CMS finalizes restrictions on Biogen's Alzheimer's drug coverage, will only fund use in clinical trials

CMS late Thursday finalized its decision to restrict coverage for Biogen’s controversial Alzheimer’s drug Aduhelm and other amyloid-targeted drugs to just patients participating in clinical trials.

“Monoclonal antibodies directed against amyloid that are approved by FDA for the treatment of AD [Alzheimer’s disease] based upon evidence of efficacy from a change in a surrogate endpoint (e.g., amyloid reduction) considered as reasonably likely to predict clinical benefit may be covered in a randomized controlled trial conducted under an investigational new drug (IND) application,” CMS said in its final decision summary.