Medicare coverage of buprenorphine-naloxone film surrounding generic entry.

Objectives: To investigate trends in Medicare coverage of buprenorphine-naloxone film before and after the FDA approval of its first generic versions.

Study Design: This study used data from the Part D Prescription Drug Plan Formulary, Pharmacy Network, and Pricing Information Files from 2015 to 2022, which provide information on all stand-alone Medicare/Medicare Advantage Prescription Drug Plans.

Methods: We examined the percentage of plans that provided coverage of brand-name and generic buprenorphine-naloxone films with strength 8 mg/2 mg during 2015-2022. Median out-of-pocket (OOP) cost for a 30-day supply was estimated among all plans that provided coverage.

Results: Generic buprenorphine-naloxone film was covered by 82% of Medicare Part D plans in 2020, 2 years after market entry. Coverage of brand-name Suboxone film decreased from 76% in 2019 to 42% in 2020. The median OOP cost of buprenorphine-naloxone films faced by Medicare enrollees decreased from $99 in 2019 to $42 in 2020, driven by the lower price of generic films. In contrast, the OOP cost for brand-name buprenorphine-naloxone film increased gradually from $85 in 2015 to $100 in 2022.

Conclusions: Medicare Part D plan formularies replaced brand-name buprenorphine-naloxone films with the newly approved generic versions. This was accompanied by a substantial decrease in estimated OOP cost faced by Part D enrollees. These changes could potentially increase access to buprenorphine among Medicare enrollees with opioid use disorder.