Blincyto Gains New Indication

Using its accelerated approval process, the U.S. Food and Drug Administration (FDA) gave Blincyto® (blinatumomab - Amgen) a new leukemia indication on March 29, 2018. A bispecific CD19-directed CD3 T-cell engager, Blincyto was first FDA approved in 2014 for treating adults who have Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (ALL) that has recurred or that is no longer responding to previous treatment. Later, a pediatric indication for the same cancer also was added. Now, it is the first drug approved for treating children and adults who are in remission for the same type of ALL, but who still have cancer cells that cannot be detected through a microscope. Called minimal residual disease (MRD), even such low levels (0.1% or more) of cancer significantly raise the chance of a relapse. For MDR-ALL, Blincyto is given for one 42-day induction cycle, followed by up to three 42-day consolidation cycles. Dosing for adults is 28mcg/day of active treatment (28 continuous days) then 14 drug-free days. Doses for patients weighing less than 45 Kg (99 pounds) are determined by the patient’s body surface area. Blincyto is administered through a continuous intravenous (IV) pump in a healthcare facility. Patients should be hospitalized for at least the first three days of their first treatment cycle, and for the first two days of the second. The labeling for Blincyto contains a boxed warning about its risk of causing potentially life-threatening cytokine release syndrome (CRS) and neurologic toxicities. CRS is a systemic inflammatory response that may cause low blood pressure and difficulty breathing. Neurologic toxicities may include confusion, convulsions and encephalopathy. A Risk Evaluation and Mitigation Strategy (REMS) for Blincyto informs healthcare providers of its serious risks and also alerts them to the potential for preparation and administration errors. Its revised prescribing information is available here.

Generics Launched for Aloxi 0.25mg/5mL

Immediately after it received U.S. Food and Drug Administration (FDA) approval on March 23, 2018, Teva Pharmaceutical Industries, Inc. launched its generic for Eisai/Helsinn’s Aloxi® (palonosetron) injection for intravenous use, 0.25mg/5mL. One authorized generic and other generics have also been introduced – at least one under a settlement agreement. However, the brand co-manufacturers are considering further legal action after their patents were invalidated by a U.S. federal appeals court. Palonosetron is a 5-HT3 receptor antagonist used to prevent nausea and vomiting associated with cancer chemotherapy (chemo) and for patients undergoing surgery. It is approved for patients as young as one month old. For children and teens up to 18 years old, doses are calculated by weight. The recommended adult dose is 0.25mg through a 30-second IV infusion about one-half hour before chemo starts. A much lower dose, 0.075mg, is given right before anesthesia for patients having surgery. Single-dose vials containing 0.075mg/1.5mL remain brand-only. According to IQVIA, global sales for Aloxi 0.25mg/5mL were around $452 million during 2017.

Toujeo Max SoloStar Approved

A larger pre-filled pen device for Toujeo® (insulin glargine 300 Units/mL) was approved by the U.S. Food and Drug Administration (FDA) on March 26, 2018. Called the Toujeo Max SoloStar®, it holds 3mL (900 units), which is twice the amount in the previously available device. Toujeo is injected subcutaneously (SC) once a day to control diabetes for adults who have either type 1 or type 2. Individual doses of Toujeo can be as high as 160 units through the Max device, as opposed to 80 units previously. Sanofi plans to introduce the larger pens in the third quarter of 2018 at the same cost as the original, smaller one. Prescribing information is available here

New Labeling Language for Tresiba

On March 26, 2018, the U.S. Food and Drug Administration (FDA) agreed that Novo Nordisk can revise the label for Tresiba® (insulin degludec). A long-acting insulin, it is used to control blood sugar levels for patients who are at least one year old. Based on results from the DEVOTE safety outcomes trial, Tresiba’s label can now indicate that it does not increase the chance of adverse cardiovascular (CV) effects compared to treatment with insulin glargine. Additionally, labeling can state that the rates of severe hypoglycemia (extremely low blood sugar) decreased by about 40% with Tresiba versus insulin glargine. Updated prescribing information for Tresiba is available here

Blincyto Gains New Indication

Using its accelerated approval process, the U.S. Food and Drug Administration (FDA) gave Blincyto® (blinatumomab - Amgen) a new leukemia indication on March 29, 2018. A bispecific CD19-directed CD3 T-cell engager, Blincyto was first FDA approved in 2014 for treating adults who have Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (ALL) that has recurred or that is no longer responding to previous treatment. Later, a pediatric indication for the same cancer also was added. Now, it is the first drug approved for treating children and adults who are in remission for the same type of ALL, but who still have cancer cells that cannot be detected through a microscope. Called minimal residual disease (MRD), even such low levels (0.1% or more) of cancer significantly raise the chance of a relapse. For MDR-ALL, Blincyto is given for one 42-day induction cycle, followed by up to three 42-day consolidation cycles. Dosing for adults is 28mcg/day of active treatment (28 continuous days) then 14 drug-free days. Doses for patients weighing less than 45 Kg (99 pounds) are determined by the patient’s body surface area. Blincyto is administered through a continuous intravenous (IV) pump in a healthcare facility. Patients should be hospitalized for at least the first three days of their first treatment cycle, and for the first two days of the second. The labeling for Blincyto contains a boxed warning about its risk of causing potentially life-threatening cytokine release syndrome (CRS) and neurologic toxicities. CRS is a systemic inflammatory response that may cause low blood pressure and difficulty breathing. Neurologic toxicities may include confusion, convulsions and encephalopathy. A Risk Evaluation and Mitigation Strategy (REMS) for Blincyto informs healthcare providers of its serious risks and also alerts them to the potential for preparation and administration errors. Its revised prescribing information is available here.

