CMS schools FDA in evidence requirements in Alzheimer’s coverage decision
In draft decision on amyloid mAbs, CMS reads Aduhelm data very differently than FDA
In a rare rebuke of FDA’s approval process, CMS has rejected the agency’s view of the evidence on amyloid mAbs to treat Alzheimer’s disease. The move dooms sales of Biogen’s Aduhelm to remain a trickle for the foreseeable future, unless the agency’s final National Coverage Determination in April changes substantially from the draft released Tuesday.
Shares of Biogen Inc. (NASDAQ:BIIB) fell $18.40 to $223.12 in after-hours trading following CMS’s publication of the draft NCD, which proposes restriction of Medicare coverage for anti-amyloid mAbs solely to the context of randomized-controlled clinical trials for Alzheimer’s. The stock move would correspond to a $2.7 billion loss in market cap should the move read through to Wednesday’s regular trading session...