CMS says Biogen approval falls under existing national coverage determination

The Centers for Medicare & Medicaid Services released a statement in response to the action by the Food and Drug Administration to grant accelerated approval to Biogen and Eisai’s product designed to treat Alzheimer’s disease: "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." Reference Link