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.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER