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.
Highlights
- Acting FDA Commissioner calls for investigation into correspondence between FDA and Biogen
- WellDyne publishes 2021 Drug Trend Report
- Amazon Pharmacy launches six-month for $6 program for Prime members
- Walmart launches ReliOn analog insulin, offers cheaper list prices than other currently available branded analog insulins
FDA Approvals and Launches
- Prevnar 20 (pneumococcal 20-valent conjugate vaccine) is approved to provide immunization against streptococcus pneumoniae.
- Kerendia (finerenone) is approved to reduce the risk of cardiovascular and kidney disease associated with type 2 diabetes.
- Astepro (azelastine nasal spray) is approved for over-the-counter (OTC) use as the first OTC antihistamine nasal spray to treat seasonal allergies.
- Soaanz (torsemide) is approved to treat edema associated with heart failure or kidney disease.
News
Acting FDA Commissioner calls for investigation into correspondence between FDA and Biogen
- The commissioner requested that the Office of Inspector General conduct an independent investigation into the interactions between the two entities during the application process prior to the approval of Aduhelm (aducanumab).
WellDyne publishes 2021 Drug Trend Report
- The PBM reported a -1.6% drug trend driven by reductions in unit cost.
- WellDyne cites the effectiveness of their targeted formulary and utilization management programs as factors contributing to the negative drug trend.
Amazon Pharmacy launches six-month for $6 program for Prime members
- Program includes select generic drugs and promises free two-day delivery.
- Residents of Hawaii, Illinois, Kentucky, Louisiana, or Minnesota are not eligible to use Amazon Pharmacy.
Walmart launches ReliOn analog insulin, offers cheaper list prices than other currently available branded analog insulins
- Private brand offerings include insulin aspart vials, priced at approximately $73 per vial, and FlexPens, approximately $86 per package
Cigna Shared Savings Program offers members a financial incentive to switch to biosimilar products
- Members will be offered a $500 debit card if they switch to a biosimilar or another preferred medication in the program.
Johnson & Johnson reaches potential $26 billion settlement with a coalition of states in national opioid lawsuit
- The states allege that the manufacturer helped contribute to the opioid abuse epidemic.
- The final settlement amount will depend on the amount of states that agree to suspend their current lawsuits.
Centene reaches $143 million settlement with Ohio and Mississippi in PBM overbilling lawsuit
- The states alleged that Medicaid programs were overbilled after Envolve Pharmacy Solutions, a subsidiary of Centene, misrepresented costs of pharmacy services.
Mississippi Attorney General files lawsuit against manufacturers and PBMs over insulin pricing
- The lawsuit alleges Consumer Protection Act violations and civil conspiracy, resulting in significant price increases despite lower production costs.
Supreme Court dismisses challenge to Affordable Care Act
- In a 7-2 decision, the court voted to uphold the law despite a challenge regarding the constitutionality of the Act's minimum coverage requirement.
Civica Rx announces partnership with Anthem and Catalent
- Civica Rx is a non-profit organization dedicated to the affordable manufacturing and acquisition of generic drugs on behalf of its hospital and healthcare partners.
- CivicaScript, a newly-named subsidiary of Civica Rx, is focused on providing lower-cost generic prescriptions to consumers in hospital and retail pharmacies.
FDA grants Breakthrough Therapy designation to donanemab, an investigational Alzheimer's disease drug
- The drug is an antibody therapy similar to the recently approved Aduhelm (aducanumab).
- Phase 3 trial data is not yet available; Lilly intends to file a biologics license application later this year based on data from a phase 2 trial.
Clinical Trials
Investigational diabetes drug tirzepatide reaches superiority endpoints in phase 3 trial
- The trial compared the investigational drug with semaglutide; both drugs were administered subcutaneously once a week.
- Semaglutide is a currently available product that is marketed as Ozempic (injectable) and Rybelsus (oral).