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
FSBP Migration Update - March 23, 2018

FSBP Migration Update - March 23, 2018

Dear Foreign Service Benefit Plan (FSBP) Member:

As we approach the end of March, I owe you an update on the status of migration. The transition has not been as seamless as any of us would have liked, and I understand your frustrations. Longer hold times, response times for written questions, longer processing time for claims, do not represent the service you have come to expect. The challenges of this transition have provided me with more opportunities to interact with you directly, but I know that's not because everything is going well. Though it has not always been evident, teams at AFSPA and Aetna have been working diligently to improve processes and return to the service you expect and deserve.

Here are some updates on specific challenges and issues:

ID Cards
Many members, particularly those overseas, did not receive their ID cards on January 1. Some were able to access temporary cards online, and AFSPA staff have ordered replacement and additional cards as you have requested them. There are still some members who have not received their cards, and we are taking steps to ensure delivery. I appreciate your patience and keeping us updated when cards arrive or not.

Claims
AFSPA management is working closely with management at Aetna to track the status of claims and our overall inventory. The numbers of claims and the processing time are not where we want them. Claims processors still are learning the new system, and those assigned to foreign claims are improving every day. With that said, we anticipate that the processing time for non-standard domestic claims (e.g. out-of-network claims, massage, acupuncture, and chiropractic claims) will be back to normal by late spring. Foreign claims are more specialized and generally take a bit longer; we anticipate that processing time for these claims will return to 10-15 days by mid-summer.

Wellness Incentive Funds
Many members had a balance in their wellness incentive account at the end of 2017. Those funds remain in the old system to reimburse members for out-of-pocket expenses for 2017 claims. The remaining balance will transfer to the new system on May 1, 2018. This date was chosen to coincide with the FSAFEDS submission deadline. You can earn 2018 incentive funds (which will be added to the Aetna system for 2018 claims) by taking the Simple Steps to Living Well Together. Please visit the Wellness Page on our website, to learn more and start earning today.

Currency Exchange Rates
Some questions have reached my desk about certain changes for 2018. One that I want to call out relates to conversion rates for foreign currency. We understand that the rate you pay at the time of service may differ from an official rate. Therefore, the Plan asks that you submit a receipt or bank statement showing the exchange rate charged when you obtained the local currency along with your claim. If you do not provide an exchange rate for the date of service, then we will use the rate published on www.oanda.com.

Contacting the Plan
We apologize that phone wait times are longer than they should be. We have added six new Health Benefits Officers to our team within the last month, and more will begin training soon. In February alone, we experienced a 165% increase in written correspondence over the same month in 2017. The usual turnaround time in 2017 for emails was 2-3 days; this year it has increased to more than 2 weeks. We have assigned two additional staff members to work on correspondence full time, with others working weekends and overtime to help reduce the backlog.

Thank you for your continued patience. I will keep you updated as there is more to report.
              

Sincerely,

Kyle Longton, COO                                                                               

Kyle-Headshot-1.jpg                                                                                 

 
22Mar

AFSPA is opening late today

Due to inclement weather and following the decision by the Office of Personnel Management, AFSPA will open on a delayed schedule today, Thursday, March 22, 2018. We will assess staff levels on an ongoing basis with the goal of commencing regular business operations as soon as possible.

Thank you.

 
21Mar

AFSPA is closed due to inclement weather

Following the decision of the Office of Personnel Management, AFSPA's office will be closed Wednesday, March 21, 2018, 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!

 
20Mar
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

New Indication for Hizentra

Hizentra® (immune globulin subcutaneous [human] 20% liquid – CSL Behring) was approved by the U.S. Food and Drug Administration (FDA) on March 16, 2018, for treating chronic inflammatory demyelinating polyneuropathy (CIDP). It will be used long-term to prevent relapse of neuromuscular disability and impairment. A progressive autoimmune disorder, CIDP causes weakness, numbness and tingling of the arms and legs due to damaged myelin sheathes (protective coverings) of the peripheral nerves. Approximately 40,000 patients in the U.S. have CIDP and about one-third of them eventually will need to use a wheelchair. In the pivotal clinical trial, 32.8% to 38.6% of patients using Hizentra relapsed or withdrew, compared to 63.2% of patients using a placebo. Although it is self-administered subcutaneously (SC), Hizentra is given through an infusion pump at doses and frequencies that vary widely depending on immune globulin levels and patient responses. Hizentra also is approved to treat primary immunodeficiency for patients who are at least two years old. A boxed warning about the possibility that it and similar products may cause blood clots is required on its labeling. Updated prescribing information is available here.

Norditropin Approved for New Indications

On February 23, 2018, Novo Nordisk’s Norditropin® (somatropin) was granted Food and Drug Administration (FDA) approval for treating children who are short for their ages, but who do not have underlying conditions that may be contributing to growth delay or failure (idiopathic shortness). It also gained an indication for the treatment of children who are short due to Prader-Willi syndrome, a rare inherited condition that has multiple symptoms. Available as self-injection pen devices containing several different strengths, Norditropin is given SC once weekly. Recommended dosing for idiopathic shortness is up to 0.47mg/Kg/week; for Prader-Willi syndrome it is 0.24mg/Kg/week. Complete prescribing information is available here

 

 

 

 
14Mar
FSBP Partners with Imperial College Healthcare NHS Trust in London

FSBP Partners with Imperial College Healthcare NHS Trust in London

The Foreign Service Benefit Plan (FSBP) proudly welcomes our newest direct billing partner, Imperial College Healthcare NHS Trust located in LondIPH_Logo_Purpleon, United Kingdom. Our direct billing arrangement covers inpatient* and complete maternity care* and includes the following five facilities:

  • St Mary’s Hospital, Lindo Wing provides the highest quality of care for surgical, medical and obstetric patients. The site specializes in a range of complex and robotic surgeries including trauma, weight loss, vascular, gynecology, ear, nose and throat, and urology, as well as their world renowned maternity services.
  • Charing Cross Hospital, Thames View is a leading center for cancer care neurosciences, neurorehabilitation, complex surgery, elective orthopedics, urologyand vascular services.
  • Hammersmith Hospital, Sainsbury Wing is a major academic center for specialist medicine. The site specializes in cardiology, cardiothoracic surgery, cancer care, renal, gynecology, clinical hematology and hepatobiliary conditions, as well as offering general clinical services.
  • Queen Charlotte’s and Chelsea Hospital is a major center for fetal medicine and offers gynecological and maternity services. It is the largest neonatal intensive care unit in the country and its labor ward has two fully equipped operating theatres with adjacent high-dependency care facilities.
  • The Western Eye Hospital is a renowned, stand-alone ophthalmic hospital and teaching center which has been established since 1865. Treatment is available for everything from common eye problems like glaucoma or cataracts to complex ophthalmic issues.


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 for assistance.

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

 
13Mar
2018 AFSPA Annual Member Meeting Webinar Presentation

2018 AFSPA Annual Member Meeting Webinar Presentation

This is a recording of the 2018 AFSPA Annual Meeting Webinar Presentation from Friday, March 2, 2018.

In this presentation, CEO of AFSPA, Paula S. Jakub, RHU, discusses the following topics:

  • FEHB Program Initiatives
  • Affordable Care Act
  • AFSPA/FSBP Updates
  • Migration Update
  • Medicare Update
 
8Mar
CIGNA to Acquire Express Scripts

CIGNA to Acquire Express Scripts

Dear AFSPA Member,

By now, you likely have seen the news that CIGNA has agreed to buy Express Scripts. This comes as no surprise. As is the case with the AETNA-CVS merger, companies continue to combine their resources as they position themselves to operate in today’s and tomorrow’s even more complex health care system.

 I have been in touch with our partners at Express Scripts, and here is what we know at this time:

  • Express Scripts will retain its name and will operate as an independent company as part of the CIGNA family
  • Their Headquarters will remain in St. Louis, MO
  • All pharmacy operations will remain the same
  • If the deal gets through the Department of Justice (DOJ), the close will be the latter half of 2018

The change will have little immediate impact on the Foreign Service Benefit Plan. Express Scripts will continue to serve as the Plan’s Pharmacy Benefit Manager, with the same team serving our account and the same pharmacists serving our members. Aetna will continue to serve as the Plan’s Administrator, with the same team handling operations, including claims, clinical management and underwriting.

As the healthcare landscape continues to evolve, AFSPA strives to remain at the forefront of benefit design and delivery, leveraging our relationships with our partners and drawing from the resources of all four, now two, of the largest and most influential companies in the healthcare field (Aetna/CVS, and now ESI and CIGNA) to create innovative solutions to meet your needs. Our focus remains finding the best way to serve you, our members, wherever you are in the world.

To Your Health,

Paula S. Jakub, RHU

Chief Executive Officer

 
8Mar
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

March 7, 2018

Trogarzo Approved for HIV

 

On March 6, 2018, Theratechnologies and TaiMed Biologics received approval from the U.S. Food and Drug Administration (FDA) for Trogarzo™ (ibalizumab-uiyk) for use in combination with other antiretroviral therapies for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen. Trogarzo is administered as an intravenous (IV) infusion as a single loading dose of 2,000mg followed by a maintenance dose of 800mg every 2 weeks. Theratechnologies plans to launch Trogarzo within six weeks. It will be available through a limited network of specialty pharmacies that includes Accredo. Full prescribing information will be available here.  

  • Brand (Generic) Name: Trogarzo™ (ibalizumab-uiyk)
  • Manufacturer: Theratechnologies and TaiMed Biologics
  • Date Approved: March 6, 2018
  • Indication: Use in combination with other antiretroviral therapies for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen
  • Dosage Forms Available: 200mg/1.33mL (150mg/mL) in single-dose vials to be diluted in 250mL of 0.9% Sodium Chloride Injection, USP for intravenous infusion
  • Launch Date: Trogarzo will be available within six weeks.
  • Estimated Annual Cost: Trogarzo is expected to cost $118,000 per year.
  • Specialty Status: Trogarzo will be added to Express Scripts’ specialty drug list.
  • Approximately 1.2 million Americans have HIV-1 infection. Up to 25,000 Americans with HIV-1 infection are considered multi-drug resistant (MDR), with approximately 12,000 of these patients failing their current antiretroviral regimen.
  • Trogarzo is a novel biologic drug known as a CD4-directed post-attachment HIV-1 inhibitor. It works by preventing HIV from infecting CD4+ immune cells to reduce the amount of HIV in the body.
  • FDA approval was based on a clinical trial that demonstrated that 43% of patients with MDR HIV-1 infection treated with Trogarzo in combination with other antiretroviral medications achieved HIV RNA suppression.
  • Trogarzo was approved under FDA’s breakthrough therapy, orphan drug and priority review programs.

 

 
5Mar
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

March 5, 2018

Express Scripts Clinical News and Notes

 

Apadaz Approved to Treat Acute Pain
KemPharm’s Apadaz™ (benzhydrocodone/acetaminophen) tablets were approved by the U.S. Food and Drug Administration (FDA) on February 23, 2018. It is an immediate-release opioid/acetaminophen combination product indicated for treating intense, acute pain that has not responded to other therapies. 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 not activated until it is exposed to 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. The U.S. Drug Enforcement Administration (DEA) will schedule Apadaz as a C-II controlled substance, meaning that it has a high possibility for abuse. 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 indicated that it is open to innovative distribution arrangements. The cost of Apadaz is expected to be close to those of comparable generics. It will be evaluated for the “Exclude at Launch” Program of the National Preferred Formulary (NPF). For full prescribing information, please click here.

FDA Approval for ZTlido
Sorrento Therapeutics announced on February 28, 2018, that its subsidiary, Scilex Pharmaceuticals, has received FDA approval for ZTlido™ (lidocaine topical system) 1.8%. It is indicated to treat post-herpetic neuralgia (PHN), which is pain that continues after a case of shingles. Because it uses a different type of patch design, ZTlido is bioequivalent to currently available lidocaine patches, such as Lidoderm® (lidocaine) Patch 5%. It has a unique adhesive, as well, which provides more consistent skin contact. Some clinical trial patients developed mild, temporary blistering, burning, irritation, itching, redness, swelling or other topical side effects where it was applied, however. A launch is expected before the end of 2018, but prescribing and pricing information have not been released. Express Scripts currently is investigating the data around ZTlido for a possible utilization management strategy, and it will be evaluated for the “Exclude at Launch” Program of the NPF.

New Indication for Verzenio
Verzenio™ (abemaciclib -- Lilly) received an additional indication on February 26, 2018. It gained approval for use along with an aromatase inhibitor, such as anastrozole or letrozole, as a first-line endocrine-based therapy to treat postmenopausal women who have advanced or metastatic hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. It also has additional approvals for breast cancer patients who already have undergone chemotherapy (chemo) and/or endocrine treatment. Verzenio selectively inhibits cyclin-dependent kinases (CDK) 4 and 6 (CDK4/6), enzymes that promote the growth and spread of cancer cells. Revised prescribing information can be found here.

Zinbryta Worldwide Market Withdrawal
On March 2, 2018, AbbVie and Biogen announced the voluntary withdrawal of Zinbryta® (daclizumab) from the worldwide market. Zinbryta, an interleukin-2 receptor blocking antibody, was launched in the U.S. market in 2016 for the treatment of relapsing forms of multiple sclerosis. The decision to discontinue marketing was made following reports of brain inflammation, known as inflammatory encephalitis and meningoencephalitis, in patients taking the drug. Although a removal timeline has not been established, Biogen and AbbVie will work collaboratively with the FDA and healthcare providers in the management of Zinbryta patients. More information should become available in the near future. According to Biogen, patients with questions or concerns should contact their healthcare provider.

Symfi Lo and Cimduo Approved to Treat HIV-1
Mylan’s two new HIV drugs, Symfi Lo™ (efavirenz /lamivudine /tenofovir disoproxil fumarate) tablets and Cimduo™ (lamivudine /tenofovir disoproxil fumarate) tablets were approved by the U.S. Food and Drug Administration (FDA) on February 5, 2018. They are indicated to treat children who weigh at least 35Kg (about 77 pounds) and adults who have HIV-1 infections. Symfi Lo, expected to be launched within the next few weeks, combines a lowered dose of a non-nucleoside reverse transcriptase inhibitor (efavirenz) with two nucleoside reverse transcriptase inhibitors as a once-daily, stand-alone treatment. Cimduo, to be introduced in the second quarter of 2018, will be used along with other antiretroviral drugs. Although exact pricing has not yet been announced, Mylan’s press release indicates that each will offer “significant discounts to the price of competing products.” Although both are similar to existing HIV medications, neither is interchangeable with any other drug. Prescribing information for Cimduo is not available, but labeling for Symfi Lo can be found here.

  • Brand (Generic) Name:
    • Symfi Lo™ (efavirenz /lamivudine/tenofovir disoproxil fumarate)
    • Cimduo™ (lamivudine/tenofovir disoproxil fumarate)
  • Manufacturer:  Mylan
  • Date Approved: February 5, 2018
  • Indication: Treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 35Kg
  • Dosage Forms Available:
    • Symfi Lo: tablets containing 400mg of efavirenz/300mg of lamivudine/300mg of tenofovir disoproxil fumarate
    • Cimduo: tablets containing 300mg of lamivudine/300mg of tenofovir disoproxil fumarate
  • Launch Date:
    • Symfi Lo – in the next few weeks
    • Cimduo – in the second quarter 2018
  • Estimated Annual Cost: Pricing information for Symfi Lo and Cimduo is not yet available.
  • Specialty Status: Symfi Lo and Cimduo will be added to Express Scripts’ specialty drug list.
  • HIV-1 is a viral infection estimated to affect approximately 1 million patients in the United States, with about 40,000 new cases diagnosed annually, according to the U.S. Centers for Disease Control and Prevention (CDC).
  • To reduce the chance of viral resistance, drugs from more than one anti-HIV class are used at the same time. Combining more than one drug into a single tablet simplifies dosing and helps to increase adherence to treatment.
  • Both Symfi Lo and Cimduo will carry boxed warnings 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.
  • Implications: Symfi Lo and Cimduo will be evaluated for the “Exclude at Launch” program of the National Preferred Formulary (NPF).

 

 
2Mar

AFSPA is closed

Due to inclement weather and following the decision by the Office of Personnel Management, AFSPA is closed, today, Friday, March 2, 2018. Our on-site Member Meeting is cancelled, however, we will conduct our online webinar as scheduled today at 10:30AM EST.

Click here to join the online webinar 
(Note: This is a live video broadcast link. If you plan on joining the online webinar meeting, we suggest that you click on the above link and bookmark the page so you can easily get to it on the day of the event) 

Business will resume Monday, March 5th at 8:30AM EST.

We apologize for the inconvenience.

 

 
26Feb
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

 

February 26, 2018

Express Scripts Clinical News and Notes

 

Osmolex ER Approved

On Feb. 16, 2018, the U.S. Food and Drug Administration approved Osmotic Pharmaceutical’s Osmolex ER™ (amantadine) tablets, which contain both immediate-release and extended-release forms of the drug. It is indicated to treat adults who have Parkinson’s disease and also to relieve extrapyramidal side effects associated with the use of other drugs. Extrapyramidal symptoms include muscle spasms, restlessness, rigidity, trembling and slowed or jerky movements. Recommended dosing is 129mg each morning, which can be increased gradually to 322mg daily, if needed. Tablets will be available in 129mg, 193mg and 258mg strengths, which are not interchangeable with any other amantadine product. Osmotic has not yet announced launch or pricing plans. Legal actions brought by the manufacturer of another extended-release amantadine product may delay the introduction of Osmolex ER. It will be evaluated for the “Exclude at Launch” program of the National Preferred Formulary (NPF). Full prescribing information is available here.

New Indication for Imfinzi

The U.S. Food and Drug Administration (FDA) approved a new indication for Imfinzi® (durvalumab – AstraZeneca) on Feb. 16, 2018. It is a programmed death ligand 1 (PD-L1) inhibitor now approved for use by patients who have Stage III non-small cell lung cancer (NSCLC) that cannot be removed by surgery and that has not worsened after the patient underwent both platinum-based chemotherapy (chemo) and radiation treatment. In a clinical study, average progression-free survival time (PFS) for patients receiving Imfinzi was nearly a year (11.2 months) longer than for patients using an inactive placebo. It was initially approved in May 2017, to treat locally advanced or metastatic urothelial carcinoma (bladder, ureter and/or urethra cancer) that progresses during or following platinum-containing chemo. Imfinzi also is indicated for patients who have urothelial carcinoma progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemo. Recommended dosing is 10mg/Kg of body weight once every two weeks as a one-hour intravenous (IV) infusion. Complete prescribing information is available here

Generics Released for Solodyn 65mg and115mg

Under the terms of a settlement agreement, Teva Pharmaceutical Industries, Inc. launched generics for Solodyn® (minocycline - Medicis) extended-release tablets in 65mg and 115mg strengths on Feb. 20, 2018. It treats patients at least 12 years old who have moderate-to-severe acne. Teva will have 180 days of exclusivity before other generics can launch in the U.S. Also on Feb. 20, 2018, Impax announced the launch of its authorized generic version of Solodyn tablets in 65mg and 115mg strengths. According to IQVIA (formerly QuintilesIMS), U.S. sales for Solodyn 65mg and 115mg amounted to $148 million during 2017.

MedWatch Update

Clarithromycin

The U.S. Food and Drug Administration (FDA) issued a safety communication on Feb. 22, 2018, to warn about prescribing clarithromycin (branded as Biaxin®) for patients who have coronary heart disease. After evaluating information from a 10-year-long follow-up study, the FDA determined that the risk of heart problems and heart-disease-related deaths — sometimes delayed by many years — is increased after taking clarithromycin. Even some patients who took only one brief course of clarithromycin were affected. A macrolide antibiotic, clarithromycin is used to treat numerous kinds of bacterial infections. Its labeling will outline the risk, prescribers should consider other antibiotics for potentially vulnerable patients and individuals should be sure their healthcare professionals know if they have heart disease. More information is available here.

   

 

 

 

 

 

 

 
20Feb
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

 

 

February 19, 2018

Express Scripts Clinical News and Notes

 

Auto-Injector Approved for Makena

On Feb. 14, 2018, the U.S. Food and Drug Administration (FDA) approved AMAG Pharmaceuticals’ Makena® (hydroxyprogesterone caproate injection) Subcutaneous (SC) Auto-Injector. It uses the VIBEX® QuickShot® SC device made by Antares Pharma. Makena is a progestin indicated to reduce the risk of preterm birth for women who are pregnant with one baby and who previously delivered one preterm baby spontaneously. Formerly, Makena was available only in vials for intramuscular (IM) administration. Orphan status for the IM form of Makena expired early in 2018, and generics for it may enter the U.S. market as early as mid-summer. Both IM and SC injections must be given by a healthcare provider. They begin between weeks 16 and 21 of the pregnancy, and then continue until week 37 or the birth of the child. Recommended dosing for the SC form is one 275mg dose injected once a week into the back of the upper arm. AMAG announced that it will launch the new SC form during the second half of March and price it equally with the IM version. Prescribing information is available here.  

Glatopa 40mg/mL Launched

Sandoz and its partner, Momenta Pharmaceuticals, launched Glatopa® (glatiramer injection) 40 mg/mL immediately after receiving U.S. Food and Drug Administration (FDA) approval for it on Feb. 12, 2018. A generic for Teva’s Copaxone® (glatiramer injection) 40 mg/mL, it treats relapsing multiple sclerosis (MS). Patients use one 40mg injection three times each week, with at least 48 hours between doses. It is dispensed in packages of 12 single-dose, pre-filled syringes. Sandoz offers patients a proprietary injection aid, Glatopaject®, which fits both the 40mg/mL syringes and those containing 20mg/mL. The two strengths are not interchangeable, however. Glatopa 20mg/mL was FDA approved in June 2015; Mylan introduced a generic to both strengths of Copaxone in October 2017; and other generics are being developed for the U.S. market. Updated prescribing information for Glatopa is available here.

Items to Watch for this Week

Friday, February 23rd  

FDA Action Date: Apadaz™ (benzhydrocodone/acetaminophen - KemPharma) immediate-release tablets: A new prodrug of hydrocodone, combined with acetaminophen, for the treatment of pain. It exhibits unique abuse-deterrent properties, because its hydrocodone component is not active until metabolized in the intestines.

Updated Patent Expiration Report Available

The Emerging Therapeutics Department has updated its patent expiration document. This report includes drugs targeted for potential generic availability over the next five years. This document is available here.  

 

 

 

 

 

 
19Feb

AFSPA is closed in observance of the holiday

AFSPA is closed, today, February 19, 2018 in observance of the holiday. We will resume our normal business hours at 8:30 am EST on Tuesday, February 20, 2018. 

 

 
16Feb
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

February 15, 2018

Erleada Approved for Prostate Cancer

 

Under its Priority Review program, the U.S. Food and Drug Administration (FDA) approved Erleada™ (apalutamide) tablets on Feb. 14, 2018. It’s a next-generation androgen receptor inhibitor and the first drug indicated to treat non-metastatic castration-resistant prostate cancer. Recommended dosing is four tablets (totaling 240mg) once a day. A gonadotropin-releasing hormone (GnRH) analog, such as Zoladex® (goserelin) implants, also should be used for patients who have not had a bilateral orchiectomy (surgical castration). Erleada will be available through a large network of specialty pharmacies that includes Accredo. List price is expected to be almost $11,000 per month. Janssen has not yet announced a launch date. Prescribing information for Erleada is available here

  • Brand (Generic) Name: Erleada™ (apalutamide)
  • Manufacturer: Janssen Pharmaceutical Companies of Johnson & Johnson
  • Date Approved: Feb. 14, 2018
  • Indication: Treatment of non-metastatic castration-resistant prostate cancer
  • Dosage Forms Available: 60mg oral tablets
  • Launch Date: Launch date is not known at this time.
  • Estimated Annual Cost: Approximately $131,000
  • Specialty Status: Erleada 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, with up to 20% resistant to surgical or chemically induced castration.
  • Approximately 90% of patients with castration-resistant prostate cancer will eventually have metastases in their bones.
  • Erleada is the first drug to be FDA approved based on a new endpoint, metastasis-free survival, instead of more common endpoints such as progression-free survival.
  • In the phase III SPARTAN Study, distant metastasis or death were reduced by 72% among patients taking Erleada compared to patients taking a placebo. Additionally, median metastasis-free survival (MFS) was 40.5 months for Erleada-treated patients, compared to 16.6 months for those taking a placebo. All study patients also either used gonadotropin-releasing hormone (GnRH) therapy or had a bilateral orchiectomy.
  • About 12% of patients taking Erleada had bone fractures and 16% had falls that were not caused by seizures or loss of consciousness. Almost one-quarter of the treated patients developed rashes after taking Erleada for an average of 82 days. However, for over 80% of the affected patients, rash resolved in around two months.
  • Based on similar results from the phase III PROSPER study, a marketing application for the same indication has been filed with the FDA for Astellas and Pfizer’s established androgen receptor inhibitor, Xtandi® (enzalutamide). No action date has been determined, yet.
  • Implications: Express Scripts currently is investigating the data around Erleada for a possible utilization management strategy. It also will be evaluated for exclude at launch on the Express Scripts National Preferred Formulary (NPF).

 

 
14Feb
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

 

February 13, 2018

Symdeko Approved to Treat Cystic Fibrosis

 

Symdeko™ (tezacaftor/ivacaftor and ivacaftor - Vertex) was approved by the U.S. Food and Drug Administration (FDA) on Feb. 12, 2018. It is indicated to treat patients with cystic fibrosis (CF) who are at least 12 years old and who are either homozygous for the F508del mutation or who have at least one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is  responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence. FDA-approved CF mutation testing will be used to verify the patient’s genotype. Recommended daily dosing is one Symdeko tablet in the morning and one Kalydeco® (ivacaftor 150mg) tablet about 12 hours later; the two drugs will be packaged together. Vertex plans to launch Symdeko this week at a wholesale acquisition cost (WAC) of $22,400 per 28-day package. It will be available through a large network of specialty pharmacies that includes Accredo. Complete prescribing information is available here.

  • Brand (Generic) Name: Symdeko™ (tezacaftor/ivacaftor)
  • Manufacturer: Vertex
  • Date Approved: Feb. 12, 2018
  • Indication: Treatment of patients with cystic fibrosis (CF) who are at least 12 years old and who are either homozygous for the F508del mutation or who have at least one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence.
  • Dosage Forms Available: Oral tablets containing a fixed-dose combination of tezacaftor 100mg and ivacaftor 150mg, packaged along with 150mg ivacaftor tablets
  • Launch Date: The week of Feb. 11, 2018
  • Estimated Annual Cost: $292,000
  • Specialty Status: Symdeko will be added to Express Scripts’ specialty drug list.
  • CF is an inherited disease caused by mutations in both of the patient’s cystic fibrosis transmembrane conductance regulator (CFTR) genes – one from each parent. CFTR genes are responsible for the proteins in ion channels on cell surfaces. Ion channels transport water and salts throughout the body. Absent or defective CFTR proteins suppress, break or damage ion channels, which results in thick mucus that disrupts breathing, leads to frequent infections and interferes with digestion. Eventually CF patients may no longer be able to digest food adequately and they may progress to respiratory failure.
  • The Cystic Fibrosis Foundation estimates that about 30,000 Americans currently have CF and that about 1,000 new patients, mostly young children, are diagnosed with it annually. Many more CF patients are surviving into adulthood, with about one-half of CF patients in the U.S. now over the age of 18 years.
  • Approximately 90% of CF patients have an F508del
  • Tezacaftor is a new 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.
  • Symdeko does not have the warnings for adverse respiratory events, increased blood pressure and interference with hormonal contraception that are associated with Vertex’s older CF combination, Orkambi® (lumacaftor/ivacaftor).
  • Implications: Express Scripts is currently investigating the data around Symdeko for a possible utilization management strategy. It will also be evaluated for exclude at launch on the Express Scripts - National Preferred Formulary (NPF).

 

 

 

 

 
13Feb
FSBP Migration Update - February 13, 2018

FSBP Migration Update - February 13, 2018

Dear Foreign Service Benefit Plan (FSBP) Member:

More than a month has passed since we began the migration  to the new Aetna platform. As Paula noted in her message last week, we received a record number of calls on January 2, and phone lines were jammed for the first two weeks. Many of you experienced estimated wait times in excess of 30 minutes. FSBP Health Benefits Officers (HBOs) and other have staff worked evenings and weekends to return calls and response to email inquiries as quickly as possible.

Starting in late January, call and email volumes have started to return to normal levels, leading to a decrease in the wait time. Six additional HBOs began taking calls in recent weeks, as well. Our commitment to our mission – to provide unparalleled service to our unique worldwide membership – remains unchanged.

Here are some updates on specific issues:

ID Cards

In the first weeks of the year, we identified problems with certain members cards. We have worked daily with our partners at Aetna on this issue. At this point most members have received correct cards, and we  will continue to work on this issue until we are confident that everyone has received their cards. As a reminder, temporary cards are available through Aetna Navigator – www.aetnanavigator.com. Log in, click on “ID Card” in the purple banner at the top of the screen, and follow the screen options to print a temporary card.

Claims

We are processing FSBP claims, and payments are being made. Claims submitted for dates of service in 2017 should be proceeding at the usual pace, with processing completed in 10-15 business days. Claims for dates of service in 2018 are taking longer. We are  reviewing claims, particularly overseas claims, to ensure that the new system is processing benefits correctly. However, this quality measure has led to a slowdown in payments. The pace of quality review has and will continue to increase as we gain confidence in the new system.

You will receive new Explanations Of Benefits (EOBs) for dates of service in 2018. There is a guide for reading the new EOB in the Migration Brochure found on our website at www.afspa.org/fsbp/migration.

These last several weeks, I have heard from many of you directly, and I appreciate you sharing your experiences with me.  Your feedback has led to process improvements. This migration has been difficult, and I sincerely regret the disruption to you, our valued members. I understand that your confidence may be shaken. However, rest assured that we will do all we can in the days, weeks, and months ahead to regain your trust and demonstrate our commitment to you.

Thank you for your continued patience. You can reach me through the secure form on our website if you have any concerns.

 

Sincerely,

Kyle Longton, COO

 
12Feb
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Generic to Syprine Available

On Feb. 7, 2018, the U.S. Food and Drug Administration (FDA) approved Teva’s AB-rated generic to Valeant’s Syprine® (trientine hydrochloride) 250mg capsules. Syprine is a chelating agent used to treat Wilson's disease in patients who cannot take another medication known as penicillamine. Wilson's disease is a rare condition where the body stores too much copper. High levels of copper in the body can cause life-threatening organ damage. Syprine was included on FDA’s recently published "off-patent, off-exclusivity" list of brand drugs that do not have approved generics available. FDA published this list and implemented a new policy to expedite the review of generic applications where competition is limited. According to IQVIA (formerly QuintilesIMS), U.S. sales of Syprine tablets amounted to $155 million for calendar year 2017. Shipments of the generic have already begun.

Feraheme Receives New Indication

AMAG Pharmaceuticals’ Feraheme® (ferumoxytol) injection was approved by the U.S. Food and Drug Administration (FDA) on Feb. 2, 2018, to treat any adult who has iron deficiency anemia that has not responded to oral iron replacement therapy. Its initial FDA approval in 2009 was limited to treating only anemia patients who have chronic kidney disease. Administered as 510mg intravenous (IV) infusions, two doses of Feraheme are given between three days and eight days apart. Treatments usually are given in physician offices, dialysis facilities or infusion centers that are required to have equipment, procedures and staff to provide immediate emergency treatment after a significant number of severe hypersensitivity (allergic) reactions occurred among patients. An observation period of at least one-half hour is suggested following each infusion. Full prescribing information is available here

Expanded Indication for Cosentyx

U.S. Food and Drug Administration (FDA) approval for Cosentyx® (secukinumab - Novartis) was extended to include treating adults who have psoriasis of the scalp, on Feb. 8, 2018. Cosentyx reduces inflammation by sticking to interleukin (IL)-17A and preventing it from activating receptors. It is the first drug in its class to be approved specifically for psoriasis. According to the National Psoriasis Foundation, about 4 million Americans have moderate-to-severe psoriasis on their scalps. In a clinical trial, scalp psoriasis cleared significantly for nearly 10 times as many patients using Cosentyx (56.9%) compared with patients using an inactive placebo (5.9%). Originally approved in 2015 to treat psoriasis, it also has additional indications for ankylosing spondylitis and psoriatic arthritis. Recommended dosing is one subcutaneous (SC) injection per week for five weeks and then once every four weeks. Complete prescribing information for Cosentyx is available here.  

Zytiga Label Expanded

On Feb. 8, 2018, Janssen Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) approved Zytiga® (abiraterone acetate) in combination with prednisone for the treatment of patients with metastatic high-risk castration-sensitive prostate cancer (CSPC). This approval was based on a Phase III study that showed that this combination reduced the risk of death by 38% compared to placebo. CSPC refers to patients who still respond to testosterone suppression therapy. Zytiga is an oral CYP17 inhibitor that was originally approved in 2011 for use in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC). For both indications, the recommended dose of Zytiga is 1,000mg once daily on an empty stomach with prednisone 5mg twice daily. Updated prescribing information is available here.

 
8Feb
From the CEO

From the CEO

Greetings and Welcome to February 2018!

First, I would like to start by telling you how much I appreciate each member. Thank you for your patronage and your loyalty to AFSPA’s plans and services.

We just completed out first month of the Aetna migration. As predicted, it was a difficult time as members navigated through the new format, received new ID cards, etc. As much as we planned for disruption and questions, with all hands on the phone deck, we received over 700 calls on January 2 alone and the hold times were long. Understandably, many members were frustrated. We appreciate your patience and understanding for then and as we go into the second month. Following quality reviews which have added a bit to processing time, 2018 claims are being released.  You will receive Explanation of Benefits (EOB’s) that look different from last year. Please refer to the migration brochure for directions on how to read the new format. Also, please be sure to begin using your new FSBP ID Card and DESTROY any old ones as they are not valid after January 1.

News on migration will continue to develop throughout the year. We will keep you updated on our website, our Facebook , and through emails. You can find all the details about migration on our dedicated migration webpage.

On another note, Foreign Service Benefit Plan (FSBP) members will receive the IRS Form 1095-B by March 2, 2018, 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 2017. 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 2017.

In addition, Federal employees will receive the IRS Form 1095-C from their employing agency. It documents that your agency offered you health coverage in 2017. If you have questions about the IRS Form 1095-C, or about lost or incorrect forms, you should call your agency using the phone number on Line 10 of the IRS form.

OPM provided great information for both employees and annuitants in their FastFacts sheet.  Please take the time to review this pertinent document.

Lastly, influenza is really bad this year with outbreaks reported in 48 states. And this year’s vaccine is only 30% effective; however, it might help lessen the symptoms. But, is it a cold or is it the flu? Click here for some useful information from the Centers for Disease Control and Prevention.

We hope your family stays safe, warm, and healthy this winter. 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  

 
8Feb
Express Scripts News Flash

Express Scripts News Flash

On Feb. 7, 2018, the U.S. Food and Drug Administration (FDA) approved Gilead Sciences’ Biktarvy® (bictegravir/emtricitabine/tenofovir alafenamide), which is abbreviated as BIC/FTC/TAF. A once daily treatment for adults who have HIV-1 infections, it combines bictegravir, a new integrase strand transfer inhibitor (INSTI), with the two nucleoside reverse transcriptase inhibitors (NRTIs) that are marketed together as Descovy®. Biktarvy is indicated to treat patients who have not yet been treated with antiretrovirals and patients who have had suppressed viral loads for at least three months on a previous HIV drug regimen. However, eligible patients must not have failed prior treatment or developed resistance to any of its components. It has a boxed warning for patients who have both HIV and hepatitis B because hepatitis B may re-emerge when Biktarvy treatment is stopped. Prescribing information is available here

  • Brand (Generic) Name: Biktarvy® (bictegravir/emtricitabine/tenofovir alafenamide)
  • Manufacturer: Gilead Sciences
  • Date Approved: Feb. 7, 2018
  • Indication: Complete regimen for the treatment of HIV-1 infection in adults who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 3 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy
  • Dosage Forms Available: Once-daily oral tablets containing 50mg of bictegravir, 200mg of emtricitabine and 25mg of tenofovir alafenamide
  • Launch Date: Feb. 13, 2018
  • Estimated Annual Cost: The average wholesale cost (WAC) of Biktarvy will be approximately $35,840 per year.
  • Specialty Status: Biktarvy will be added to Express Scripts’ specialty drug list.
  • HIV-1 is a viral infection estimated to affect approximately one million patients in the United States, with about 40,000 new cases diagnosed annually, according to the U.S. Centers for Disease Control and Prevention (CDC).
  • To reduce the chance of viral resistance, drugs from more than one anti-HIV class are used at the same time. Combining drugs into one tablet simplifies dosing and helps to increase adherence to treatment.
  • In four phase III clinical studies lasting 48 weeks or longer, Biktarvy performed as well as standard HIV treatment with no unusual or increased interactions, resistance or side effects.
  • Implications: Biktarvy will be evaluated for exclude at launch on the Express Scripts National Preferred Formulary (NPF).
 
