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.
- Kaiser Family Foundation releases 2020 Employer Health Benefits Survey
- Price and cost-sharing rules are finalized requiring insurers to disclose negotiated prices and cost-sharing information
- Most-favored nation and point-of-sale rebate regulations finalized
- Federal government partners with retail pharmacies to promote access to future COVID-19 vaccines
- Veklury (remdesivir) is FDA-approved to treat COVID-19 in patients requiring hospitalization
- World Health Organization (WHO) study finds no reduction in mortality rates associated with COVID-19 patients treated with remdesivir
FDA Approvals and Launches
- Veklury (remdesivir) is approved to treat COVID-19 in patients requiring hospitalization.
- Ultomiris (ravulizumab-cwvz) 100 mg/mL is approved to treat certain blood disorders.
- The formulation improves upon the 10 mg/mL formulation by allowing for reduced infusion times.
- Eysuvis (loteprednol etabonate) ophthalmic suspension is approved to treat dry eye disease.
- Inmazeb (atoltivimab/maftivimab/odesivimab-ebgn) is approved to treat the Ebola virus.
- Bronchitol (mannitol) inhalation powder is approved to treat symptoms of cystic fibrosis.
Kaiser Family Foundation releases 2020 Employer Health Benefits Survey
- The survey describes the distribution of cost-sharing tiers, formulary structures, and benefit designs among 1,765 surveyed employers.
Price and cost-sharing rules are finalized requiring insurers to disclose negotiated prices and cost-sharing information
- Rule applies to “almost all health insurance companies and self-insured plans.”
- The requirements for publicly available data files will take effect January 2022 with full member cost-sharing information required by January 2024.
Most-favored nation and point-of-sale rebate regulations finalized
- The Most Favored Nation rule would operate as a seven-year model, phasing in international pricing on Part B drugs over the next four years in fee-for-service (FFS) Medicare.
- The point-of-sale rebate rule would require rebates and price concessions to be credited to consumers at the point of sale for all Medicare Part D plans.
- Both rules were finalized despite procedural questions and are likely to face legal challenges.
Federal government partners with retail pharmacies to promote access to future COVID-19 vaccines
- Under Operation Warp Speed, a collaboration between the U.S. Department of Health and Human Services (HHS), the U.S. Department of Defense, and other federal agencies, an estimated 60% of retail pharmacies will participate in the federal allocation program.
Biosimilar market share grows as competition with reference products increases
- Annualized savings due to biosimilars is an estimated $6.5 billion and continues to increase.
- Biosimilar products with slower market share growth may still reduce overall costs by contributing to reference product price decreases.
- Biosimilars of Remicade (infliximab) have a combined market share of 16%. However, the average sales price of the reference drug has decreased 45% since the launch of the biosimilars.
UnitedHealth Group acquires DivvyDose in $300 million deal
- DivvyDose is a home-delivery pharmacy that focuses on patients with multiple medications.
Blue Shield of California reports $10 million in savings associated with drug transparency tools
- The tools give healthcare providers point-of-sale information on drug prices for their patients so that they can write more personalized and affordable prescriptions.
Clinical Trials and Research
WHO study finds no reduction in mortality rates associated with COVID-19 patients treated with remdesivir
- Veklury (remdesivir) was approved by the FDA on October 22, one week after the WHO study’s interim results were published.
Phase 3 trial demonstrates superiority of deucravacitinib compared to Otezla (apremilast) in the treatment of psoriasis
- Deucravacitinib is an investigational drug taken orally, once daily.
Prevnar 13 competitor V114 achieves primary endpoints in phase 3 vaccine trial
- V114 produced efficacy comparable to Prevnar 13 while also providing protection against two additional serotypes of pneumococcal bacteria.