CMS Statement on FDA Accelerated Approval of Lecanemab
The Centers for Medicare & Medicaid Services (CMS) is releasing the following statement from Administrator Chiquita Brooks-LaSure, with accompanying background information, in response to the action by the Food and Drug Administration (FDA) to grant accelerated approval to a new product designed to treat Alzheimer’s disease:
“Alzheimer’s disease is a devastating illness that affects millions of Americans and their families,” said CMS Administrator Chiquita Brooks-LaSure. “At CMS, we will continue to expeditiously review the data on these products as they become available and are committed to timely access to treatments, including drugs, that improve clinically meaningful outcomes.”
Additional Background Information:
CMS has a responsibility to ensure people with Medicare have appropriate access to therapies that are reasonable and necessary for use in the Medicare population. As announced in April 2022, CMS laid out how FDA-approved monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease could be covered by Medicare. Because Eisai’s product, lecanemab, was granted accelerated approval by the FDA, it falls under CMS’s existing national coverage determination. CMS is examining available information and may reconsider its current coverage based on this review.
If lecanemab subsequently receives traditional FDA approval, CMS would provide broader coverage using the framework we announced last year, under coverage with evidence development, on the same day. For FDA traditional approval the drug demonstrates evidence of efficacy from a direct measure of clinical benefit. The same would apply to any monoclonal antibody directed against amyloid for the treatment of Alzheimer's disease. The national coverage determination may be found at https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&ncaid=305.
In the April 2022 National Coverage Determination (NCD), CMS stated it was interested in data that could answer the following questions:
- Does the antiamyloid mAb meaningfully improve health outcomes (i.e., slow the decline of cognition and function) for patients in broad community practice?
- Do benefits, and harms such as brain hemorrhage and edema, associated with use of the antiamyloid mAb, depend on characteristics of patients, treating clinicians, and settings?
- How do the benefits and harms change over time?
CMS continues to actively engage with all interested stakeholders and is reviewing data that may answer these Coverage with Evidence Development (CED) questions that were listed in the April 2022 NCD. CMS encourages any stakeholder to send relevant data to assist in a reconsideration of the current coverage.
CMS follows a standard and formal process to develop or reconsider NCDs that includes opportunities for the public to participate and submit comments. Per the statute, CMS generally issues a proposed NCD and accompanying decision memorandum within six months from the initiation of the NCD analysis. When the proposed NCD is issued, it will initiate a 30-day public comment period with the final NCD due within 60 days from end of the 30-day public comment period. For additional information on the NCD process, see https://www.cms.gov/Medicare/Coverage/DeterminationProcess/Downloads/FR08072013.pdf (August 2013 FR notice) and https://www.cms.gov/Medicare/Coverage/DeterminationProcess (CMS Coverage webpage regarding the Medicare Coverage Determination Process).