On January 11, 2022 CMS announced it would cover FDA-approved monoclonal antibody drugs, such as aducanumab, for individuals with Alzheimer’s on Medicare only if they were enrolled in a qualifying clinical trial. This has been a controversial decision.
The Dementia Action Alliance:
- Feels the FDA erred in its accelerated approval of aducanumab, a drug that has not shown clinical benefit yet has shown serious adverse effects.
- Strongly supports CMS’s decision to limit access to aducanumab to people enrolled in qualifying clinical trials in order to better study the drug’s efficacy and adverse effects among a broader, diverse population of people with Alzheimer’s.
- Recommends that CMS, in deciding its long-range coverage determination, not require coverage limitation for all anti-amyloid monoclonal antibody drugs. Instead, we recommend CMS assess each drug individually on its merits after successfully completing Phase 3 trials.
Susan Wehry, MD from DAA has written a discussion brief to provide background information about the issue and the pros and cons of CMS’ decision. Click here for the discussion brief.
CMS NEEDS TO HEAR FROM YOU
BY THURSDAY, FEB 10, 2022.