Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer's Disease (CAG-00460N)
Medicare national coverage determination establishing coverage with evidence development (CED) for FDA-approved monoclonal antibody drugs directed against amyloid for treatment of Alzheimer's disease in patients with MCI due to AD or mild AD dementia with confirmed amyloid pathology, when furnished in accordance with approved clinical trials.
CMS established national coverage determination for FDA-approved monoclonal antibodies directed against amyloid for AD under CED for patients with MCI due to AD or mild AD dementia with confirmed amyloid pathology.
Coverage Summary
Scope: Medicare national coverage determination (CAG-00460N) establishing coverage with evidence development (CED) for FDA-approved monoclonal antibody drugs directed against amyloid for treatment of Alzheimer's disease in patients with mild cognitive impairment (MCI) due to AD or mild AD dementia with confirmed amyloid pathology, when furnished in accordance with approved clinical trials.
Coverage stance: Covered with criteria — Medicare will cover FDA-approved anti-amyloid monoclonal antibodies for eligible patients only under the CED requirements specified in the NCD.
Subject: Monoclonal antibodies directed against amyloid for Alzheimer's disease (anti-amyloid drugs).
Overview: CMS issued national coverage determination CAG-00460N effective April 7, 2022, permitting Medicare coverage of FDA-approved monoclonal antibodies targeting amyloid for treatment of Alzheimer's disease only when furnished in accordance with coverage with evidence development (CED) — i.e., for patients meeting the clinical criteria (MCI due to AD or mild AD dementia with confirmed amyloid pathology) and enrolled in an approved clinical trial.
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