The Centers for Medicare & Medicaid Services yesterday proposed that Medicare cover monoclonal antibodies that target amyloid to treat Alzheimer’s disease for beneficiaries enrolled in qualifying clinical trials. The Food and Drug Administration last June approved the first such Alzheimer’s treatment, Biogen’s Aduhelm (aducanumab), using its accelerated approval pathway. 

“This proposed National Coverage Determination is the result of robust evidence analysis conducted through a thorough review process that found while there may be the potential for promise with this treatment, there is also the potential for harm to patients,” said CMS Chief Medical Officer Lee Fleisher, M.D. “This harm may range from headaches, dizziness, and falls, to other potentially serious complications such as brain bleeds.”

Under the proposed NCD, Medicare would cover the drug, related services and other routine costs, which may include PET scans if required by a trial protocol, CMS said. The agency will accept comments on the proposed NCD for 30 days.

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