AAN submits formal coverage reconsideration request to CMS for Alzheimer’s treatment

The American Academy of Neurology has submitted a formal national coverage determination reconsideration request to CMS regarding current coverage of amyloid-targeting monoclonal antibodies for Alzheimer’s disease, including Leqembi.

According to a press release from the AAN, the amended request proposed a two-pronged coverage plan. The first group of Medicare beneficiaries — for whom Leqembi (lecanemab, Eisai/Biogen) has demonstrated safety and efficacy — would be granted access without being subject to CMS “coverage with evidence development” (CED) requirements. The second group would be subject to existing CED guidelines that permit coverage only if enrolled in a clinical study in which additional safety and efficacy data can be collected.

The AAN submitted its initial request in early February. Since then, it has held frequent discussions with CMS and included neurologists who specialize in AD to refine and expand the recommendation to an appropriate patient population, should lecanemab receive traditional FDA approval.

“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,” AAN President Carlayne E. Jackson, MD, FAAN, said in the release. “The American Academy of Neurology is eager to continue lending our expertise to ensure that Medicare beneficiaries have access to safe and effective treatments.”