On February 17, 2023, a bipartisan group of Senators sent the Secretary of Health and Human Services, Javier Baccera, and the Administrator of the Centers for Medicare and Medicaid Services (CMS), Chiquita Brooks-LaSure, a letter requesting that CMS reconsider their decision to require Coverage with Evidence Determination (CED) that was levied after the accelerated approval of aducanumab. The letter followed a similar request from the Alzheimer’s Association, made in December 2022. The CED decision significantly limited access to aducanumab and other monoclonal antibodies (should they be approved), requiring that coverage would be granted only if Medicare beneficiaries were enrolled in a CMS-approved randomized trial. The hope of the Senators and of the Alzheimer’s Association was that CMS would reconsider their approach in light of the convincing and consistent data of a clinical benefit observed for lecanemab, which also received accelerated approval in January. CMS responded on February 22, 2023, however, indicating that they would not at this time revisit their previous decision.
And so, for now at least, access to these medications will remain limited and coverage difficult to achieve.
What remains unclear, however, is whether lecanemab will achieve full (compared to accelerated) approval by the FDA, as many expect it will, and whether that will make a difference for CMS. The February response from CMS indicated a willingness and intent to reconsider their stance as new information becomes available, including if the FDA were to grant full approval to a monoclonal antibody for demonstrated clinical benefit. It is conceivable that full approval could help sway their approach, with options ranging from full coverage to a less restrictive CED, such as enrollment in a patient registry.