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.

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