7Feb

AFSPA is opening late today

Due to inclement weather and following the decision by the Office of Personnel Management, AFSPA will open on a delayed schedule today, Wednesday, February 7, 2018. We will assess staff levels on an ongoing basis with the goal of commencing regular business operations as soon as possible.

Thank you.

 
5Feb
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Lutathera Radiopharmaceutical Approved

Under Priority Review, the U.S. Food and Drug Administration (FDA) approved Lutathera® (lutetium Lu 177 dotatate – Advanced Acceleration Applications) on Jan. 26, 2018. Lutathera, an orphan drug, is the first radiopharmaceutical indicated to treat adults who have gastroenteropancreatic neuroendocrine tumors (GEP-NETs). It contains a peptide that targets cancer cells and a radioactive element that destroys them. Radiopharmaceuticals give off low levels of radiation to diagnose or treat diseases. The peptide part of Lutathera sticks to somatostatin receptors on tumor cells and then invades the cells where the radiation damages the cancer’s DNA beyond repair. Recommended dosing is two vials given by intravenous (IV) infusion once every eight weeks for four cycles. Neuroendocrine tumors usually occur in hormone-releasing organs, such as the thyroid and pancreas, which are influenced by nerve impulses. GEP-NETs affect about 171,000 Americans with approximately seven new cases diagnosed annually for every 100,000 in population. Most patients are diagnosed after 50 years of age, partly because GEP-NETs progress slowly with few symptoms. Advanced Acceleration Applications, a Novartis subsidiary, launched Lutathera shortly after approval. The wholesale acquisition cost (WAC) of Lutathera is $47,500 per dose or $190,000 for the 4-dose treatment regimen. It will be administered by physicians who are trained and authorized 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, Lutathera will not be available through Accredo, or other specialty pharmacies, since it will be delivered directly to the facilities where it is given. Complete prescribing information is available here.

New Dosage Form for Vancomycin

Firvanq™ (vancomycin – CutisPharma, Inc.) for oral solution was granted U.S. Food and Drug Administration (FDA) approval on Jan. 29, 2018. The first oral liquid form of vancomycin, it is indicated for treating Clostridium difficile diarrhea and Staphylococcus aureus enterocolitis (inflammation of the small intestine and colon). Available in other formulations since the 1960s, vancomycin generally is reserved for serious infections that have not responded to other antibiotics, including methicillin. Firvanq will be marketed in two strengths: 25mg/mL and 50mg/mL. Its launch is planned for April 2, 2018. Prescribing information is available here

Zomacton Approved to Treat Adult Growth Hormone Deficiency 

Ferring Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (FDA) approved a new indication for its growth hormone (GH) product, Zomacton® (somatropin), on Jan. 29, 2018. Marketed to treat pediatric patients since 1995, it now is indicated to replace GH for adults with deficiencies. It is available in 5mg and 10mg vials of powder that must be mixed with bacteriostatic sodium chloride (for 5mg vials) or sterile water (10mg vials) that is included with Zomacton. Once diluted, vials can be kept in the refrigerator for up to 14 days (5mg vials) or 28 days (10mg vials). Dosing is by weight with subcutaneous (SC) injections given either three, six or seven days a week for pediatric patients. Adults use Zomacton every day. The 5mg strength may be administered either by syringe or through a proprietary, needle-free delivery device, the Zoma-Jet™5, but the 10mg version is drawn into syringes for injection. Full prescribing information for Zomacton is available here.

New Avycaz Indication

Allergan’s combination antibacterial agent Avycaz® (ceftazidime/avibactam) was U.S. Food and Drug Administration (FDA) approved on Feb. 1, 2018, to treat two additional types of infections. Primarily used for hospitalized patients, it is now approved for adults who have hospital-acquired bacterial pneumonia or ventilator-associated bacterial pneumonia caused by strains of bacteria susceptible to it. First FDA approved in 2015, it is also indicated to treat complicated abdominal and urinary tract infections. It is given by IV infusion three times a day for 14 days. Full prescribing information is available here

Generic Launched for Sustiva Tablets

On Feb. 1, 2018, Mylan released efavirenz tablets, 600mg, to the U.S. market. A generic for Sustiva® tablets (Bristol-Myers Squibb), it is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that is taken once daily along with other drugs to treat HIV-1 infections. Although efavirenz is indicated for patients as young as three months old, it is not recommended as first-line treatment because it may cause central nervous system side effects, such as confusion, dizziness, drowsiness and insomnia. Mylan is eligible for 180 days of exclusivity for the generic tablets. Sustiva capsules (available in 50mg, 100mg and 200mg strengths) remain brand-only with one authorized generic for each strength. According to IQVIA (formerly QuintilesIMS), U.S. sales of Sustiva tablets amounted to slightly more than $113 million for calendar year 2017.

MedWatch Updates

Loperamide

The U.S. Food and Drug Administration (FDA) has asked manufacturers of the anti-diarrheal drug, loperamide (also sold under the brand name, Imodium® A-D), to change their packaging to smaller quantities and/or blister packs. Related to opioids, loperamide affects opioid receptors in the gastrointestinal (GI) system to slow down transit time and relieve diarrhea. Currently available only in over-the-counter (OTC) versions, loperamide is indicated to be used for no more than a few days at a time. Often, however, it comes in multi-unit bottles containing hundreds of tablets, capsules or liquid doses. In the last few years, the FDA has become increasingly aware that some individuals are taking excessively large doses of loperamide to achieve opioid-like euphoria or to reduce symptoms of opioid withdrawal. Massive doses can cause very serious heart rhythm irregularities. Between 2010 and 2015, loperamide was associated with 15 deaths, either alone or in combination with other drugs. By limiting the package sizes and making the purchase of large quantities more difficult, the FDA hopes to reduce loperamide misuse. The FDA’s entire safety communication -  is available here

Ocaliva

The U.S. Food and Drug Administration (FDA) is requiring a boxed warning and a new table clearly showing recommended dosing to be put on the labeling for Ocaliva® (obeticholic acid) tablets. Approved to treat the rare liver disease, severe primary biliary cholangitis (PBC), Ocaliva usually is taken daily by patients. However, for the 2% to 3% of patients who have moderate or severe (Child-Pugh Class B or C) liver damage, the dose is reduced to once or twice weekly. Too much Ocaliva can further injure the liver. Since the drug was launched in mid-2016, misinterpretation of the dosing schedule has resulted in reports of patients receiving it too often. At least seven deaths and 11 cases of severe liver damage have been attributed to doses of Ocaliva that were higher or more frequent than recommended. Prescribers are urged to test liver function for every patient before initiating Ocaliva treatment, counsel patients on signs of potentially serious side effects, monitor patients frequently and adjust dosing as necessary. Patients should notify their physicians immediately if they experience sudden symptoms of liver damage -- especially intense itching and yellowing of the skin or eyes. The manufacturer, Intercept Pharmaceuticals, also will provide a Medication Guide for patients filling Ocaliva prescriptions. The FDA advisory is available here

 
29Jan
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

New Indication for Trulance

Trulance® (plecanatide – Synergy Pharmaceuticals), was first approved by the U.S. Food and Drug Administration (FDA) one year ago to treat chronic idiopathic constipation. It now has an additional indication. It was approved on Jan. 25, 2018, for treating adults who have irritable bowel syndrome with constipation (IBS-C). According to the International Foundation for Functional Gastrointestinal Disorders, irritable bowel syndrome (IBS) affects between 10% and 15% of Americans, but many have not been diagnosed. Approximately two-thirds of patients with IBS are female, and patients usually are younger than 50 years of age when diagnosed. Although no specific cause is known, about 10% of IBS cases follow a stomach infection. Stress and food intolerances also have been linked to episodes. Symptoms, which vary widely in both severity and frequency, include abdominal discomfort, bloating, cramping, gas and mucus in the stool. Patients also have chronic constipation, diarrhea (IBS-D) or a mixture of both (IBS-M). In two clinical trials, patients with IBS-C who took Trulance averaged fewer symptoms and more normal bowel movements than patients who were taking an inactive placebo. Recommended dosing is one tablet (3mg) once daily. Trulance should not be used by patients younger than 18 years old because it could cause serious, even fatal, dehydration. Updated 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.

 
23Jan
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Pediatric Use Extended for Fluarix

On Jan. 11, 2018, the U.S. Food and Drug Administration (FDA) approved the use of Fluarix® Quadrivalent (influenza vaccine - GlaxoSmithKline) for children as young as six months old. It contains four strains of inactivated, standardized influenza virus that produce antibodies after vaccination. Dosing is the same (0.5mL) for all age groups. For children up to eight years old who have not had flu vaccinations before, two doses are recommended to be given one month or more apart in the first year. Most previously vaccinated children need only one shot per flu season, but particularly vulnerable children, such as those with serious chronic health conditions, may be better protected with two.  Complete prescribing information is at: http://us.gsk.com/media/1444444/pi-fluarix_11jan2018.pdf.

Expanded Indication for Gilotrif

Boehringer Ingelheim’s tyrosine kinase inhibitor (TKI), Gilotrif® (afatinib) received additional approval from the FDA on Jan. 12, 2018. Its use was extended to the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) tumors that have non-resistant epidermal growth factor receptor (EGFR) L861Q, G719X and/or S768I mutations as verified by an FDA-approved diagnostic test. Gilotrif has previous approvals for treating squamous cell carcinoma of the lung that has progressed after treatment with platinum-based chemotherapy (chemo) and also for treating NSCLC with EGFR exon 19 deletions and/or exon 21 L858R mutations. Recommended dosing for most patients is one 40mg tablet each day until the cancer gets worse or the side effects become too severe. Taking Gilotrif may be associated with serious diarrhea, skin reactions and liver damage. It may harm a developing baby if taken during pregnancy. For prescribing information, please see: http://www.gilotrif.com/.

Trisenox Receives New Indication

Under priority review, the FDA approved Trisenox® (arsenic trioxide – Teva) injection on Jan. 12, 2018, as initial treatment for certain patients who have acute promyelocytic leukemia (APL). It is now indicated to treat adults newly-diagnosed with low-risk APL characterized by t(15;17) translocations or PML/RAR-alpha gene expression. Its original FDA approval was for the same indication, but only after treatment with chemo. Used along with tretinoin, Trisenox is given by intravenous (IV) infusions at weight-based doses to induce remission and then for consolidation therapy. The total number of doses in each phase is limited. In addition, using Trisenox may cause serious side effects, such as heart blockages, other heart problems and a syndrome that affects lung function, that require boxed warnings on its label. Patients may need electrocardiograms and electrolyte tests before and during treatment.  Complete prescribing information is at: http://www.trisenox.com/trisenox-prescribing-information.pdf.

MedWatch Update

Varubi

In a letter sent to healthcare providers in mid-January 2018, Tesaro, Inc. detailed important safety information about one of its drugs, Varubi® (rolapitant) injectable emulsion. Indicated for use with dexamethasone and a 5-HT3 receptor antagonist, such as ondansetron, it prevents delayed nausea and vomiting caused by emetogenic (nausea-producing) cancer chemotherapy (chemo). Although an oral tablet form of Varubi has been on the U.S. market since 2015, the injectable version was first FDA approved on Oct. 25, 2017. In post-market testing, a number of patients receiving the injectable form experienced anaphylaxis (extremely severe allergic reactions) or other serious hypersensitivity responses. Most of the side effects happened soon after the infusions began, but others developed later. Tesaro is advising physicians to avoid the use of injectable Varubi for patients who previously have had anaphylaxis and those with allergies to soybean oil or other plants in the pea family. Additionally, facilities where Varubi is infused should have emergency measures in place for patients who may need them.

 
16Jan
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

New Indication for Lynparza

Lynparza® (olaparib tablets – AstraZeneca) received approval from the U.S. Food and Drug Administration (FDA) for a new indication on Jan. 12, 2018. Originally approved to treat a specific type of advanced ovarian cancer, it now is indicated for metastatic human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has mutations in the BRCA gene. A companion diagnostic blood test identifies patients appropriate for treatment. Lynparza is a poly ADP-ribose polymerase (PARP) inhibitor that blocks an enzyme that cancer cells use to restore their DNA. It is the first PARP inhibitor to gain an indication for breast cancer and the first drug of any class to be designated for BRCA-mutation breast cancer. Recommended dosing is 300mg (two 150mg tablets) twice a day for as long as the cancer is managed and the patient is not experiencing unbearable side effects. The capsule form of Lynparza is not interchangeable with the tablets. Prescribing information is available here.

MedWatch Update

Cough and Cold Medicines Containing Opioids

On Jan. 11, 2018, the U.S. Food and Drug Administration (FDA) strengthened a Drug Safety Communication it had issued in April 2017. Manufacturers of prescription cough and cold products that contain the opioid products codeine or hydrocodone now must restrict their use only to adults. A review of available studies found that the advantages of using opioids to treat coughs and colds for patients under the age of 18 do not justify their considerable risks. FDA is requiring label changes for each product, including age limits and extension of the boxed warnings to provide information about abuse, addiction, misuse and overdose for all cough and cold products that contain an opioid. Boxed warnings also must caution about serious breathing problems and death that may be associated with opioid use. Parents are advised that colds rarely need drug treatment and that opioid-containing products are not appropriate for children’s coughs and colds. Prescribers are being reminded that alternative drugs – both prescription and non-prescription – are available, if needed. Caregivers and doctors should work together to determine the best treatment for each child. More information, including a list of affected products, is available here.

 
9Jan
Message from the Chief Operating Officer

Message from the Chief Operating Officer

Message from the Chief Operating Officer  
January 4, 2018 

 

Dear Foreign Service Benefit Plan (FSBP) Member:

We warned that there would be some disruption with the migration to the Aetna computer platform, and the last few days have proven those statements true. I appreciate the understanding and patience you have shown as we have worked to resolve the issues that have come up. I want to take this opportunity to provide some guidance on some of the questions we have received thus far.

ID Cards

Some members have not received their new ID cards yet. The mailing was completed on December 20. With the holiday rush and delays with overseas mailing times, some cards are still on their way to you. If you need a temporary card in the meantime, you can obtain one through Aetna Navigator. You can register for Navigator using your Social Security Number, rather than your new ID number. As of this morning, Aetna Navigator is back online following an outage yesterday and part of Tuesday. Once logged in, please click the link for ID Card on the top menu in the purple ribbon. Next, click on View ID Card and then on print/download ID card.

My Online Services

Members enrolled in FSBP prior to 1/1/18 can review the details of their claims for dates of service 12/31/17 and prior in My Online Services (MOS). Inside MOS, you may see that your coverage terminated effective 12/31/17 even though you are still a member of FSBP. This termination date in MOS is a result of the migration. Your current information is in Aetna Navigator.

Obtaining Prescriptions

If you do not have your new card and are not able to obtain a temporary card and need to fill a prescription, take your old card with you. The pharmacy staff can contact Express Scripts to verify your enrollment. They have their system set up for cross referencing old ID numbers and new ID numbers.

Contacting Us

We have experienced a large increase in calls in the last several days. While we prepared for this with additional staff and training, the call volume has resulted in longer than expected wait times. We are attempting to answer and return calls as quickly as possible but we also want to ensure that we are providing accurate and thorough responses to questions.

I appreciate your patience as we work through this migration together. 
                  
Thank you,                                                         
Kyle Longton, COO                                                                               

                                                                                  

 
8Jan
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

First Generic for Estrace Vaginal Cream

On Dec. 29, 2017, Mylan launched its estradiol vaginal cream, 0.01% immediately after approval by the U.S. Food and Drug Administration (FDA). Indicated to treat symptoms of vulvar and vaginal atrophy due to menopause, it is AB rated to Allergan’s Estrace® Cream. Recommended dosing is 2Gm to 4Gm applied vaginally once a day for up to two weeks. Doses should then be tapered to a maintenance dose of 1Gm one to three times per week. Estradiol vaginal cream can be used alone or in combination with a progesterone replacement product. Treatment should be reviewed frequently and restricted to the shortest duration feasible based on individual outcomes and risks. All estrogens, including estradiol vaginal cream, carry a boxed warning that using them may increase the risk of having breast or endometrial cancer. They should not be used, either alone or with a progestin, to prevent cardiovascular diseases or dementia. For the 12-month period ending on Oct. 31, 2017, IQVIA (formerly QuintilesIMS) estimated U.S. sales of Estrace Vaginal Cream at $449 million.

Generic Launched for Sustiva

Rising Pharmaceuticals announced on Jan. 2, 2018, that it has introduced to the U.S. market a generic for Sustiva® (efavirenz – Bristol-Myers Squibb) capsules, 50mg and 200mg. The drug, a non-nucleoside reverse transcriptase inhibitor (NNRTI), is used along with other antiretroviral drugs to treat patients who have HIV-1. It is U.S. Food and Drug Administration (FDA) approved for children as young as three months old. Pediatric dosing is determined by weight; the recommended adult dose is 600mg once daily, usually at bedtime. According to IQVIA, sales for Sustiva capsules were a little over $4 million in the 12 months that ended on October 31, 2017.

2017 Issues Document

In 2017, the U.S. Food and Drug Administration (FDA) approved 54 new medications, known as new molecular entities (NMEs) and therapeutic Biologic License Applications (BLAs), which is slightly lower that the all-time high of 56 new medications approved in 2015. This document is intended to provide a brief overview of FDA’s approval activity for 2017. The “FDA Approvals for 2017” Issues Document is available here.

 
2Jan
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Oral Solution Form of Valsartan Approved

Prexxartan® (valsartan) oral solution, the first commercial liquid dosage form for an angiotensin II receptor blocker (ARB), was approved by the U.S. Food and Drug Administration (FDA) on December 19, 2017. It will be used to manage high blood pressure for patients who are 6 years old or older and who have trouble swallowing tablets. Prexxartan also has indications for heart failure and for left ventricular dysfunction after a heart attack. It is taken twice a day. For children, dosing is by weight; adult doses range from 20mg to 160mg. Labeling carries a boxed warning against its use during pregnancy because it can harm the developing baby. A launch is expected in the first half of 2018. Prexxartan will be evaluated for the “Exclude at Launch” program of the National Preferred Formulary. Prescribing information is available here.

Generic for Reyataz Launched

Teva Pharmaceutical Industries launched a generic for Reyataz® (atazanavir) capsules on December 27, 2017. It is a once-daily protease inhibitor that is used in combination with other drugs to treat HIV-1 infection for patients who are at least 6 years old and who weigh at least 15kg (about 33 pounds). U.S. sales of Reyataz were estimated at $402 million for the 12-month period that ended on October 31, 2017.

Expanded Indication for Procysbi

Procysbi® (cysteamine bitartrate) is a specialty drug used to treat the rare condition nephropathic cystinosis, which affects about 500 American patients. Nephropathic cystinosis is an inherited metabolic lysosomal storage disorder that causes a protein, cystine, to accumulate throughout the body. It can result in blindness, kidney failure, muscle wasting and premature death. If they are not treated, children with cystinosis do not live to age 10. On December 7, 2017, the FDA extended the use of Procysbi to children as young as 1 year old. Dispensed as 25mg and 75mg capsules, it is dosed by weight once every 12 hours. Although it generally should not be taken with food, capsules may be opened and the contents sprinkled into no more than four ounces (one-half cup) of applesauce, berry jelly or fruit juice for patients who cannot swallow capsules. Updated prescribing information is available here

MedWatch Update

Tasigna Labeling Change

The U.S. Food and Drug Administration (FDA) announced on December 22, 2017, that the label for a Novartis kinase inhibitor, Tasigna® (nilotinib), has been updated with information on discontinuing treatment. Approved in 2007 to treat adults who have Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML), Tasigna blocks BCR-ABL, a fusion gene present in the majority of CML patients. CML, a slowly progressing cancer of the blood and bone marrow, usually is diagnosed in middle age. For most patients, drug treatment is continual until the drug no longer works or the patient can no longer tolerate its side effects. However, the chance of developing resistance to treatment increases with the length of drug therapy. Based on evidence from two clinical trials, the FDA has determined that some patients whose early chronic-phase CML has been managed for at least three years while they were taking Tasigna may stop treatment. They should be monitored closely for disease progression, however, which would require a return to active treatment. More information regarding the change is available here.  

 
29Dec

AFSPA is closing early in observance of the holiday

AFSPA will close at 2:00 PM EST on  December 29, 2017 in observance of the holiday. We will resume our normal business hours at 8:30 am EST on Tuesday, January 2, 2018

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

 
22Dec

AFSPA is closing early today, Friday, December 22

AFSPA will close at 2:00 PM EST on  December 22, 2017 in observance of the holiday. We will resume our normal business hours at 8:30 am EST on Tuesday, December 26, 2017

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

 

 
21Dec
Express Scripts News Flash

Express Scripts News Flash

On Dec. 20, 2017, the U.S. Food and Drug Administration (FDA) approved Merck and Pfizer’s Steglatro™ (ertugliflozin), a drug for use in combination with diet and exercise to improve glycemic control in adults with type 2 diabetes. Steglatro is the fourth approved product belonging to a class of drugs known as sodium-glucose co-transporter 2 (SGLT2) inhibitors. Drugs in this class work by blocking reabsorption of glucose by the kidneys; thereby increasing glucose excretion in the urine and lowering blood glucose levels. The recommended starting dose is 5mg once daily, taken in the morning with or without food. The dose can be increased to 15mg once daily in those tolerating the drug and requiring additional glycemic control. FDA also approved Segluromet™ and Steglujan™, which are ertugliflozin combinations with metformin and Januvia® (sitagliptin – Merck), respectively. Full prescribing information is available here.

  • Brand (Generic) Name: Steglatro™ (ertugliflozin)
  • Manufacturer: Merck and Pfizer
  • Date Approved: December 20, 2017
  • Indication: Steglatro is indicated for use as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
  • Dosage Forms Available: 5mg and 15mg tablets
  • Launch Date:   Early 2018
  • Estimated Annual Cost: Pricing information is not yet available. However, it likely will be similar to that of the other SGLT-2 inhibitors, which have an average wholesale price of about $3,400 per year of therapy.
  • Type 2 diabetes is the most common form of the disease affecting about 24 million people in the U.S. and accounting for more than 90% of diabetes cases.
  • Other SGLT-2 inhibitors available in the U.S. are Farxiga® (dapagliflozin – AstraZeneca), Invokana® (canagliflozin – Janssen) and Jardiance® (empagliflozin – Boehringer Ingelheim / Lilly)
  • Implications: Express Scripts currently is investigating the data around Steglatro (ertugliflozin) for a possible utilization management strategy. Steglatro also will be evaluated for exclude at launch on the Express Scripts National Preferred Formulary (NPF).
 
20Dec
Express Scripts News Flash

Express Scripts News Flash

The U.S. Food and Drug Administration (FDA) approved Spark Therapeutics’ Luxturna™ (voretigene neparvovec-rzyl) on Dec. 19, 2017. It is a unique gene therapy indicated to treat confirmed biallelic RPE65 mutation-associated retinal dystrophy, a rare genetic condition in which patients with the mutations gradually lose vision; many ultimately become totally blind. Luxturna must be injected into the subretinal space by an ophthalmic surgeon. It is given once into one affected eye and then six days to 18 days later into the other eye. Using a viral vector, it transfers intact copies of the RPE65 gene directly behind the retina. Retinal surgeons trained by Spark Therapeutics will be administering Luxturna at selected treatment centers. Spark plans on launching Luxturna in the first quarter of 2018. It will be available exclusively through CuraScript Specialty Distribution and Accredo Specialty Pharmacy.  Complete prescribing information is available here

  • Brand (Generic) Name: Luxturna™ (voretigene neparvovec-rzyl)
  • Manufacturer: Spark Therapeutics
  • Date Approved: December 19, 2017
  • Indication: For the treatment of confirmed biallelic RPE65 mutation-associated retinal dystrophy
  • Dosage Forms Available: Subretinal injections containing 5?×?1011 vector genomes of voretigene neparvovec in 0.3 mL of solution
  • Launch Date: Late in the first quarter of 2018
  • Estimated Annual Cost: Pricing information will be available in early January 2018.
  • Specialty Status: Luxturna will be added to Express Scripts’ specialty drug list.
  • Biallelic RPE65 mutation-associated retinal dystrophy is one of several eye conditions that result from genetic mutations in a set of about 220 genes that control for retinal pigment epithelium-specific 65 kDa protein; retinoid isomerohydrolase (RPE65). Together, they are believed to affect between 1,000 and 2,000 individuals in the United States. Patients with the conditions slowly lose vision to some degree. Most with biallelic RPE65 mutation-associated retinal dystrophy become completely blind by young adulthood.
  • Luxturna is the first gene therapy for a hereditary condition and the first treatment for any of the RPE65-associated vision conditions.
  • It will be administered in sterile facilities by ophthalmic surgeons with experience in eye surgery. Each eye is treated separately with one injection of Luxturna directly into space near the retina so that the drug is in contact with photoreceptor membranes where it delivers normally functioning gene copies. At least six days later, the other eye will be treated.
  • In a phase III clinical trial of 31 patients, those receiving Luxturna had significant visual improvement beginning about a month after the procedure and lasting for at least a year.
  • Luxturna was approved under FDA’s breakthrough therapy, orphan drug and priority review programs.
  • Implications: Express Scripts is not currently planning to include Luxturna within the Advanced Utilization Management (AUM) program since this medication will be predominately billed under the medical benefit.  If your client’s intent is to manage Luxturna on the medical benefit, please check their set-up to ensure the medication is not available through the pharmacy benefit.
 
19Dec
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

On Dec. 20, 2017, the U.S. Food and Drug Administration (FDA) approved Merck and Pfizer’s Steglatro™ (ertugliflozin), a drug for use in combination with diet and exercise to improve glycemic control in adults with type 2 diabetes. Steglatro is the fourth approved product belonging to a class of drugs known as sodium-glucose co-transporter 2 (SGLT2) inhibitors. Drugs in this class work by blocking reabsorption of glucose by the kidneys; thereby increasing glucose excretion in the urine and lowering blood glucose levels. The recommended starting dose is 5mg once daily, taken in the morning with or without food. The dose can be increased to 15mg once daily in those tolerating the drug and requiring additional glycemic control. FDA also approved Segluromet™ and Steglujan™, which are ertugliflozin combinations with metformin and Januvia® (sitagliptin – Merck), respectively. Full prescribing information is available here.

  • Brand (Generic) Name: Steglatro™ (ertugliflozin)
  • Manufacturer: Merck and Pfizer
  • Date Approved: December 20, 2017
  • Indication: Steglatro is indicated for use as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
  • Dosage Forms Available: 5mg and 15mg tablets
  • Launch Date:   Early 2018
  • Estimated Annual Cost: Pricing information is not yet available. However, it likely will be similar to that of the other SGLT-2 inhibitors, which have an average wholesale price of about $3,400 per year of therapy.
  • Type 2 diabetes is the most common form of the disease affecting about 24 million people in the U.S. and accounting for more than 90% of diabetes cases.
  • Other SGLT-2 inhibitors available in the U.S. are Farxiga® (dapagliflozin – AstraZeneca), Invokana® (canagliflozin – Janssen) and Jardiance® (empagliflozin – Boehringer Ingelheim / Lilly)
  • Implications: Express Scripts currently is investigating the data around Steglatro (ertugliflozin) for a possible utilization management strategy. Steglatro also will be evaluated for exclude at launch on the Express Scripts National Preferred Formulary (NPF).
 
19Dec

FSBP PARTNERS WITH MEDICLINIC CASERMA EDERLE

Featured Partner: MediClinic Caserma Ederle    

The Foreign Service Benefit Plan proudly welcomes the MediClinic Caserma Ederle in Pozzonovo, Italy as a direct billing partner.  The MediClinic Caserma Ederle offers free parking, onsite restaurants, and a LCD Video system supplying patient updates and wait times. Additionally, the facility has staff and providers that speak fluent English, French, Spanish and German. This facility is conveniently located approximately 30 miles from the Caserma Ederle military complex. 

Our direct billing arrangement with the MediClinic Caserma Ederle covers accidental injury*, inpatient*, routine physical exams/screenings*, and all covered outpatient medical services**.

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 +1 202-833-4910 for assistance.

* Accidental injury, inpatient, and routine physical exams/screenings: Member pays no deductible.  FSBP pays 100% of covered services.
**All covered outpatient medical services: Member pays applicable calendar year deductible and 10% coinsurance.  

 
19Dec
Express Scripts News Flash

Express Scripts News Flash

Generic Launched for Viagra

On Dec. 11, 2017, the first generic for Viagra® (sildenafil – Pfizer) was launched in the United States. Viagra is a phosphodiesterase-5 (PDE-5) inhibitor used to treat erectile dysfunction (ED). Due to patent lawsuit settlements, Teva can market its generics with 180 days of exclusivity. Pfizer is also releasing an authorized generic through its Greenstone generics division. Other generics will enter the U.S. market on June 9, 2018. For 2017, sales of Viagra in the United States were expected to total $1.4 billion. More information about the generic can be found on Teva’s website here.

  • Brand Drug: Viagra® (sildenafil – Pfizer)
  • Generic Manufacturer:  Teva
  • Indication: erectile dysfunction (ED)
  • Dosage Forms Available: 25mg, 50mg and 100mg tablets
  • Launch Date: December 11, 2017
  • Annual U.S. Sales: $1.4 billion
  • Viagra was approved by the U.S Food and Drug Administration (FDA) in 1998.
  • An estimated 18 million men in the U.S. are diagnosed with erectile dysfunction.
  • Other PDE-5 inhibitors approved for treating erectile dysfunction include Cialis® (tadalafil – Lilly) and Levitra® (vardenafil – Bayer/GlaxoSmithKline).
  • Due to settlement agreements, Teva can launch generics to Cialis beginning Sept. 27, 2018. The company can also launch a generic to Levitra “shortly before” the patent on Levitra expires on Oct. 31, 2018.
  • While progress is not known, Pfizer and Lilly/Sanofi have previously expressed interest in attempting to make Viagra and Cialis, respectively, available without a prescription.

Generic to Viread 300mg Launched

On Dec. 15, 2017, Teva Pharmaceuticals announced the launch of its AB-rated generic to Gilead’s Viread® (tenofovir disoproxil fumarate) 300mg tablets. Viread is a nucleotide analog HIV-1 reverse transcriptase inhibitor approved for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 2 years of age and older. Viread is also an HBV reverse transcriptase inhibitor approved for the treatment of chronic hepatitis B in adults and pediatric patients 12 years of age and older.

  • Brand Drug: Viread® (tenofovir disoproxil fumarate – Gilead)
  • Generic Manufacturer:  Teva Pharmaceuticals
  • Indication: Use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 2 years of age and older and for the treatment of chronic hepatitis B in adults and pediatric patients 12 years of age and older
  • Dosage Forms Available: 300mg tablets
  • Launch Date: December 15, 2017
  • Annual U.S. Sales: $762 million in the U.S., according to IMS data as of October 2017.
  • Teva’s launch of its generic to Viread 300mg tablets is based on a patent settlement agreement it reached with Gilead. Additional generics to Viread 300mg are expected on Jan. 26, 2018. Generics to Viread 150mg, 200mg and 250mg tablets are also expected to launch on Jan. 26, 2018.
 
15Dec

AFSPA is closing early today, Friday, December 15

AFSPA is closing early, today Friday, December 15, 2017 in celebration of the holiday. Additionally, we will be returning to normal telephone hours beginning Monday, December 18, 2017.  Telephone hours will be 8:30 a.m. – 5:30 p.m. EST Monday thru Friday.

Since Open Season has ended, you are probably wondering where your ID cards are.  Our Plan Administrator, Aetna, will begin mailing them this week! 

If you have family enrollment, you will only receive 2 ID cards.  The cards will include up to 5 covered dependents.  If you have more than 5 dependents, an additional card will be sent.  Additional family ID cards may be obtained by contacting our Member Quality Services (MQS) Team at [email protected], or through Aetna Navigator®, which will be available on or after January 1, 2018.

Remember to destroy your current ID card once you receive the new one, as they will be invalid after January 1st.

You may also contact the MQS Team if you have any questions regarding your Open Season Enrollment.

 
15Dec

Telephone hours return to normal schedule 12/18/2017

Open Season has officially ended.  Therefore, we will be returning to normal telephone hours beginning Monday, December 18, 2017.  Telephone hours will be 8:30 a.m. – 5:30 p.m. EST Monday thru Friday.

Since Open Season has ended, you are probably wondering where your ID cards are.  Our Plan Administrator, Aetna, will begin mailing them this week! 

If you have family enrollment, you will only receive 2 ID cards.  The cards will include up to 5 covered dependents.  If you have more than 5 dependents, an additional card will be sent.  Additional family ID cards may be obtained by contacting our Member Quality Services (MQS) Team at [email protected], or through Aetna Navigator®, which will be available on or after January 1, 2018.

Remember to destroy your current ID card once you receive the new one, as they will be invalid after January 1st.

You may also contact the MQS Team if you have any questions regarding your Open Season Enrollment.

 
11Dec

State of Emergency Due to Wildfires in California

The Governor of California has declared a State of Emergency due to wildfires. The following counties are now included in the State of Emergency in California: Los Angeles, San Diego, Santa Barbara and Ventura.

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 December 6, 2017 and expiration date of January 5, 2018

 
11Dec
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Lonhala Magnair Approved for COPD

On Dec. 5, 2017, Sunovion Pharmaceuticals, Inc. received U.S. Food and Drug Administration (FDA) approval for Lonhala™ Magnair™ (glycopyrrolate) inhalation solution. It is indicated for continuing maintenance treatment of chronic obstructive pulmonary disease (COPD). Lonhala is a long-acting muscarinic antagonist (LAMA); it is the first nebulized LAMA approved for COPD. It is delivered through the portable electric Magnair device only; no other nebulizers are designed to be used with it. Dosing is a 1 mL vial (25mcg) once in the morning and once in the evening. Each treatment lasts between two and three minutes. Launch is planned for early in 2018 as an initial kit containing a complete Magnair system plus 60 vials of Lonhala. Refills will include a replacement for the Magnair handset, which is similar to a multi-dose inhaler. During treatments, the patient breathes normally into the mouthpiece of the device. No details about pricing presently are available. Lonhala Magnair will be evaluated for the “Exclude at Launch” program of the National Preferred Formulary. Prescribing information is available here.

New Indication for Taltz

Eli Lilly’s interleukin 17A (IL-17A) inhibitor, Taltz® (ixekizumab) injection, received a new indication on Dec. 1, 2017. The U.S. Food and Drug Administration (FDA) approved it for treating adult patients who have psoriatic arthritis (PsA). It can be used as monotherapy or in combination with methotrexate or another conventional disease-modifying antirheumatic drug (cDMARD). However, it should not be used along with other biologic DMARDs. Available in single-use, pre-filled autoinjectors and syringes, Taltz is given as two separate subcutaneous (SC) injections of 80mg each once every four weeks to treat PsA. Because the risk of infections may be increased among patients using it, a tuberculosis (TB) test should be given before beginning it. Revised prescribing information is available here.  

Repatha Approved for Cardiovascular Protection

Repatha® (evolocumab – Amgen) was U.S. Food and Drug Administration (FDA) approved on Dec. 1, 2017, for decreasing the chance of cardiovascular (CV) events among patients who have CV disease. In a large clinical trial, the risk of heart attacks and strokes was reduced by 27% and 21%, respectively, for patients using Repatha along with appropriate statin doses as compared with patients using a placebo and a statin. A proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor, it was first approved in 2015 for treating patients who have heterozygous familial hypercholesterolemia (HeFH), homozygous familial hypercholesterolemia (HoFH) or clinical atherosclerotic CV disease (ASCVD) that requires additional lowering of low-density lipoprotein cholesterol (LDL-C) despite diet changes and maximum doses of other LDL?lowering therapies, such as statins. The recommended doses for Repatha are 140mg once every two weeks or 420mg once every month by SC injection. It is available in pre-filled syringes and autoinjectors containing 140mg each or as an on-body infuser, which holds 420mg in a 3.5mL cartridge of solution that is delivered over nine minutes. Full prescribing information is available here.

Full Approval for Avastin to Treat Glioblastoma 

Genentech received full U.S. Food and Drug Administration (FDA) approval on Dec. 5, 2017, for Avastin® (bevacizumab) to treat adults who have recurring glioblastoma. A common form of brain cancer, glioblastoma is diagnosed in approximately 12,300 U.S. citizens each year. An accelerated approval for the indication had been granted in 2009, pending results of an ongoing clinical trial involving more than 400 patients. In the study, overall survival (OS) rates were not statistically different, but average progression-free survival (PFS) time was 4.2 months for patients using both Avastin and lomustine as compared with 1.5 months for patients taking only lomustine. Avastin is a humanized monoclonal antibody that inhibits vascular endothelial growth factor (VEGF). It has additional indications for non-squamous non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC) and some types of cervical, colorectal and ovarian cancers. Using it may cause serious side effects, which include hemorrhages, interference with wound healing (including after surgeries) and perforation of the gastrointestinal tract. Prescribing information for Avastin is available here.

