January 12, 2022
Life Sciences
  • Medicare officials said the program should restrict coverage of Aduhelm, Biogen’s Alzheimer’s drug, to patients participating in randomized, controlled clinical trials. The agency made its decision after reviewing scientific evidence and various stakeholder opinions and concluding that there remain significant doubts about whether the potential benefits of Aduhelm for patients outweigh the safety risks. It is the first time that CMS has limited Medicare beneficiaries’ access to an FDA approved drug in this way. (Decision summary here; Articles here, here, here, here, here, here, and here)