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.
- The U.S. Supreme Court upholds Arkansas Act 900 regulating pharmacy benefit manager (PBM) practices
- Drug manufacturers implement annual price increases
- Highly publicized joint venture Haven Healthcare disbands
- CVS Health nationwide survey describes factors that may affect COVID-19 vaccine adoption
FDA Approvals and Launches
- Ebanga (ansuvimab-zykl) is approved to treat the ebolavirus.
- Imcivree (setmelanotide) is approved for weight management in three rare genetic disorders.
- Klisyri (tirbanibulin) is approved to treat actinic keratosis.
- Gemtesa (vibegron) is approved to treat symptoms of an overactive bladder.
The U.S. Supreme Court upholds Arkansas Act 900 regulating PBM practices
- The act mainly regulates PBM reimbursement to pharmacies, ensuring rates higher than the pharmacies’ acquisition costs.
- The ruling may encourage other states to pass similar laws regulating PBM practices.
Drug manufacturers implement annual price increases
- List prices, which don’t reflect net prices paid after rebates, increased by an average of 3.3%.
Highly publicized joint venture Haven Healthcare disbands
- In 2018, Amazon, Berkshire Hathaway, and JPMorgan Chase founded Haven Healthcare with a goal of addressing issues in the employer healthcare market.
CVS Health nationwide survey describes factors that may affect COVID-19 vaccine adoption
- 28% of people surveyed were interested in receiving a vaccine as soon as possible whereas 17% did not plan to receive the vaccine at all.
Employers consider whether to mandate COVID-19 vaccinations
- Employers may consider public safety, the benefits of a safer work environment, and the concerns of those who worry about the safety of the vaccine before exercising the legal right to mandate vaccination.
Centene acquires Magellan Health and specialty pharmacy PANTHERx
- Centene will acquire 5.5 million members on government-sponsored plans, 2 million PBM members, and 16 million medical pharmacy members
- PANTHERx specializes in providing care to patients with rare conditions and will work under the umbrella of Centene’s Evolve Pharmacy Solutions program.
Federal Trade Commission (FTC) issues report describing Hatch-Waxman patent settlements
- The report describes patent settlements occurring in 2017 between brand and generic manufacturers.
- The total amount of final settlements remained close to the record high set in 2016.
- The number of reverse-payment agreements, otherwise known as “pay-for-delay” agreements, remains low compared to previous years.
Amgen releases 2020 Biosimilars Trends Report
- The report describes trends among the 28 FDA-approved and 18 market-launched biosimilar products.
- The report includes comparisons between biosimilar and reference product prices, market share trends, and class-specific trends.
Elixir drug pipeline report highlights six developments to watch in 2021
- Developments include increases in the orphan drug and gene therapy markets, an investigational type 1 diabetes drug, and commentary on the COVID-19 vaccine.
Long-acting injectable HIV drug combination produces positive results in phase 3b study
- The combination of cabotegravir and rilpivirine given intramuscularly every eight weeks was found to be non-inferior to dosing given every four weeks.
- This investigational treatment has the potential to increase adherence over standard treatments that must be dosed daily.