Bio­gen vows to fight CM­S' draft cov­er­age de­ci­sion for Aduhelm be­fore April fi­nal­iza­tion

Bio­gen ex­ec­u­tives made clear in an in­vestor call Thurs­day they are not prepar­ing to run a new CMS-ap­proved clin­i­cal tri­al for their con­tro­ver­sial Alzheimer’s drug any­time soon.

As re­quest­ed in a draft na­tion­al cov­er­age de­ci­sion from CMS ear­li­er this week, Bio­gen and oth­er an­ti-amy­loid drugs will need to show “a mean­ing­ful im­prove­ment in health out­comes” for Alzheimer’s pa­tients in a ran­dom­ized, place­bo-con­trolled tri­al to get paid for their drugs, rather than just the re­duc­tion in amy­loid plaques that won Aduhelm its ac­cel­er­at­ed ap­proval in June.

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