Centers for Medicare and Medicaid Services (CMS) finalized its decision to restrict coverage for Biogen Inc's (NASDAQ: BIIB) Alzheimer's drug Aduhelm and other amyloid-targeted drugs to just patients participating in clinical trials.
"Monoclonal antibodies directed against amyloid that FDA approves for 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.
