The Centers for Medicare and Medicaid Services’ (CMS) Administrator Chiquita Brooks-LaSure announced that Eisai’s Leqembi (lecanemab) will be covered under Medicare Part B, contingent on clinicians’ and hospitals’ participation in a nationwide, CMS-facilitated registry to track outcomes.

Broader coverage will begin on the day of the drug’s traditional approval, when it comes through, and CMS’ proposed method will aim to collect more real-world evidence on the drug’s use, as per the 1 June statement. upon its widespread use. While Leqembi was awarded an accelerated approval in January 2023, a decision on a traditional approval is expected by 6 July. Before that, the US Food and Drug Administration (FDA) Peripheral and Central Nervous System Drugs Advisory Committee will debate Leqembi’s traditional approval on 9 June, based on results from the Phase III Clarity AD study (NCT03887455). The FDA will then consider the results of the committee for an approval decision in the following weeks.

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CMS likens this registry-focused method to a process previously used for coverage of transcatheter aortic valve replacement which later determined the CMS’ national coverage determination for the treatment. In the official statement, Brooks-LaSure said, “If the FDA grants traditional approval, CMS is prepared to ensure anyone with Medicare Part B who meets the criteria is covered.” Clinical investigators commonly use registries to gather information on patient outcomes.

Leqembi is one of two FDA-approved Alzheimer’s therapies that use monoclonal antibodies directed against amyloid. The FDA first gave Biogen’s Aduhelm (aducanumab) an accelerated approval in June 2021 However, in April 2023, CMS announced that coverage for this class of Alzheimer’s therapies would only be available for treatments with traditional FDA approvals. Starting from 10 May, Alzheimer’s advocates protested this verdict outside ten CMS regional offices and the US Department of Health and Human Services (HHS) headquarters in Washington, D.C. Bipartisan members of Congress also joined the efforts on 26 May. The groups held signs saying “#Accessnow” and “#Moretime”, asking CMS to consider how limited access could affect Alzheimer’s patients.

The recent 1 June CMS registry plan has received criticism from Alzheimer’s advocates and industry alike. A statement from the industry group PhRMA said, “CMS is reaffirming their plan to severely restrict patient access to FDA-approved medicines, leaving in place barriers to potentially life-changing treatment options for a devastating illness.” The organisation argued that the implementation of a registry would block access and questioned whether the lack of further details about the registry would delay coverage for seniors further. The Alzheimer’s Association also said that registries were “unnecessary hurdles” for access to FDA-approved treatments. Biogen and Eisai have yet to comment on the CMS decision, as of press time.