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.
- President Trump signs executive order on “most-favored-nation” drug prices
- U.S. Department of Health and Human Services (HHS) issues final rule on plan for Canadian drug importation
- OptumRx announces annual formulary updates
- CVS Health announces annual formulary updates
- Generic versions of HIV drugs Truvada (emtricitabine/tenofovir disoproxil) and Atripla (efavirenz/emtricitabine/tenofovir disoproxil) are launched
- Meta-analysis finds decreased COVID-19 mortality rate associated with corticosteroid treatment
FDA Approvals and Launches
- Generic versions of HIV drugs Truvada (emtricitabine/tenofovir disoproxil) and Atripla (efavirenz/emtricitabine/tenofovir disoproxil) are launched.
- Generic versions of multiple sclerosis drug Tecfidera (dimethyl fumarate) are launched.
- Mylan launches long-acting insulin Semglee (insulin glargine) as an alternative to Lantus (insulin glargine).
- The two products are not currently interchangeable.
- Winlevi (clascoterone cream), a first in-class androgen inhibitor, is approved to treat acne.
- Trelegy (fluticasone furoate/umeclidinium/vilanterol) receives additional approval as a maintenance treatment for asthma.
President Trump signs executive order on “most-favored-nation” drug prices
- The executive order directs HHS to develop rulemaking for “most-favored-nation” payment models for Medicare Part B and Part D.
HHS issues final rule creating opportunities for Canadian drug importation
- The ruling will allow states and other entities to submit plans for drug importation with several regulatory safeguards.
U.S. House Oversight Committee releases two reports describing pricing tactics of Celgene and Teva
- The reports describe price-fixing tactics and the “uninhibited price increases” of Copaxone (glatiramer acetate) and Revlimid (lenalidomide).
OptumRx announces annual formulary updates
- The pharmacy benefit manager (PBM) announced the following changes to its Premium Formulary: six down-tiered products, six up-tiered products, and 27 exclusions.
CVS Health announces annual formulary updates
- The PBM announced the following changes to its Standard Control Formulary: 57 new exclusions, six drugs added back, and one drug added to Tier 1.
UnitedHealthcare implements Accumulator Adjustment Medical Benefit program effective January 2021
- The program requires healthcare providers to directly submit manufacturer copay coupon information when billing for specialty medications under the medical benefit.
California governor signs bill SB-852 directing state to partner with manufacturers to produce and distribute generic and biosimilar drugs
- Under the bill, the California Health and Human Services Agency is expected to identify a list of targeted drugs on or before July 2022.
Court upholds ruling invalidating Vascepa (icosapent ethyl) patent protections
- Ruling leaves open the possibility for the release of generic versions of the cholesterol drug.
Cigna rebrands health services groups as Evernorth
- The Evernorth brand includes Express Scripts, Accredo specialty pharmacy, and Evicore medical benefit management, among others.
Clinical Trials and Research
Meta-analysis finds decreased COVID-19 mortality rate associated with corticosteroid treatment
- World Health Organization cites trial and publishes COVID-19 treatment guidelines suggesting corticosteroid treatment as standard of care.
Retrospective study associates deficiency in vitamin D with increased incidence of COVID-19
- The authors suggest the use of randomized clinical trials to further evaluate their findings and caution that the relationship may be correlational rather than causal.