 
8Dec
From the CEO

From the CEO

Dear Valued AFSPA Member,

As 2017 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 am grateful to the AFSPA employees who provide you with the level of service you expect. We hope to continue our strong relationship with you in 2018.

To begin, I want to remind you that Open Season ends on Monday, December 11. You have a few days left to review your options and make changes to your Federal Employee Health Benefit (FEHB) Program enrollment, your Federal Employees Dental and Vision Insurance Program (FEDVIP) enrollment, and your FSAFEDS enrollment. We prepared an Open Season video to provide you more guidance on how to navigate through your Open Season. Also, please review the FEHB Checklist form from OPM. 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.

For those who have the Foreign Service Benefit Plan (FSBP), the migration from the Coventry computer platform to the Aetna platform is coming quickly. On January 1, 2018, My Online Services will be replaced by Aetna Navigator. You will receive new ID cards with new ID numbers.  Please destroy all previous ID cards you may have, as they will not be valid after January 1, 2018.  Lastly, your Explanation of Benefits (EOBs) will look different. During this process, some disruption is inevitable. However, FSBP is committed to making the transition as smooth as possible. Please review the Migration Brochure that was included in your Open Season Mailing. It outlines all the major changes and lets you know what to expect in the upcoming months.

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 services to support you through this busy time of year. Digital Coaching uses online tools to create a personalized plan for successful behavior change. Health Coaching allows you to talk on the phone one-on-one with a health coach. A more intensive service includes myStrength, an online mental health support program. It helps you overcome anxiety, while improving your overall well-being. Those in the U.S. also can utilize Telehealth Services through our vendor, Amwell. You can participate in video visits with a therapist for ongoing counseling. Always remember, you can reduce seasonal anxieties by being realistic, planning properly, and seeking support. Regardless of where you are in the world, FSBP is here to help, if you need us. 

It is particularly important to make positive choices during the holiday season. Focus on a balance of food and activity. Incorporate healthier recipes in your meals and don’t forget to exercise. Please review some other helpful tips from the Centers for Disease Control and Prevention.

As always, our mission is to provide you with “unparalleled service.” It is our pleasure to serve you and we thank you for entrusting us with your health care needs. I 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

 
6Dec

STATES OF EMERGENCY DUE TO WILDFIRES IN VENTURA COUNTY CALIFORNIA

The Governor of California has issued a State of Emergency for Ventura county 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 December 6, 2017 and expiration date of January 5, 2018.

 
4Dec
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Sublocade Approved for Opioid Use Disorder

On Nov. 30, 2017, the U.S. Food and Drug Administration (FDA) approved Indivior’s Sublocade™ (buprenorphine), a once-monthly subcutaneous injection for the treatment of moderate-to-severe opioid use disorder (OUD). It can be used in patients who have initiated treatment with a transmucosal buprenorphine-containing product, followed by dose adjustments for a minimum of 7 days. Sublocade should be used as part of a complete treatment program that includes counseling and psychosocial support. The drug is injected under the skin (subcutaneously) in the abdominal region by a health care professional. The recommended dose is 300mg monthly for the first two months, followed by 100mg monthly maintenance doses. The maintenance dose can be increased to 300mg monthly if the benefits are determined to outweigh the risks. Indivior plans on launching Sublocade 100mg/5mL and 300mg/1.5mL syringes during the 1st quarter of 2018; it will be available through a limited network of specialty pharmacies that includes Accredo. Sublocade must be prescribed and dispensed as part of a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the product is not distributed directly to patients. Complete prescribing information is available here.

Express Scripts is currently investigating the data around Sublocade for a possible utilization management strategy. Sublocade will be added to Express Scripts’ specialty drug list since it will only be available through a limited network of specialty pharmacies.

New Indication for Isentress Oral Solution

Isentress® (raltegravir) for oral suspension was approved for an additional pediatric indication by the U.S. Food and Drug Administration (FDA) on Nov. 22, 2017. An integrase inhibitor, it can be given, along with other antiretrovirals, to treat HIV-1 infections for babies less than one month old. The infants must weigh 2 Kg (about 4.5 pounds) or more and treatment should begin within 24 to 48 hours, if the mother took Isentress between two hours and 24 hours before the birth. Dosing, which depends on the baby’s weight, is by oral syringe once daily for the first week and then twice daily until the child is four weeks old. At four weeks, twice daily dosages still are determined by weight, but they increase significantly. Each dose is prepared individually by mixing one packet of Isentress powder with 10mL (about two teaspoons) of water no more than 30 minutes later. Unused suspension cannot be saved, it should be thrown away. Complete prescribing information is available here.  

FDA Approves Ogivri, a Biosimilar to Herceptin

On Dec. 1, 2017, the U.S. Food and Drug Administration (FDA) approved Mylan and Biocon’s Ogivri (trastuzumab-dkst), a biosimilar to Genentech’s Herceptin® (trastuzumab). Ogivri was approved for both Herceptin-approved indications. It is indicated for treating patients with breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumors overexpress the HER2 gene (HER2+). It is administered as an intravenous (IV) infusion. Ogivri is not considered a generic medication nor is it considered automatically interchangeable with its innovator brand, Herceptin. The dose of Ogivri varies depending on the indication. Launch information is not available at this time. Full prescribing information is available here.

 
27Nov
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

First Two-Drug Combination Approved to Treat HIV
Juluca®, ViiV Healthcare’s fixed-dose combination, which contains 50mg of dolutegravir and 25mg of rilpivirine, was approved by the U.S. Food and Drug Administration (FDA) on November 21, 2017. Dolutegravir, branded as Tivicay® (ViiV) is a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI) and rilpivirine, brand-name Edurant® (Janssen), is an HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI). The combination is indicated for once daily oral dosing, with food, to treat adults who have HIV-1 infection that has been virologically suppressed to HIV-1 RNA levels of less than 50 copies per mL on a stable antiretroviral regimen for at least six months. Juluca replaces current therapy for patients with no history of treatment failure and no known substitutions associated with resistance to the individual components of the combination. Juluca’s complete prescribing information can be found here.

New Dosage Form and Delivery System for Enbrel
On November 17, 2017, Amgen announced the launch of Enbrel Mini™ with AutoTouch™ reusable auto-injectors, which were FDA-approved in September, 2017. Enbrel® (etanercept) injection is a tumor necrosis factor (TNF) inhibitor used for the treatment of chronic inflammatory conditions such as ankylosing spondylitis, polyarticular juvenile idiopathic arthritis, plaque psoriasis, psoriatic arthritis and rheumatoid arthritis. It is injected subcutaneously (SC) once a week. The AutoTouch device, designed for easy use by patients with limited hand strength, has an ergonomic handle, a concealed needle, variable injection speeds and a sensor to insure proper placement. Sound cues (chimes) indicate when cartridges are inserted correctly. Single-dose, 50mg/mL cartridges are filled with a new, less irritating formulation of the drug. Enbrel’s labeling carries a boxed warning that using it may be associated with severe infections and that patients should be checked for tuberculosis (TB) before beginning it, while undergoing therapy and for several months after Enbrel treatment ends. All recommended vaccinations should be given before treatment starts. Additionally, some children and teens who used Enbrel or drugs like it developed lymphoma or other forms of cancer. For revised prescribing information, click here.

New Lower Strength of Auvi-Q Approved for Use in Young Children
Auvi-Q® (epinephrine injection) 0.1mg received FDA approval on November 20, 2017, to treat pediatric patients who weigh between 7.5Kg (16.5 pounds) and 25Kg (33 pounds). It is an auto-injector that delivers a smaller dose of epinephrine to block allergic reactions. Because it is designed for use in small children, the injector needle is shorter and the dose is smaller than in other Auvi-Q devices. The new injector has a voice feature that announces each step in the directions for use. Like Auvi-Q 1.5mg and 3mg auto-injectors, the lower dose will be dispensed in cartons containing two devices pre-filled with active drug and one inactive practice device. Detailed instructions are included with each prescription as well. Kaléo, Auvi-Q’s manufacturer, has not released its launch or pricing plans. Prescribing information can be found here.

 
22Nov

AFSPA is closing early!

AFSPA will close at 2:00 PM ET on Wednesday, November 22. We will remain closed in observance of the holiday. We will resume our normal business hours at 7:00 am EDT on Monday, November 27.

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

 
20Nov
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

FDA Approves the First Medication that Contains a Tracking Device

On Nov. 14, 2017, Otsuka received approval from the Food and Drug Administration (FDA) for the first drug product that includes a sensor to track ingestion. Developed in cooperation with Proteus Digital Health, the drug, Abilify Mycite® (aripiprazole tablets with sensor), is an atypical antipsychotic with several indications that include some aspects of bipolar I disorder, major depression and schizophrenia. Each tablet contains an ingestible event marker (IEM) about the size of a sand grain. When the sensor comes in contact with stomach acid, a signal goes to a patch the patient wears. Information is transmitted to a smartphone app and the patient can designate healthcare providers and/or caregivers to receive the data. If the patient wishes, other information, such as activity levels, mood and sleep, can be tracked, but those functions are not yet FDA approved. The initial launch for Abilify Mycite will be very limited – through a small group of providers and for carefully selected patients only. Estimated cost is not available. Dosing recommendations are from 2mg to 15mg per day depending on the condition being treated, but no more than 30mg should be taken per day. Labeling for Abilify Mycite carries a boxed warning that the chance of death is increased for elderly patients who have dementia-related psychoses. Complete prescribing information is available here.

Expanded Indication for Vraylar

Vraylar™ (cariprazine – Allergan) received U.S. Food and Drug Administration (FDA) approval for a new indication on Nov. 13, 2017. Already approved to treat acute schizophrenia and acute manic or mixed bipolar I disorder episodes, it now has approval for maintenance treatment of schizophrenia. With an estimated 2.4 million American adults affected, schizophrenia is difficult to treat – partly because individual response is unpredictable. As many as 80% of patients relapse within two years after starting treatment unless they receive maintenance therapy. In clinical trials that lasted up to 72 weeks, 29.7% of patients taking Vraylar had a relapse as compared to 49.5% of those taking a placebo. Vraylar is taken once a day with a recommended daily dose range between 3mg and 6mg. The risk of death increases when it is used by elderly patients who have psychoses associated with dementia, so a boxed warning cautions against use for older patients. It also is not indicated for pediatric use. Full prescribing information is available here.

New Formulation and Pediatric Indication for Tekturna

Noden Pharma announced on Nov. 14, 2017, that the U.S. Food and Drug Administration (FDA) has approved Tekturna® (aliskiren) oral pellets for treating patients who are at least 6 years old and who weigh at least 20Kg (about 44 pounds). Available as oral tablets since 2007, Tekturna previously was indicated only for adults. Used to manage high blood pressure, it is the only direct renin inhibitor to be FDA approved. It blocks the ability of renin to tighten blood vessels causing them to relax and lowering blood pressure. According to the American Academy of Pediatrics, about 3.5% of children and teens – up to 25 million -- have high blood pressure and an additional 3.5% are at risk for developing it. The recommended pediatric dose for Tekturna is 75mg or 150mg daily for patients weighing between 20Kg and 50Kg (110 pounds). Those over 50Kg should take the adult dose of 150mg or 300mg once a day. For individuals who have trouble swallowing, capsules each containing 37.5mg of Tekturna pellets may be opened and the contents swallowed either by themselves or immediately after being mixed with small amounts of ice cream, pudding, milk or water. The form of the drug that contains a diuretic, Tekturna® HCT (aliskiren/hydrochlorothiazide), is not approved for pediatric patients. Tekturna’s updated prescribing information is available here.

Faslodex Receives Expanded Indication

Faslodex® (fulvestrant), AstraZeneca’s estrogen-receptor antagonist, was U.S. Food and Drug Administration (FDA) approved on Nov. 15, 2017, for use in combination with Verzenio™ (abemaciclib – Eli Lilly). Used together, they treat women who have advanced or metastatic hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer that has worsened after treatment with an endocrine drug, such as tamoxifen or anastrozole. Approved for the same indication and combination in September, Verzenio selectively inhibits cyclin-dependent kinases 4 and 6 (CDK4/6), which are enzymes that promote the growth and spread of cancer cells. In a clinical study, average progression-free survival (PFS) was about seven months longer for participants taking Faslodex and Verzenio compared with patients taking Faslodex by itself (16.4 months vs. 9.3 months). Dosing is on 28-day cycles with one 500mg intramuscular (IM) injection of Faslodex on the first and fifteenth days of cycle one, followed by one dose on day one of each successive cycle. One 150mg Verzenio tablet is taken orally twice every day. On the U.S. market for 15 years, Faslodex has previous indications for breast cancer patients. Its revised prescribing information is available here

Gazyva Indications Expanded

Genentech’s Gazyva® (obinutuzumab) was U.S. Food and Drug Administration (FDA) approved on Nov. 16, 2017, for treating adults who have stage II bulky, stage III or stage IV advanced follicular lymphoma that has not had previous treatment. Initially, it will be given along with chemotherapy (chemo), for six to eight 28-day cycles. Dosing is by IV infusion at 1,000mg per treatment. Gazyva will be administered on days one, eight and 15 of the first cycle; only on the first day of the next five to seven cycles; and then once every two months for up to two years. If the patient responds to combination therapy with chemo, treatment will continue with only Gazyva after the first six to eight cycles. Some patients using it developed progressive multifocal leukoencephalopathy (PML), a rare life-threatening viral infection that damages the brain. Additionally, hepatitis B was reactivated for some patients who had been treated for it previously. Labeling for Gazyva bears a boxed warning for both PML and hepatitis B. It is available in single-dose 40mL vials containing 1,000mg of active drug. Its full prescribing information is available here

Express Scripts is not currently planning to include Gazyva within Automated Utilization Management (AUM) since this medication is IV/infused and will predominately be seen on the medical benefit.  If your intent is to manage Gazyva on the medical benefit, please check with your account team to ensure the medication is not available through the pharmacy benefit.

Additional Indication for Sutent

On Nov. 16, 2017, Sutent® (sunitinib) was approved by the U.S. Food and Drug Administration (FDA) as adjuvant therapy to prevent the recurrence of renal cell carcinoma (RCC) for adults who are at high risk for its return after having a cancerous kidney removed. Sutent is a multi-kinase inhibitor that also has indications for pancreatic cancer and gastrointestinal stromal tumors. Taken orally once a day, its dosing varies depending on the condition being treated. In a clinical study of about 600 post-surgical RCC patients, the average length of disease-free survival was 6.8 years for patients taking Sutent versus 5.6 years among those taking an inactive placebo. Sutent has a number of potentially serious side effects including possible liver damage that could be fatal. A boxed warning and patient medication guide detail the risks. Prescribing information is available here.

 
20Nov
Express Scripts News Flash

Express Scripts News Flash

Hemlibra Approved for Hemophilia A

On Nov. 16, 2017, the U.S. Food and Drug Administration (FDA) approved Genentech’s Hemlibra® (emicizumab-kxwh) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A who have developed antibodies called factor VIII inhibitors. The recommended dose is 3 mg/kg injected under the skin (subcutaneously) once weekly for the first 4 weeks, followed by 1.5 mg/kg once weekly. Genentech has already launched the product through a limited network of specialty pharmacies that includes Accredo. Complete prescribing information is available here

  • Brand (Generic) Name: Hemlibra® (emicizumab-kxwh)
  • Manufacturer:  Genentech
  • Date Approved: November 16, 2017
  • Indication: Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors.
  • Dosage Forms Available: Single-use vials containing 30mg/mL, 60mg/0.4mL, 105mg/0.7mL and 150mg/mL of Hemlibra.
  • Launch Date: According to Genentech, the product has already launched.
  • Estimated Annual Cost: The cost is dependent upon the patent's weight. However, at an average weight of 127 pounds, therapy will cost approximately $482,000 for the first year of treatment and then approximately $448,000 per year thereafter.
  • Specialty Status: Hemlibra will be added to Express Scripts’ specialty drug list.
  • Hemophilia A is a rare, chronic, genetic bleeding disorder affecting approximately 16,000 adults and children in the United States. It is caused from insufficient clotting Factor VIII activity, which is a protein in the blood that controls bleeding. Patients with hemophilia A experience bleeding episodes that cause pain, irreversible joint damage and possibly life-threatening hemorrhages.
  • An estimated one in three people with severe hemophilia A develop factor VIII inhibitors, or antibodies to the factor VIII replacement therapies. The presence of these inhibitors can result in an increased risk for life-threatening bleeds or repeated bleeds.
  • Hemlibra is a bispecific monoclonal antibody – it replaces the activity of coagulation factor VIII by sticking to both activated coagulation factor IXa and factor X to prevent bleeding episodes for patients who have hemophilia A and inhibitors to Factor VIII.
  • A boxed warning on Hemlibra labeling cautions that severe blood clots (thrombotic microangiopathy and thromboembolism) have been observed in patients who were also given a rescue treatment (activated prothrombin complex concentrate) to treat bleeds for 24 hours or more while receiving Hemlibra therapy.
  • Hemlibra was approved nearly three months ahead of schedule under FDA’s breakthrough therapy and priority review programs.
  • Implications: Hemlibra will be evaluated for the Exclude at Launch Program for the National Preferred Formulary.
 
17Nov
Express Scripts News Flash

Express Scripts News Flash

Fasenra Approved for Severe Asthma

The U.S. Food and Drug Administration (FDA) approved Fasenra™ (benralizumab – AstraZeneca) on Nov. 14, 2017. An adjunct therapy, it will be used for maintenance treatment of patients at least 12 years old who have severe eosinophilic asthma. It works by blocking interleukin-5 (IL-5) receptors on the surfaces of eosinophils, a type of white blood cell. In clinical studies, patients using Fasenra along with their standard asthma drugs had improved lung function and fewer asthma attacks than patients receiving their usual asthma medications plus a placebo. Recommended dosing is 30mg given by a healthcare provider subcutaneously (SC) once every two months after the first three doses are administered at one-month intervals. AstraZeneca plans to launch Fasenra in the next few weeks at a first-year wholesale acquisition cost (WAC) of $38,000. Prescribing information is available here.

  • Brand (Generic) Name: Fasenra™ (benralizumab)
  • Manufacturer:  AstraZeneca
  • Date Approved: November 14, 2017
  • Indication: For the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype.
  • Dosage Forms Available: Single-use, pre-filled syringes each containing 30mg of Fasenra for SC injection.
  • Launch Date: AstraZeneca will launch Fasenra within the next few weeks.
  • Estimated Cost: $38,000 for year one; $28,000 to $33,000 in the following years.
  • Specialty Status: Fasenra will be added to Express Scripts’ specialty drug list.
  • According to the U.S. Centers for Disease Control and Prevention (CDC), more than 22 million Americans have asthma and between 5% and 10% of patients with asthma have severe asthma. Approximately 50% of patients with severe asthma have an eosinophilic phenotype.
  • Fasenra reduces severe asthma attacks by sticking to IL-5 receptors on eosinophils, white blood cells that contribute to increased sensitivity of the airways among asthma patients.
  • In clinical studies, patients using Fasenra had up to 50% fewer asthma attacks per year than patients receiving a placebo. Additionally, Fasenra allowed three-quarters of the patients using it to reduce or discontinue their oral corticosteroids.
  • Cinqair® (reslizumab – Teva) and Nucala® (mepolizumab – GlaxoSmithKline) are other IL-5 inhibitors that are FDA approved for treating severe eosinophilic asthma. Cinqair is infused intravenously (IV) and Nucala given SC; they are both administered once-monthly by a healthcare professional.
  • Implications: Express Scripts currently is investigating the data around Fasenra for a possible utilization management strategy.

Mepsevii Approved for Mucopolysaccharidosis VII

On Nov. 15, 2017, the U.S. Food and Drug Administration (FDA) approved Mepsevii™ (vestronidase alfa-vjbk) injection. It replaces an enzyme, beta-glucuronidase, which is missing for patients who have a very rare inherited condition known as mucopolysaccharidosis type VII (MPS VII). Indicated for both children and adults, it is given once every two weeks as a four-hour intravenous (IV) infusion at 4mg/Kg. The manufacturer, Ultragenyx Pharmaceutical, Inc. will release it later in November exclusively through Accredo Specialty Pharmacy. Pricing information has not yet been announced. A boxed warning cautions that some patients have experienced severe allergic reactions from Mepsevii, so infusions should be given in a facility prepared to handle emergencies. Patients should remain in the facility for at least one hour after each infusion. Complete prescribing information for Mepsevii is available here.

  • Brand (Generic) Name: Mepsevii™ (vestronidase alfa-vjbk) 
  • Manufacturer:  Ultragenyx Pharmaceutical, Inc.
  • Date Approved: November 15, 2017
  • Indication: For the treatment of pediatric and adult patients who have mucopolysaccharidosis VII (MPS VII, Sly syndrome).
  • Dosage Forms Available: Single-use vials containing 10mg/5mL for IV infusion.
  • Launch Date: November 2017
  • Estimated Cost: Pricing information is not yet available.
  • Specialty Status: Mepsevii will be added to Express Scripts’ specialty drug list.
  • Only about 150 to 200 patients in the world are believed to have MPS VII. The lack of an enzyme needed to metabolize certain carbohydrates causes them to build up over time, eventually damaging tissues.
  • Although symptoms vary, they include abnormal bone development, breathing difficulty, cardiovascular problems and liver damage. Most patients do not survive into adulthood.
  • Mepsevii is the first drug to be FDA approved for treating MPS VII. It was designated as an orphan drug and granted fast track review; it also qualified for a Rare Pediatric Disease Priority Review Voucher.
 
13Nov
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

New Vaccine Approved to Prevent Hepatitis B

Heplisav-B™ [hepatitis B vaccine, recombinant (adjuvanted)], was approved by the U.S. Food and Drug Administration (FDA) on Nov. 9, 2017, for preventing all subtypes of hepatitis B. It includes a Toll-like Receptor (TLR) 9 agonist that increases immune response to the hepatitis B surface antigen in it. Indicated for adults, it will be given as two intramuscular (IM) injections spaced one month apart. Currently available hepatitis B vaccines require more doses to be administered over longer times. Additionally, in clinical trials, Heplisav-B was effective for higher percentages of participants receiving it than an already available vaccine was. Hepatitis B, a highly contagious, incurable viral infection of the liver, can be sexually transmitted or acquired from contact with blood infected with it. Untreated, it can result in cirrhosis, cancer or death. Because children are vaccinated against hepatitis B, nearly all new diagnoses in the United States – about 3,400 acute cases and 14,500 chronic cases in 2015 – are among adults. The U.S. Centers for Disease Control and Prevention (CDC) recommends hepatitis B vaccinations for adults who have diabetes and those who may be at higher risk through their lifestyles, occupations or travel. Dynavax, Heplisav-B’s manufacturer, expects to launch Heplisav-B in the first quarter of 2018. Its full prescribing information is available here.

New Anti-Emetic Approved

On Nov. 9, 2017, the U.S. Food and Drug Administration (FDA) approved Heron Therapeutics’ Cinvanti™ (aprepitant) injectable emulsion, for IV infusion. It will be used to prevent chemotherapy-induced nausea and vomiting (CINV) among adults. It must be used along with the other anti-emetic drugs, dexamethasone and a serotonin-3 (5-HT3) receptor inhibitor such as ondansetron. It can be administered to prevent CINV caused by chemo drugs that are either moderately or highly associated with CINV. Both acute and delayed episodes may be prevented and Cinvanti can be used for first treatments as well as for subsequent rounds of chemo. A substance P/neurokinin-1 (NK1) receptor antagonist, it works by blocking receptor sites in the brain. Heron is planning to introduce it in January 2018. Doses are given as a 30-minute infusion about 30 minutes before the start of chemo on the first day. Recommended dosing is 130mg for chemo that has a high risk of causing CINV and 100mg for drugs with moderate risk. Packaged in single-dose 130mg vials, Cinvanti does not contain polysorbate 80, an inactive ingredient that has caused infusion site reactions and hypersensitivity for some patients receiving products that include it. Prescribing information is available here.

Prevymis Approved for Transplant Patients

The U.S. Food and Drug Administration (FDA) approved Merck’s Prevymis™ (letermovir) on Nov. 8, 2017. To be launched as both oral tablets and intravenous (IV) infusion, it is the first in a new class of antiviral drugs known as non-nucleoside cytomegalovirus (CMV) inhibitors. Although other drugs treat CMV, Prevymis is the first drug indicated to prevent CMV infection and disease for CMV-seropositive adults who receive hematopoietic stem cell transplants (previously called bone marrow transplants). Of the estimated 8,500 Americans who undergo a stem cell transplant each year, between 65% and 80% are CMV-seropositive – making them more prone to have an infection. Prevymis will be given as infusions beginning on the day of the transplant or any day up to 28 days later, and switched to tablets as soon as the patient can tolerate them and continued until the 100th day after the procedure. Recommended dosing is 480mg once a day. Wholesale acquisition cost for each 480mg tablet is $195 and for a 480mg single-use vial is $270. Complete prescribing information is available here

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

Pediatric Indication for Vimpat

The U.S. Food and Drug Administration (FDA) extended labeling for Vimpat® (lacosamide – UCB, Inc.) on Nov. 3, 2017. Its indications now include treatment for patients as young as four years old. Originally approved in 2009 for adults, Vimpat treats partial-onset seizures. Its intravenous (IV) form is not recommended for patients under the age of 18 years, but both oral tablets and an oral solution are available. For children and teens, doses are taken twice daily at amounts determined by the patient’s weight. Updated prescribing information for Vimpat is available here.

First Drug Approved to Treat Erdheim-Chester Disease

Based on results of a phase II basket study, the U.S. Food and Drug Administration (FDA) approved Zelboraf® (vemurafenib - Genentech) tablets to treat Erdheim-Chester Disease (ECD) on Nov. 6, 2017. Basket studies enroll patients whose tumors have specific mutations rather than patients with cancers of specific organs. ECD is one in a group of related conditions that all involve overproduction of a specific type of white blood cells, which collect abnormally in bones, organs and other body tissues. It is believed to affect about 500 Americans. Most patients with it are diagnosed in their 50s or 60s, around three-quarters are men and about half have BRAF V600E mutations. Current treatments include corticosteroids, certain chemotherapy drugs, interferons, radiation and surgery. Zelboraf, a kinase inhibitor, also is indicated to treat patients who have inoperable or metastatic melanoma that has BRAF V600E mutations. Recommended dosing for both indications is 960mg (four tablets) taken at approximate 12-hour intervals. Prescribing information for Zelboraf is available here.

Expanded Indication for Alecensa

Also on Nov. 6, Genentech announced that the U.S. Food and Drug Administration (FDA) has approved Alecensa® (alectinib) capsules for first-line treatment of metastatic non-small cell lung cancer (NSCLC) that tests positive for anaplastic lymphoma kinase (ALK) using an FDA-approved diagnostic test. Originally FDA approved in late 2015, it had been indicated only as second-line therapy after treatment with a competitor, Xalkori® (crizotinib – Pfizer) was no longer effective or became intolerable. In the phase III ALEX trial, however, average progression-free survival (PFS) time for patients receiving Alecensa was over twice as long (25.7 months) as for those taking Xalkori (10.4 months). The American Cancer Society estimates that new cases of ALK-positive NSCLC will account for between 2% and 7% of the estimated 180,000 Americans diagnosed with NSCLC in 2017. Unlike most cancers, it mainly affects non-smoking individuals in their 30s and 40s. Women and those of Asian ancestry are more likely to have it, as well. Recommended Alecensa dosing is 600mg (four capsules) twice a day along with a meal. Patients taking it will need to have liver function tests every month. Revised prescribing information is available here.

Auryxia Gains New Indication

Auryxia® (ferric citrate) was U.S. Food and Drug Administration (FDA) approved on Nov. 6 to treat iron deficiency anemia for patients who have chronic kidney disease (CKD) but who do not need to have dialysis. Both an iron replacement and a phosphorus binder, it previously had approval to manage phosphorus levels for patients on dialysis. For its new indication, the recommended dose of Auryxia is one tablet (210mg) three times a day with meals. Doses may be increased, if needed, to a maximum of 12 tablets per day. Auryxia’s prescribing information is available here

Fourth Indication for Adcetris

On Nov. 9, the U.S. Food and Drug Administration (FDA) approved Seattle Genetics’ antibody-drug conjugate, Adcetris® (brentuximab vedotin) to treat the most common forms of cutaneous T-Cell Lymphoma (CTCL). It now is indicated for adult patients who have been treated previously for primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF). It is administered by IV infusion once every three weeks at a dose of 1.8mg/Kg of the patient’s body weight. Each dose is limited to a maximum of 180mg and the total number of doses is limited to 16 per patient. In the phase III ALCANZA clinical study,  67.2% of patients using Adcetris had improvements in objective response rates (ORR) compared to 20.3% of patients who received the standard of care, either methotrexate or bexarotene. Average progression-free survival (PFS) times were longer, as well; 16.7 months for those receiving Adcetris versus 3.5 months for patients in the standard-of-care group. Previously FDA approved for some types of ALCL and some Hodgkin lymphomas, Adcetris is being investigated both as monotherapy and in combination with other oncology drugs for its effectiveness in treating several other cancers. Labeling carries a boxed warning that some patients using it developed progressive multifocal leukoencephalopathy (PML), a very rare life-threatening viral infection that damages the brain. Complete prescribing information is available here

Pediatric Indication for Sprycel 

A new indication for Bristol-Myers Squibb’s kinase inhibitor Sprycel® (dasatinib) tablets was U.S. Food and Drug Administration (FDA) approved on Nov. 10, 2017. Its new approval is for treating children and adolescents who are in the chronic phase of Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) and who weigh at least 10Kg (22 pounds). Only about 3% of children with leukemia have CML, but it often progresses more rapidly for young patients. Daily dosing of Sprycel for pediatric patients in clinical trials was 60mg/square meter of body surface area up to a total of 100mg per day. Doses should be evaluated once every three months and adjusted according to changes in the patient’s weight. Bone growth also should be watched since Sprycel has caused growth delays for some patients. Other major possible side effects include blood abnormalities, excessive bleeding, heart irregularities and pulmonary hypertension. Sprycel also has adult indications to treat some types of CML and acute lymphoblastic leukemia (ALL) that are Ph+. It is supplied as 20mg, 50mg, 70mg, 80mg, 100mg and 140mg oral tablets. Revised 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

 
6Nov
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Ophthalmic Drug, Vyzulta, Approved

On Nov. 2, 2017, Vyzulta™ (latanoprostene bunod ophthalmic solution, 0.024%) was approved by the U.S. Food and Drug Administration (FDA). It is an ophthalmic prostaglandin used once daily to decrease intraocular pressure (IOP) for patients with open-angle glaucoma or ocular hypertension. Recommended dosing is one drop in the affected eye(s) each evening. Vyzulta dissociates into latanoprost acid and butanediol mononitrate, which work in different ways to promote draining of aqueous humor (liquid in the front of the eye). Using it may cause changes in eye and eyelid color. Eyelash properties, including length and thickness, also may be affected. In the U.S., Vyzulta will be distributed by a Valeant subsidiary company, Bausch + Lomb, which developed the drug jointly with Nicox SA. No launch date or pricing plans are available, yet. Full prescribing information is available here.

Express Scripts is currently investigating the data around Vyzulta for a possible utilization management strategy. Vyzulta will be evaluated for the Exclude at Launch Program for the National Preferred Formulary.

New Indication for Xarelto

The U.S. Food and Drug Administration (FDA) approved a new indication for Xarelto® (rivaroxaban – Janssen Pharmaceuticals) 10mg tablets on Oct. 27, 2017. An oral factor Xa inhibiting anticoagulant, Xarelto now is indicated to decrease the risk of repeated venous thromboembolism (VTE) after the patient has taken anticoagulants for six months or longer. Originally FDA approved in 2011, it has several other indications and two additional strengths (15mg and 20mg). Boxed warnings caution that hematomas (blood clots outside a blood vessel) have occurred for patients who undergo spinal procedures, such as neuraxial anesthesia, while taking it. Some of those patients are paralyzed. In addition, stopping Xarelto before its prescribed end date may increase the risk of thrombotic events, including strokes. All anticoagulants may cause excessive, sometimes fatal, bleeding. Currently, no other drug is available to counteract Xarelto’s effects. Updated prescribing information is available here.

 
4Nov
From the CEO

From the CEO

Welcome to November 2017! 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. Consider adding dental coverage, life insurance, or a disability plan from AFSPA.  

Extended Health Plan Hours

To assist with your Open Season needs, the Foreign Service Benefit Plan (FSBP) will institute extended operating hours. Beginning Monday, November 6, our Health Benefits Officers will be available 7am to 5:30pm EST. These extended hours will be in effect throughout Open Season, for your convenience. Please call us during these earlier hours with your questions and concerns related to the health plan.
 

Open Season Briefings 
Open Season officially begins Monday, November 13, 2017. As you may know, 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 any plan under the FEHB Program can attend these briefings. This year’s topics include OPM Initiatives, Prescription Drugs, Access to Care, Wellness Programs, FSAFEDS, and FEDVIP. Please plan to attend and bring your questions. See the November schedule below:

  • November 6 – Misawa, Sollars Elementary School Library, 3:15pm
  • November 6 – Kadena AFB, Kadena High School
  • November 7 – Kadena AFB – details being finalized  
  • November 8 – Yokosuka, Building A-20, Classroom – 10:30am and 12pm
  • November 8 – Yokosuka, Sullivan School Complex, 3pm
  • November 13 – Yongsan, Seoul American Elementary School Library, 3:30pm
  • November 13 – Yokota, Yokota West Elementary School Multi-Purpose Room, 3pm
  • November 14 – Osan AFB, Bldg. 936, Rm. 214, 1pm
  • November 14 – Osan AFB, Osan American Elementary School, 4pm
  • November 14 – Atsugi, Shirley Lanham Elementary School, 3:30pm
  • November 15 – Camp Humphreys, Humphreys Central Elementary School Library, 2:40pm
  • November 15 – Zama, Zama High School, 3pm
  • November 16 – Ikego, Ikego Elementary School, 2:45pm
  • November 16 – Daegu, Korea – details being finalized  

We hope to see you at one of our Open Season Briefings. For those who are unable to attend, we have produced a video of my talk that will be available beginning Nov 13 – the first day of Open Season. Please go to our website, www.afspa.org/openseason.

Open Season is November 13 through December 11 this year. Please carefully review your options in FEHB, FEDVIP, and FSAFeds to make an informed decision that works best for you and your family.

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. By doing that, watching your portion size, and burning a few calories with a long walk after dinner, you may start a healthy new Thanksgiving family tradition.

This year, thank your body by maintaining a healthy diet during the traditional gatherings. Reduce your salt intake, control your portions, and load your plate with vegetables. This might be a good time to take advantage of the “Not One Ounce” Holiday Program offered by the Mediterranean Wellness Program.  On this 8-week plan, participants can lose rather than gain weight during the holiday season.

AFSPA’s Facebook Page
Many of our members have chosen to like us on Facebook. With over 700 followers, AFSPA can use social media to hear from you in a whole new way. We regularly share healthy living ideas, fitness tips, and member benefits. This Open Season, AFSPA will use social media to connect with you even more. A useful health tip will be posted each day. Please check our Facebook page every day between mid-November and mid-December. You will learn something new to use all year long.

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

 
31Oct
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Calquence Approved to Treat Mantle Cell Lymphoma

Under its accelerated approval program, the U.S. Food and Drug Administration (FDA) approved AstraZeneca’s Calquence® (acalabrutinib) on Oct. 31, 2017, well ahead of its expected action date. With breakthrough therapy and orphan designations, it is indicated to treat adults who have mantle cell lymphoma (MCL) and who already have received one or more previous therapies. Calquence inhibits Bruton tyrosine kinase (BTK), an enzyme cancers use to proliferate and spread. Recommended dosing is one capsule (100mg) taken orally about once every 12 hours. AstraZeneca plans on launching Calquence within one week. It will be dispensed through a limited network of specialty pharmacies that does not include Accredo. Full prescribing information is available here

  • Brand (Generic) Name: Calquence® (acalabrutinib)
  • Manufacturer:  AstraZeneca Pharmaceuticals LP
  • Date Approved: October 31, 2017
  • Indication: Treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.
  • Dosage Forms Available: 100mg oral capsules
  • Launch Date: Within one week
  • Estimated Cost: $171,100
  • Specialty Status: Calquence will be added to Express Scripts’ specialty drug list.
  • MCL accounts for 3% to 6% of non-Hodgkin lymphoma (NHL) cases in the United States. Approximately 3,300 Americans are diagnosed with MCL each year. Typically, it is aggressive -- by the time it is diagnosed, it usually has spread to the bone marrow and lymph nodes.
  • In a clinical trial of 124 patients who have MCL and who had treatment with non-BTK inhibitors, 40% had a partial response to Calquence treatment and an additional 40% had a complete response. The average amount of time to each patient’s best response was just short of two months and median duration of response had not been reached when results were reported. Some responses were continuing past 20 months.
  • The most serious side effects reported with using it are arrhythmias, cytopenias, hemorrhage, infections and secondary cancers.
  • Calquence will compete with the other FDA-approved BTK inhibitor, Imbruvica® (ibrutinib – Pharmacyclics/Janssen), which also has indications to treat other types of cancer. Other drugs approved to treat MCL include Velcade® (bortezomib – Takeda) and Revlimid® (lenalidomide – Celgene).
  • It is in phase III studies for use in combination with Treanda® (bendamustine – Cephalon) and Rituxan® (rituximab – Genentech) as a first-line treatment for MCL. Trials of its use for other types of cancer also are ongoing.
  • Indications: Express Scripts currently is investigating the data around Calquence for a possible utilization management strategy.
 
