Significant Cost Determination for Medicare Coverage of Monoclonal Antibodies for the Treatment of Alzheimer’s Disease

Relevant to: Cost, PDPs, MAOs, PACE

On April 7, 2022, CMS issued the “Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease” National Coverage Determination (NCD 200.3). This NCD outlines Medicare coverage policy for monoclonal antibodies that target amyloid (or plaque) for the treatment of Alzheimer’s disease. Under NCD 200.3, Medicare covers monoclonal antibodies that the Food and Drug Administration (FDA) has not yet determined to have shown a clinical benefit (or that receive an accelerated FDA approval), in the case of FDA or National Institutes of Health (NIH) approved trials. The NCD also provides Medicare coverage for monoclonal antibodies that receive traditional approval from the FDA under coverage with evidence development. Any physician administering monoclonal antibodies that receive traditional approved by the FDA must submit data to at least one registry-based study. On July 6, 2023, the FDA granted the first traditional approval of an amyloid-targeting monoclonal antibody to Leqembi (lecanemab).

See the full guidance for more information.