It’s Important for CMS to Hear From You!

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.

BY THURSDAY, FEB 10, 2022.