30Oct
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

GlaxoSmithKline’s Shingles Vaccine Approved

Shingrix (zoster vaccine recombinant, adjuvanted) received approval from the U.S. Food and Drug Administration (FDA) on Oct. 20, 2017. Given as two intramuscular (IM) injections between two months and six months apart, it is indicated to prevent shingles (herpes zoster) for adults who are 50 years old or older. In clinical studies, Shingrix was effective for approximately 90% of patients in preventing both acute shingles and the postherpetic neuralgia (PHN) that follows it for up to one-fifth of patients with shingles. On Oct. 25, 2017, the Advisory Council on Immunization Practices of the Centers for Disease Control and Prevention (CDC) voted to recommend Shingrix as the preferred shingles vaccine in the U.S. The council also suggested re-vaccination for individuals who already had been vaccinated with Merck’s less effective Zostavax® (zoster vaccine, live), which has been the only shingles vaccine available in the U.S. since its approval in May 2006. Additionally, the council lowered the age at which the vaccination should be given from 60 years old to 50 years old. Although chickenpox and shingles are caused by the same virus that may reactivate as individuals age and their immune systems weaken, Shingrix does not prevent chickenpox and it is not intended for use by children. GlaxoSmithKline plans to launch it soon, but a definite date has not been announced. List price is expected to be about $140 per injection. Full prescribing information is available here

Simponi Aria Gets Additional Indications

Simponi Aria® (golimumab - Janssen) was approved by the U.S. Food and Drug Administration (FDA) on Oct. 20, 2017, for treating active cases of psoriatic arthritis (PsA) and ankylosing spondylitis (AS) among adults. It was first approved by the FDA to treat rheumatoid arthritis (RA) in 2013. A tumor necrosis factor (TNF) blocker, Simponi Aria is given by intravenous (IV) infusion once every eight weeks after two doses are administered in the first four weeks of treatment. Recommended dosing is 2mg/Kg of the patient’s body weight. All TNF blockers have the potential, listed in boxed warnings on their labeling, to cause severe infections that may include tuberculosis (TB). They carry a further warning that use by children or teens has been associated with cases of lymphoma or other cancers. Prescribing information for Simponi Aria is available here

New Dosage Form for Exenatide

The U.S. Food and Drug Administration (FDA) approved a new dosage form of AstraZeneca’s Bydureon® (exenatide extended release) on Oct. 20, 2017. Bydureon BCise™ is a glucagon-like peptide-1 (GLP-1) receptor agonist. Self-injected once a week, it treats adults who have type 2 diabetes and whose blood sugar needs additional lowering despite diet, exercise and one or more oral antidiabetes medications. It will be dispensed in disposable, pre-filled devices that contain the recommended dose of 2mg. Bydureon BCise should not be used along with insulin or as the first treatment for diabetes. Labeling for it includes a boxed warning for patients or close relatives of 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

 Myasthenia Gravis Indication for Soliris

On Oct. 23, 2017, Alexion Pharmaceuticals received U.S. Food and Drug Administration (FDA) approval of its complement inhibitor, Soliris® (eculizumab), for treating some patients with generalized myasthenia gravis (gMG). Believed to affect as many as 60,000 Americans, MG is an autoimmune condition that progressively weakens muscles. For patients, abnormal proteins, including specific antibodies, interfere with acetylcholine, a neurotransmitter that prompts muscles to contract. Symptoms usually begin for women before 40 years of age, but after 60 years of age for men. Vision problems, such as double vision, and difficulties with speaking or swallowing are common initial symptoms as the small muscles in the head weaken. Symptoms improve when the affected muscles are rested. Eventually, however, larger muscle groups are involved and most patients experience increasing fatigue, develop breathing problems and lose freedom of movement. Soliris is indicated for the 5% to 10% of patients with generalized MG who test positive for anti-acetylcholine receptor (AchR) antibodies. Recommended dosing is by IV infusion at 900mg each week for four weeks; 1,200mg in the fifth week and then 1,200mg once every two weeks. One vial (300mg) of Soliris retails for about $7,200. It has previous approvals for two other rare conditions, paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS) that together are estimated to have only a few thousand U.S. patients. Soliris must be administered by specially trained and certified providers under a risk evaluation and mitigation strategy (REMS). It has a boxed warning about possibly severe meningococcal infections that have been associated with its use. Updated prescribing information for Soliris is available here

Intravenous Varubi Approved

The U.S. Food and Drug Administration (FDA) approved an IV form of Varubi® (rolapitant - Tesaro) on Oct. 25, 2017. It is indicated to be used along with dexamethasone and a 5-HT3 receptor antagonist, such as ondansetron, to prevent delayed nausea and vomiting caused by emetogenic (nausea-producing) cancer chemotherapy (chemo). Available for about two years in oral tablet form, it works by blocking receptors for human substance P/neurokinin 1 (NK-1), which contributes to chemotherapy-induced nausea and vomiting (CINV). Dosing is 166.5mg (one vial) given over 30 minutes no more than two hours before chemo begins. Doses of Varubi IV should be separated by at least two weeks. With launch planned for November, it will be dispensed in single-dose vials of injectable emulsion that does not need to be reconstituted or diluted before administration. Prescribing information is available here.  

Generic for Coreg CR

Sun Pharmaceutical Industries was granted U.S. Food and Drug Administration (FDA) approval for its generic of Coreg CR® (carvedilol - GlaxoSmithKline) extended-release capsules on Oct. 25, 2017. An alpha/beta blocker, carvedilol treats high blood pressure, heart failure and other heart conditions. The extended-release version is taken once daily. Generics will be available in the same four strengths (10mg, 20mg, 40mg and 80mg) as the brand. Sun has not released its launch or pricing plans. QuintilesIMS estimates that U.S. sales of Coreg CR amounted to $208 million for the 12 months ended on Aug. 31, 2017.

 
23Oct
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

FDA Expands Approved Use of Stelara

The U.S. Food and Drug Administration (FDA) approved the expanded use of Stelara® (ustekinummab – Janssen Biotech), a human interleukin-12 and -23 antagonist, on Oct. 13, 2017. The psoriasis indication has now been expanded to include treatment of adolescent patients as young as 12 years of age. The recommended dose is determined by the weight of the patient. It is given as subcutaneous injections once every 12 weeks after the first two injections, which are given four weeks apart. Plaque psoriasis is an autoimmune inflammatory condition that causes itchy, white patches on the skin. Stelara is also approved for treating psoriatic arthritis and Crohn’s disease. Full prescribing information is available here.

 
20Oct
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

CAR-T Therapy Approved for B-Cell Lymphomas

Yescarta™ (axicabtagene ciloleucel), a chimeric antigen receptor (CAR)-T treatment for specific types of lymphoma, was approved by the U.S. Food and Drug Administration (FDA) on Oct. 18, 2017. The gene therapy is indicated to treat adult patients with relapsed or refractory forms of non-Hodgkin lymphoma (NHL), which include diffuse large-B cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL) or transformed follicular lymphoma (TFL) that already has been treated at least twice with other drugs. Yescarta will be administered in certified facilities by healthcare professionals trained in its use. Complete prescribing information is available here.

  • Brand (Generic) Name: Yescarta™ (axicabtagene ciloleucel)
  • Manufacturer:  Kite, a Gilead Company
  • Date Approved: October 18, 2017
  • Indication: to treat adult patients who have a relapsed or refractory large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma, after two or more lines of systemic therapy
  • Dosage Forms Available: A cell suspension of 2 × 106 CAR-positive viable T cells per Kg of patient’s body weight (maximum of 2 × 108 CAR-positive viable T cells) in approximately 68 mL for infusion
  • Launch Date: Immediately after approval
  • Estimated Cost: $373,000
  • Specialty Status: Yescarta will be added to Express Scripts’ specialty drug list.
  • Non-Hodgkin lymphoma (NHL) has several different subtypes, including some that advance rapidly, resist conventional treatment and/or return. Yescarta is third-line treatment for adult patients whose lymphomas are still progressing. Up to 7,500 patients may be candidates for its use, each year.
  • B-cell lymphomas produce CD19 proteins on their cell surfaces. Yescarta is produced by collecting and then altering some of the patient’s T cells so that they bind specifically to CD19. Processing takes about three weeks. When the modified CAR-T cells are infused back into the patient, they inactivate CD19, destroying the cancer cells that produce it. Once reinfused, Yescarta is believed to remain functional, so it may prevent or delay lymphoma recurrence.
  • In clinical trials, patients were treated with chemotherapy for three days followed by one infusion of Yescarta.  Among 101 patients with relapsed or refractory large B-cell lymphoma, 51% had complete response (CR) after an average of about one month.
  • Because using it may be associated with potentially fatal neurological side effects and cytokine release syndrome (CRS), Yescarta has boxed warnings and a risk evaluation and mitigation strategy (REMS). Neurological problems may include confusion, headaches, seizures and tremors. CRS is a flu-like reaction that can result in cardiac arrest.
  • Actemra® (tocilizumab - Genentech) is approved to treat CRS for patients at least two years old. Facilities certified to administer Yescarta are required to have Actemra readily available.
  • Patients need pretreatment with chemotherapy and they will be monitored at least one week after treatment for possible adverse effects.
  • Yescarta will be given only in healthcare facilities certified to administer it. Sixteen centers already are certified; 14 more are in the process. Staff members receive specialized training to treat Yescarta patients and also to recognize and manage potential side effects.
  • Yescarta was developed by Kite Pharmaceuticals, which was acquired by Gilead earlier this month.
  • The first FDA-approved CAR-T therapy, Kymriah™ (tisagenlecleucel - Novartis) launched in September. Although it is produced in the same way as Yescarta, Kymriah has a more limited indication — to treat B-cell acute lymphoblastic lymphoma (ALL) that has relapsed at least twice or that no longer responds to standard treatment for patients under the age of 25.
 
18Oct
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Zilretta Approved for Osteoarthritis of the Knee

The U.S. Food and Drug Administration (FDA) approved Zilretta™ (triamcinolone acetonide extended-release injectable suspension) on Oct. 6, 2017. It is a corticosteroid treatment administered as a single intra-articular injection (directly into the affected joints) to ease pain associated with knee osteoarthritis. Relief extends over approximately three months. Currently, it is not indicated for use by any other route of injection or in any other joints. It is to be administered by specialists, such as rheumatologists and orthopedists, in an office or clinic setting. Zilretta is expected to list at a cost of about $570 per injection. Flexion Therapeutics plans to start introducing it in the next few weeks, with a full launch later in the year. Prescribing information is available here.

FDA Approval for Lyrica CR

On Oct. 11, 2017, the U.S. Food and Drug Administration (FDA) approved Lyrica® CR (pregabalin) extended-release tablets. It is indicated for once-daily use to treat diabetic peripheral neuropathy (DPN) and post-herpetic neuralgia (PHN). Like Lyrica, which is taken two or three times a day, the extended-release version is a C-V controlled substance. Its recommended dosing is 165mg after the evening meal. If needed, doses can be increased to as much as 330mg/day for DPN or up to 660mg/day for PHN. It will be available in strengths of 82.5mg, 165mg and 330mg. Pfizer expects to launch it in January 2018. Lyrica CR is not approved for fibromyalgia or seizures. Complete prescribing information for it is available here

Influenza 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. As usual, vaccines began to be released in mid-July for the 2017?2018 North American season. 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 the flu season is well underway still offers protection. This document provides a general update for the 2017?2018 flu season and highlights Express Scripts program offerings. The document 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

Updated Patent Expiration Report Available

The Emerging Therapeutics Department has updated its patent expiration document. This report includes drugs targeted for potential generic availability over the next five years. This document is available here

 
10Oct

State of Emergency due to Wildfires in California

The Governor of California has declared a State of Emergency due to Wildfires. The following counties in California are impacted: Napa, Sonoma and Yuma.

Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an emergency benefit 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.

 
10Oct

States of Emergency due to Tropical Storm Nate in Alabama, Florida and Louisiana

The Governors of Alabama, Florida and Louisiana have declared a State of Emergency due to Tropical Storm Nate.  All counties are impacted in Alabama and Louisiana. The following counties in Florida are impacted: 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, Baker, Union, Bradford, and Alachua.

Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an emergency benefit 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.

 
10Oct
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Generic Abacavir Oral Solution Launched

After being U.S. Food and Drug Administration (FDA) approved in September 2016, Camber Pharmaceuticals released its generic to ViiV Healthcare’s Ziagen® oral solution on Aug. 17, 2017. Abacavir is a nucleoside reverse transcriptase inhibitor (NRTI) used in combination with other antiretroviral drugs to treat HIV. The oral solution form is approved for children as young as three months old and for older individuals who have difficulty swallowing tablets. For children and adolescents, it is dosed by weight up to a maximum of the adult dose, which is 600mg/day. It is taken either once or twice daily. IMS estimates that Ziagen oral solution sales were $2 million for calendar year 2016.

Lexiva Generic Launched

Mylan’s generic to Lexiva® (fosamprenavir – ViiV Healthcare) 700mg tablets was launched on Sept. 18, 2017. A protease inhibitor, fosamprenavir is used in combination with drugs from other classes to treat HIV-1. Recommended dosing is one or two tablets twice a day. According to GlaxoSmithKline (the parent company of ViiV), U.S. sales for Lexiva tablets and oral suspension amounted to about $39 million in 2016.

New Strength for Alunbrig

The U.S. Food and Drug Administration (FDA) approved Takeda Pharmaceutical Company’s Alunbrig® (brigatinib) tablets in a 180mg strength on Oct. 2, 2017. Alunbrig is indicated to treat anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) that is refractory or resistant to Xalkori® (crizotinib – Pfizer/EMD Serono). It previously was available only in 30mg and 90mg tablets. Recommended dosing is 90mg daily for one week followed by 180mg daily. The new strength is expected to be launched before the end of the year. Alunbrig’s prescribing information is available here

Additional Indication for Botox Cosmetic

Already approved to temporarily fill in lines at the corners of the eyes (crow’s feet) and vertical lines on the forehead between the eyebrows (glabellar lines), Botox® Cosmetic (onabotulinumtoxinA) now has a new indication. On Oct. 2, 2017, the U.S. Food and Drug Administration (FDA) approved it to smooth moderate-to-severe horizontal lines across the forehead. It will be injected by a healthcare professional as 0.1mL (4 units) into each of five sites along the forehead at the same time that an additional five 0.1mL doses are used to treat glabellar lines. Improvement usually persists for about three months. All botulinum products, including Botox Cosmetic, carry boxed warnings that their effects may spread to areas far from the injection sites, potentially causing adverse reactions that could include serious breathing and/or swallowing problems. Side effects may occur long after the injections have been administered. Full prescribing information is available here.

Higher Strength Approved for Ingrezza

An 80mg strength capsule for Ingrezza® (valbenazine) was U.S. Food and Drug Administration (FDA) approved on Oct. 5, 2017. Ingrezza is a selective vesicular monoamine transporter 2 (VMAT2) inhibitor indicated to treat tardive dyskinesia (TD) for adults. TD typically involves uncontrollable movements of the face, including the eyes, jaw, lips and tongue, but it also can affect other parts of the body. It is a side effect from long-term use of some drugs — primarily antipsychotics. Recommended dosing for Ingrezza is 40mg per day for the first week, then an increase to 80mg once a day. Neurocrine Biosciences plans to release the new strength within two weeks. Full prescribing information is available here

First Generic Approved for Toviaz

The generic of Toviaz® (Pfizer), fesoterodine fumarate extended-release capsules, was approved on Oct. 5, 2017, by the U.S. Food and Drug Administration (FDA). Available in 4mg and 8mg strengths, fesoterodine fumarate is used to manage overactive bladder symptoms such as urinary frequency. The generic manufacturer, Zydus Cadila, has not yet announced pricing or launch plans. According to IMS, sales for Toviaz were nearly $196 million for the 12-month period that ended on Aug. 31, 2017.

Concern Over Gabapentin Abuse

Although it currently is not a controlled substance, gabapentin increasingly is being misused in ways similar to opioid abuse. First U.S. Food and Drug Administration (FDA) approved to be taken in combination with other drugs for treating epileptic seizures, it also has an indication to treat postherpetic neuralgia (PHN), the nerve pain that persists after having shingles. Gabapentin misuse appears to be most common among individuals already misusing alcohol or other drugs. Some use it to enhance effects from methadone, opioids or heroin; others claim that high doses provide feelings of excitement, sociability and/or tranquility. Both gabapentin and its follow-on, Lyrica® (pregabalin - Pfizer), are analogs of gamma-aminobutyric acid (GABA). An inhibitory neurotransmitter that slows down nerve impulses, GABA generally has relaxing effects. Lyrica, already classed as a C-V controlled substance, has FDA approvals for treating seizures, fibromyalgia and PHN. Both drugs are used off-label for a number of other conditions, including some anxiety disorders. In the U.S., pregabalin is sold only as the brand; but gabapentin has been available generically since 2004. It also is marketed as the brands Neurontin® (Pfizer), Gralise® (Depomed) and Horizant® (gabapentin enacarbil - Arbor Pharmaceuticals). Recently, authorities in the United Kingdom began action to reclassify gabapentin-type drugs as controlled, and some U.S. states have begun tracking gabapentin and pregabalin prescriptions for signs of misuse.

 
6Oct
From the CEO

From the CEO

Welcome to Fall 2017!

I am very pleased to announce the Foreign Service Benefit Plan’s 2018 Premiums:

2018 FSBP Premiums

 

We are pleased to offer a comprehensive benefit package at very competitive rates. As always, the Plan is committed to providing unparalleled service that our unique worldwide membership requires. We strive to demonstrate that every day, even through our premiums.

In many parts of the world, this means transitioning from warm weather to cold weather. You may want to consider getting a flu shot. According to the Centers for Disease Control and Prevention, everyone six months of age and older should get a flu vaccine every season. The Foreign Service Benefit Plan (FSBP) covers flu vaccinations at 100% when obtained at an in-network provider or provider outside the U.S. Many agencies will begin offering the vaccine right there at the workplace. In our ongoing commitment to “Walking the Walk,” AFSPA staff received our vaccines in our office on September 25. If we can do it, you can too!

October is Breast Cancer Awareness Month. Breast cancer is the most common cancer among women in the United States. Annual mammograms can detect cancer early when it is most treatable. FSBP covers Breast Cancer Screening mammograms once per calendar year, for women age 35 and older. This year, FSBP began covering a new form of mammogram called 3D breast tomosynthesis, which improves the detection of breast cancer. And starting in 2018, mammograms will be covered for women of all ages. Age and frequency limitations do not apply to screenings if there is a family history or high-risk factors. Please get the screenings you need to identify any health problems early.

Open Season is fast approaching. This year, the enrollment period is from November 13 to December 11, 2017. AFSPA staff always 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 any plan under the Federal Employees Health Benefits (FEHB) Program is invited to attend.  This year’s topics include:

  • Benefits and OPM Initiatives
  • Prescription Drugs
  • Access to Care
  • Wellness Programs
  • Overseas Considerations
  • FSAFEDS
  • FEDVIP

See a few October dates below:

  • October 16 – Hohenfels, ACS Training Room, Room 221, Building 10 – 12:30 PM
  • October 16 – Hohenfels Elementary School, Room 253, 3 pm
  • October 17 –  Grafenwoehr Bldg 244, Room 125, 9 am
  • October 17 – Netzaberg Middle School Information Center, 2:40
  • October 18 – Vilsek Bldg 333, 9 am  
  • October 18 – Vilsek High School Library/Info Center, 3:15
  • October 23 – Naples, Capo Fellowship Hall, 9 am
  • October 23 – Naples Elementary School Media Center, 2:45
  • October 30 - 30 – Alconbury Middle School, Library – 3:15pm
  • October 31 – Lakenheath High School, Library – 4pm

For a complete list of our Open Season visits this year, please go to www.afspa.org/openseason and visit our Facebook page www.facebook.com/afspacares. If you are in the area, please plan to attend one of our Open Season briefings.

Look for your new Fall Newsletter in your mailbox. Those of you with the Health Plan will also receive a special brochure outlining the details of our Migration from Coventry to Aetna. As the transition will be complete January 1, 2018, please review the Migration Brochure to prepare you for the upcoming changes.

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

 
6Oct

Continued Support from Express Scripts for Hurricane Maria (Puerto Rico)

Continued Support from Express Scripts for Hurricane Maria (Puerto Rico)

  • Express Scripts is working with FEMA, the American Red Cross and additional available resources to ensure all measures and efforts are made to deliver critical specialty medications to patients in Puerto Rico.
  • Members may use https://www.healthcareready.org/rxopen to find local pharmacies that are currently open to access local fills.
  • A local courier in Puerto Rico has been secured to deliver medication, in partnership with Express Scripts employees, to accessible areas of the island to our patients once medication arrives. An Express Scripts employee will travel with the medication to and throughout Puerto Rico to make sure medications are delivered to patients in need. 
  • We are collaborating with local resources with generator power to maintain temperature-sensitive items.
  • Although communications have been disrupted on the island, all efforts to communicate with patients in Puerto Rico are being made by patient outreach teams.
  • Our member communications team is currently working on additional communication options. 
  • The Emergency Access to Benefits/Refill Too Soon override process has been implemented already.
 
6Oct
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Generic to Copaxone 40mg/mL Approved

On Oct. 3, 2017, Mylan received approval from the U.S. Food and Drug Administration (FDA) for glatiramer injection 40mg/mL, the first A-rated generic to Teva’s Copaxone® 40mg/mL. At the same time, Mylan’s 20mg/mL glatiramer also was approved. Both are used to treat relapsing multiple sclerosis (RMS) with the 40mg/mL strength self-injected subcutaneously three times a week and the 20mg/mL strength used daily. As one of the first applications to file for a generic to Copaxone 40mg/mL, the company may be eligible for “shared” generic exclusivity for this strength. While the company has indicated that the launch is imminent, formal launch plans have not been released. Full prescribing information is not yet available.

  • Brand (Generic) Name: Copaxone® (glatiramer acetate - Teva)
  • Manufacturer:  Mylan
  • Date Approved: October 3, 2017
  • Indication: Treatment of patients with relapsing forms of multiple sclerosis
  • Dosage Forms Available: 20mg/mL and 40mg/mL in single-dose prefilled syringes for subcutaneous injection
  • Launch Date: TBD, however, according to the company’s press release, Mylan will begin shipping immediately.
  • Annual US Sales: Quintiles IMS estimated U.S. sales for branded Copaxone at $4.3 billion ($3.6 billion for the 40mg/mL strength) during the 12 months that ended on July 31, 2017.
  • Specialty Status: Generic glatiramer 40mg/mL will be added to Express Scripts’ specialty drug list.
  • Multiple sclerosis is a chronic, inflammatory condition of the central nervous system that can cause a variety of symptoms including blurred vision, numbness or tingling in the limbs and problems with strength and coordination. Approximately 400,000 Americans have MS.
  • While approved, Mylan now has to decide whether to launch its generic to the 40mg/mL strength “at risk” or wait for additional patent rulings that should occur in 2018.
  • Other pharmaceutical companies involved in developing generics to the 40mg/mL strength of Copaxone include Amneal, Dr. Reddy’s, Pfizer/Synthon and Sandoz/Momenta.
  • Glatopa®, Sandoz’s A-rated generic for the 20mg/mL strength, has been the only available generic to Copaxone 20mg/mL since its launch in June 2015.
  • Implications:  Express Scripts is currently investigating the data around the generic for Copaxone 40mg to determine placement within the existing utilization management strategies.
 
2Oct
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

New Rapid-Acting Insulin Approved

The U.S. Food and Drug Administration (FDA) approved Novo Nordisk’s rapid-acting insulin, Fiasp® (insulin aspart injection) 100Units/mL, on Sept. 29, 2017. It is indicated to manage blood sugar levels for adults with either type 1 or type 2 diabetes. Because it has been modified to increase absorption, the effects of Fiasp may begin as soon as 20 minutes after injection. Novo Nordisk plans to price Fiasp evenly with its NovoLog® (insulin aspart), but it has not yet announced a date for Fiasp’s release. Recommendations are to inject Fiasp before a meal or within 20 minutes of beginning to eat. It will be dispensed in 10mL multi-dose vials and pre-filled FlexTouch® pen devices. Full prescribing information is available here

Tenth Indication Approved for Keytruda

Under its accelerated approval program, the U.S. Food and Drug Administration (FDA) granted a new indication for Keytruda® (pembrolizumab - Merck) on Sept. 22, 2017. The human programmed death receptor-1 (PD-1)-blocking antibody now is approved to treat recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma that expresses PD-L1. Eligible patients must have disease progression during or after finishing treatment with at least two other therapies -- including chemotherapy (chemo) containing fluoropyrimidine and platinum-based drugs. Additionally, their tumors will have to test positive for PD-1 with the Dako PD-L1 IHC 22C3 pharmDx companion diagnostic test. Either in combination with other drugs or alone, Keytruda has indications to treat multiple other types of cancer. In May 2017, it became the first drug to be FDA 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. Full prescribing information is available here.  

Opdivo Receives New Indication

Opdivo® (nivolumab) injection for intravenous (IV) use, Bristol-Myers Squibb’s PD-1 inhibitor, was U.S. Food and Drug Administration (FDA) approved on Sept. 22, 2017, to treat some patients who have hepatocellular carcinoma (HCC). The most common type of liver cancer, HCC is expected to cause about 29,000 U.S. deaths in 2017. It is associated with chronic liver diseases such as hepatitis and non-alcoholic steatohepatitis (NASH). Previously approved to treat a number of other cancer types, Opdivo now is indicated as second-line for HCC patients who previously were treated with Nexavar® (sorafenib). Recommended dosing for the new HCC indication is one 240mg infusion every two weeks. Complete prescribing information for Opdivo is available here

Verzenio Approved to Treat Breast Cancer

On Sept. 28, 2017, the U.S. Food and Drug Administration (FDA) approved Eli Lilly’s Verzenio™ (abemaciclib) for use in combination with fulvestrant for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy. It also is approved as monotherapy for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting. Verzenio selectively inhibits cyclin-dependent kinases (CDK) 4 and 6 (CDK4/6), enzymes that promote the growth and spread of cancer cells. The recommended starting dose in combination with fulvestrant is 150mg twice daily; as monotherapy, the recommended starting dose is 200mg twice daily. Lilly plans on launching Verzenio within the next two weeks. It will be available through a limited network of specialty pharmacies that includes Accredo. Full prescribing information is available here

Updated Hepatitis C Issues Document Available

The standard of care for treating chronic hepatitis C (CHC) has been evolving. This Issues Document describes current and pipeline medications for treating hepatitis C and how Express Scripts and Accredo can effectively manage this market. This latest update includes the new pan-genotypic hepatitis C medications Vosevi™ and Mavyret™. The pipeline table also has been updated. The Hepatitis C Issues Document is available here

 

 
26Sep
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Solosec Approved to Treat Bacterial Vaginosis

A new single-dose, oral antimicrobial, Solosec™ (secnidazole – Symbiomix Therapeutics) was U.S. Food and Drug Administration (FDA) approved on Sept. 15, 2017. It is indicated to treat women who are at least 18 years old and who have vaginal infections caused by specific kinds of bacteria. Solosec is dispensed in packets of granules. Recommended dosing is one packet, containing 2Gm of Solosec, sprinkled onto a soft food, such as yogurt, and consumed within one-half hour. It may be taken alone or during a meal. The launch is expected early in 2018. In clinical studies, about 10% of women taking Solosec developed fungal vaginal infections, compared to about 3% of women who took an inactive placebo. Most of the infections were not serious, though, and all the affected women were treated successfully with an antifungal agent. Complete prescribing information is available here.  

FDA Approval for Adzenys ER

On Sept. 15, the U.S. Food and Drug Administration (FDA) approved Neos Therapeutics’ third drug for attention deficit hyperactivity disorder (ADHD). Adzenys ER™, an oral liquid form of extended-release amphetamine, is indicated to treat ADHD for children as young as six years old. It is taken once every morning, with doses based on the patient’s age. Supplied in 450mL (about 15-ounce) bottles, Adzenys ER contains 1.25mg of amphetamine in each milliliter. A boxed warning on its labeling cautions that, as a C-II controlled substance, it is subject to misuse and it also may cause dependence. Patients will receive a medication guide with every prescription. Adzenys ER is bioequivalent (interchangeable) with Adderall XR® (mixed salts of a single-entity amphetamine) capsules. The launch is expected early next year. Prescribing information is available here

Trelegy Ellipta Approved

The first inhaler that contains three medications for maintenance treatment of chronic obstructive pulmonary disease (COPD) was approved by the U.S. Food and Drug Administration (FDA) on Sept. 18, 2017. Trelegy™ Ellipta®, jointly developed by GlaxoSmithKline and Innoviva, contains a corticosteroid (fluticasone furoate, 100mcg), a long-acting muscarinic antagonist (umeclidinium, 62.5mcg) and a long-acting beta2-adrenergic agonist (vilanterol, 25mcg) in a dry-powder inhaler. It is indicated for patients who already are using some of the included drugs, but who need additional control of airway obstruction or worsening COPD. 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. GlaxoSmithKline plans to release it in the U.S. soon. Its complete prescribing information is available here.

Xhance Approved to Treat Nasal Polyps

A new formulation of the inhaled corticosteroid fluticasone propionate was approved by the U.S. Food and Drug Administration (FDA) on Sept. 18, 2017, to relieve congestion and inflammation caused by polyps in the nose. Xhance™ uses the proprietary Exhalation Delivery System developed by its manufacturer, Optinose®. To use the nasal spray device, the patient inserts part of the device into one nostril and then blows on another part to deliver 93mcg of fluticasone per spray. It is approved for use in adults age 18 years and older at a recommended dose of one spray into each nostril twice a day. Some patients may need to use two sprays per nostril twice a day and the full effects may not be felt for up to 16 weeks of regular use. Using Xhance may cause bleeding, fungal infections or sores inside the nose. Beginning in the first quarter of 2018, it will be dispensed in full units each including the spray device and a 16mL bottle containing 120 sprays. Full prescribing information is available here.

Generic Approved for Tamiflu Oral Suspension

The U.S. Food and Drug Administration (FDA) has approved the first generic for Genentech’s Tamiflu® (oseltamivir) oral suspension. Nesher Pharmaceuticals, a U.S. subsidiary of Zydus Cadila, announced it had received approval on Sept. 14, 2017. Oseltamivir oral suspension is indicated for acute treatment of influenza (flu) when started no more than 48 hours after flu symptoms are first observed. Patients two weeks of age and older may use it. Generic oseltamivir capsules have been available in the U.S. since December 2016. Plans for pricing and a launch date for the oral suspension have not yet been released. 

New Indication for Somatuline Depot

Somatuline® Depot (lanreotide – Ipsen Biopharmaceuticals) was granted a new indication on Sept. 18, 2017. The long-acting somatostatin analog, first approved in 2007 to treat acromegaly, is now indicated for treating adult carcinoid syndrome. Acromegaly includes uncontrolled growth of the face, feet and hands caused by excess growth hormone secretion; carcinoid syndrome is due to over production of serotonin and other substances that results in breathing problems, diarrhea, fast heartbeats and skin reactions such as flushing. Somatuline Depot also is approved for treating neuroendocrine tumors of the gastro-entero-pancreatic system (GEP-NETs). Administered by a healthcare professional as deep subcutaneous (SC) injections once every four weeks, doses vary depending on the condition being treated. Updated prescribing information is available here.

FDA Expands Rapivab Indication

BioCryst Pharmaceuticals’ Rapivab® (peramivir injection) was given approval by the U.S. Food and Drug Administration (FDA) for pediatric use on Sept. 21, 2017. Rapivab, a neuraminidase inhibitor, is now indicated to treat influenza (flu) for patients who are at least two years old and who have had flu symptoms for no more than 48 hours. As an intravenous (IV) injection, it provides an alternative for patients who cannot use an oral flu treatment. Rapivab is given as one 600mg dose over 15 minutes or longer. Prescribing information is available here

 

 

 

 

 

 
19Sep

State of Emergency due to an Earthquake in Mexico City, Mexico

News reports are circulating of a 7.1 magnitude earthquake in Mexico City, Mexico with major impact. FSBP is therefore activating its state of emergency response. Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an emergency benefit override for home delivery of medications if needed. You may provide a temporary alternate address (either online at www.express-scripts.com or by calling 1-800-818-6717). Alternately, you may obtain a prescription from your local health care provider, fill it on the economy and send us a claim.

 
18Sep
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Privigen Approved for Chronic Inflammatory Demyelinating Polyneuropathy

On September 14, 2017, the U.S. Food and Drug Administration (FDA) approved CSL Behring’s Privigen® [Immune Globulin Intravenous (Human), 10% Liquid] for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP) to improve neuromuscular disability. CIDP is a progressive autoimmune disorder that causes weakness, numbness and tingling of the arms and legs due to damaged myelin sheath (protective covering) of the peripheral nerves. Approximately 40,000 patients in the U.S. have CIDP. Privigen was originally approved in 2007; it is also indicated to treat primary humoral immunodeficiency (PI) and chronic immune thrombocytopenic purpura (ITP) in patients 15 years of age and older. Privigen is administered by intravenous (IV) infusion. Full prescribing information is available here.

 
15Sep
Express Scripts News Flash

Express Scripts News Flash

 

FDA Approves Mvasi, a biosimilar to Avastin

On September 14, 2017, the U.S. Food and Drug Administration (FDA) approved Allergan and Amgen’s Mvasi™ (bevacizumab-awwb), a biosimilar to Genentech’s Avastin®. Mvasi is approved for treating metastatic colorectal cancer, non-squamous non-small cell lung cancer, glioblastoma, metastatic renal cell carcinoma, and cervical cancer. It was not approved for three Avastin indications (ovarian, fallopian tube, and primary peritoneal cancer) because they are still protected by Orphan Drug Exclusivity (ODE). The dose of Mvasi varies depending on the indication. While launch plans for Mvasi are unknown, it will likely be delayed until July 2019. Full prescribing information is available here.

  • Brand (Generic) Name: Mvasi™ (bevacizumab-awwb)
  • Manufacturer: Allergan and Amgen
  • Date Approved: September 14, 2017
  • Indication: Mvasi is approved for treating metastatic colorectal cancer, non-squamous non-small cell lung cancer, glioblastoma, metastatic renal cell carcinoma, and cervical cancer.
  • Dosage Forms Available: 100mg/4mL and 400mg/16mL solution in single dose vials for IV infusion.
  • Launch Date: Launch plans for Mvasi are not known at this time. However, it will likely be delayed until at least July 2019.
  • Estimated Annual Cost: Pricing information is not available at this time.
  • Specialty Status: Mvasi will be added to Express Scripts’ specialty drug list.
  • According to IMS Health, U.S. annual sales for Avastin were approximately $3 billion.
  • While approved, the launch of Mvasi will likely be delayed until an Avastin patent expires in July 2019
  • Mvasi is the seventh biosimilar approved by FDA. In addition to Avastin, the agency has also approved biosimilars to Enbrel® (etanercept – Amgen), Neupogen® (filgrastim – Amgen), Humira® (adalimumab – AbbVie) and Remicade® (infliximab – Janssen).
  • Biosimilars to Neulasta® (pegfilgrastim – Amgen), Herceptin® (trastuzumab – Genentech) and Rituxan® (rituximab – Genentech) are also under FDA review.

Aliqopa Approved for Follicular Lymphoma

On September 14, 2017, Bayer received U.S. Food and Drug Administration (FDA) approval of Aliqopa™ (copanlisib) for the treatment of adults with relapsed follicular lymphoma who have received at least two prior systemic therapies. The recommended dose of Aliqopa is 60mg administered as a one-hour intravenous (IV) infusion on Days 1, 8 and 15 of a 28-day treatment cycle. Bayer is expected to launch Aliqopa immediately. It will only be available through hospitals and clinics; Accredo will not be dispensing Aliqopa. Full prescribing information is available here

  • Brand (Generic) Name: Aliqopa™ (copanlisib)
  • Manufacturer: Bayer
  • Date Approved: September 14, 2017
  • Indication: Treatment of adults with relapsed follicular lymphoma who have received at least two prior systemic therapies.
  • Dosage Forms Available: 60mg lyophilized powder in single-dose vials for reconstitution and further dilution for IV infusion
  • Launch Date:  September 15, 2017
  • Estimated Annual Cost: Pricing information is not yet available.
  • Specialty Status: Aliqopa will be added to Express Scripts’ specialty drug list.
  • Each year in the U.S., more than 72,000 patients are diagnosed with some form of non-Hodgkin lymphoma (NHL). Follicular lymphoma is the most common subtype, accounting for approximately 22% of these cases. Limited treatment options are available for patients who relapse after prior therapies.
  • Aliqopa is a phosphatidylinositol-3-kinase (PI3K) inhibitor with inhibitory activity predominantly against the PI3K-alpha and PI3K-delta isoforms expressed in malignant B cells.
  • Aliqopa was approved two months ahead of schedule under FDA’s accelerated approval, orphan drug and priority review programs. 
  • FDA’s accelerated approval of Aliqopa was based on a single-arm Phase II trial of 104 patients with follicular B-cell NHL who had relapsed following at least two prior treatments. Aliqopa demonstrated an overall response rate of 59% for a median of 12.2 months. Continued approval is dependent upon a confirmatory trial that demonstrates a clinical benefit.
 
