Highlights
- Clarivate publishes annual “Drugs to Watch” report
- Drug Channels summarizes 2025 “Big 3” PBM formulary changes
- CVS Health launches CostVantage pricing model for its retail pharmacies
U.S. Food and Drug Administration (FDA) approvals and launches
- Ozempic (semaglutide) is approved for the additional indication of treating chronic kidney disease.
- Merilog (insulin-aspart-szjj) is approved as a biosimilar to NovoLog (insulin aspart).
- Journavx (suzetrigine) is approved as a novel, non-opioid treatment for moderate to severe acute pain.
- Alyftrek (vanzacaftor, tezacaftor, and deutivacaftor) is approved as a combination treatment for cystic fibrosis.
News
Clarivate publishes annual “Drugs to Watch” report
- The report spotlights 11 recently launched or launch-anticipated drugs expected to achieve blockbuster status or to revolutionize treatment in the next five years.
- Drugs spotlighted include insulin dosed once-weekly, a novel GLP-1 combination therapy, and an Alzheimer’s treatment.
Drug Channels summarizes 2025 “Big 3” PBM formulary changes
- Insights include the observation that the PBMs’ private-label biosimilars are being consistently preferred over reference products and other market competitors.
- Drug Channels also suggests that the number of formulary exclusions appears to have plateaued in recent years.
CVS Health launches CostVantage pricing model for its retail pharmacies
- The model increases the simplicity of retail pharmacy pricing by basing reimbursement on acquisition cost plus a consistent, defined markup and fee.
- The previous model incorporated various markups for different drugs and resulted in the subsidization of some drugs at the expense of other, more profitable drugs.
Supreme Court to rule on the constitutionality of Affordable Care Act (ACA) preventive care
- The ACA requires most plans to cover a set of preventive services at no cost to members, examples of which include certain screenings, vaccinations, and contraception.
- The lawsuit, Braidwood Management, Inc. v. Becerra, specifically addresses the constitutionality of the U.S. Preventive Services Task Force, the panel of experts that makes recommendations about clinical preventative services.
Zepbound (tirzepatide) expected to surpass Ozempic (semaglutide) in popularity due to recent clinical evidence
- Ozempic was first-to-market in the obesity GLP-1 space and, as of 2024, retains the majority of the space’s market share.
- Zepbound recently received a unique FDA approval for the treatment of obstructive sleep apnea and also displayed more significant weight loss results than Ozempic in a recent phase 3 clinical trial.
FDA removes semaglutide from drug shortage list
- Semaglutide is the active ingredient in obesity GLP-1 Wegovy and diabetes GLP-1 Ozempic and has been in shortage since 2022.
- Drug compounders will no longer be permitted to make semaglutide-containing products since this practice is contingent on the product being on the FDA’s drug shortage list.
TD Cowen publishes results of its “Annual Drug Pricing Survey”
- The survey anticipates that brand drug acquisition cost per unit will increase by an average of 8% over the next three years.
- Other observations discuss topics such as the downstream effects of the Inflation Reduction Act (IRA), biosimilar adoption rates, and obesity drug coverage.
Coalition of state and territory attorneys general publish letter urging FDA to address counterfeit GLP-1 products
- The letter emphasizes the overwhelming popularity of GLP-1s and how this popularity contributes to dangerous practices such as the production of unregulated and counterfeit products.
Health Action Council and UnitedHealthcare publish report on obesity epidemic
- The report estimates the cost of obesity on both a large scale and an individual scale, comments on trends between national regions, genders, and ages, and discusses its effect on comorbid conditions.