Pharmacy Briefing is a monthly summary of select U.S. Food and Drug Administration (FDA) approvals and launches, treatment guidelines and research updates, and other newsworthy events that have the potential to impact commercial drug utilization or costs.
- PBMs introduce new policies in response to COVID-19 pandemic (Milliman article)
- Cost-effectiveness study finds that Descovy (emtricitabine/tenofovir alafenamide) is not worth its higher cost
- FiercePharma publishes annual “top 10 drugs losing U.S. exclusivity” list
- Sandoz agrees to pay $195 million criminal penalty, admits to antitrust conspiracy
FDA Approvals and Launches
- Generic version of Daraprim (pyrimethamine) is approved to treat toxoplasmosis and malaria
- Isturisa (osilodrostat) is approved to treat Cushing’s disease
- Ofev (nintedanib) receives additional approval to treat chronic fibrosing interstitial lung diseases.
- ArmonAir Digihaler (fluticasone propionate) Inhalation Powder is approved to treat asthma.
- Zeposia (ozanimod) is approved to treat relapsing forms of multiple sclerosis.
- The manufacturer announced that the drug’s launch will be delayed indefinitely due to the pandemic.
Pharmacy benefit managers (PBMs) introduce new policies in response to COVID-19 pandemic
(Milliman article authored by Andrew Jackson, Brian Anderson, and Marc Guieb)
- Utilization management changes include automatic extension of prior authorizations, refill-too-soon overrides, and imposing quantity limits on certain drugs.
- Many health plan members are transitioning to mail-order services to fill prescriptions.
Yale School of Public Health and Massachusetts General Hospital cost-effectiveness study finds that Descovy (emtricitabine/tenofovir alafenamide) is not worth its higher cost
- Descovy and Truvada (emtricitabine/tenofovir disoproxil fumarate) are the only approved medications for use in HIV pre-exposure prophylaxis (PrEP) therapy.
FiercePharma publishes annual “top 10 drugs losing U.S. exclusivity” list
(emtricitabine/tenofovir disoproxil fumarate), with $2.64 billion in 2019
sales, tops the list.
- A generic version of Truvada is expected to be released in September 2020.
Sandoz agrees to pay $195 million criminal penalty, admits to antitrust conspiracy
- The manufacturer was charged for conspiring with four generic drug companies to fix the price of several drug products.
Sanofi publishes “Prescription Medicine Pricing: Our Principles and Perspectives” annual pricing report
- In 2019, the average aggregate list price of Sanofi products increased 2.9% whereas the average aggregate net price of these same products decreased 11.1%.
FDA adds Black Box Warning for Singulair and generic montelukast equivalents
- Serious side effects found during an observational study include suicidal thought and actions.
Costco purchases equity interest in Navitus Health
- Equity interest includes a stake in Lumicera Health Services, Navitus’s specialty pharmacy.
Health insurers and drug manufacturers spar over 2021 CMS manufacturer coupon proposal
- The Centers for Medicare and Medicaid Services (CMS) proposal would allow insurance providers to determine whether manufacturer coupons apply to patient cost-sharing accumulator programs.
Brand and authorized generic EpiPen (epinephrine auto-injector) may contain manufacturing defects
- Patients and pharmacists should inspect their products and contact the manufacturer if defects are discovered.
Clinical Trials and Research
Two Phase 3 trials of investigational cholesterol drug inclisiran successfully achieve efficacy outcomes
- Inclisiran, dosed twice annually, was found to reduce LDL cholesterol by approximately 50% over a study period of approximately one and a half years.