13Sep
FSBP Expands Direct Billing Partnerships in Seoul Korea

FSBP Expands Direct Billing Partnerships in Seoul Korea

The Foreign Service Benefit Plan proudly welcomes Catholic University of Korea- Seoul St. Mary’s Hospital and Soon Chun Hyang University Hospital in Seoul Korea as direct billing partners.

Soon Chun Hyang University Hospital is conveniently located near the ITAEWON and provides care to approximately 6,000 international patients a year.  Our direct billing arrangement with Soon Chun Hyang University Hospital covers inpatient* and complete maternity care*.

The Catholic University of Korea Seoul St. Mary’s Hospital is the largest among Korean hospitals consisting of a single building with1,320 sick beds.  Our direct billing arrangement with the Catholic University of Korea Seoul St. Mary’s Hospital covers inpatient*, accidental injury*, complete maternity care*, and all covered outpatient care**.

We strive to simplify your care overseas and are delighted to have these billing arrangements. If you have overseas direct billing questions, please visit our FSBP Overseas Partners page on our website, email us, or call us at +1 202-833-4910 for assistance.

Thank you for being a valued FSBP member.

* Accidental injury, inpatient, and complete maternity care: Member pays no deductible. FSBP pays 100% of covered services.
** All covered outpatient care: Member pays applicable calendar year deductible and 10% coinsurance.

 
11Sep

States of Emergency due to Hurricane Irma in Georgia and Alabama

The Governors of Georgia and Alabama have declared a State of Emergency due to Hurricane Irma. All counties are impacted in Alabama. The following counties in Georgia are impacted: Appling, Atkinson, Bacon, Baker, Baldwin, Ben Hill, Berrien, Bibb, Bleckley, Brantley, Brooks, Bulloch, Calhoun, Candler, Charlton, Chattahoochee, Clay, Clinch, Coffee, Colquitt, Cook, Crawford, Crisp, Decatur, Dodge, Dooly, Dougherty, Early, Echols, , Effingham, Emanuel, Evans, Grady, Harris, Houston, Irwin, Jeff Davis, Jefferson, Jenkins, Johnson, Jones, Lamar, Lanier, Laurens, Lee, Long, Lowndes, Macon, Marion, Meriwether, Miller, Mitchell, Monroe, Montgomery, Muscogee, Peach, Pierce, Pike, Pulaski, Quitman, Randolph, Schley, Screven, Seminole, Stewart, Sumter, Talbot, Tattnall, Taylor, Telfair, Terrell, Thomas, Tift, Toombs, Treutlen, Troup, Turner, Twiggs, Upson, Ware, Washington, Wayne, Webster, Wheeler, Wilcox, Wilkinson and Worth.

Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an emergency benefit 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.

 
11Sep
Keeping our Members Informed

Keeping our Members Informed

As you may have heard by now, Equifax, one of the largest credit reporting firms in the country recently suffered a data breach.  Equifax estimates that data on around 143 million US customers was obtained in the breach.  This data includes: names, birth dates, social security numbers, credit card numbers, as well as other information.  Many cybersecurity experts are already saying that this breach could be even worse than the Office of Personnel Management data breach back in 2015 where personal information on many government employees was compromised.

In this high tech world that we live in today, we need to make sure that we are extra vigilant in monitoring and protecting our personal information as best we can. 

Even though AFSPA is not directly involved,  we realize the Equifax breach might affect our members – anyone who has or has applied for a mortgage, an auto loan, a credit card, etc.  We have  attached a link to the Equifax website where you can see if your personal information may have been compromised.  Equifax announced that they would offer free credit monitoring services to US consumers for one year.  As with any agreement of this nature, we advise our members to read all the terms and conditions before signing up or agreeing to anything.

Take a look at the URL below to learn more about the breach and also to check to see if your information was compromised.

https://www.equifaxsecurity2017.com/

 
11Sep
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

New Injection Approved for Knee Osteoarthritis

Durolane® (hyaluronic acid, intra-articular) was approved by the U.S. Food and Drug Administration (FDA) on August 29, 2017, to treat pain caused by osteoarthritis of the knees. Like similar, previously approved products, Durolane will be injected by a healthcare professional directly into affected joints to help replace the natural fluids that provide lubrication, protection and pain relief. Each injection provides up to six months of pain relief. First approved in Europe sixteen years ago, Durolane also is available in numerous other countries, including Canada and Mexico. The manufacturer, Bioventus, plans a U.S. launch early next year.

Durolane will be added to Express Scripts’ specialty drug list.

Austedo Approved for Tardive Dyskinesia

The U.S. Food and Drug Administration (FDA) approved Teva’s Austedo® (deutetrabenazine) to treat tardive dyskinesia on August 30, 2017. Tardive dyskinesia is a side effect from long-term use of some drugs — primarily antipsychotics. It typically involves uncontrollable movements of the face, including the eyes, jaw, lips and tongue; but it also can affect other parts of the body. Austedo originally was approved in April for adult patients who have a similar condition, chorea, which is caused by Huntington’s disease. It is believed to modulate signals between nerves by temporarily decreasing the amounts of monoamines, such as dopamine and serotonin, within the brain. To treat tardive dyskinesia, the recommended starting dose is 12mg each day, which may be increased at weekly intervals to a maximum of 48mg daily. A boxed warning on Austedo’s label cautions that depression and suicidality may be increased among patients taking it. Prescribing information for it is available here.

New Dosing for Orfadin

On September 1, 2017, the U.S. Food and Drug Administration (FDA) approved a new dosing schedule for the Swedish Orphan Biovitrum (Sobi) drug, Orfadin® (nitisinone). Used with dietary restrictions, Orfadin 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. Results from a clinical study showed that taking one dose per day was as effective as the previously recommended twice-daily dose schedule for patients who are at least five years old and who have been on a stable dose of Orfadin for at least four weeks. Updated prescribing information is available here

Tracleer Gets a Pediatric Indication

Tracleer® (bosentan), an oral endothelin receptor antagonist that treats pulmonary arterial hypertension (PAH), is now U.S. Food and Drug Administration (FDA) approved for patients as young as three years old. The FDA granted the pediatric indication and approved a new 32mg dispersible tablet on Sept. 6, 2017. PAH is progressively worsening high blood pressure in the arteries between the heart and the lungs, which forces the heart to beat harder and damages the arteries. Tracleer is taken twice a day with doses dependent on body weight for children under the age of 12 years. Its manufacturer, Actelion, plans to market the 32mg tablets in the next few weeks. The new tablets can be divided easily to customize doses and they can be dissolved in a teaspoon of water for patients who cannot swallow the larger 62.5mg and 125mg film-coated tablets. Labeling carries a boxed warning that Tracleer may cause liver damage and severe birth defects. It is dispensed under a risk evaluation and mitigation strategy (REMS) that requires all patients, pharmacies and prescribers involved in its use to be registered with the program. Full prescribing information is available here.

 

 
6Sep
From the CEO

From the CEO

Greetings and Welcome to September 2017! This means that summer is ending. Many have started a new school year or maybe even moved to a new post. These changes can cause us to vary our routine and even vary our meals.

Along those lines, September is Fruits & Veggies—More Matters ® Month. Eating more fruits and vegetables helps you and your family be at their best and it may reduce the risk of many diseases. I found a great website that provides tons of information on topics from the Top 10 Reasons to Eat More Fruits and Veggies (which we all should) to Fruit and Vegetable Storage 101. Check out the website for yourself.

Also, it is not too late to receive $200 in incentive rewards by completing your Health Risk Assessment (HRA) and Biometric Screening. You can quickly take your HRA online at My Online Services or on the phone with a health coach by calling 866-237-1442. You can obtain a Biometric Screening at a Quest Diagnostic Patient Service Center (PSC) at your convenience. Visit my.questforhealth.com and enter the registration key “aetnafsbp2017” to register and locate a PSC location near you or on your way home. For members who are overseas or who prefer to have their Biometric Screening through their physician, you can print your own Physician Result form. Your provider can complete it and send to Quest Diagnostics. Then, you might as well complete a Healthy Action for another $50 wellness incentive reward. The HRA, Biometric Screening, and Healthy Action must be completed by December 1, 2017 to earn the reward(s). You only have a few months left.  

Lastly, September is Life Insurance Awareness Month. This makes it the perfect time to look at ways to better protect your family’s future. Funeral expenses and outstanding bills can create an added burden for your loved ones. To assist, AFSPA offers a comprehensive package of life insurances policies for our members’ unique needs. Learn more about your options and how to estimate coverage of your needs by browsing the “Life Insurances” section of the AFSPA website. You can apply or enroll in any of our plans at any time.

This time of year is busy for AFSPA as we continue to go through the Migration process, prepare the 2018 FSBP brochure, and get ready for Open Season travel. We will keep you informed through our website, on Facebook, in the Fall newsletter, and our Open Season mailing. Again this year, look for new benefits and programs at a great premium for 2018!
 

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

 
9Sep

States of Emergency due to Hurricane Irma in the US Virgin Islands, Georgia, North and South Carolina and Wildfires in California (Los Angeles County)

The Governors of the US Virgin Islands, Georgia, North and South Carolina have declared a State of Emergency due to Hurricane Irma. All counties are impacted in the US Virgin Islands, North and South Carolina. The following counties in Georgia are impacted: Appling, Atkinson,  Bacon, Brantley, Bryan, Bulloch, Burke, Camden, Candler, Charlton, Clinch, Coffee, Echols, Effingham, Emanuel, Evans, Glynn, Jenkins, Jeff Davis, Liberty, Long, McIntosh, Pierce, Screven, Tattnall, Toombs, Treutlen, Wayne and Ware.

The Governor of California has declared a State of Emergency due to Wildfires, impacting Los Angeles County.

Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an emergency benefit 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.

 
6Sep

States of emergency from Irma and Washington wild fires

The Governors of Florida and Puerto Rico have issued States of Emergency for all counties due to Hurricane Irma.

The Governor of Washington has issued a State of Emergency for all counties due to fires.

Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an emergency benefit 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.

 
5Sep
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

New Rabies Immune Globulin Approved

On August 25, 2017, the U.S. Food and Drug Administration (FDA) granted approval for Kedrab™ [rabies immune globulin (human)]. It provides temporary, passive protection against rabies infection, when given immediately after contact with a rabid or possibly rabid animal. A full course of rabies vaccine, which gives active protection, must follow treatment with it. Kedrab will be dispensed in 2mL or 10mL vials each containing 150 IU/mL. Dosing is by body weight – a one-time dose of 20 IU/Kg is injected into the animal bite, if possible, and into muscles as far from the bite as practical. Because it is made from human blood plasma, Kedrab has a slight risk of containing infective viruses. Individuals given it also may have allergic reactions or blood problems, such as clots or ruptured red blood cells. Live vaccines for other diseases, such as measles or polio, should not be given until at least three months after treatment with Kedrab. Made by Kamada, Kedrab will be distributed in the U.S. by Kedrion Biopharma, Inc., beginning in early 2018.  Prescribing information is available here

First Drug Approved for Chagas Disease

Accelerated approval was granted by the U.S. Food and Drug Administration (FDA) on August 29, 2017, for benznidazole. The first drug fully approved in the United States to treat Chagas disease, benznidazole is an antiparasitic agent used to treat acute Chagas infection for children between 2 and 12 years of age. Doses based on body weight are given orally twice a day for 60 days. Also called American trypanosomiasis, Chagas disease is caused by the parasite Trypanosoma cruzi and is transmitted primarily through contact with triatomine bugs. The Centers for Disease Control and Prevention (CDC) estimates that approximately 300,000 Americans have Chagas disease, which progresses in two phases. The acute phase has only general symptoms that are similar to the flu and that last for a few weeks after exposure. Infection is confirmed with a blood test for antibodies to the T. cruzi parasite. If untreated, the infection may become chronic. Usually asymptomatic, chronic Chagas disease lasts for decades and eventually results in serious heart and digestive system problems for 30% or more of individuals who have it. Reinfection is possible after treatment. Launch and pricing plans for benznidazole have not yet been released, but the manufacturer, Chemo Group, has partnered with non-profit groups to price it reasonably, prioritize its distribution in areas needing it and use part of the profits for developing other drugs for neglected conditions.

New Antibacterial Drug Approved

The U.S. Food and Drug Administration (FDA) approved Vabomere™ (meropenem/vaborbactam) injection on August 29, 2017. It combines a previously approved antibiotic with a new beta-lactamase inhibitor. An intravenous (IV) formulation, it is indicated to treat adults who have complicated urinary tract infections (cUTI) caused by specific types of bacteria. Designated by FDA as a qualified infectious disease product (QIDP), Vabomere was given both fast-track and priority approval. QIPDs treat serious bacterial or fungal infections, including those resistant to other anti-infective therapies. Recommended dosing is 4Gm (two vials) given as a three-hour infusion once every eight hours for up to two weeks. Rempex, a subsidiary of The Medicines Company, plans to release Vabomere before the end of 2017. Its complete prescribing information is available here

New Indication for Faslodex

Faslodex® (fulvestrant - AstraZeneca) injection, an estrogen-receptor blocker, received an additional U.S. Food and Drug Administration (FDA) indication on August 25, 2017. It now is approved as a single agent to treat post-menopausal patients who have hormone-receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer, but who have not yet received endocrine therapy. In the FALCON clinical trial for fulvestrant and anastrozole compared in hormonal therapy-naïve advanced breast cancer, average progression-free survival rates were about three months longer for patients given Faslodex as they were for patients taking AstraZeneca’s oral aromatase inhibitor, Arimidex® (anastrozole). Recommended dosing for Faslodex is one 500mg dose divided into two intramuscular (IM) injections once a month after three loading doses during the first month of treatment. Full prescribing information for Faslodex is available here.

Expanded Indication for Victoza

Novo Nordisk announced on August 25, 2017, that the U.S. Food and Drug Administration (FDA) had approved Victoza® (liraglutide) to decrease risk of major adverse cardiovascular (CV) events for adults who have both type 2 diabetes and documented CV disease. A glucagon-like peptide-1 (GLP-1) receptor agonist, it first was FDA approved in 2010, along with diet changes and exercise, to improve blood sugar control for adults with type 2 diabetes. Recommended dosing is 0.6mg, 1.2mg or 1.8mg once a day delivered subcutaneously (SC) through a pre-filled, multi-dose pen-like device. Victoza is known to cause some types of thyroid tumors, so it carries a boxed warning against its use by patients or close relatives of patients who have medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2). Prescribing information is available here.

Actemra Indicated for CAR-T Side Effects

In tandem with its approval of the first CAR-T therapy, Kymriah™ (tisagenlecleucel – Novartis) on August 30, 2017, the U.S. Food and Drug Administration (FDA) also approved Genentech’s Actemra® (tocilizumab) to treat cytokine release syndrome (CRS), a possible major side effect of treatment with CAR-T products. An immune reaction, CRS usually is a mild flu-like condition that causes fever, headache, nausea and rash. Sometimes called a cytokine storm, severe CRS can become life-threatening, however, potentially causing acute respiratory syndrome, heart failure, multi-organ collapse or death. In one clinical trial, nearly 50% of the 68 patients treated with Kymriah developed severe cases of CRS. Actemra is a monoclonal antibody that interferes with interleukin-6 (IL-6) to reduce inflammation. Indicated for patients two years old and older, Actemra is given intravenously (IV) at a dose of 8mg/Kg or 12mg/Kg depending on body weight to control CRS. Up to four doses of Actemra, separated by eight hours or more, may be needed, as may concurrent high doses of steroids. A boxed warning in Actemra’s label cautions that patients are at increased risk of having serious infections, including tuberculosis, while undergoing treatment with it. Revised prescribing information is available here

 
1Sep
Express Scripts News Flash

Express Scripts News Flash

FDA Approves Mylotarg for CD33 Positive Acute Myeloid Leukemia

On September 1, 2017, the U.S. Food and Drug Administration (FDA) approved MylotargTM (gemtuzumab ozogamicin - Pfizer) injection for intravenous use after it had been off the market since October 2010. The antibody-drug conjugate now is indicated to treat adults newly diagnosed with acute myeloid leukemia (AML) that expresses the CD33 antigen. It also gained an indication for CD33 positive AML patients as young as 2 years old who have relapsed after or who no longer respond to standard treatment. As initial therapy, it will be given either as monotherapy or along with chemotherapy. It will be used alone for second-line treatment. Dosing is by body weight. Launch is expected next week through the same distribution channel as Pfizer’s Besponsa® (inotuzumab ozogamicin), which includes one specialty pharmacy, Biologics. Accredo will not have access to Mylotarg. Full prescribing information is available here.

  • Brand (Generic) Name: MylotargTM (gemtuzumab ozogamicin)
  • Manufacturer: Pfizer
  • Date Approved: September 1, 2017
  • Indication: Mylotarg is approved for treatment of newly diagnosed CD33-positive acute myeloid leukemia (AML) in adults and treatment of relapsed or refractory CD33-positive AML in adults and in pediatric patients 2 years and older.
  • Dosage Forms Available: Single-dose vials containing 4.5mg of Mylotarg for reconstitution and intravenous infusion
  • Launch Date: Mylotarg is expected to be launched within one week.
  • Estimated Annual Cost:  Pricing information is not available at this time.
  • Specialty Status: Mylotarg will be added to Express Scripts’ specialty drug list.
  • AML is a rare and aggressive cancer of the blood and bone marrow. Approximately 21,000 patients are diagnosed with AML each year in the United States. An estimated 90% of AML produces large amounts of an antigen, CD33.
  • Mylotarg combines an antibody specific for CD33 and ozogamicin, which attacks and destroys AML.
  • It originally was given accelerated approval in 2000 as monotherapy for patients 60 years and older whose CD33 positive AML had relapsed after chemotherapy. Additional clinical trials uncovered significant safety concerns for the targeted patient group at the approved doses. Voluntary market withdrawal followed in October 2010.
  • The new indications are for different patient populations and recommended doses have been reduced.
  • A boxed warning on Mylotarg labeling cautions that it could cause potentially severe or fatal liver damage.
 
1Sep

State of Emergency due to Tropical Storm Harvey in Oklahoma

The Governor of Oklahoma has declared a State of Emergency due to Tropical Storm Harvey to allow displaced members from Texas and Louisiana to refill prescriptions in Oklahoma . All counties are impacted.

Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an emergency benefit 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.

 
1Sep

State of Emergency due to Tropical Storm Harvey in Texas

The Governor of Texas has declared a State of Emergency due to Tropical Storm Harvey. The following counties are impacted: Bastrop, Burleson, Polk and San Jacinto.

Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an emergency benefit 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.

 
1Sep
Express Scripts News Flash

Express Scripts News Flash

On August 30, 2017, the U.S. Food and Drug Administration (FDA) approved KymriahTM (tisagenlecleucel – Novartis), a personalized cellular therapy to treat patients under the age of 25 years who have B-cell acute lymphoblastic leukemia (ALL) that have relapsed at least twice or no longer respond to standard treatments. It is the first gene therapy approved for use in the U.S. Kymriah attaches a gene containing a chimeric antigen receptor (CAR) to T-cells harvested from each individual patient. When the modified cells are infused back into the patient, they seek out CD19, a protein overexpressed by ALL cells. The drug will be administered as a one-time intravenous (IV) infusion only at a certified treatment center that will have staff members trained to recognize signs of adverse reactions. Novartis announced that it will price Kymriah at $475,000 and will adjust cost according to outcomes for patients who respond to treatment after the first month. Frozen in liquid nitrogen, Kymriah will be delivered directly to the facilities that give it, not through pharmacies. Full prescribing information is available here.

  • Brand (Generic) Name: KymriahTM (tisagenlecleucel)
  • Manufacturer: Novartis
  • Date Approved: August 30, 2017
  • Indication: Kymriah is appproved for the treatment of patients up to 25 years of age with B-cell precursor ALL that is refractory or in second or later relapse
  • Dosage Forms Available: Genetically modified, patient-specific T-cells frozen in single IV bags containing between 10mL and 50mL of suspension for IV infusion
  • Launch Date: Launch plans for Kymriah are not known at this time.
  • Estimated Annual Cost: $475,000
  • Specialty Status: Kymriah will be added to Express Scripts’ specialty drug list.
  • ALL is the most common cancer among children, teens and young adults -- with about 3,100 new cases diagnosed annually according to the National Cancer Institute. After successful treatment, ALL reoccurs in approximately 20% of patients.
  • Kymriah uses the patient’s immune system. T-cells are collected from the blood, linked with a gene that contains a CAR sensitized to CD19 antigens and reintroduced to the patient. These cells replicate and target CD19, which is present more abundantly on ALL cells than on normal cells.
  • Patients need pretreatment with chemotherapy and they will be monitored for possible adverse effects that may need drug therapy as well.
  • In a clinical trial of 63 patients, the overall remission rate was 83% three months after treatment with Kymriah.
  • Adverse neurological events, such as delirium and encephalopathy; and/or cytokine release syndrome (CRS), an overreaction to T-cell activation, may be associated with Kymriah infusions. Because either may be fatal, labeling carries a boxed warning and Kymriah also has a risk evaluation and mitigation strategy (REMS).
  • Kymriah potentially may cause other severe side effects that include acute kidney injury, hypotension and susceptibility to infections.
  • Kymriah was approved one month ahead of schedule under the FDA’s breakthrough therapy and priority review programs.
  • Another CAR-T therapy, Kite’s axicabtagene ciloleucel, is under FDA review for treating patients who have relapsed and/or refractory aggressive B-cell non-Hodgkin lymphoma (NHL) and who are not candidates for a stem-cell transplant. It is expected to be approved by November 29, 2017. Kite recently was purchased by Gilead.
 
29Aug
Express Scripts News Flash

Express Scripts News Flash

FDA Approves Cyltezo, a Second Biosimilar to Humira

On August 25, 2017, the U.S. Food and Drug Administration (FDA) approved Boehringer Ingelheim’s Cyltezo™ (adalimumab – adbm), a biosimilar to AbbVie’s Humira®. Cyltezo is approved for treating adults with rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease and ulcerative colitis. It is also approved for treating children four years of age and older with polyarticular juvenile idiopathic arthritis. The dose of Cyltezo varies depending on the indication. While Boehringer Ingelheim’s launch plans for Cyltezo are unknown, it is possible that launch could be delayed for two or more years due to patent litigation. Full prescribing information is available here.

  • Brand (Generic) Name: Cyltezo™ (adalimumab – adbm)
  • Manufacturer: Boehringer Ingelheim
  • Date Approved: August 25, 2017
  • Indication:Cyltezo is approved for treating adults with rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease and ulcerative colitis. It is also approved for treating children four years of age and older with polyarticular juvenile idiopathic arthritis.
  • Dosage Forms Available:40mg/0.8mL solution in single-dose prefilled glass syringes for subcutaneous injection
  • Launch Date: Launch plans for Cyltezo are not known at this time.
  • Estimated Annual Cost:  Pricing information is not available at this time.
  • Specialty Status: Cyltezo will be added to Express Scripts’ specialty drug list.
  • Cyltezo represents the second FDA-approved biosimilar to AbbVie’s Humira. Amgen’s Amjevita™ (adalimumab – atto) was approved September 23, 2016. Similar to Cyltezo, launch of Amjevita is not expected for at least a couple years.
  • Cyltezo is not considered a generic medication nor is it considered automatically interchangeable with its innovator brand, Humira.
 
28Aug
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Gocovri Approved for Parkinson’s Disease

On August 24, 2017, the U.S. Food and Drug Administration (FDA) approved Adamas Pharmaceuticals’ Gocovri™ (amantadine) extended-release capsules for treating involuntary muscle movement, or dyskinesia, in patients with Parkinson’s disease receiving levodopa-based therapy. Levodopa is a standard treatment of Parkinson’s disease, but can cause levodopa-induced dyskinesia (LID). The company estimates that about 200,000 people, or 20% of the estimated 1 million Parkinson’s disease patients in the U.S., suffer from LID. Administered once-daily at bedtime, dosing is 137mg per day for one week, and then increased to the recommended daily dose of 274mg. This product is an extended-release formulation of generically-available amantadine, which has been used off-label for this indication. According to Adamas, the extended-release properties allow for consistently high levels of amantadine throughout the day. Adamas plans on making Gocovri 68.5mg and 137mg capsules available in the fourth quarter of 2017 with a formal product launch in January 2018. Prescribing information is available here.

New Combination Approved to Treat Gout

Ironwood Pharmaceuticals’ Duzallo® was approved by the U.S. Food and Drug Administration (FDA) on August 18, 2017. A fixed-dose combination, it includes 200mg of lesinurad, a uric acid transporter (URAT1) inhibitor that increases elimination of uric acid, and either 200mg or 300mg of allopurinol, a xanthine oxidase inhibitor that  decreases uric acid production. It is approved to treat hyperuricemia (high blood levels of uric acid) associated with gout in patients who have not achieved target serum uric acid (sUA) levels with a medically appropriate daily dose of allopurinol alone. Recommended dosing for Duzallo is one tablet each morning along with food and water. Patients should drink at least two liters (about one-half gallon) of fluid per day. A boxed warning advises that taking lesinurad (also sold separately as Zurampic®) has been associated with sudden kidney failure. Kidney function testing is recommended before beginning and then periodically during treatment with any lesinurad-containing product. Ironwood plans to launch Duzallo in the fourth quarter of 2017. Although exact pricing has not been released, a cost similar to Zurampic’s is expected. Prescribing information is available here.

 

 
28Aug

State of Emergency due to Tropical Storm Harvey in Texas

The Governor of Texas has declared a State of Emergency due to Tropical Storm Harvey. The following counties are impacted: Atascosa, Bexar, Brazos, Caldwell, Cameron, Comal, Grimes, Guadalupe, Hardin, Jasper, Kerr, Lee, Leon, Madison, Montgomery, Newton, Tyler, Walker, Washington and Wiilacy.

Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an emergency benefit 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.

 
25Aug

State of Emergency due to Tropical Storm Harvey in Louisiana

The Governor of Louisiana has declared a State of Emergency due to Tropical Storm Harvey. All counties are impacted.

Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an emergency benefit 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.

 
24Aug

State of Emergency due to Tropical Storm Harvey in Texas

The Governor of Texas has declared a State of Emergency due to Tropical Storm Harvey. The following counties are impacted: Aransas, Austin, Bee, Calhoun, Chambers, Colorado, Brazoria, DeWitt, Fayette, Fort Bend, Galveston, Goliad, Gonzales, Harris, Jackson, Jefferson, Jim Wells, Karnes, Kleberg, Lavaca, Liberty, Live Oak, Matagorda, Nueces, Refugio, San Patricio, Victoria, Waller, Wharton, and Wilson.

Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an emergency benefit 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.

 

 

 
21Aug
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

New Approvals for Lynparza

On August 17, 2017, the U.S. Food and Drug Administration (FDA) granted full approval to Lynparza® (olaparib – AstraZeneca and Merck) for treating patients with BRCA mutated (gBRCAm) advanced ovarian cancer who have been treated with chemotherapy (chemo) at least three times. Lynparza is a poly ADP-ribose polymerase (PARP) inhibitor, which prevents cancer cells from repairing chemo-caused damage to their DNA. The original indication has now been finalized following similarly successful results from further studies. In addition, FDA approved a new indication – for maintenance treatment of patients who have recurrent epithelial ovarian, fallopian tube or primary peritoneal cancers. Treatment is not dependent on BRCA status, but patients must have a complete or partial response after platinum-based chemo. FDA also approved a new oral tablet dosage form (in 100mg and 150mg strengths), which was launched immediately after its approval. Although the capsule form will be discontinued gradually, it is not directly interchangeable with the tablets. Recommended dosing of the tablets for both indications is 300mg taken twice a day. Full prescribing information for Lynparza tablets is available here.


Generic Approved for Fosrenol

Natco Pharma announced on August 16, 2017, that the U.S. Food and Drug Administration (FDA) has approved its generics for Shire’s Fosrenol® (lanthanum carbonate). The drug reduces hyperphosphatemia (high blood phosphate levels) for patients with end-stage renal disease (ESRD). Recommended dosing is 1,500mg to 3,000mg per day divided into three doses and taken with food. Although Natco’s generic is the first to be FDA approved, its exclusivity status currently is unclear. According to QuintilesIMS, sales for Fosrenol amounted to approximately $122 million for the year ending on June 30, 2017. Natco plans to launch lanthanum carbonate 500mg, 750mg and 1,000mg tablets shortly and market it in a partnership with Lupin Pharmaceuticals.

Besponsa Approved for Acute Lymphoblastic Leukemia

On August 17, 2017, Pfizer received U.S. Food and Drug Administration (FDA) approval of Besponsa® (inotuzumab ozogamicin) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Besponsa is administered as a one-hour intravenous (IV) infusion. Recommended dosing for the first cycle is 0.8mg/m2 on Day 1, 0.5mg/m2 on Day 8 and 0.5mg/m2 on Day 15. Dosing for subsequent cycles varies based on response to therapy. Pfizer is expected to launch Besponsa on August 21, 2017. It will be available through open distribution. Full prescribing information is available here.

 

 

 
15Aug
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

New Delivery System Approved for QVAR

The U.S. Food and Drug Administration (FDA) approved QVAR® RediHaler™ (beclomethasone dipropionate HFA), a corticosteroid in a breath-actuated inhalation device, on August 3, 2017. Indicated as long-term preventive maintenance treatment for asthma, it can be used by patients as young as four years old. To use it, the patient just needs to breathe in from the inhaler. No hand-eye coordination to squeeze the device while breathing in is necessary. Additionally, the device does not need to be shaken, primed or used with a spacer. Teva plans to release QVAR RediHalers containing either 40mcg or 80mcg per inhalation in the first quarter of 2018. Recommended dosing ranges from 40mcg to 320mcg twice a day depending on the patient’s age and the asthma’s severity. Prescribing information for QVAR RediHaler is available here.

New Form of Pitavastatin Approved

Lupin’s Nikita™ (pitavastatin sodium) tablets were approved by the U.S. Food and Drug Administration (FDA) on August 4, 2017. It will be used, in combination with diet changes and exercise, to regulate cholesterol, lipoprotein and triglyceride levels for patients who have primary hyperlipidemia or mixed dyslipidemia. Nikita was approved through FDA’s 505(b)(2) pathway, allowing the submitting company to use documentation from a similar product that already is FDA approved rather than requiring a repeat of the clinical trials. In this case, the reference product is Livalo® (pitavastatin calcium – Kowa Company). The two drugs, however, are not A-rated or automatically interchangeable. Livalo currently has patents protecting it from direct generic competition until at least Dec. 25, 2020. Recommended dosing for Nikita is once daily. It will be manufactured in 1mg, 2mg and 4mg tablets. Lupin has not announced pricing or launch plans. Complete prescribing information is available here.

Nikita will be evaluated for the exclude at launch program on the NPF.

CaroSpir Liquid Approved

The U.S. Food and Drug Administration (FDA) approved CMP Pharma’s CaroSpir® (spironolactone oral suspension, 25mg/5mL), a new liquid formulation of the potassium-sparing diuretic for treating patients with high blood pressure, heart failure or edema. According to the manufacturer, the new formulation will provide another treatment option for patients who have difficulty swallowing or cannot swallow tablets. The recommended starting dose is dependent upon the indication. The company expects to launch CaroSpir 118mL and 473mL bottles during the fourth quarter of the year. Complete prescribing information is available here.  CaroSpir will be evaluated for the exclude at launch program on the NPF.

MedWatch Update

Opana ER

Endo Pharmaceuticals has announced that it will stop shipping Opana® ER (oxymorphone extended release) tablets to its customers on September 1, 2017. Opana ER is being discontinued after the FDA determined that its risks outweigh its value for treating patients with long-term moderate-to-severe pain. Although it was re-formulated in 2012, Opana ER was not FDA designated as abuse-deterrent. It still can be abused by injection or snorting. In June, FDA requested Opana ER be removed from the U.S. market.

 
7Aug
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Abilify Maintena Receives New Indication

Otsuka’s Abilify Maintena®, an extended-release formulation of aripiprazole, was granted a new indication on July 28, 2017. The U.S. Food and Drug Administration (FDA) approved it to be used as a single agent for the maintenance treatment of adults who have bipolar I disorder. It is an atypical antipsychotic drug that previously was approved to treat schizophrenia. The recommended dose is 400mg injected intramuscularly (IM) by a healthcare professional once a month  A boxed warning cautions against using Abilify Maintena to treat dementia-related psychoses for elderly patients because it may increase their risk of death. Complete prescribing information is available here

Expanded Indication for Kalydeco

On July 31, the U.S. Food and Drug Administration (FDA) approved Kalydeco® (ivacaftor - Vertex) to treat cystic-fibrosis patients who are age 2 years and older and who have any of five additional mutations that cause splicing defects in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. The original FDA approval, in 2012, was for patients with one of 23 other specific mutations. For patients 6 years old and older, dosing is one 159mg tablet per day. Younger patients take smaller doses of powdered Kalydeco that is mixed into soft foods. Approximately 600 additional patients will be eligible for treatment with the new indications. Prescribing information for Kalydeco is available here

New Indication for Opdivo

Bristol-Myers Squibb received a new indication on July 31, 2017, for its programmed death receptor-1 (PD-1) checkpoint inhibitor, Opdivo® (nivolumab) injection for intravenous (IV) use. It now is indicated to treat patients at least 12 years old who have microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed despite treatment with  fluoropyrimidine, oxaliplatin, and irinotecan. A 240mg dose of Opdivo is infused   once every two weeks until the cancer worsens or the patient can no longer tolerate using the drug. The FDA initially approved Opdivo in December 2014 as a breakthrough therapy for advanced melanoma. It also has several additional indications, both alone and in combination with other drugs, to treat various types of cancer. Using it may be associated with several possible immune-related adverse effects, including infections in the intestines, kidneys, liver or lungs, which can be severe or even fatal. Opdivo’s full prescribing information is available here

Generic Launched for Transderm Scop

On July 31, 2017, Perrigo launched an AB-rated generic for Transderm Scop® (scopolamine) 1.5mg patches. Transdermal scopolamine is used to prevent nausea and vomiting induced by motion or by surgery. To prevent motion sickness, one patch is adhered to clean, dry, hairless skin behind one ear and worn for three days. For patients undergoing surgical procedures, one patch should be placed behind the ear the evening before the scheduled procedure and it should remain in place for 24 hours after the surgery. Pricing for the generic has not yet been announced. For the 12 months ended on May 31, 2017, sales for Transderm Scop amounted to about $158 million.

Imbruvica Indicated for Chronic Graft-versus-Host-Disease

The U.S. Food and Drug Administration (FDA) announced on August 2, 2017, that it has approved Pharmacyclics’ Imbruvica® (ibrutinib) to treat adults who have chronic graft-versus-host disease (cGvHD). Between 30% and 70% of patients who receive a stem cell transplant from a donor develop the potentially life-threatening condition in which the immune cells in the donated tissue (the graft) attack the transplant recipient (the host) as foreign. Usually, treatment with corticosteroids controls GvHD, but some patients have a chronic form of the condition that does not resolve. A Bruton’s tyrosine kinase inhibitor with prior indications for several cancers, Imbruvica is the first drug to be FDA approved to treat such resistant cGvHD. In a clinical trial, nearly 50% of cGvHD patients taking Imbruvica responded to therapy for at least five months. Dosing is 420mg (three 140mg capsules) once a day until the cancer returns, the cGvHD gets worse or the patient cannot take Imbruvica any longer. Updated prescribing information is available here.

Mavyret Approved for Hepatitis C

On August 3, 2017, the U.S. Food and Drug Administration (FDA) approved AbbVie’s Mavyret™ (glecaprevir 300mg/pibrentasvir 120mg) for the treatment of patients with chronic hepatitis C virus (HCV) genotype (GT) 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis. It is also indicated for the treatment of adult patients with HCV GT 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor, but not both. The recommended dose of Mavyret is three tablets once daily with food for 8, 12 or 16 weeks, depending on which (if any) medications the patient has previously tried and whether or not the patient has compensated cirrhosis. Please refer to the prescribing information for details regarding dosing. AbbVie plans on launching Mavyret on August 8, 2017. It will be available through open distribution. Full prescribing information is available here

 
7Aug
Express Scripts News Flash

Express Scripts News Flash

Vyxeos Approved for Acute Myeloid Leukemia

The U.S. Food and Drug Administration (FDA) approved Vyxeos™ (daunorubicin/cytarabine - Jazz Pharmaceuticals) on Aug. 3, 2017, to treat some patients with acute myeloid leukemia (AML). Specifically, it is indicated for adults who have either newly diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC). It will be dispensed as 44mg daunorubicin and 100mg cytarabine powder for reconstitution and intravenous (IV) administration. Due to its liposomal formulation, Vyxeos cannot be interchanged with any other drugs. Recommended dose is determined by both body surface area (BSA) and stage of treatment (induction or consolidation). Jazz plans to launch Vyxeos within one week. Full prescribing information is available here.

