CMS announces plan for Medicare coverage of approved Alzheimer's drugs

Medicare will cover drugs that may slow the progression of Alzheimer’s disease if granted traditional approval from the FDA, according to a press release from CMS.

To qualify for coverage, patients must be enrolled in Medicare Part B and have a diagnosis of mild cognitive impairment or early dementia caused by AD. CMS will also require that patients participate in a registry, working with a qualified physician to collect and submit data on how the drugs work.

The FDA has granted accelerated approval to two drugs in the class, Aduhelm (aducanumab, Biogen) and Leqembi (lecanemab, Eisai/Biogen), but neither has received traditional approval, which would make them eligible for broader Medicare coverage. A decision on traditional approval for lecanemab is expected within weeks, CMS stated, with the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee discussing results of a confirmatory trial on June 9.

Physicians and clinical teams will be able to submit data on the drugs through a nationwide portal that CMS will make available when any gain traditional approval. The information will be accessible for studies to further understanding of the drugs.

CMS Administrator Chiquita Brooks-LaSure, MPP, said in the release that she hopes to “see more private sector partners in this work making their own announcements soon,” adding that she was “pleased” to outline the agency’s plan to cover the drugs.

In the release, CMS noted its previous use of a registry participation requirement in granting traditional approval to transcatheter aortic valve replacement.