Hundreds of advocates from across New York, New Jersey, and Connecticut rally outside the Centers for Medicare and Medicaid Services (CMS) regional office in downtown Manhattan (Jacob Javitz Federal Building). The protestors were asking CMS to reverse its decision and cover two FDA-approved Alzheimer’s drugs, Leqembi and Aduhelm. Credit: Luiz C. Ribeiro for NY Daily News via Getty Images

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

Broader coverage will begin on the day of the drug鈥檚 traditional approval, when it comes through, and CMS鈥� proposed method will aim to collect more real-world evidence on the drug鈥檚 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鈥檚 traditional approval on 9 June, based on results from the Phase III (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 which later determined the CMS鈥� national coverage determination for the treatment. , Brooks-LaSure said, 鈥淚f the FDA grants traditional approval, CMS is prepared to ensure anyone with Medicare Part B who meets the criteria is covered.鈥� Clinical investigators commonly use registries to gather information on patient outcomes.

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

The recent 1 June CMS registry plan has received criticism from Alzheimer鈥檚 advocates and industry alike. A statement from the industry group PhRMA said, 鈥淐MS 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.鈥� 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 also said that registries were 鈥渦nnecessary hurdles鈥� for access to FDA-approved treatments. and have yet to comment on the CMS decision, as of press time.