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.
- Consumers and third-party payers may be eligible for recent class action lawsuit settlement payments
- Descovy (emtricitabine/tenofovir alafenamide) is approved for use as HIV pre-exposure prophylaxis (PrEP) therapy
- Allergan reaches $750 million settlement over antitrust charges
- California bans “pay for delay” drug manufacturer agreements
FDA Approvals and Launches
- Descovy (emtricitabine/tenofovir alafenamide) is approved for use as HIV pre-exposure prophylaxis (PrEP) therapy.
- Prior to this approval, only Truvada (emtricitabine/tenofovir disoproxil) was approved for this indication.
- Generic versions of Truvada are expected to be available in September 2020.
- Aklief (trifarotene) cream and Amzeeq (minocycline) foam are approved to treat acne vulgaris.
- Beovu (brolucizumab-dbll) is approved to treat age-related macular degeneration.
- Alternative delivery system of Fasenra (benralizumab) is approved to treat eosinophilic asthma. The pen allows patients to self-administer at home.
- Reyvow (lasmiditan) is approved for the acute treatment of migraine.
- Stelara (ustekinumab) receives additional approval to treat ulcerative colitis.
- Vumerity (diroximel fumarate) is approved to treat relapsing forms of multiple sclerosis.
Consumers and third-party payers may be eligible for recent class action lawsuit settlement payments
More information can be found at these settlement websites:
Allergan reaches $750 million settlement over antitrust charges
- Lawsuit alleges that Forest Laboratories, an Allergan subsidiary, removed Namenda (memantine) from the market to force patients to switch to Namenda XR before Namenda lost patent exclusivity.
California bans “pay for delay” drug manufacturer agreements
- “Pay for delay” refers to agreements in which brand drug manufacturers pay generic drug manufacturers to delay the release of cheaper generic products.
Walgreens partners with Centene and RxAdvance, promises lower costs through increased coordination of care
- RxAdvance uses a cloud-based transactional platform and clinical intelligence system, allowing pharmacists to make more informed point-of-care decisions.
CVS Health introduces Specialty Expedite program to streamline onboarding of members with specialty prescriptions
- The program focuses on reducing the time necessary for pharmacies to process utilization management (i.e., prior authorization and step therapy) approvals.
Insulin Price Reduction Act proposes rollback of insulin list prices
- The bipartisan congressional proposal incentivizes manufactures to reduce list prices to those set in 2006 by also guaranteeing that insurers must cover any products that fall into this category.
UnitedHealth report asserts that administration of specialty drugs outside of hospital outpatient settings can reduce national healthcare costs by $4 billion
- Report encourages use of physician offices and home infusion services, citing a possible annual savings of $16,000 to $37,000 per privately insured patient, depending on condition.
FDA Advisory Committee votes in favor of withdrawing Makena (hydroxyprogesterone caproate) from the market
- A placebo-controlled trial found no difference in efficacy between placebo and treatment.
Clinical Trials and Research
Institute for Clinical and Economic Review (ICER) revises report evaluating rheumatoid arthritis drugs, finds new drug Rinvoq (upadacitinib) to be cost-effective
- Rinvoq is associated with improved remission rates and lower disease activity compared to Humira (adalimumab).
- Treatment with Rinvoq also comes at a higher price. However, these costs still remained within the upper end of ICER’s cost-utility threshold.
California releases prescription drug wholesale acquisition cost (WAC) pricing increase report
- Three-year median increase in WAC was 25.8%, equivalent to an 8% compounded annual increase.
American Heart Association publishes advisory promoting use of prescription omega-3 fatty acids to reduce triglycerides
- Two prescription omega-3 fatty acids currently available are Lovaza (omega-3-acid ethyl esters), which is also available as a generic, and Vascepa (icosapent ethyl).