  • Brand (Generic) Name: Vyxeos™ (daunorubicin/cytarabine) liposome for injection
  • Manufacturer:  Jazz Pharmaceuticals
  • Date Approved: August 3, 2017
  • Indication:  For treating adults who have newly diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC).
  • Dosage Forms Available: Single-use vials containing 44mg daunorubicin/100mg cytarabine encapsulated in liposomes as a lyophilized powder cake for reconstitution and administration via intravenous infusion
  • Launch Date: Within one week
  • Estimated Annual Cost:  Pricing information is not yet available
  • Specialty Status: Vyxeos will be added to Express Scripts’ specialty drug list.
  • According to the American Cancer Society (ACS), approximately 21,000 patients – mostly adults over 45 years of age – are diagnosed with AML in the U.S. each year. AML begins in immature bone-marrow cells, which are more subject to mutations among older patients. AML may be more aggressive for older individuals and standard treatments may be too strong for them to tolerate.
  • Although multiple drug options are available to treat AML, none has the same indications as Vyxeos does.
  • Vyxeos encapsulates daunorubicin and cytarabine in liposomes that penetrate into the bone marrow, infiltrating AML cells more than normal cells. Once inside, the liposomal shells break apart, releasing the drugs.
  • Its pivotal clinical study included 309 patients between the ages of 60 and 75. Average overall survival for patients receiving Vyxeos was longer (9.6 months) than for patients treated with daunorubicin and cytarabine as separate agents. (5.9 months). Although at least 6% of patients in each group died during the study, patients treated with Vyxeos generally had better response rates and more of them improved enough to undergo stem cell transplants.
  • Recommended dosing for induction therapy is 44mg daunorubicin/100mg cytarabine per square meter (m2) of body surface area (BSA). Induction treatments are given on the first, third and fifth days of initial Vyxeos treatment. For patients who do not respond, a second induction with the same dose, but on days one and three only, may be given after two weeks to five weeks. Once response is shown, consolidation cycles are administered on the first and third days once every two weeks to five weeks at 29mg daunorubicin/65mg cytarabine per m2.
 
4Aug

State of Emergency in Florida Due to Tropical Storms

The Governor of Florida has declared a State of Emergency due to Tropical Storms. The counties of Brevard, Broward, Charlotte, Citrus, Collier, DoSoto, Glades, Hardee, Hendry, Hernando, Highlands, Hillsborough, Indian River, Lake, Lee, Manatee, Martin, Miami-Dade, Monroe, Okeechobee, Orange, Osceola, Palm Beach, Pasco, Pinellas, Polk, Sarasota, Seminole, St. Lucie, Sumter and Volusia are impacted.

Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an emergency benefit 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.

 
4Aug
From the CEO

From the CEO

Greetings and Welcome to August 2017! This means summer is winding down and a new school year is coming quickly, which is a good time for those of you with children to visit the pediatrician and the dentist to ensure a successful and healthy school year.

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.

Need a Second Opinion on a Diagnosis when Overseas?

Did you know FSBP has a special arrangement with Cleveland Clinic? Patients who receive treatment in foreign countries can receive a second opinion for certain diagnoses, through the e-Cleveland Clinic. Refer to page 96 of the 2017 FSBP Brochure for more information on this important benefit. Cleveland Clinic also provides educational materials and other resources free to our members. Please see their information on heartburn and acid reflux as well as a schedule for their August online health chats.

Update your Information in our Member Portal

Lastly, have you moved? If so, please let us know. 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.

Look for the 2017 Summer Newsletter in your mailbox. It highlights AFSPA’s activities, services, and new programs, such as IT Security, our new Advanced Illness support program, and important information on the upcoming migration to the Aetna computer platform.

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

 
2Aug
Express Scripts News Flash

Express Scripts News Flash

Idhifa Approved to Treat Acute Myeloid Leukemia

The U.S. Food and Drug Administration (FDA) announced on Aug. 1, 2017, that it had approved Idhifa® (enasidenib) oral tablets. The first in its therapy class, Idhifa is indicated for treating adults who have relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation that has been detected by an FDA approved test, RealTime™ IDH2 Assay (Abbott Laboratories). Idhifa was developed jointly by Celgene and Agios Pharmaceuticals. Its recommended dosing is 100mg 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 Idhifa. Celgene and Agios plan on launching Idhifa immediately; it will be available through a limited network of specialty pharmacies that includes Accredo. Prescribing information is available here.

  • Brand (Generic) Name: Idhifa® (enasidenib)
  • Manufacturer:  Celgene and Agios
  • Date Approved: August 1, 2017
  • Indication:  Treatment of adults with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA approved test.
  • Dosage Forms Available:  50mg and 100mg oral tablets
  • Launch Date: Idhifa will be launched immediately.
  • Estimated Annual Cost:  $300,000
  • Specialty Status: Idhifa will be added to Express Scripts’ specialty drug list.
  • According to the American Cancer Society (ACS), approximately 21,000 patients – mostly adults over 45 years of age – are diagnosed with AML in the United States each year. Between 8% and 19% of patients with AML have IDH2 mutations.
  • AML usually begins in immature bone-marrow cells, which normally develop into a type of white blood cells known as myeloid cells. Because young myeloids divide very quickly, myeloid cancer can spread rapidly, as well; even when it is treated early and aggressively. Relapses or resistance to treatment are fairly common.
  • Idhifa is the first in a new class called IDH2 inhibitors. It blocks the activity of IDH2, an enzyme located in mitochondria, which are cell structures responsible for changing nutrients into energy. Normal IDH2 assists in the energy transition process, but mutated forms produce high levels of a chemical (2-hydroxyglutarate or 2-HG) that may contribute to cancer formation and growth.
  • Approval of Idhifa was based on a single-arm trial in which 19% patients experienced complete remission, or no evidence of disease and full recovery of blood counts, for a median of 8.2 months.
  • Almost 15% of clinical trial participants receiving Idhifa developed differentiation syndrome, a potentially fatal condition caused by very fast production of immature myeloid cells. Its symptoms include fever, difficult breathing, low blood pressure, swelling and rapid weight gain.
 
31Jul
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Second Biosimilar for Remicade Launched

Merck and Samsung Bioepis released Renflexis™ (infliximab-abda) in the United States on July 24, 2017. It is the second U.S. Food and Drug Administration (FDA)-approved biosimilar to be launched for Janssen Biotech’s tumor necrosis factor (TNF) inhibitor, Remicade® (infliximab). Pfizer/Celltrion’s biosimilar, Inflectra® (infliximab-dyyb), entered the U.S. market in November 2016. Like Remicade and Inflectra, Renflexis is FDA approved for treating ankylosing spondylitis, Crohn’s disease (for both adults and children), plaque psoriasis, psoriatic arthritis, rheumatoid arthritis (RA) and ulcerative colitis. Dosing varies by indication. A boxed warning and medication guide for all infliximab drugs notifies patients and prescribers about their potential to cause lymphomas or other cancers among children and teens, as well as serious infections for patients of any age who use them. The expected wholesale acquisition cost (WAC or list price) for a 100mg vial of Renflexis is  $750, which is about $420 less per vial than the brand and about $200 less than Inflectra. In 2016, U.S. sales for Remicade were approximately $5 billion, according to Johnson & Johnson, Janssen’s parent company. Full prescribing information is available here

Expanded Age Indication for Yervoy

Following a review of clinical studies with teens and children, the U.S. Food and Drug Administration (FDA) approved a pediatric indication for Yervoy® (ipilimumab – Bristol-Myers Squibb) injection for intravenous (IV) use. It now can be used to treat patients 12 years of age and older who have advanced stages of metastatic melanoma. At 3mg/Kg, dosing is based on the patient’s weight, not age. A total of four Yervoy doses are infused. Each is given over a 90-minute period with one every three weeks. Product labeling 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, thyroid and other functions before Yervoy is initiated and before each dose. Complete, revised prescribing information is available here.

New Indication for Fycompa

On July 26, 2017, Eisai, Inc. announced that the U.S. Food and Drug Administration (FDA) had approved Fycompa® (perampanel) for use as a single agent to treat patients 12 years of age and older with epilepsy who have partial-onset seizures with or without secondarily generalized seizures. Fycompa is a selective, non-competitive ionotropic alpha-amino-3-hydroxy-5-methyl-4-isoxazoleproprionic acid (AMPA) receptor antagonist – the only drug in its class. It originally was approved in October 2012 for the same types of seizures, but only in combination with other anti-epileptic drugs. It has an additional indication as part of a combination regimen to treat patients at least 12 years old who have primary generalized tonic-clonic seizures. Available in oral tablets and an oral suspension, its recommended dosing is 8mg to 12mg once a day at bedtime. 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 to cause dependence and/or abuse. Updated prescribing information is available here

Teva Launches Generic for Epiduo

Teva’s adapalene 0.1%/benzoyl peroxide 2.5%, topical gel, an AB-rated generic for Epiduo®, (Galderma Laboratories) was introduced in both 45mg tubes and 45mg pumps on July 28, 2017. It contains antibacterial and anti-inflammatory components that treat acne for patients who are nine years old and older. A pea-sized amount of the gel is applied once a day to each clean, dry affected area. Individuals using it are cautioned to avoid too much exposure to natural and artificial sunlight or use a strong sunscreen because the retinoid (adapalene) increases the risk of sunburn. Teva expects to have 180 days of exclusivity. As estimated by IMS, annual U.S. sales of Epiduo through the end of March 2017 were $251 million. Epiduo® Forte (adapalene 0.3%/benzoyl peroxide 2.5%) gel remains brand-only.

 
25thJul
Express Scripts News Flash

Express Scripts News Flash

Vosevi Approved for Hepatitis C

On July 18, 2017, Gilead announced that the U.S. Food and Drug Administration (FDA) approved Vosevi™ (sofosbuvir 400mg/velpatasvir 100mg/voxilaprevir 100mg) for the re-treatment of chronic hepatitis C virus (HCV) infection in adults with genotypes 1, 2, 3, 4, 5 or 6 previously treated with an NS5A inhibitor-containing regimen, or with genotype 1a or 3 previously treated with a sofosbuvir-containing regimen without an NS5A inhibitor. The recommended dose of Vosevi is one tablet once daily for 12 weeks. Gilead plans on launching Vosevi on Monday, July 24. It will be available through open distribution. Full prescribing information is available here

  • Brand (Generic) Name: Vosevi™ (sofosbuvir/velpatasvir/voxilaprevir)
  • Manufacturer:  Gilead
  • Date Approved: July 18, 2017
  • Indication:  Vosevi is indicated for the re-treatment of chronic hepatitis C virus (HCV) infection in adults with genotypes 1, 2, 3, 4, 5 or 6 previously treated with an NS5A inhibitor-containing regimen, or with genotype 1a or 3 previously treated with a sofosbuvir without an NS5A inhibitor.
  • Dosage Forms Available:  Tablets containing 400mg sofosbuvir, 100mg velpatasvir, and 100mg voxilaprevir
  • Launch Date: July 24, 2017
  • Estimated Annual Cost:  The wholesale acquisition cost (WAC) of the 12-week regimen is set at $74,760, which is at parity to Gilead’s Epclusa® (sofosbuvir 400mg/velpatasvir 100mg).
  • Specialty Status: Vosevi will be added to Express Scripts’ specialty drug list.
  • Vosevi contains sofosbuvir, a nucleotide analog polymerase inhibitor, velpatasvir, an NS5A inhibitor, and voxilaprevir, a protease inhibitor.
  • Vosevi was approved under FDA’s priority review and breakthrough therapy programs.

AbbVie’s glecaprevir/pibrentasvir is another pan-genotypic regimen that is expected to be approved by Aug. 19, 2017, as an 8-week regimen in treatment-naïve patients and as a 12-week regimen in direct-acting antiviral-experienced chronic HCV-infected patients.

 
25Jul
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Benlysta Subcutaneous Injection Approved

On July 21, 2017, GlaxoSmithKline (GSK) announced the U.S. Food and Drug Administration (FDA) approval of a new subcutaneous (SC) formulation of Benlysta® (belimumab) for the treatment of adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE). Benlysta is a biologic drug that inhibits the protein B-lymphocyte stimulator (BLyS). It has been on the market since 2011 as a one-hour intravenous (IV) infusion. The recommended dose of Benlysta IV is 10mg/kg every four weeks following induction dosing, while the recommended dose for Benlysta SC is 200mg once weekly. Patients are able to self-administer the SC formulation after receiving proper training by a healthcare provider. GSK plans on launching Benlysta SC in late August. Similar to Benlysta IV, it will be available through a large network of specialty pharmacies that includes Accredo. Click here for full prescribing information.

First Generic Approved for Renvela Tablets

The U.S. Food and Drug Administration (FDA) approved Aurobindo Pharma Limited’s generic to Genzyme’s Renvela® (sevelamer carbonate) tablets on July 17, 2017. Sevelamer carbonate is indicated to control phosphorous levels in the blood of patients as young as six years old who need dialysis to manage chronic kidney disease. The drug attaches to phosphorous, which then is eliminated from the body because sevelamer carbonate is not absorbed. The recommended adult dose is one or two tablets three times a day. Estimated sales of Renvela tablets amounted to about $1.9 billion for the 12 months that ended on May 31, 2017. The generic already has been launched. In mid-June, Aurobindo launched an A-rated generic to the oral suspension dosage form of Renvela.


Generic to Androgel 1.62% Packets Approved

Perrigo recently announced the approval of its A-rated generic to AbbVie’s Androgel® (testosterone gel) 1.62% packets, CIII, a product approved for treating men who have deficiencies or absences of natural (endogenous) testosterone. Although FDA approved, launch plans have not been released for the generic. According to Perrigo’s press release, U.S. sales of Androgel 1.62% packets were approximately $88 million for the 12 months ending May 2017. Generics to Androgel 1% have been available since January 2015.

 
19Jul
Express Scripts News Flash

Express Scripts News Flash

Nerlynx Approved as Adjuvant for HER2+ Breast Cancer

Puma Biotechnology, Inc. announced on July 17, 2017, that the U.S. Food and Drug Administration (FDA) approved Nerlynx™ (neratinib). A tyrosine kinase inhibitor, Nerlynx is an oral, once-a-day, extended adjuvant treatment for adults who have early stage HER2-overexpressed/amplified breast cancer. Intended to prevent cancer recurrence, it will be used following adjuvant treatment with Herceptin® (trastuzumab). Recommended dosing is six tablets (totaling 240mg) taken once daily for one year. To manage diarrhea associated with its use, patients are advised to take Imodium® (loperamide) for at least the first eight weeks of Nerlynx treatment. Puma plans on launching Nerlynx in September. It will be available through a limited network of specialty pharmacies that includes Accredo. Complete prescribing information is available here

  • Brand (Generic) Name: Nerlynx™ (neratinib)
  • Manufacturer: Puma Biotechnology
  • Date Approved: July 17, 2017
  • Indication: Extended adjuvant treatment for adults with early-stage HER2-overexpressed / amplified breast cancer, following adjuvant treatment with Herceptin
  • Dosage Forms Available:  40mg tablets
  • Launch Date: September 2017
  • Estimated Annual Cost:  Pricing information is not yet available.
  • Specialty Status: Nerlynx will be added to Express Scripts’ specialty drug list.
  • According to the National Cancer Institute, about 250,000 American women will be diagnosed with breast cancer in 2017. Approximately 15% of breast cancers are HER2 positive, an aggressive form of the disease that recurs for up to one-quarter of patients even after treatment with surgery and Herceptin.
  • Nerlynx is the first  drug to be FDA-approved for long-term adjuvant treatment. However, Perjeta® (pertuzumab - Genentech) has been on the U.S. market since 2012 to treat HER2+ breast cancer in combination with Herceptin. Even though it must be infused once every three weeks after initial dosing, Perjeta could compete with Nerlynx to prevent recurrences.
  • In clinical studies, approximately one-half of participants receiving Nerlynx developed serious diarrhea. To control it, Puma recommends that patients take Imodium for the first 56 days of Nerlynx therapy.

 

 
18Jul
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Blincyto Receives Full Approval

Amgen’s Blincyto® (blinatumomab) initially was approved in December 2014 under the U.S. Food and Drug Administration’s (FDA) breakthrough therapy, priority review and accelerated approval provisions. Based on phase 2 study results and dependent on further confirmation of clinical benefits, it was indicated for treating patients who have Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell-precursor acute lymphoblastic leukemia (ALL). On July 11, 2017, FDA gave it full approval and also expanded its indications to include Philadelphia chromosome-positive (Ph+) patients. The only monotherapy drug approved for treating these forms of ALL, Blincyto also is the only FDA approved immuno-oncology drug that uses bispecific CD19-directed CD3 T cell engager (BiTE®) technology. It is administered in up to five 42-day cycles that include continuous intravenous (IV) infusions on the first 28 days, followed by 14 days without treatment. Dosing is weight based. Hospitalization is recommended for the first nine days of the first treatment cycle and the first two days of the second cycle. A risk evaluation and mitigation strategy (REMS), Medication Guide for patients and a boxed warning on the labeling for Blincyto all caution about its potential to cause life-threatening adverse effects. Among patients in clinical trials, cytokine release syndrome (CRS) and neurologic toxicities, such as confusion and seizures, occurred. CRS is a flu-like condition that produces fever, headache, low blood pressure, nausea and rash. Caused by inflammatory response to the activation of T cells, it can be severe or even fatal. Revised prescribing information is available here.   

Tremfya Approved for Psoriasis

On July 13, 2017, Janssen received U.S. Food and Drug Administration (FDA) approval of Tremfya™ (guselkumab) for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic or phototherapy. Tremfya is a biologic in a new class of medications that inhibit interleukin (IL)-23. After the initial doses at weeks 0 and 4, it is administered every 8 weeks by subcutaneous injection. Janssen plans on launching Tremfya this week. It will be available through open distribution; therefore, Accredo will have access to this medication. Full prescribing information is available here.  

 
12Jul
FSBP Partners with The London Clinic

FSBP Partners with The London Clinic

Featured Partner: The London Clinic

The Foreign Service Benefit Plan is excited to announce our newest direct billing arrangement partner – The London Clinic. The London Clinic is one of the UK’s largest private hospitals dedicated to providing personalized healthcare with a breadth of surgical and medical expertise.  With over 1,000 staff in specialist teams at The London Clinic across all clinical and non-clinical areas, combined with over 300 consultant surgeons and physicians they are prepared to assist you with your care.

Our direct billing arrangement with The London Clinic covers inpatient and day patient care at four locations:

  • The London Clinic Main Hospital
  • The Duchess of Devonshire Wing
  • The London Clinic Outpatient Department
  • The London Clinic Eye Centre

For covered inpatient care, the London Clinic will bill us directly.  For all covered day patient care, you pay your deductible and 10% coinsurance.  Please note The London Clinic may bill you if a balance remains for any services not covered.

As a new patient with The London Clinic, please contact their International Office via email [email protected] or by calling +44 (0) 203 219 3266 for assistance with finding a consultant, making appointments, and assisting you with coordinating your admissions.

We strive to simplify your care overseas and are delighted to have this billing arrangement with The London Clinic.  However, if you have overseas direct billing questions, please visit our FSBP Overseas Partners page on our website, email us, or call us at +1 202-833-4910 for assistance.  Thank you for being a valued FSBP member.

Cheers to your health!

 
11Jul
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Endari Approved for Sickle Cell Disease

The U.S. Food and Drug Administration (FDA) approved Endari™ (L-glutamine) oral powder on July 7, 2017. A replacement for an amino acid deficiency resulting from sickle cell disease, Endari is indicated to decrease complications, such as acute attacks (sickle cell crises), for patients as young as five years old. In clinical trials that lasted 48 weeks, patients taking it had fewer crises, emergency room visits and hospitalizations than patients receiving placebo. They reported less pain, as well. Sickle cell disease is a genetic condition that deforms red blood cells into a characteristic crescent or sickle shape and makes them less flexible. The damaged blood cells get trapped in blood vessels, blocking normal blood flow and limiting the amounts of oxygen reaching body tissues. Anemia, fatigue, jaundice and swollen hands and feet occur frequently. Dehydration, extreme heat or cold, illness and stress can bring about crises, which also may happen spontaneously and unpredictably. Eventually, internal organs sustain significant damage. About 100,000 Americans have sickle cell disease, which is more common among individuals of African, southwest Asian, Middle Eastern, Hispanic or southern European heritage. For use, Endari powder is combined with eight ounces of a cold or lukewarm drink or about four ounces to six ounces of soft food, like pudding or applesauce, and then consumed right away. Recommended dosing is a total of 10Gm to 30Gm per day, based on body weight and taken in two doses. The manufacturer, Emmaus Life Sciences, Inc., has not yet announced launch or pricing plans for Endari. Complete prescribing information is available here.   

Generic Launched for Vigamox

Lupin launched moxifloxacin ophthalmic solution, 0.5%, the generic for Novartis’ Vigamox®, on July 5, 2017. Moxifloxacin is a fluoroquinolone antibiotic used in the eyes to treat conjunctivitis (eye infections) caused by bacteria that are susceptible to it. IMS reports that Vigamox had sales of $268 million in the U.S. for the 12-months ending on March 31, 2107.

New Indication for Orencia

On June 30, 2017, Bristol-Myers Squibb’s Orencia® (abatacept) gained the U.S. Food and Drug Administration (FDA) approval to treat adults with psoriatic arthritis (PsA). First FDA approved in 2005 for treating adults who have rheumatoid arthritis (RA), Orencia also has an indication to treat juvenile idiopathic arthritis (JIA) for patients at least two years old. It can be used alone or combined with other drugs, but it should not be given along with tumor necrosis factor (TNF) inhibitors, such as Enbrel® (etanercept) or other biologicals, such as Kineret® (anakinra). Available in both intravenous (IV) injection and subcutaneous (SC) forms, Orencia is administered once a month (IV) or once a week (SC) depending on the condition and the patient’s weight. Revised prescribing information is available here

 
5Jul
From the CEO

From the CEO

Greetings and Welcome to July 2017! That means summer is in full swing. While enjoying the seasonal activities, I encourage you to maintain a healthy diet. Attending summer barbeques and family reunions can invite temptations to eat unhealthy foods. Please eat fruits and vegetables with every meal and snack. They can help your body fight off sickness. Plus, nutritious eating can give you energy and help you stay at a healthy weight. Our Mediterranean Wellness Program offers a Summer Seminar Series – a practical 9-week guide to staying healthy all summer. Enroll anytime. Learn more about the Mediterranean Wellness Program here.

July is Herbal/Prescription Interaction Month 

Medication interactions can have harmful, even deadly effects. Many commonly prescribed medications have potentially fatal side effects from interactions with other medications, over-the-counter drugs, supplements, herbal preparations, and even food. Know that over-the-counter drugs are medications too

Patients who are on these medications often don’t have access to a pharmacist with the clinical expertise to help them understand the risks and get the most benefit from their medication. Express Scripts continually works behind the scenes to assure your safety.

Update all prescriptions taken including over-the-counter drugs, herbal preparations and vitamins on your Express-Scripts Patient Medical Profile. Here’s how:

July is National Minority Mental Health Awareness Month

Lastly, it is a time to focus on the importance of mental wellness and effective mental health care. We also can make others aware of available resources. The Foreign Service Benefit Plan offers many benefits to address your mental health needs including Digital Coaching, Health Coaching, and myStrength™ - the online mental health support program, and even video visits through our Telehealth Services with American Well. Learn about these programs and other Special features in Section 5(a) and 5(h) of your Plan Brochure.

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

 
5Jul

State of Emergency in Utah Due to Wildfires

The Governor of Utah has declared a State of Emergency due to Wildfires. All counties are impacted.

Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an emergency benefit 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.

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

Closing early on July 3- In observance of Independence Day

AFSPA will close at 3 pm EDT on Monday, July 3. We will remain closed through the Independence Day holiday on Tuesday, July 4th. We will resume our normal business hours at 8:30 am EDT on Wednesday, July 5th.

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

 
3Jul
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Triptodur Approved to Treat Central Precocious Puberty

The U.S. Food and Drug Administration (FDA) approved Triptodur™ (triptorelin) extended-release injectable suspension on June 30, 2017. It is a gonadotropin releasing hormone (GnRH) agonist approved to treat children at least two years old for central precocious puberty. Triptodur is to be given as one 22.5mg intramuscular (IM) injection every 24 weeks. It is packaged as a powder that will be reconstituted and administered by a healthcare professional. Children using it should be monitored every few months for bone age, height and blood sex-steroid levels. The U.S. distributor for Triptodur, Arbor Pharmaceuticals, plans a launch in the fourth quarter of 2017. Full prescribing information is available here.

New Indication for Vectibix

Amgen announced on June 29, 2017, that Vectibix® (panitumumab) has been approved by the U.S. Food and Drug Administration (FDA) to treat patients with metastatic wild-type RAS colorectal cancer. It can be used as initial therapy in combination with FOLFOX (folinic acid, fluorouracil and oxaliplatin) or by itself for patients with cancer that has progressed despite prior chemotherapy with fluoropyrimidine, oxaliplatin, and irinotecan. Along with the new indication, FDA also approved a companion diagnostic test to validate RAS status. On the U.S. market since late 2006, Vectibix has several other colorectal cancer indications. Recommended dosing is once every two weeks at 6mg/Kg infused intravenously (IV) over 30 minutes to 90 minutes, depending on the size of the dose. It carries a boxed warning that 90% of patients using it as monotherapy in clinical trials developed skin reactions ranging from dryness and itching to skin cracks and shedding. Reactions were severe for about 15% of patients. Complete prescribing information for Vectibix is available here.

 
27Jun
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

BevyxXa Approved for Clot Prevention

On June 23, 2017, the U.S. Food and Drug Administration (FDA) approved Portola Pharmaceuticals’ BevyxXa™ (betrixaban). It is an oral, once-daily factor Xa inhibitor indicated to prevent venous thromboembolism (VTE) in hospitalized adults with acute illnesses who are at high risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE. The recommended dose is an initial dose of 160mg on day 1, followed by 80mg once daily at the same time each day, with food. Treatment should continue for 35 to 42 days. According to Portola, BevyxXa will be available as 40mg and 80mg capsules sometime between August and November 2017. Full prescribing information is available here.  

New Fluoroquinolone Antibiotic Approved

Baxdela™ (delafloxacin) was approved by the U.S. Food and Drug Administration (FDA) on June 19, 2017. It treats adults who have acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible gram-positive and gram-negative bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). Baxdela is the first FDA-approved drug for Melinta Therapeutics, which has not released launch or pricing plans. Available as both oral tablets and intravenous (IV) infusions, Baxdela is dosed at 12 hour intervals for five days to 14 days. One 450mg tablet is equivalent to and interchangeable with one 300mg infusion. All fluoroquinolone antibiotics have the potential to cause tendonitis or tendon ruptures, peripheral neuropathy and central nervous system (CNS).reactions ranging from dizziness to toxic psychosis. A boxed warning on their labeling alerts patients to the risks and also cautions against their use for patients who have myasthenia gravis. Full prescribing information is available here.  

FDA Approved Cotempla XR-ODT

On June 19, 2017, Neos Therapeutics received U.S. Food and Drug Administration (FDA) approval for its once-daily Cotempla XR-ODT™ (methylphenidate) extended-release orally disintegrating tablets. It is indicated to treat attention deficit hyperactive disorder (ADHD) for children and teens between the ages of six and 17 years. Launch is planned for the autumn of 2017 in blister-packages containing 8.6mg, 17.3mg or 25.9mg tablets. Because it is a C-II controlled substance Cotempla XR-ODT has a medication guide for patients and a boxed warning about its possible abuse, misuse and/or dependence. Cotempla XR-ODT’s prescribing information is available here.  

Mydayis Approved for Treating ADHD

On June 20, 2017, U.S Food and Drug Administration (FDA) also approved Shire’s ADHD medication, Mydayis™ (mixed salts of single-entity amphetamine product, CII) capsules. It is approved for treating ADHD in patients 13 years of age and older. The recommended starting dose is 12.5mg once daily. If needed, this dose can be titrated by 12.5mg per week to a maximum daily dose of 25mg in children (13 to 17 years) and 50mg per day for adults. Mydayis has a duration of action up to 16 hours, and is a follow-on to the company’s Adderall XR® (mixed salts of single-entity amphetamine product, CII), which lasts for up to 12 hours. Shire is planning on launching Mydayis 12.5mg, 25mg, 37.5mg and 50mg extended-releases capsules during the third quarter of 2017. Pricing information is not yet available. Full prescribing information is available here.  

Mekinist and Tafinlar Combination Approved for Lung Cancer

On June 23, 2017, the U.S. Food and Drug Administration (FDA) granted approval for GlaxoSmithKline’s Mekinist® (trametinib) and Tafinlar® (dabrafenib) as a combination therapy to treat patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test. The combination was previously approved for treating advanced melanoma that has metastasized or that cannot be surgically removed, and that has been tested as positive for specific genetic mutations – BRAF V600E or BRAF V600K. Mekinist and Tafinlar are oral kinase inhibitors; Mekinist inhibits MEK and Tafinlar inhibits BRAF. Full prescribing information is available here.  

Rituxan Hycela Approved

On June 22, 2017, the U.S. Food and Drug Administration (FDA) approved Genentech’s Rituxan Hycela™ (rituximab and hyaluronidase human) for subcutaneous injection. It is indicated to treat previously untreated and relapsed or refractory follicular lymphoma, previously untreated diffuse large B-cell lymphoma, and previously untreated and previously treated chronic lymphocytic leukemia. Patients can use Rituxan Hycela only after they have received at least one full dose of a rituximab product by intravenous infusion. While both are administered by a healthcare professional, treatment with Rituxan Hycela can be administered in five to seven minutes, compared to 1.5 hours or more for intravenous Rituxan. According to Genentech, the new formulation will be available within the next one to two weeks. Full prescribing information is available here.  

Haegarda Approved for Hereditary Angioedema

On June 22, 2017, the U.S. Food and Drug Administration (FDA) approved CSL Behring’s Haegarda® (C1 esterase inhibitor subcutaneous [human]). It is indicated for routine prophylaxis to prevent hereditary angioedema (HAE) attacks in adolescent and adult patients. The recommended dose is 60 international units (IU) of Haegarda per kilogram (kg) of body weight, injected subcutaneously twice weekly (every 3 or 4 days). CSL Behring plans to launch Haegarda during the third quarter of 2017. It will be available through a limited network of specialty pharmacies that will include Accredo. Complete prescribing information is available here.  

 

 
23Jun

State of Emergency Due to Tropical Storm Cindy in Louisiana

The Governor of Louisiana has declared a State of Emergency due to Tropical Storm Cindy. All counties are impacted.

Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an emergency benefit 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.

 
21Jun

State of Emergency Due to Tropical Storm Cindy in Alabama

The Governor of Alabama has declared a State of Emergency due to Tropical Storm Cindy. All counties are impacted.

Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an emergency benefit 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.

 
19Jun
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

New Indication for Darzalex

On June 16, 2017, Janssen Biotech announced that a new indication has been approved by the U.S. Food and Drug Administration (FDA) for its Darzalex® (daratumumab) injection. It is now approved for use in combination with pomalidomide and dexamethasone for treating patients with multiple myeloma who have received at least two prior therapies including Revlimid® (lenalidomide – Celgene) and a proteasome inhibitor (PI). Darzalex, a CD38-directed antibody, was originally approved in November 2015 for use as a monotherapy in patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent. In November 2016, it received additional approvals for use in combination with lenalidomide and dexamethasone, or Velcade® (bortezomib – Takeda) and dexamethasone, for treating patients with multiple myeloma who have received at least one prior therapy. Updated prescribing information for Darzalex will soon be available here

First Generic Launched for Pataday

Teva Pharmaceutical Industries launched olopatadine ophthalmic solution 0.2%, the first A-rated generic to Alcon Laboratories’ Pataday®, on June 9, 2017. Olopatadine is a mast cell stabilizer that helps to relieve itchy eyes caused by allergic conjunctivitis. Recommended dosing is one drop in the affected eye(s) each day. It is dispensed in 5mL plastic dropper bottles that contain 2.5mL of solution. QuintilesIMS estimates that U.S. sales for Pataday accounted for $303 million in the 12 months that ended on March 31, 2017. Teva will have 180 days of generic exclusivity.

Generic for Renvela Oral Suspension

On June 13, 2017, the U.S. Food and Drug Administration (FDA) approved Aurobindo Pharma Limited’s A-rated generic to Genzyme’s Renvela® (sevelamer carbonate) oral suspension. It is indicated to control phosphorous levels in the blood of patients as young as six years old who need dialysis to manage chronic kidney disease. The drug attaches to phosphorous, which then is eliminated from the body because sevelamer carbonate is not absorbed. Aurobindo has already begun shipments of the generic, which is available in individual foil packets that each contains either 0.8Gm or 2.4Gm of the drug. According to IMS Health, 2016 annual sales for Renvela oral suspension were approximately $137 million.

Acticlate Generic Approved

On June 14, 2017, Mayne Pharma Group received approval from the U.S. Food and Drug Administration (FDA) for its doxycycline hyclate tablets, 75mg and 150mg. Although a number of generic doxycycline products already are on the U.S. market, Mayne’s are the first for Acticlate® (Aqua Pharmaceuticals). Mayne will also have 180-day exclusivity. Doxycycline is an antibiotic indicated to treat numerous bacterial infections, including anthrax, cholera and some eye, respiratory, sexually-transmitted and urinary infections. The 75mg and 150mg tablets primarily are marketed, in combination with other therapy, to treat severe acne. Annual U.S. sales for Acticlate through the end of April 2017 were approximately $250 million, according to QuintilesIMS.

Symjepi Approved

On Jun. 15, 2017, the U.S. Food and Drug Administration (FDA) approved Adamis Pharmaceuticals’ Symjepi™ (epinephrine) injection for the emergency treatment of allergic reactions (Type I) including anaphylaxis. It is a single-dose, pre-filled syringe for manual injection that contains 0.3mg/0.3mL of epinephrine. The recommended dose for patients who weigh at least 30kg (66 pounds) is one injection, administered intramuscularly (IM) or subcutaneously (SC) into the thigh. Adamis plans to launch Symjepi by mid-summer in a package that contains two syringes. Pricing information is not yet available. However, according to the manufacturer, Symjepi will be discounted to its main competitor, EpiPen® (epinephrine auto-injector – Mylan). Full prescribing information is available here

Updated "Near Term Pipeline: Highly Impacted Therapy Classes” Issues Document Available

The Office of Clinical Evaluation and Policy (OCEP) has updated the “Near Term Pipeline: Highly Impacted Therapy Classes” Issues document. Several pipeline products will significantly influence drug spend by the end of 2017. Awareness of products that will have high cost or that may impact large patient populations encourages payers not only to build proactive management strategies for utilization management, but also to anticipate future plan costs. This document includes an “ESI Perspective” section, describing potential strategies that may be used to help ensure appropriate utilization of these therapies. The document is available here.  

Updated Biosimilar Issues Document Available

The Emerging Therapeutics department has updated the Biosimilars Issues Document to include the U.S. Supreme Court’s ruling that 180-day notice of biosimilar launch can be given before the U.S. Food and Drug Administration (FDA) approval and that the patent dance is optional under federal law. Based on the 180-day notice ruling, going forward, biosimilar manufacturers will be able to launch their biosimilars upon FDA approval rather than having to wait six months to launch. The Biosimilars Issues Document is available here.  

 
12Jun
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

New Dosage Approved for Aristada

A fourth strength (1,064mg) of Aristada® (aripiprazole lauroxil – Alkermes) extended-release was approved by the U.S. Food and Drug Administration on June 5, 2017. An injectable suspension used for treating schizophrenia, Aristada now is available in single-use, prefilled syringes containing 441mg, 662mg, 882mg or 1,064mg. Lower doses are given once every four weeks or once every six weeks by a healthcare professional. The highest dose is administered once every eight weeks. Aristada is injected into the muscle of the upper arm (the lowest dose, only) or buttock. A boxed warning on its label cautions that antipsychotic drugs, including Aristada, increase the risk of death when used for elderly patients whose psychosis is caused by dementia. Full prescribing information is available here

First Generic for Truvada

On June 8, 2017, the FDA approved Teva Pharmaceutical’s generic for the 200mg/300mg strength of Truvada® (emtricitabine/tenofovir disoproxil fumarate – Gilead Sciences) tablets. Other strengths of Truvada remain brand only. The drug is indicated for use in combination with other antiretroviral drugs to treat HIV-1 infections for adults and children who weigh 17Kg (about 40 pounds) or more. Along with safe-sex practices and regular HIV testing, emtricitabine/tenofovir disoproxil fumarate also is FDA approved as pre-exposure prophylaxis (PrEP) for HIV-negative individuals who are at high risk of being infected. As the first generic to be FDA approved, Teva’s product has 180 days of exclusivity However, no launch or pricing plans have been announced. According to Gilead’s 2016 annual report, all strengths of Truvada accounted for U.S. sales of nearly $2.1 billion, last year.


Generic Approved for Lialda

The first generic for Shire’s Lialda® (mesalamine) 1.2Gm delayed-release tablets was FDA approved on June 5, 2017. Zydus Cadila was first to file, so it has 180 days of exclusivity for the drug, which is taken orally to treat mild-to-moderate ulcerative colitis. Launch is projected for July or August, but pricing currently is unknown. IMS estimates that global sales for Lialda were $1.2 billion for the 12-month period ending on April 30, 2017.

 
5Jun
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Zerviate Approved to Treat Allergic Conjunctivitis

On May 30, 2017, the U.S. Food and Drug Administration (FDA) approved Nicox’s Zerviate™ (cetirizine ophthalmic solution) 0.24% to reduce itching, redness, swelling and watering of the eyes caused by allergic conjunctivitis (eye inflammation from pollen or other irritants). Although cetirizine, a second-generation antihistamine, has been available in oral forms for more than 20 years, Zerviate is the first eye drop formulation. Nicox has not announced launch or pricing plans for Zerviate. Recommended dosing is one drop into the affected eye(s) once a day. Click here for Zerviate’s complete prescribing information. Express Scripts is currently investigating the data around Zerviate for a possible utilization management strategy.

New Dose for Isentress

A new formulation of Merck’s Isentress® (raltegravir), a human immunodeficiency virus (HIV) integrase strand transfer inhibitor, was approved by FDA on May 26, 2017. Isentress® HD (raltegravir) is dosed at 1,200mg orally once-daily, administered as two 600mg tablets, taken along with other antiretroviral drugs to treat adults and children who weigh 40 Kg (88 pounds) or more and who have HIV-1. Patients who are new to HIV therapy and patients whose HIV load is suppressed while they are taking 1,600mg of Isentress (two 400mg tablets twice a day) are candidates for Isentress HD. However, it is not interchangeable with chewable or liquid forms of Isentress. Merck expects to launch Isentress HD in about one month. Click here for full prescribing information is available.

 
5Jun

Direct Billing Arrangements Update

As a follow up to our January 26, 2017 communication where we notified you of our efforts to update our direct billing arrangements, we are pleased to announce we have reinstated several direct billing arrangements with the following China and German facilities. Below is a list of the reinstated facilities as of June 5, 2017.

We understand the importance of these direct billing arrangements: To simplify receiving care while overseas and avoid prepaying the bill.

If you have any questions related to the process of receiving care at over 100 of our overseas partners direct billing facilities around the world, please call us at 202-833-4910. 

Thank you for being a valued FSBP member!

 

Country

City

Facility

Billing Arrangement

Reinstated

China

Beijing

Beijing United Family Hospital Co. Ltd

Inpatient/  Routine annual physical exam/ Accidental Injury/  Complete maternity care/ All covered outpatient services

March 16, 2017

Beijing United Family Hospital Management Co., Ltd

Inpatient/  Routine annual physical exam/ Accidental Injury/  Complete maternity care/ All covered outpatient services

March 16, 2017

Beijing United Family Jian Guo Men Clinic Co., Ltd

Inpatient/  Routine annual physical exam/ Accidental Injury/  Complete maternity care/ All covered outpatient services

March 16, 2017

Beijing United Family Chao Wai Clinic Co. Ltd (CBD Clinic)

Inpatient/  Routine annual physical exam/ Accidental Injury/  Complete maternity care/ All covered outpatient services

March 16, 2017

Beijing United Family LiangMa Clinic Co., Ltd

Inpatient/  Routine annual physical exam/ Accidental Injury/  Complete maternity care/ All covered outpatient services

March 16, 2017

Beijing United Family Health Center Co. Ltd (New Hope)

Inpatient/  Routine annual physical exam/ Accidental Injury/  Complete maternity care/ All covered outpatient services

March 16, 2017

Beijing United Family Rehabilitation Hospital Co. Ltd.

Inpatient/  Routine annual physical exam/ Accidental Injury/  Complete maternity care/ All covered outpatient services

March 16, 2017

Beijing United Family Fu Xing Men Clinic Co. Ltd (Financial Street)

Inpatient/  Routine annual physical exam/ Accidental Injury/  Complete maternity care/ All covered outpatient services

March 16, 2017

Beijing United Family Wudaokou Clinic Co. Ltd

Inpatient/  Routine annual physical exam/ Accidental Injury/  Complete maternity care/ All covered outpatient services

March 16, 2017

Beijing United Family Guangqumen Clinic Co. Ltd

Inpatient/  Routine annual physical exam/ Accidental Injury/  Complete maternity care/ All covered outpatient services

March 16, 2017

Guangzhou

 

Guangzhou United Family Yue Xiu Clinic

Inpatient/ Accidental Injury/ Complete maternity care/ All covered outpatient services

March 15, 2017

Guangzhou United Family Hospital Co. Ltd

Inpatient/ Accidental Injury/ Complete maternity care/ All covered outpatient services

March 15, 2017

Shanghai

Shanghai He Man Jia Clinic Co 

Inpatient/  Routine annual physical exam / Accidental Injury/  Complete maternity care/ All covered outpatient services

March 20, 2017

Shanghai United Family Hospital Inc.

Inpatient/  Routine annual physical exam / Accidental Injury/  Complete maternity care/ All covered outpatient services

March 20, 2017

Shanghai United Family Clinic- Minhang, Inc.

Inpatient/  Routine annual physical exam / Accidental Injury/  Complete maternity care/ All covered outpatient services

March 20, 2017

Germany

Berlin

Krankenhaus Waldfriede

Inpatient

April 7, 2017

Heidelberg

Universitätsklinikum Heidelberg

Inpatient

May 8, 2017

Mainz

Universitätsklinik Mainz

Inpatient

May 8, 2017

Mannheim

Theresienkrankenhaus und St. Hedwig-Klinik

Inpatient

June 3, 2017

 

 

 

 
5Jun
From the CEO

From the CEO

Welcome to Summer 2017! By now, you should have seen the Spring AFSPA in Action Newsletter in your mailbox. It highlights our Annual Meeting that occurred in March 2017. The Newsletter discusses managing your blood pressure, telehealth, and frequently asked questions from members. As always, COO Kyle Longton explains our handling of some of your most difficult situations and responds to member concerns in his ongoing AFSPA Listens column. See an electronic copy of the Spring 2017 AFSPA in Action Newsletter here.   

June is Migraine and Headache Awareness month.  For anyone who has suffered from even one migraine, you know how painful and even debilitating it can be.  Please refer to page 8 of our Spring Newsletter for helpful tips.  FSBP members have access to pharmacists who specialize in the treatment of migraine headaches in the Express Scripts Neuroscience Therapeutic Resource Center through our cobranded website.

June is also Men’s Health MonthTo the 48% of our FSBP members who are men, please take the time to pay attention to your health.  If it has been more than a year since your last full physical exam, then pick up the phone today and call your primary care physicians office and book yourself an appointment.  The Plan covers your annual physical exam at 100% if you use an in-network provider in the U.S.  or any covered provider outside the U.S.  In addition, we cover:

  • Preventive services, counseling, and screenings that have a recommendation of “A” or “B” from the Unites States Preventive Task Force (USPSTF) and also are covered under the Affordable Care Act (ACA)
  • Adult routine immunizations endorsed by the Centers for Disease Control (CDC)

Summertime also means traveling to visit family or looking forward to a much-needed vacation. If you plan to travel this summer or if you have family coming to visit you, whether internationally or domestically, please consider applying for AFSPA’s travel insurance. AFSPA’s travel insurance provides referrals to physicians and hospitals, payment for medical claims, emergency evacuation, and emergency accidents and illnesses.  This plan is especially important for family members visiting you overseas if their health insurance, like Medicare, does not cover services outside the U.SSee the full description of AFSPA’s travel insurance services here.

I hope you and your family continue to make healthy choices throughout the 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

 
1Jun
Express Scripts News Flash

Express Scripts News Flash

Rebinyn Approved for Hemophilia B

On May 31, 2017, the U.S. Food and Drug Administration (FDA) approved Rebinyn® [Coagulation Factor IX (Recombinant), GlycoPEGylated) – Novo Nordisk]. Also known as nonacog beta pegol or N9-GP, Rebinyn is an extended-release form of blood clotting Factor IX, indicated to control bleeding episodes, including before and after surgery, for patients with hemophilia B. Dosing is as needed and infused intravenously (IV) at 40 international units (IU) per Kg of the patient’s body weight for minor-to-moderate bleeds or invasive procedures; and 80IU/Kg for more serious bleeds or major surgery. Rebinyn is not approved for regular use to prevent bleeding episodes. Launch is anticipated during the first six months of 2018 through a limited network of specialty pharmacies that will include Accredo. Click here for complete prescribing information.

  • Brand (Generic) Name: Rebinyn® [Coagulation Factor IX (Recombinant), GlycoPEGylated]
  • Manufacturer: Novo Nordisk
  • Date Approved: May 31, 2017
  • Indication: Rebinyn is indicated for use in adults and children with hemophilia B for on-demand treatment and control of bleeding episodes and for perioperative management of bleeding.
  • Dosage Forms Available: Single-use vials containing 500 IU, 1,000 IU or 2,000 IU of Rebinyn, packaged with a syringe containing sterile solution for reconstitution for IV infusion
  • Launch Date: First half of 2018
  • Estimated Annual Sales:  Pricing information is not yet available.
  • Specialty Status: Rebinyn will be added to Express Scripts’ specialty drug list.
  • Hemophilia B is a hereditary bleeding disorder affecting approximately 4,000 patients in the United States. Patients produce insufficient amounts of clotting Factor IX, which leads to bleeding episodes that cause pain, irreversible joint damage and possibly life-threatening hemorrhages.
  • Several other recombinant Factor IX products are FDA approved for treating hemophilia B episodes and perioperative bleeding. Alprolix® (Biogen) and Idelvion® (CSL Behring) are long-acting forms. BeneFIX® (Pfizer), Ixinity® (Emergent Biosolutions) and Rixubis® (Baxter) are shorter acting.
  • Rebinyn is not indicated to prevent bleeding episodes. However, the other Factor IX products can be used on a regular schedule for prevention.
 
1Jun
Express Scripts News Flash

Express Scripts News Flash

Generic Strattera Launched

The U.S. Food and Drug Administration (FDA) has approved the first AB-rated generics to Lilly’s Strattera® (atomoxetine), a drug approved for the treatment of attention-deficit/hyperactivity disorder (ADHD) in pediatric and adult patients. Generic exclusivity was not granted. Therefore, FDA approved generics from several manufacturers. Shipments of the generics have already begun.

  • Brand (Generic) Name: Strattera® (atomoxetine - Lilly)
  • Manufacturer: Apotex, Aurobindo, Glenmark and Teva
  • Indication: Treatment of attention-deficit/hyperactivity disorder (ADHD).
  • Dosage Forms Available:  10mg, 18mg, 25mg, 40mg, 60mg, 80mg and 100mg capsules
  • Launch Date: May 30, 2017
  • Annual U.S. Sales: $1.1 billion for the most recent twelve months ending in April 2017 according to IMS Health.
  • Strattera is a non-stimulant drug originally approved by FDA in 2002.
  • The last patent for Strattera expired on May 26, 2017. As a result, FDA was able to approve all eligible atomoxetine abbreviated new drug applications (ANDAs).
 
30May
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Actemra Approved to Treat Giant Cell Arteritis

An additional indication was granted on May 22, 2017, by the U.S. Food and Drug Administration (FDA), for Genentech’s Actemra® (tocilizumab). It is an interleukin-6 (IL-6), first approved in 2010, to treat rheumatoid arthritis. Actemra also has additional indications for types of juvenile arthritis, as well. Now, it has become the first drug approved for patients with giant cell arteritis. Sometimes called temporal arteritis because it mainly affects arteries in the head and neck, giant cell arteritis involves inflammation of the inside linings of the arteries. The disease usually occurs after the age of 50 years, and is about three times more common among women than men. In the United States, only around 700 individuals in every 100,000 of population have it. To treat giant cell arteritis, 162mg of Actemra will be injected subcutaneously (SC) once a week. Initially, it will be given along with a corticosteroid, but the steroid dose will be decreased gradually until it is stopped. The label for Actemra cautions that its use may predispose patients to having opportunistic bacterial, fungal, viral or other infections. Before Actemra is started, prospective patients should be tested for latent tuberculosis. Click here for full prescribing information.

Zykadia Gains a New Indication

On May 26, 2017, the U.S. Food and Drug Administration (FDA) approved the expanded use of Novartis’ Zykadia® (ceritinib) to include the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive, as detected by an FDA-approved test. In the clinical trial, ASCEND-4, the average progression-free survival (PFS) was about 16.6 months for Zykadia-treated patients compared to about 8.1 months for patients treated with other standard drugs. Zykadia is an oral tyrosine kinase inhibitor (TKI) originally approved in 2014 for use in patients with ALK-positive metastatic NSCLC who progressed on or are intolerant to Pfizer’s Xalkori® (crizotinib). It is supplied as 150mg oral capsules with a recommended dose is five capsules (750mg) taken once a day. Click here for full prescribing information.

New Indication for Keytruda

For the first time, the U.S. Food and Drug Administration (FDA) has approved a drug to treat multiple types of cancer that have specific genetic characteristics (biomarkers), rather than cancers that develop from a particular body tissue. Under accelerated FDA approval, Merck’s Keytruda® (pembrolizumab) was given an indication on May 23, 2017, for treating colorectal cancer and any solid tumors that are microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). It can be used by both adults and children who have exhausted available treatments for appropriate inoperable or metastatic cancers that have worsened despite previous drug therapy. Keytruda is a human programmed death receptor-1 (PD-1)-blocking antibody initially FDA approved in September 2014. It is an immuno-oncology (I/O) drug that increases the ability of the body’s immune system to destroy cancer cells. MSH-I and dMMR tumors, estimated to affect between 15,000 and 20,000 Americans each year, are associated most often with cancers of the colon/rectum, endometrium and gastrointestinal tract. Keytruda is administered by intravenous (IV) infusion once every three weeks for up to two years, until the cancer begins to progress or until the patient can no longer take the drug. The recommended dose of Keytruda for children is 2mg/Kg of body weight (up to 200mg); for adults, the dose is 200mg. Click here for updated prescribing information.

 
23May
Express Scripts News Flash

Express Scripts News Flash

Kevzara Approved to Treat Rheumatoid Arthritis

Sanofi and Regeneron Pharmaceuticals received approval for Kevzara® (sarilumab) from the U.S. Food and Drug Administration (FDA) on May 22, 2017. It is indicated to treat adults who have moderate-to-severe rheumatoid arthritis (RA) that has not been controlled adequately by previous treatment with other disease-modifying antirheumatic drugs (DMARDs). Kevzara is a monoclonal antibody that works by blocking interleukin-6, which is associated with inflammation. Recommended dosing is one 200mg subcutaneous (SC) injection once every two weeks either alone or in combination with methotrexate or other non-biological RA drugs. Labeling for Kevzara carries a boxed warning that patients using it are at an increased risk of developing infections, including some that may be life threatening. Sanofi and Regeneron launched Kevzara upon approval. It is available through open distribution. Click here for full prescribing information.

  • Brand (Generic) Name: Kevzara® (sarilumab)
  • Manufacturer: Sanofi/Regeneron Pharmaceuticals
  • Date Approved: May 22, 2017
  • Indication: Treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs
  • Dosage Forms Available:  Single-dose, pre-filled syringes in packages of two syringes, each containing 150mg or 200mg of Kevzara for subcutaneous injection
  • Launch Date: May 22, 2017
  • Estimated Annual Cost: Annual wholesale acquisition cost in the U.S. is $39,000 for either strength.
  • Specialty Status: Kevzara will be added to Express Scripts’ specialty drug list.
  • Rheumatoid arthritis is an inflammatory, autoimmune disease that attacks joints. Over 1.3 million American adults have rheumatoid arthritis, which causes pain, stiffness, swelling and deformity of the affected joints.
  • The only other IL-6 inhibitor presently FDA approved is Actemra® (tocilizumab - Genentech), which is available in both SC and intravenous (IV) forms.
  • Several other classes of DMARDs are available to treat rheumatoid arthritis. Currently, the most used are biological agents known as tumor necrosis factor alpha (TNFα) inhibitors, such as Enbrel® (etanercept - Amgen) and Humira® (adalimumab - AbbVie). Other biologics for RA include Orencia® (abatacept - Bristol-Myers Squibb) and Rituxan® (rituximab - Genentech/Biogen). Non-biologic agents include hydroxychloroquine, methotrexate and sulfasalazine -- mostly available as generics.
  • A boxed warning for Kevzara cautions that its use may predispose patients to opportunistic bacterial, fungal, viral or other infections. Before it is used, prospective patients should be tested for latent tuberculosis.
  • Kevzara will compete with Actemra; as well as with TNFα inhibitors and other biologicals.
  • A third IL-6 inhibitor, sirukumab (Janssen/GlaxoSmithKline), is under FDA review for treating rheumatoid arthritis. Its action date is September 23, 2017.

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

 
22May
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

FDA Expands Approved Use of Kalydeco

On May 17, 2017, the U.S. Food and Drug Administration (FDA) expanded the approved use of Kalydeco® (ivacaftor - Vertex), a product for treating cystic fibrosis (CF) in patients at least 2 years of age. Previously, it was indicated for use in patients who had one of 10 mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. The new indication expanded use to include patients who have one mutation in the CFTR gene that is responsive to Kalydeco based on clinical and/or in vitro assay data. This expanded indication increases treatment to include 33 mutations, impacting an additional estimated 900 patients. Click here for full prescribing information.

New Indications for Keytruda

On May 18, 2017, Merck’s Keytruda® (pembrolizumab) was granted two new indications. It received accelerated approval to treat locally advanced or metastatic urothelial carcinoma (bladder, ureter and/or urethra cancer) in patients who are not eligible for cisplatin-containing chemotherapy. Accelerated approval is given for drugs with clinical study information showing promise for treating serious or life-threatening diseases, even though studies are not completed. Keytruda also received standard approval to treat patients with locally advanced or metastatic urothelial carcinoma who have progressed on or after platinum-containing chemotherapy, or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Keytruda, a human programmed death receptor-1 (PD-1)-blocking antibody, boosts the immune system’s ability to attack cancer cells. Keytruda's label now includes indications in melanoma, non-small cell lung cancer (NSCLC), squamous cell cancer of the head and neck (SCCHN), classical Hodgkin's lymphoma and urothelial carcinoma. Click here for revised prescribing information.


MedWatch Update

Safety Warning for Canagliflozin Drugs

Acting on new information from ongoing clinical trials, the U.S. Food and Drug Administration revised a Safety Communication that it had issued last year. Invokana®, Invokamet® and Invokamet® XR, the three FDA-approved drugs containing canagliflozin, now must have a boxed warning about their higher risk of foot and leg amputations for patients who take them. Although the risk is still very small at less than one affected patient per 1,000, participants taking canagliflozin in the CANVAS and CANVAS-R studies had about twice the risk of needing an amputation as patients taking an inactive placebo. A sodium-glucose cotransporter-2 (SGLT2) inhibitor, canagliflozin is used to treat type 2 diabetes. Whether other SGLT2 inhibitors have similar risks is not yet known. The FDA is cautioning physicians to review patient histories for peripheral vascular disease or any other conditions that might predispose individuals to amputations before prescribing canagliflozin. Doctors also should monitor all patients taking it and consider a different drug if patients have diabetic nephropathy, foot ulcers or any other complication that might result in amputation. Current canagliflozin patients are advised to continue taking the drug as prescribed, but to report immediately any pain, sores or infections on their feet or legs. More information about canagliflozin’s safety is available here.

 
19May

Direct Billing Arrangements Update

As a follow up to our January 26, 2017 communication where we notified you of our efforts to update our direct billing arrangements, we are pleased to announce we have reinstated several direct billing arrangements with the following China and German facilities.

We understand the importance of these direct billing arrangements: To simplify receiving care while overseas and avoid prepaying the bill. If you have any questions related to the process of receiving care at over 100 of our overseas partners direct billing facilities around the world, please call us at 202-833-4910. 

Thank you for being a valued FSBP member!

 

Country

City

Facility

Billing Arrangement

Reinstated

China

Beijing

Beijing United Family Hospital Co. Ltd

Inpatient/  Routine annual physical exam/ Accidental Injury/  Complete maternity care/ All covered outpatient services

March 16, 2017

Beijing United Family Hospital Management Co., Ltd

Inpatient/  Routine annual physical exam/ Accidental Injury/  Complete maternity care/ All covered outpatient services

March 16, 2017

Beijing United Family Jian Guo Men Clinic Co., Ltd

Inpatient/  Routine annual physical exam/ Accidental Injury/  Complete maternity care/ All covered outpatient services

March 16, 2017

Beijing United Family Chao Wai Clinic Co. Ltd (CBD Clinic)

Inpatient/  Routine annual physical exam/ Accidental Injury/  Complete maternity care/ All covered outpatient services

March 16, 2017

Beijing United Family LiangMa Clinic Co., Ltd

Inpatient/  Routine annual physical exam/ Accidental Injury/  Complete maternity care/ All covered outpatient services

March 16, 2017

Beijing United Family Health Center Co. Ltd (New Hope)

Inpatient/  Routine annual physical exam/ Accidental Injury/  Complete maternity care/ All covered outpatient services

March 16, 2017

Beijing United Family Rehabilitation Hospital Co. Ltd.

Inpatient/  Routine annual physical exam/ Accidental Injury/  Complete maternity care/ All covered outpatient services

March 16, 2017

Beijing United Family Fu Xing Men Clinic Co. Ltd (Financial Street)

Inpatient/  Routine annual physical exam/ Accidental Injury/  Complete maternity care/ All covered outpatient services

March 16, 2017

Beijing United Family Wudaokou Clinic Co. Ltd

Inpatient/  Routine annual physical exam/ Accidental Injury/  Complete maternity care/ All covered outpatient services

March 16, 2017

Beijing United Family Guangqumen Clinic Co. Ltd

Inpatient/  Routine annual physical exam/ Accidental Injury/  Complete maternity care/ All covered outpatient services

March 16, 2017

Guangzhou

 

Guangzhou United Family Yue Xiu Clinic

Inpatient/ Accidental Injury/ Complete maternity care/ All covered outpatient services

March 15, 2017

Guangzhou United Family Hospital Co. Ltd

Inpatient/ Accidental Injury/ Complete maternity care/ All covered outpatient services

March 15, 2017

Shanghai

Shanghai He Man Jia Clinic Co 

Inpatient/  Routine annual physical exam / Accidental Injury/  Complete maternity care/ All covered outpatient services

March 20, 2017

Shanghai United Family Hospital Inc.

Inpatient/  Routine annual physical exam / Accidental Injury/  Complete maternity care/ All covered outpatient services

March 20, 2017

Shanghai United Family Clinic- Minhang, Inc.

Inpatient/  Routine annual physical exam / Accidental Injury/  Complete maternity care/ All covered outpatient services

March 20, 2017

Germany

Berlin

Krankenhaus Waldfriede

Inpatient

April 7, 2017

Heidelberg

Universitätsklinikum Heidelberg

Inpatient

May 8, 2017

Mainz

Universitätsklinik Mainz

Inpatient

May 8, 2017

 

 

 

 
15May
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Kisqali/Femara Combination Package Approved

The U.S. Food and Drug Administration (FDA) approved a combination package that contains two Novartis drugs, Kisqali® (ribociclib) and Femara® (letrozole) on May 4, 2017. Kisqali initially was FDA approved in March 2017 as first-line treatment for postmenopausal women who have metastatic or advanced hormone receptor positive (HR2+), human epidermal growth factor receptor-2 negative (HER2-) breast cancer. It is indicated for use along with any aromatase inhibitor, such as anastrozole, exemestane or letrozole. The co-packs, which each contain a one-month supply of both drugs, will be launched later in May at a cost equal to Kisqali’s alone. Available in three strengths, they will be sold through an open network of specialty and traditional pharmacies. Kisqali is on Express Scripts’ specialty drug list; therefore, this combination package will be included as well. Click here for full prescribing information.

Second Indication for Bavencio

Under the U.S. Food and Drug Administration's  (FDA) accelerated approval program, Bavencio® (avelumab - EMD Serono/Pfizer) was approved on May 9, 2017, to treat patients with locally advanced or metastatic urothelial carcinoma that has progressed during or after platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. Urothelial carcinoma accounts for around 90% of bladder cancer cases, affecting nearly 80,000 Americans each year. Once urothelial carcinoma metastasizes, the five-year survival rate is only about 5%. Bavencio is a programmed death receptor-ligand 1 (PD-L1)-blocking antibody given by intravenous (IV) infusion once every two weeks. It originally was FDA approved on March 23, 2017, to treat Merkel cell carcinoma, which is an aggressive type of skin cancer. Click here for complete prescribing information.

New Indication for Keytruda

On May 9, 2017, Merck’s Keytruda® (pembrolizumab) was granted a new indication to be used first-line to treat metastatic nonsquamous non-small cell lung cancer (NSCLC), whether or not the cancer expresses PD-L1. Keytruda will be used in combination therapy with Alimta® (pemetrexed – Eli Lilly) and carboplatin. Positive results from additional trials will be needed for full approval. Keytruda, a human programmed death receptor-1 (PD-1)-blocking antibody, boosts the immune system’s ability to attack cancer cells. Previously, the Keytruda/Alimta/carboplatin combination was limited to treating patients with NSCLC that expresses PD-1 as confirmed by a companion diagnostic test. Keytruda has additional indications for treating melanoma, classic Hodgkin lymphoma and head and neck cancers. Click here for revised prescribing information.

 
12May

State of Emergency Due to Severe Weather in Texas

The Governor of Texas has declared a State of Emergency due to severe weather. The Texan counties of Henderson, Rains and Van Zandt are impacted.

Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an emergency benefit 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 temporary alternate addresses (either online at www.express-scripts.com or by calling 1-800-818-6717) or request a local fill as needed.

 
9May
Express Scripts News Flash

Express Scripts News Flash

Radicava Approved to Treat Amyotrophic Lateral Sclerosis

On May 5, 2017, the U.S. Food and Drug Administration (FDA) approved Radicava™ (edaravone injection) for intravenous use. It treats patients with amyotrophic lateral sclerosis (ALS). Also known as Lou Gehrig’s disease, ALS gradually destroys the nerves involved in voluntary movement. Radicava’s manufacturer, MT Pharma America, a subsidiary of the Japanese company Mitsubishi Tanabe Pharma Corp., plans a U.S. launch in August. Each 60mg (two IV bag) Radicava dose will be given by a health provider as a 60-minute intravenous (IV) infusion. During the first 28-day dosing cycle, it will be administered once a day on the first 14 days, then not at all for the next 14 days. Subsequent cycles will include infusions of Radicava on 10 of the first 14 days, then 14 days without treatment. Complete prescribing information is available here.   

  • Brand (Generic) Name: Radicava™ (edaravone)
  • Manufacturer: MT Pharma America
  • Date Approved: May 5, 2017
  • Indication:Amyotrophic lateral sclerosis (ALS)
  • Dosage Forms Available:  30mg/100mL of solution in a single-use IV bag
  • Launch Date: August 2017
  • Estimated Annual Cost: $145,500
  • Specialty Status:  Radicava will be added to Express Scripts specialty drug list.
  • In the United States, about 20,000 individuals have ALS, a progressive disease that destroys nerve cells in the brain and spinal cord (central nervous system or CNS). Patients who have it gradually lose the abilities to move, speak, swallow and even breathe. With most patients diagnosed between the ages of 40 years and 70 years, life expectancy is only three years to five years after ALS diagnosis. 
  • Around 5% to 10% of ALS patients inherit the defective gene, but the majority of cases are “sporadic” – they have no obvious cause.
  • Previously, the only FDA-approved drug for ALS was Rilutek® (riluzole – sanofi-aventis U.S.) tablets, which is believed to reduce potentially damaging excess levels of a neurotransmitter, glutamate, in the CNS.
  • In the small, six-month-long clinical trial of Radicava that was conducted in Japan, disease progression was slower for participants who were treated with it compared with those who received placebo. Many of the participants in each group also were taking Rilutek. Although the way it works is not known, Radicava may shield CNS nerves from damage.
 
9May

STATE OF EMERGENCY IN FLORIDA DUE TO WILDFIRES

The Governor of Florida has declared a State of Emergency due to wildfires. All counties in Florida are impacted.

Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an emergency benefit 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 temporary alternate addresses (either online at www.express-scripts.com or by calling 1-800-818-6717) or request a local fill as needed.

 
8May
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

New Indication Approved for Bunavail

Bunavail® (buprenorphine/naloxone – BioDelivery Sciences International) buccal film was given a second indication by the U.S. Food and Drug Administration (FDA) on April 27, 2017. Bunavail is a C-III controlled substance that was originally approved in 2014 for the maintenance phase of opioid addiction treatment. Now, it also is indicated for initial (induction) treatment for patients beginning therapy. Using BioDelivery’s proprietary BioErodible MucoAdhesive (BEMA®) technology, Bunavail sticks to the inside of the cheek and dissolves to release the drugs. It is used once a day in comprehensive treatment plans that include counseling and psychosocial support. Under the Drug Addiction Treatment Act (DATA), prescribing of Bunavail is restricted to physicians who are specially trained and registered with the U.S. Department of Health and Human Services. Patients are given a medication guide that details correct use of Bunavail, as well as warnings about its many possible side effects. With a recommended daily maintenance dose of 8.4mg buprenorphine/1.4mg naloxone, Bunavail is available in three strengths. Its full prescribing information is available here.  


Expanded Indication for Ravicti

On April 28, 2017, the FDA approved Ravicti® (glycerol phenylbutyrate – Horizon Pharma) oral liquid for treating patients who are as young as two months of age and who have a urea cycle disorder. Rare hereditary conditions estimated to affect fewer than 150 new patients per year in the U.S., urea cycle disorders are caused by shortages of one or more enzymes that eliminate nitrogen (converted into ammonia) from the blood. For patients with a urea cycle disorder, excess ammonia accumulates — eventually causing brain damage, which could result in death. Ravicti initially was FDA approved to treat urea cycle disorder patients two years of age and older. It must be used along with a protein-restricted diet and, possibly, dietary supplements. The recommended dose of Ravicti is 4.5mL/m2/day to 11.2mL/m2/day in three equally divided doses that are given, along with food or infant formula, by mouth, nasogastric tube or gastrostomy tube. Complete prescribing information is available here.   

 
4May
From the CEO

From the CEO

Greetings and welcome to May 2017! At the American Foreign Service Protective Association (AFSPA), we aim to provide you with a valuable combination of services that you can use to manage your health and well-being. Just to name a few, AFSPA offers comprehensive health coverage through the Foreign Service Benefit Plan (FSBP), dental coverage, long-term care planning services, travel benefits, life insurance, and disability income insurance.

May is National Disability Insurance Awareness Month

Disability income insurance is often overlooked because many people think a disabling illness or injury will never happen to them. But it happens more than they think.  Most Federal employees earn very generous sick leave benefits, but it may take a while, several years, to build up adequate time.  While many in the Federal workforce have enough sick leave to get them through months of a long-term illness or injury,  many more are faced with severe financial challenges should they not be able to work for an extended period of time. If you are a newly hired employee, do not have a substantial amount of sick leave, or you just want added protection, you should consider applying for AFSPA’s Disability Plan which covers 60% of your annual salary –that’s up to $5,000 a month. We offer two (2) disability plans you can choose from to meet your needs. Click here to learn more.

FSBP Member Benefit: Quest Diagnostics – Outpatient Lab Card

Did you know that FSBP members can receive covered outpatient lab tests performed in the U.S. at no cost - no deductible, no copays, and no coinsurance, as long as you use the Quest Diagnostics Outpatient Lab Card Program? If you are an FSBP member, a Lab Card packet recently was mailed to you that includes two (2) Lab Cards and four (4) stickers to affix to your FSBP ID card(s). To use this benefit, simply present your Quest Diagnostics Lab Card and/or FSBP ID card with the Lab Card sticker affixed to it to your physician and mention you would like to use the Quest Outpatient Lab Card benefit! Click here to learn more.

Senior Living Foundation supports Foreign Affairs Day

Lastly, the Senior Living Foundation (SLF) is once again a proud sponsor of Foreign Affairs Day, happening on Friday, May 5, 2017. This event serves as a homecoming for retirees from the State Department and provides them with an opportunity to engage with active officers and learn about current developments at State. Visit the SLF website at www.slfoundation.org to view past event photos or to make a worthwhile contribution to the Foundation. Your tax deductible donation will assist the many elderly Foreign Service colleagues who turn to the Foundation when they have nowhere else to go for assistance.

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

 
2May
Clinical Matters News Flash

Clinical Matters News Flash

Imfinzi Approved for Bladder Cancer

On May 1, 2017, the U.S. Food and Drug Administration (FDA) gave accelerated approval to AstraZeneca’s Imfinzi™ (durvalumab). It is a programmed death ligand 1 (PD-L1) inhibitor approved for use in patients whose locally advanced or metastatic urothelial carcinoma (bladder, ureter and/or urethra cancer) progresses during or following platinum-containing chemotherapy. Imfinzi also is indicated for patients who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Recommended dosing is 10mg/Kg of body weight once every two weeks as a one-hour intravenous (IV) infusion. Complete prescribing information is available here

  • Brand (Generic) Name: Imfinzi™ (durvalumab )
  • Manufacturer: AstraZeneca
  • Date Approved: May 1, 2017
  • Indication: To treat patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy
  • Dosage Forms Available:  single-use vials each containing either 500mg of Imfinzi in 10mL of solution or 120mg in 2.4mL
  • Launch Date: Launch plans are unknown at this time
  • Estimated Annual Cost: Pricing information not yet available. However, it will likely be in line with similar products with a cost of at least $150,000 per year.
  • Specialty Status:  Infinzi will be added to Express Scripts specialty drug list.
  • Urothelial carcinoma also is called transitional cell carcinoma because it usually begins in the transitional cells that line the urinary tract. It is the most common form of bladder cancer, affecting nearly 80,000 Americans each year. About three times as many men as women have it and most newly diagnosed patients are 55 years old or older.
  • Ventana Medical System’s VENTANA PD-L1 (SP263) Assay also was FDA approved on May 1, 2017 as a companion diagnostic
  • Imfinzi is a programmed death ligand 1 (PD-L1) inhibitor -- immunotherapy that helps the body’s immune system attack cancer cells
  • Interim results from participants in the main clinical trial showed an objective response rate of 26.3% among patients who scored high on the diagnostic test for PD-L1.
  • Other PD-1/PD-L1 blockers are available in the U.S. In May 2016, Genentech’s Tecentriq™ (atezolizumab) became the first PD-L1 blocker to gain an FDA indication for bladder cancer, with approval for first-line bladder cancer treatment granted in February 2017. Bristol-Myers Squibb’s Opdivo® (nivolumab) was approved for urothelial carcinoma in February 2017 and Merck’s Keytruda® (pembrolizumab) is expected to be approved by June 14, 2017, for the same indication, as well.
 
2May

States of Emergency Due to Flooding in Arkansas and Kansas

The Governors of Arkansas and Kansas have declared States of Emergency due to flooding. All counties in Arkansas are impacted. The following counties in Kansas are impacted: Bourbon, Cherokee, Cheyenne, Crawford, Decatur, Gove, Graham, Greeley, Logan, Neosho, Norton, Rawlins, Sheridan, Sherman, Thomas, Wallace and Wichita.  

Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an emergency benefit 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 temporary alternate addresses (either online at www.express-scripts.com or by calling 1-800-818-6717) or request a local fill as needed.

