CMS not ready to re­con­sid­er its block on cov­er­ing new Alzheimer's drugs

The Cen­ters for Medicare and Med­ic­aid Ser­vices won’t yet re­con­sid­er a de­ci­sion that FDA-ap­proved, amy­loid-tar­get­ing mon­o­clon­al an­ti­bod­ies for Alzheimer’s dis­ease shouldn’t be cov­ered out­side of clin­i­cal tri­als.

The agency’s Jan­u­ary 2022 rul­ing, known as a na­tion­al cov­er­age de­ter­mi­na­tion, or NCD, set the prece­dent for cov­er­age of Bio­gen’s first Alzheimer’s drug Aduhelm, which won an ac­cel­er­at­ed ap­proval in June 2021. In Aduhelm’s case, the CMS de­ci­sion to re­quire fur­ther tri­als ul­ti­mate­ly led to the drug’s com­mer­cial flop.

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Venture & Research Associate

Alexandria Real Estate Equities

San Francisco, CA, USA