CMS unveils preliminary Aduhelm coverage decision

CMS intends for Medicare to cover Aduhelm, Biogen's Alzheimer's disease treatment, for patients taking part in clinical trials, the agency announced Jan. 11. 

The national coverage determination decision memorandum covers FDA-approved Alzhimer's disease treatments using monoclonal antibodies that target amyloid — with Aduhelm being the only drug fitting that description. 

"CMS has proposed an evidence-based coverage policy after experts reviewed all relevant publicly available evidence and feedback received from stakeholders," said CMS Administrator Chiquita Brooks-LaSure. "Before finalizing this proposal, we will have more opportunities to hear from people with Medicare living with mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's disease dementia, their family members and caregivers, as well as many other stakeholders, including patient advocacy groups, medical experts, states, payers, and industry professionals."

The determination kicks off a 30-day window for public comment. Then, CMS will announce a final determination April 11. 

Physicians and former Medicare advisors have called on CMS to cover Aduhelm only for patients in clinical trials.

Payers have been waiting on an early recommendation from CMS, which will set a coverage precedent for private insurers to follow down the road.

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