 
26Mar
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

 

 

 

Fifth Indication for Adcetris

Adcetris® (brentuximab vedotin - Seattle Genetics) received approval from the U.S. Food and Drug Administration (FDA) on March 20, 2018, as initial therapy for untreated stage III or stage IV classical Hodgkin lymphoma (cHL). It will be used along with chemotherapy. Adcetris, which combines an anti-cancer drug with a monoclonal antibody, has previous indications for already treated cHL and other types of lymphomas. For its new indication, recommended dosing is 1.2 mg/Kg (up to 120mg per dose) given as 30-minute intravenous (IV) infusions. Patients are treated once every two weeks for a maximum of 12 doses. A boxed warning cautions that, although rare, using Adcetris has been associated with cases of progressive multifocal leukoencephalopathy (PML), a serious brain infection that can result in death. Revised prescribing information is available here

 New Pediatric Indications for Tasigna

The U.S. Food and Drug Administration (FDA) gave approval to Novartis’ tyrosine kinase inhibitor (TKI), Tasigna® (nilotinib), on March 22, 2018, for treating children and teens who are in chronic phase Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML). According to the National CML Society, only about 3% of pediatric leukemia patients have CML. Tasigna can be used for children at least one year old who are new to treatment, as well as for those who already have had TKI therapy that did not work or that caused unbearable side effects. Tasigna is taken orally at recommended pediatric doses of 230mg/m2 twice a day, up to a maximum of 400mg per dose. It must be taken two hours before or one hour after eating. Its label has a boxed warning that taking it has been associated with disturbances in heart rhythm and that some affected patients have died as a result. Full prescribing information is available here

Generic Launched for Norvir Tablets

On March 20, 2018, the West-Ward Pharmaceuticals subsidiary of Hikma Pharmaceuticals introduced the first AB-rated generic for Norvir® (ritonavir) tablets. Ritonavir is a protease inhibitor used in combination with other antiretroviral agents to treat HIV-1 for patients as young as one month old. Recommended dosing for adult patients who are not taking an additional protease inhibitor is 600mg (six tablets) twice a day. However, ritonavir is used more commonly and at lower doses as a booster for other drugs in the same class. West-Ward, which has 180 days of generic exclusivity in the U.S., intends to offer patient assistance and copayment programs along with Internet and written educational materials. Labeling for ritonavir carries a boxed warning that using it with several other drugs, including some treatments for angina, cardiac arrhythmias, migraines or psychoses, could result in severe side effects. No generics are available yet for Norvir capsules or oral solution. IQVIA estimates that 2017 sales of all strengths and dose forms of Norvir amounted to nearly $214 million in the U.S.

Generic for Mutamycin

Mylan launched mitomycin injection, the generic for Mutamycin®, in 5mg, 10mg and 20mg vials on March 20, 2018. Mitomycin, an antibiotic that has anticancer effects, is used to treat adults who have cancers of the stomach or pancreas. It is given by IV, usually once every six or eight weeks, along with other cancer drugs. A boxed warning advises that only physicians familiar with the use of mitomycin should give infusions and that using it may cause potentially severe adverse effects, such as bone marrow suppression, several types of anemia and kidney failure. Blood tests and other evaluations are recommended for each patient after each infusion. For the 12-month period that ended Jan. 31, 2018, U.S. sales of Mutamycin were approximately $59 million, according to IQVIA.

Ilumya Approved for Plaque Psoriasis

On March 21, 2018, Sun Pharma announced that the U.S. Food and Drug Administration (FDA) approved Ilumya™ (tildrakizumab-asmn) for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Ilumya is a biologic drug known as an interleukin-23 (IL-23) inhibitor. The recommended dose is 100mg by subcutaneous (SC) injection at Weeks 0 and 4, and every 12 weeks thereafter. Sun Pharma plans on launching Ilumya in late June or early July. It will be available through a large network of specialty pharmacies that includes Accredo. Full prescribing information is available here

Issues Document Available: Praluent – Cardiovascular (CV) Outcomes Update

Praluent® (alirocumab injection for subcutaneous use – Regeneron/Sanofi) is a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor antibody that is highly effective at lowering low-density lipoprotein cholesterol (LDL-C) levels. On March 10, 2018, Sanofi/Regeneron announced topline results of their cardiovascular outcomes study, the ODYSSEY Outcomes trial (n = 18,924), at an American College of Cardiology (ACC) meeting. The trial involved adults who had experienced a recent acute coronary syndrome (ACS) event 1 to 12 months prior to randomization (acute myocardial infarction [MI] or unstable angina) that required hospitalization who had inadequate control of lipids (e.g., LDL-C ≥ 70 mg/dL). The study showed that when Praluent was added to maximum-tolerated statin therapy, the risk of coronary heart disease (CHD) death, nonfatal myocardial infarction (MI), fatal or non-fatal ischemic stroke, or unstable angina that required hospitalization was reduced by 15% among patients compared with patients who received only background statin therapy. This Issues Document summarizes the topline results from Praluent’s cardiovascular outcomes trial presented March 10, 2018, at ACC. The issues document is available here

 

 

 

 

 

 

 

 

 

 

 

 
23Mar