 
1May
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Liquid Dose Form of Methotrexate Approved

Xatmep™ (methotrexate) Oral Solution was approved by the U.S. Food and Drug Administration (FDA) on April 25, 2017. It is indicated to treat pediatric patients who have acute lymphoblastic leukemia (ALL) or polyarticular juvenile idiopathic arthritis (pJIA). For ALL, it will be used along with other oncology drugs and taken once a week at a dose of 20mg/m2. Recommended dosing for pJIA is 10mg/m2 per week. 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 reactions, infections or skin reactions. If methotrexate is taken during pregnancy, the fetus may be harmed severely. Xatmep’s manufacturer, Silvergate Pharmaceuticals, has not yet disclosed launch or pricing plans. It will be dispensed in 120mL bottles containing 2.5mg/mL of methotrexate. Complete prescribing information is available here


RoxyBond Approved for Pain

Inspirion Delivery Sciences announced the U.S. Food and Drug Administration (FDA) approval for RoxyBond™ (oxycodone) tablets on April 26, 2017. A C-II controlled substance, RoxyBond is an immediate-release opioid intended to treat severe pain that needs continual management and that does not respond to other treatments. It has been formulated; both chemically and physically, to be difficult to break, crush or dissolve; making it challenging to abuse by injection. It still may be misused through ingestion, inhalation or intravenous (IV) administration, however. Labels for all opioids, regardless of their abuse-deterrent properties, have a boxed warning that taking them may be associated with abuse, addiction, misuse, overdose and death. Babies born to women who use them during pregnancy may suffer neonatal withdrawal syndrome and older children may overdose, possibly fatally, from taking them unintentionally. To be released as 5mg, 15mg and 30mg strength tablets, RoxyBond’s launch date has yet to be determined. Full prescribing information is available here

Liver Cancer Indication Approved for Stivarga

Under the U.S. Food and Drug Administration's (FDA) priority review process, Stivarga® (regorafenib - Bayer) was approved on April 26, 2017, to treat hepatocellular carcinoma (HCC) for patients previously treated with Nexavar® (sorafenib - Bayer). Both drugs are oral tyrosine kinase inhibitors (TKIs) that work in different ways. Stivarga interferes with several enzymes that promote cancer growth, including some in the vascular endothelial growth factor (VEGF) pathway. In the phase III RESOURCE clinical trial, overall survival time for HCC patients who took 160mg of Stivarga per day for the first 21 days of each 28-day cycle averaged 10.6 months as compared to 7.8 months for study participants taking an inactive placebo. Patients in both groups also received supportive care, such as pain management. Stivarga has prior FDA indications as second-line therapy for metastatic colorectal cancer and for gastrointestinal stromal tumors (GIST). Its labeling has a boxed warning that it may cause liver damage, so liver function must be monitored carefully during its use. Complete prescribing information for Stivarga is available here

Thymoglobulin Approved to Prevent Acute Kidney Transplant Rejection

Sanofi’s Thymoglobulin® [anti-thymocyte globulin (rabbit)] has received a second U.S. Food and Drug Administration (FDA) indication — for preventing acute rejection of transplanted kidneys. It is given along with immunosuppressant therapy, as well as antibacterials, antifungals or antivirals if needed. It has been FDA approved since 1998 for treating kidney transplant rejection. Recommended dosing to prevent rejection is 1.5mg/Kg of body weight administered once a day as an intravenous (IV) infusion. It is administered over six hours on the first day and then over four hours on following days. The first infusion begins before blood flow is established to the transplanted kidney and treatment lasts between four days and seven days. The labeling for Thymoglobulin includes a boxed warning that it should be administered only in a hospital and by clinicians who are experienced with its use due to the risk it might suppress immune function too much. Both platelet count and white blood cell count should be monitored during therapy and after treatment is discontinued. Thymoglobulin’s prescribing information is available here


Praluent Approved for Once-a-Month Dose

On April 24, 2017, the U.S. Food and Drug Administration (FDA) approved a once-monthly dose for the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, Praluent® (alirocumab). Jointly developed by Regeneron Pharmaceuticals and Sanofi, Praluent treats adults who have heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD) and who require additional lowering of low-density lipoprotein (LDL) cholesterol despite diet modifications and the maximum dose of a HMG-CoA reductase inhibitor (statin). Praluent is available in syringes or auto-injector pens, each pre-filled with 75mg or 150mg of the drug. For the once-monthly dose, two of the 150mg doses will be given at the same time but at different sites on the abdomen, thighs or upper arms. Prescribing information is available here

Rydapt Approved for Acute Myeloid Leukemia and Systemic Mastocytosis

On April 28, 2017, Novartis received approval from the U.S. Food and Drug Administration (FDA) for Rydapt® (midostaurin) for the first-line treatment of adults with FMS-like tyrosine kinase 3 mutation-positive (FLT3+) acute myeloid leukemia (AML) as detected by an FDA-approved test, in combination with chemotherapy. It is also approved to treat adults with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN) or mast cell leukemia (MCL). The recommended dose for AML is 50mg twice daily with food. For ASM, SM-AHN and MCL, the recommended dose is 100mg twice daily with food. Novartis plans on launching Rydapt in the near future. It will be available through open distribution. Full prescribing information is available here

Tymlos Approved to Treat Osteoporosis

Tymlos™ (abaloparatide) was approved by the U.S. Food and Drug Administration (FDA) on April. 29, 2017, to treat postmenopausal women who have osteoporosis and who also have a high risk of fracture. A human parathyroid hormone related peptide (PTHrP[1-34]) analog, its recommended dose is one 80mcg subcutaneous injection into the abdomen each day. A boxed warning on its labeling warns that using Tymlos may increase the risk of osteosarcoma (bone cancer). Tymlos is available in pre-filled, disposable pen devices containing 30 doses (a total of 3,120mcg) of Tymlos in a total 1.56mL of solution.  Using it for longer than a total of two years is not recommended, whether or not use is continuous. The manufacturer, Radius Health, plans to launch Tymlos in late-May 2017; it will be available through open distribution. Full prescribing information is available here.  

Alunbrig Approved for Non-Small Cell Lung Cancer

Takeda Oncology’s Alunbrig™ (brigatinib) received accelerated approval from the U.S. Food and Drug Administration (FDA) on April 28, 2017. An oral tyrosine kinase inhibitor (TKI), Alunbrig is  indicated for treating patients who have metastatic anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC) and who have progressed on or are intolerant to Xalkori® (crizotinib – Pfizer/EMD Serono). Alunbrig is available in 30mg and 90 mg tablets.  Recommended dosing is 90mg per day for one week, followed by 180mg per day, if the patient can tolerate the higher dose. Takeda Oncology plans on launching Alunbrig in mid-May. It will be available through a limited network of specialty pharmacies that includes Accredo. Complete prescribing information is available here

 

 
1May

States of Emergency Due to Flooding in Missouri and Oklahoma

The Governors of Missouri and Oklahoma have declared States of Emergency impacting all counties in each state due to flooding.

Express Scripts (the Plan’s Pharmacy Benefit Manager) has activated an emergency benefit 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 temporary alternate addresses (either online at www.express-scripts.com or by calling 1-800-818-6717) or request a local fill as needed.

 
28Apr
 Express Scripts News Flash

Express Scripts News Flash

Brineura Approved for Late Infantile Neuronal Ceroid Lipofuscinosis Type 2

The U.S. Food and Drug Administration (FDA) approved Brineura™ (cerliponase alfa) on April 27, 2017. It is an enzyme replacement therapy for children at least three years old who have a rare form of Batten disease known as late infantile neuronal ceroid lipofuscinosis type 2 (CLN2). It helps affected children maintain the ability to crawl or walk. Brineura is infused under sterile conditions directly into cerebrospinal fluid of the brain using an implanted reservoir and catheter. The recommended dose is 300mg administered over four and one-half hours every two weeks. BioMarin Pharmaceuticals plans to begin sales within six weeks. Distribution will be through hospitals only. Prescribing information is available here

  • Brand (Generic) Name: Brineura (cerliponase alfa)
  • Manufacturer: BioMarin Pharmaceuticals
  • Date Approved: April 27, 2017
  • Indication: To slow the loss of the ability to walk or crawl (ambulation) in symptomatic pediatric patients three years of age and older with late infantile neuronal ceroid lipofuscinosis type 2 (CLN2)
  • Dosage Forms Available:  150mg/5mL (30mg/mL) solution, two single-dose vials per carton co-packaged with Intraventricular Electrolytes Injection 5mL in a single-dose vial for intraventricular infusion
  • Launch Date: Early June 2017
  • Estimated Annual Cost: Pricing information not yet available.
  • Specialty Status:  Brineura will be added to Express Scripts specialty drug list.
  • Batten disease includes a collection of hereditary neurological disorders that affect only two to four babies in every 100,000 live births. 
  • Patients with CLN2 lack the enzyme tripeptidyl peptidase-1 (TPP1), which causes developmental delays, muscle spasms, seizures, vision loss and other neurological symptoms. Only about 20 infants per year are born with CLN2 in the United States. Symptoms typically begin between the ages of two and four years, patients gradually lose function, including speech and most cases are fatal before the age of 12 years.
  • Brineura is the first drug FDA approved to treat CLN2. Continuing studies will test its use for children under two years of age and its long-term effects over 10 years.
  • Before Brineura is given, patients should be pre-treated with an antihistamine, a fever reducer and/or a corticosteroid. After administration, electrolyte infusions are recommended.
 
27Apr
Express Scripts News Flash

Express Scripts News Flash

Generics to Vytorin Launched

The U.S. Food and Drug Administration (FDA) approved AB-rated generics to Merck’s Vytorin® (ezetimibe and simvastatin), a product approved to lower high blood cholesterol. Generic exclusivity was not granted. Shipments of the generics have already begun from at least three companies, Dr. Reddy’s Laboratories, Impax and Teva.

  • Brand Drug: Vytorin® (ezetimibe and simvastatin – Merck)
  • Indication: For use as an adjunctive therapy to diet to treat patients with primary or mixed hyperlipidemia. It is also approved as an adjunct to other lipid-lowering treatments for patients with homozygous familial hypercholesterolemia (HoFH).
  • Generic Manufacturer(s): Dr. Reddy’s Laboratories, Impax, Teva
  • Launch Date: April 26, 2017
  • Dosage Forms Available: Tablets (ezetimibe/simvastatin): 10mg/10mg, 10mg/20mg, 10mg/40mg, 10mg/80mg
  • Annual U.S. Sales: $687 million for the twelve month period that ended on Feb. 28, 2017, according to IMS Health.
  • Vytorin, a combination of two drugs, was first approved by the FDA in 2005. Simvastatin (Zocor®, generics) belongs to a class of cholesterol-lowering medications known as HMG-CoA reductase inhibitors, or “statins”. Ezetimibe (Zetia®, generics) is a unique drug that inhibits the absorption of cholesterol by the small intestine.
 
19Apr
“FSBP Members - Coming Soon To Your Mailbox

“FSBP Members - Coming Soon To Your Mailbox"

Your Quest Diagnostic Lab Card is in route to you! 

A Lab Card packet containing a welcome letter, two (2) Lab Cards and four (4) stickers to put on your FSBP ID card(s) or medical files at your Doctor’s office, and a document explaining how the Lab Card program works. 

While waiting for your Lab Card, you can print a temporary one by visiting www.Labcard.com, select the option “print a temporary card” or request one by email at [email protected].

Questions?  Call one of our Health Benefits Officers at 202-833-4910 for assistance.

As always, thank you for being a valued FSBP member!

 
18Apr
Clinical News and Notes

Clinical News and Notes

MedWatch Update

Aranesp, Epogen and Procrit

The U.S. Food and Drug Administration (FDA) has rescinded the risk evaluation and mitigation strategy (REMS) for the erythropoiesis-stimulating agents (ESAs) Aranesp® (darbepoetin alfa – Amgen), Epogen® (epoetin alfa – Amgen), and Procrit® (epoetin alfa – Johnson &Johnson). Beginning in 2004, FDA requested labeling updates, physician communications and other regulatory changes after continuing reports of severe side effects from ESAs. They may increase the risk of serious anemias, adverse cardiovascular events, worsened kidney disease and tumor progression or recurrence for some cancers types. In 2011, a REMS was implemented, requiring healthcare professionals who prescribe and hospitals that dispense ESAs for cancer patients to enroll in training under the APPRISE Oncology Program. It also requires that patients be counseled about risks and that both patients and prescribers sign forms acknowledging the risks prior to initiating ESA therapy. After analyzing more recent information, which includes usage patterns, FDA has withdrawn the REMS and discontinued the APPRISE Oncology Program. Additional information is available here.

 

 

 
14Apr
Product Recall

Product Recall

Express Scripts Managing EpiPen® (epinephrine injection, USP) and EpiPen Jr® (epinephrine injection, USP) Auto-Injectors Recall

Epinephrine is the first-line treatment for a life-threatening allergic reaction (anaphylaxis) and access to this product is critical in the event of an emergency. Meridian Medical Technologies, a Pfizer company and Mylan’s manufacturing partner for EpiPen Auto-Injector, has announced a voluntary recall for select lots of EpiPen® (epinephrine injection, USP) and EpiPen Jr® (epinephrine injection, USP) Auto-Injectors.  The recalled lot numbers are below and were distributed from December 15, 2015 through July 1, 2016. 

Express Scripts Pharmacy has mailed member notification letters this week.

Additional Information:

Product: EpiPen®  (epinephrine injection, USP) Auto-Injectors and EpiPen Jr® (epinephrine injection, USP) Auto-Injectors

  • Dosage: EpiPen® is 0.3 MG; EpiPen Jr® is 0.15 mg
  • Indication: treatment for a life-threatening allergic reaction (anaphylaxis)
  • Manufacturer: Meridian Medical Technologies
  • Lots impacted for EpiPen Jr®:
  • Lot: 5GN767/Expiry: April 2017
  • Lot: 5GN773/Expiry: April 2017
  • Lot:  6GN215/Expiry: Sep. 2017
  • Lots impacted for EpiPen®:
  • Lot: 5GM640/ Expiry: May 2017
  • Lot: 6GM081/ Expiry: September 2017
  • Lot:  6GM198/ Expiry: October 2017
  • Lot: 5GM631/ Expiry: April 2017
  • Lot: 6GM088/ Expiry: October 2017
  • Lot: 6GM087/ Expiry: October 2017
  • Lot: 6GM082/ Expiry: September 2017
  • Lot: 6GM199/ Expiry: October 2017
  • Lot: 6GM072/ Expiration Date: September 2017
  • Lot: 6GM091/ Expiration Date: October 2017
  • Type of recall: Voluntary
  • Reason for Recall: due to the potential that these devices may contain a defective part that may result in the devices’ failure to activate.
  • Return/Replacement information: Patients with unused EpiPen or EpiPen Jr. Auto-Injector product bearing the recalled lot number should contact Stericycle at 877-650-3494, Monday through Friday 8 a.m. - 10 p.m. ET, or Saturday and Sunday 8 a.m.-5 p.m. ET.  Stericycle will provide a voucher number to cover the cost for replacing each 2 pak of recalled product. Stericycle will also facilitate the return of the recalled product for Mylan.
 
13Apr
Express Scripts News Flash

Express Scripts News Flash

Ingrezza Approved for Tardive Dyskinesia

On April 11, 2017, Neurocrine Biosciences received approval from the U.S. Food and Drug Administration (FDA) for Ingrezza™ (valbenazine) capsules for the treatment of adults with tardive dyskinesia (TD). The initial dose is 40mg once daily. After a week, it can be increased to the recommended dose of 80mg once daily. Neurocrine plans on a May 1, 2017 launch. It will be available through a limited network of specialty pharmacies that does not include Accredo. Full prescribing information is available here.  

  • Brand (Generic) Name: Ingrezza™ (valbenazine)
  • Manufacturer: Neurocrine Biosciences
  • Date Approved: April 11, 2017
  • Indication: Treatment of adults with tardive dyskinesia
  • Dosage Forms Available: 40mg capsules
  • Launch Date: Ingrezza will be launched on May 1, 2017
  • Estimated Annual Cost: Neurocrine plans to announce the price for Ingrezza on its launch date.
  • Specialty Status: Ingrezza will be added to Express Scripts’ specialty drug list.
  • Tardive dyskinesia, which is characterized by abnormal, involuntary movements, affects as many as 500,000 patients in the U.S.
  • Ingrezza is a vesicular monoamine transporter 2 (VMAT2) inhibitor.
  • Austedo™ (deutetrabenzine – Teva) and Xenazine® (tetrabenazine – Valeant Pharmaceuticals, generics) are also VMAT2 inhibitors; however they are only approved for treating chorea associated with Huntington’s disease.
  • Prescribing information for both Austedo and Xenazine contains a boxed warning concerning the risk of depression and suicidality. Ingrezza’s labeling does not contain a similar boxed warning.
  • Austedo is expected to receive an expanded indication to treat tardive dyskinesia by August 30, 2017.
 
10Apr
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Full Approval and Extended Indication for Ibrance

On March 31, 2017, the U.S. Food and Drug Administration (FDA) converted the initial accelerated approval of Pfizer’s Ibrance® (palbociclib) to regular approval. It now has full approval, along with any aromatase inhibitor (such as anastrozole, exemestane or letrozole), for the initial treatment of postmenopausal women who have advanced or metastatic hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. Ibrance was the first cyclin-dependent kinase 4/6 (CDK 4/6) inhibitor to receive FDA approval. The drug works by interfering with parts of cancer cell division. It has had accelerated approval for the first-line indication since February 2015, but only in combination with letrozole. Results from the Phase 3 PALOMA-2 trial showed that the average progression-free survival (PFS) time for women who took the combination of Ibrance with letrozole was a little over two years as compared to about 14.5 months for those taking a placebo with letrozole. It also has approval, combined with Faslodex® (fulvestrant - AstraZeneca) injection, as first-line therapy to treat HR+/HER2- breast cancer that has worsened after previous endocrine-based treatment. The recommended dosing is on 28-day cycles with one 125mg capsule taken daily on the first 21 days, only. The Ibrance dose may be reduced if side effects occur. Prescribing information is available here.   


Sovaldi and Harvoni Approved for Pediatric Hepatitis C 

On April 7, 2017, FDA approved the use of Gilead’s Sovaldi® (sofosbuvir) and Harvoni® (ledipasvir/sofosbuvir) for treating hepatitis C virus (HCV) infections in patients as young as 12 years of age, or at least 77 pounds (35kg). Both are oral direct-acting antiviral drug regimens for treating HCV infections. Harvoni can be used in children who have genotype 1, 4, 5 or 6 chronic HCV infections. Sovaldi is indicated for use, in combination with ribavirin, in pediatric patients with genotype 2 or 3 chronic HCV infection. According to the Centers for Disease Control and Prevention (CDC), an estimated 23,000 to 46,000 children in the U.S. are infected with HCV, usually infected at birth. Updated prescribing information is available here:

 
5Apr
Express Scripts News Flash

Express Scripts News Flash

Austedo Approved for Chorea Associated with Huntington’s Disease

On April 3, 2017, Teva received approval from the U.S. Food and Drug Administration (FDA) for Austedo™ (deutetrabenazine) for the treatment of chorea associated with Huntington’s disease (HD). The recommended starting dose is 6mg once daily. The dose should be titrated up at weekly intervals by 6mg per day to a maximum dose of 24mg twice daily. Total daily doses of 12mg or above should be divided into two doses. Teva plans on launching Austedo within the next 3 weeks. It will be available through a limited network of specialty pharmacies that does not include Accredo. Full prescribing information can be found here

  • Brand (Generic) Name: Austedo™ (deutetrabenazine)
  • Manufacturer: Teva Pharmaceutical Industries
  • Date Approved: April 3, 2017
  • Indication: Treatment of chorea associated with Huntington’s disease
  • Dosage Forms Available: 6mg, 9mg and 12mg tablets
  • Launch Date: By April 25, 2017
  • Estimated Annual Cost: The wholesale acquisition cost (WAC) of Austedo is $60,000 per year for the recommended dose of 24mg twice daily.
  • Specialty Status: Austedo will be added to Express Scripts’ specialty drug list.
  • Huntington’s disease (HD) is a fatal neurodegenerative disorder that affects more than 35,000 Americans. Chorea, which occurs in approximately 90% of patients with HD, is associated with abnormal, involuntary movements.
  • Austedo is a vesicular monoamine transporter 2 (VMAT2) inhibitor.
  • Xenazine® (tetrabenazine – Valeant Pharmaceuticals, generics), another VMAT2 inhibitor, has been the only drug approved for HD since 2008. Xenazine is dosed three times daily compared to twice daily for Austedo.
  • Similar to Xenazine, the labeling for Austedo contains a boxed warning concerning the risk of depression and suicidality. However, the risk of depression and suicidality is lower with Austedo compared to Xenazine.
  • Austedo is expected to receive an expanded indication to treat tardive dyskinesia by Aug. 30, 2017. Tardive dyskinesia, which is characterized by abnormal, involuntary movements, affects as many as 500,000 patients in the U.S.
  • A third VMAT2 inhibitor, Ingrezza (valbenazine – Neurocrine Biosciences), is expected to be approved for tardive dyskinesia by April 11, 2017.
 
3Apr
From the CEO

From the CEO

Greetings and Welcome to April 2017! What a privilege and a responsibility it is to play a role in serving more than 67,000 AFSPA members every day. I am honored by the trust that each person places in the Foreign Service Benefit Plan (FSBP) and our other programs.

April is designated as World Autism Month. This annual event sets aside time to help increase understanding of Autism Spectrum Disorder. Applied Behavior Analysis (ABA) has proven to be successful in the treatment of autism. It uses the principles of learning and motivation from the scientific study of behavior. FSBP now covers medically necessary assessment and treatment of Autism Spectrum Disorder with ABA. FSBP pays 90% of the Plan allowance when services are delivered by an in-network behavioral health provider or a provider outside the 50 United States, and 70% of the Plan allowance for out-of-network providers. The covered providers must possess specific licenses or certifications in ABA therapy, as explained in the FSBP Brochure. All treatment must be preauthorized, even if rendered outside the USA. We are pleased to provide a benefit that supports treatment for autism.

FSBP has updated our Notice of Privacy Practices (NPP), effective April 1, 2017. The Notice of Privacy Practices describes how your medical information may be used and disclosed. It also explains how you can get access to this information.

The NPP describes:

  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. 

Please review the NPP carefully. For the reference, this updated NPP appears on the “All About FSBP” web page, under the "Your right to access your protected health information" section. It also appears:

  • On FSBP’s website footers;
  • On Member Portal;
  • On My Online Services (MOS - the shared Coventry/Aetna and FSBP website);
  • In new FSBP member packets; and
  • In other FSBP member communications, where applicable.

If you have any questions about the content of the updated NPP, please call a Health Benefits Officer at 202-833-4910.

Lastly, you may know from our 2016 Summer Newsletter that AFSPA strives to “walk the walk” in terms of wellness and fitness. This past March, AFSPA held a health fair for its employees, hosted by Virginia Hospital Center. The staff were able to check their blood pressure, create their own stress ball, and test their flexibility. We provided numerous resources on wholesome eating and proper nutrition. One handout even cited information on healthy food options at popular fast food restaurants. The AFSPA staff enjoyed the opportunity to interact with the various health professionals. Like you, we are taking “Simple Steps” to lead a healthier lifestyle.

As a reminder, please look for your 2017 AFSPA in Action Spring Newsletter to arrive in your mailboxes soon. I hope you enjoy the season. 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

Qudexy XR Indicated to Prevent Migraine Headaches

Upsher-Smith Laboratories’ Qudexy® XR (topiramate) extended-release capsules got FDA approval on March 30, 2017, to prevent migraine headaches for patients at least 12 years old. Previously approved to manage some types of seizures, Qudexy XR will be taken once daily at bedtime to block migraines. Its starting dose is 25mg, which is increased over four weeks or longer to a maintenance dose of 100mg per day. Medication Guides for Qudexy XR and other drugs like it warn that the drugs may cause fever, mood changes and vision problems. Patients taking Qudexy XR for any reason should not stop it suddenly. Prescribing information is available here

 
30Mar
Express Scripts News Flash

Express Scripts News Flash

Zejula Approved for Recurring Ovarian Cancer Treatment

Tesaro, Inc. received priority-review approval for Zejula™ (niraparib) from the U.S. Food and Drug Administration (FDA) on March 27, 2017. It is indicated for maintenance treatment of women who have responded at least partially to platinum-based chemotherapy for recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer. Although it is a poly ADP-ribose polymerase (PARP) inhibitor, Zejula does not require testing for a biomarker, such as BRCA gene mutations, like other PARP inhibitors do. Recommended dosing is 300mg (three capsules) orally once a day until the cancer worsens or side effects are unbearable. Launch is planned for late April and cost will not be disclosed until then. Distribution will be through a limited network. Full prescribing information is available here

  • Brand (Generic) Name: Zejula™ (niraparib)
  • Manufacturer: Tesaro, Inc.
  • Date Approved: March 27, 2017
  • Indication: Maintenance treatment of women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete response (CR) or partial response (PR) to platinum-based chemotherapy.  
  • Dosage Forms Available: 100mg oral capsules
  • Launch Date: Expected in late April 2017
  • Estimated Annual Cost: Not yet known
  • Specialty Status: Zejula will be added to Express Scripts' specialty drug list.
  • According to the National Cancer Institute, approximately 22,000 cases of ovarian cancer - most beginning in the fallopian tubes - are diagnosed each year in the U.S. Depending on the state at diagnosis, five-year survival rates range from about 30% to around 90%.
  • PARP inhibitors destroy cancer cells or limit their growth by interfering with an enzyme cancer cells need to repair damage caused by drug treatment. 
  • Zejula will compete with two other FDA-approved PARP inhibitors. Lynparza™ (olaparib - AstraZeneca), which was approved in December 2014, is used as monotherapy for patients with advanced ovarian cancer that already has been treated with three or more lines of chemotherapy. Also as a single agent, Rubraca® (rucaparib – Clovis Oncology) was FDA approved in December 2016 for advanced ovarian cancer that has been treated at least twice with chemotherapy. However, both Lynparza and Rubraca are used for patients who have BRAC deletions verified by FDA-approved companion diagnostic testing.
  • Zejula does not require genetic testing before its use. 

 

 
30Mar
Express Scripts News Flash

Express Scripts News Flash

Bavencio Approved for Merkel Cell Carcinoma

On March 23, 2017, EMD Serono and Pfizer received approval from the U.S. Food and Drug Administration (FDA) for Bavencio® (avelumab) for the treatment of adult and pediatric patients 12 years of age and older with metastatic Merkel cell carcinoma (mMCC). Bavencio is a programmed death receptor-ligand 1 (PD-L1)-blocking antibody. Recommended dosing is 10mg/kg as an intravenous (IV) infusion every 2 weeks. Bavencio was launched upon approval. It is available through a limited network of specialty pharmacies and distributors that does not include Accredo or CuraScript Specialty Distribution. Full prescribing information is available here.  

  • Brand (Generic) Name: Bavencio® (avelumab)
  • Manufacturer: EMD Serono (a subsidiary of Merck KGaA) and Pfizer
  • Date Approved: March 23, 2017
  • Indication: Treatment of adult and pediatric patients 12 years of age and older with metastatic Merkel cell carcinoma.
  • Dosage Forms Available: 200mg/10mL (20mg/mL) solution in single-dose vials for intravenous infusion.
  • Launch Date: Bavencio was launched upon approval.
  • Estimated Annual Cost: Bavencio is expected to cost approximately $156,000 per year.
  • Specialty Status: Bavencio will be added to Express Scripts’ specialty drug list.
  • Each year in the U.S., approximately 1,600 patients are diagnosed with MCC. Metastatic MCC is an aggressive type of skin cancer with less than 20 percent of patients surviving beyond five years.
  • While chemotherapy is currently used to treat mMCC, Bavencio is the first FDA-approved therapy for this cancer type.
  • Bavencio is a programmed death receptor-ligand 1 (PD-L1)-blocking antibody. It is an immunotherapy that helps the body’s immune system attack cancer cells.
  • Merck's Keytruda® (pembrolizumab), Bristol-Myers Squibb’s Opdivo® (nivolumab) and Genentech’s Tecentriq® (atezolizumab) are other PD-1/PD-L1 blocking antibodies that are currently available on the market.
  • Bavencio was approved two months ahead of schedule under FDA’s accelerated approval, breakthrough therapy and priority review programs. 
  • FDA approval was based on a Phase II trial in patients with mMCC that demonstrated that 33 percent of patients treated with Bavencio had complete or partial shrinkage of their tumors. EMD Serono and Pfizer are conducting confirmatory studies to verify that the drug provides a clinical benefit in these patients. 
  • An expanded approval for advanced or metastatic urothelial carcinoma is expected by August 27, 2017.
 
30Mar
Express Scripts News Flash

Express Scripts News Flash

Xadago Approved for Parkinson’s Disease

On March 21, 2017, the U.S. Food and Drug Administration (FDA) approved Newron Pharmaceuticals’ Xadago® (safinamide) as an add-on treatment for patients with Parkinson’s disease who are currently taking levodopa/carbidopa and experiencing “off” episodes. An “off” episode is a time when a patient’s medications are not working well, causing an increase in Parkinson’s symptoms, such as tremor and difficulty walking. Treatment with Xadago should be started at 50mg per day. This daily dose may be increased to 100mg per day, if needed. According to US WorldMed, the company that will market the drug in the U.S., availability and prescribing information are not yet available.

  • Brand (Generic) Name: Xadago® (safinamide)
  • Manufacturer: Newron Pharmaceuticals
  • Date Approved: March 21, 2017
  • Indication: Xadago was approved for use as an add-on treatment for patients with Parkinson’s disease who are currently taking levodopa/carbidopa and experiencing “off” episodes.
  • Dosage Forms Available: 50mg and 100mg film-coated tablets
  • Launch Date: A launch date has not been established at this time.
  • Estimated Annual Cost: Product pricing is not yet available.
  • Parkinson's disease is the second most common chronic progressive neurodegenerative disorder in the elderly after Alzheimer’s disease, affecting 1-2% of individuals aged ≥ 65 years worldwide.
  • It is estimated more than one million Americans live with Parkinson's disease and 50,000 new cases are diagnosed each year.
  • Xadago blocks the activity of monoamine oxidase-B (MAO-B), an enzyme that breaks down dopamine. Low dopamine levels may lead to problems with balance, movement, muscle control and other symptoms of Parkinson’s disease.
  • Due to its high selectivity of Xadago to the MAO-B enzyme, it does not have any dietary restrictions.
  • Other selective MAO-B inhibitors include resagaline (Azilect® – Teva/generic) and selegiline (Depreny®, Eldepryl®, Emsam®, Zelapar®, generics).
 
20Mar
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Additional Indication for Keytruda

The U.S. Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab – Merck) for use in certain patients with classical Hodgkin lymphoma (cHL). On March 14, 2017, Keytruda gained an indication for use in patients whose cHL either has not responded to other therapies or has recurred despite at least three previous treatments. For cHL, the recommended adult dose is 200mg. For children, the dose is 2mg/kg up to a maximum of 200mg. Keytruda is given as an intravenous (IV) infusion once every three weeks until cHL gets worse or the drug’s side effects become unbearable. If cHL does not progress, treatment can continue for as long as two years. Originally approved in 2014 to treat advanced melanoma, Keytruda also has indications for non-small cell lung cancer and head and neck cancers. It is a human programmed death receptor-1 (PD-1)-blocking antibody that boosts the immune system’s ability to attack cancer cells. Complete prescribing information is available here.

Generics to Minastrin 24 FE Chewable Tablets Now Available

On March 16, 2017, Lupin announced the launch of its A-rated generics to Minastrin® 24 Fe chewable tablets. The oral contraceptive 28-day pack contains 24 norethindrone acetate and ethinyl estradiol (1mg / 0.02mg) chewable tablets and four non-hormonal ferrous fumarate tablets (75mg). While approved by FDA in May 2016, Lupin has now launched its generic with the trade name of Mibelas 24 Fe. Teva also launched an authorized generic to this product, which is essentially the brand drug repackaged into generic-looking packaging. According to IMS Health, Minastrin 24 Fe chewable tablets had U.S. sales of approximately $360 million for the 12 months ending December 2016.

Repatha Cardiovascular Outcomes Issues Document Available

Repatha® (evolocumab – Amgen) 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 17, 2017, Amgen’s FOURIER study (n = 27,564) was published in the New England Journal of Medicine. The study shows that when Repatha was added to statin therapy (± Zetia,) the risk of the composite endpoint of cardiovascular (CV) death, myocardial infarction (MI), stroke, hospitalization for unstable angina, or coronary revascularization was reduced by 15% among patients who had clinically evident atherosclerotic cardiovascular disease (ASCVD) compared with patients who received only background statin therapy (± Zetia). This Issues Document summarizes Repatha’s clinical outcomes trial, provides a patent litigation update concerning Repatha and Praluent® (alirocumab – Sanofi/Regeneron) and highlights how Express Scripts’ Pharmacy and Therapeutics (P&T) committee will review the FOURIER data, make appropriate alterations in utilization management (UM) programs and continue to assess the formulary status within this class of medications.  The Issues Document is available here

MedWatch
Viberzi

On March 15, 2017, FDA issued a MedWatch alert for Allergan’s Viberzi® (eluxadoline) tablets. Since Viberzi’s U.S. approval in May 2015 to treat irritable bowel syndrome with diarrhea (IBS-D), FDA has investigated 120 reports of pancreatitis among patients using it. At least 76 patients had to be hospitalized and two patients died. Specifically, patients who have had their gallbladders removed are at increased risk. FDA is recommending that physicians prescribe medications other than Viberzi for patients without gallbladders. Additionally, it suggests that patients discuss alternative treatment choices with their doctors. Patients who take Viberzi are cautioned to watch for signs of pancreatitis, such as nausea and vomiting or severe abdominal/stomach pain that may also affect the back or right shoulder, whether or not their gallbladders have been removed. FDA’s full Safety Communication is available here.    

 
14Mar

The Governors of Maryland, New Jersey, New York, Connecticut, and Virginia have declared States of Emergency

The Governors of Maryland, New Jersey, New York, Connecticut, and Virginia have declared States of Emergency due to Winter Storm Stella impacting all counties in each state. Express Scripts (FSBP's Pharmacy Benefit Manager) has activated the Emergency Access to Benefits/Refill Too Soon override process for the impacted areas with an effective date of March 14, 2017 and expiration date of April 13, 2017 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 temporary alternate addresses (either online at www.express-scripts.com or by calling 1-800-818-6717) or request a local fill as needed.

 
14Mar
Express Scripts News Flash

Express Scripts News Flash

Kisqali Approved to Treat Breast Cancer

The U.S. Food and Drug Administration (FDA) approved Kisqali® (ribociclib -- Novartis) on March 13, 2017. Kisqali is 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. It selectively inhibits cyclin-dependent kinase (CDK) 4 and 6 (CDK4/6), enzymes that promote the growth and spread of cancer cells. It will be used in combination with an aromatase inhibitor, such as anastrozole, exemestane or letrozole. Recommended dosing is on four-week cycles, with 600mg (three tablets) of Kisqali taken once daily every day for 21 days, then stopped for the next seven days. The aromatase inhibitor is taken continually without a break. Kisqali will be distributed through an open network. Its complete prescribing information is available here

  • Brand (Generic) Name: Kisqali® (ribociclib)
  • Manufacturer: Novartis
  • Date Approved: March 13, 2017
  • Indication: Treatment of postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer.
  • Dosage Forms Available: 200mg tablets
  • Launch Date: Novartis plans to launch within a few days of approval.
  • Estimated Annual Cost: The wholesale acquisition cost of a 28-day supply of the 600mg dose is $10,950 or approximately $142,700 per year.
  • Specialty Status:  Kisqali will be added to the Express Scripts specialty drug list
  • According to the American Cancer Society, approximately 250,000 cases of invasive breast cancer are diagnosed, annually.  More than 70 percent of those cases are HR+/HER2-.
  • In the main clinical study, average progression-free survival was about nine months longer for participants taking Kisqali plus letrozole compared with patients taking letrozole by itself (25.3 months vs. 16.0 months).
  • Kisqali may cause QT prolongation, which is an abnormal heartbeat that may lead to death.  A baseline electrocardiogram (ECG) should be taken before treatment begins, about halfway through the first line treatment cycle, at the start of the second cycle and then periodically during treatment.  Additionally, electrolyte levels should be tested at the beginning of the first six cycles and then at regular intervals. 
  • Liver function also should be checked before starting therapy, every two weeks during the first two cycles, at the start of the next four cycles and then as considered appropriate.
  • The only other CDK4/6 inhibitor currently FDA approved for treating breast cancer is Pfizer's lbrance (palbociclib).  It is indicated for use only with letrozole, not with other aromatase inhibitors.  It does not, however, require heart or liver monitoring.
  • FDA designated Kisqali as a breakthrough therapy and approved it ahead of schedule under priority review.
 
14Mar

AFSPA opens at 10:30AM - 3/14/17

AFSPA is opening at 10:30am (EDT), today, Tuesday, March 14, 2017.

Thank you.

 
14Mar

AFSPA is opening late today

Due to inclement weather and following the decision by the Office of Personnel Management, AFSPA will open on a delayed schedule today, Tuesday, March 14, 2017. We will assess staff levels on an ongoing basis with the goal of commencing regular business operations as soon as possible.

Thank you.

 

 

 
13Mar
Express Scripts Clinical News and Notes

Express Scripts Clinical News and Notes

Noctiva Approved to Treat Nighttime Urination

The U.S. Food and Drug Administration (FDA) approved Serenity Pharmaceutical’s Noctiva™ (desmopressin) nasal spray on March 3, 2017. It is indicated to treat adults who have nocturnal polyuria. Also called nocturia, the condition wakes patients with the need to urinate twice or more duri