FOR IMMEDIATE RELEASE ON June 12, 2023
AAN Submits National Coverage Determination Reconsideration Request to CMS
MINNEAPOLIS – The American Academy of Neurology (AAN) , the world’s largest association of neurologists and neuroscience professionals, has submitted a Formal National Coverage Determination (NCD) Reconsideration Request to the Centers for Medicare & Medicaid Services (CMS) regarding the existing national coverage determination on Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease, including the new therapy lecanemab. “It is neurologists who care for the millions of Alzheimer's patients enrolled in Medicare, so we appreciate the Centers for Medicare & Medicaid Services’ thoughtful consideration of the American Academy of Neurology’s reconsideration request that would expand access to critically needed therapies,” said American Academy of Neurology President Carlayne E. Jackson, MD, FAAN. “The American Academy of Neurology is eager to continue lending our expertise to ensure that Medicare beneficiaries have access to safe and effective treatments.” Since submitting our original request on February 2, 2023, the American Academy of Neurology has been engaged in frequent discussions with the Centers for Medicare & Medicaid Services. Included in these discussions have been neurologists who are experts in Alzheimer’s disease. Discussions have included ways to refine and expand our recommendation to promote access for appropriate patients if lecanemab receives traditional approval from the Food and Drug Administration (FDA) in the coming weeks. The American Academy of Neurology’s amended reconsideration request proposes a two-pronged coverage plan. The first group of Medicare beneficiaries, people for whom the safety and efficacy of this therapy have been thoroughly demonstrated in research, would have access to lecanemab without being subject to the Centers for Medicare & Medicaid Services “coverage with evidence development” (CED) requirements. The second subset of Medicare beneficiaries would be subject to the existing CED requirements, receiving coverage only if enrolled in a clinical study where additional data on safety and efficacy can be collected. The American Academy of Neurology understands the importance of thorough and accurate evidence-gathering to address gaps in existing data on the safety and efficacy of these therapies for certain patient populations and looks forward to continuing discussions with the Centers for Medicare & Medicaid Services on how to refine coverage policy.