On April 7, 2022, the Centers for Medicare & Medicaid Services (CMS) released a final National Coverage Analysis (NCA) decision memo, Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease. The final decision provides for coverage beyond CMS-approved randomized controlled trials (RCTs) and trials supported by the National Institutes of Health (NIH) that were described in the proposed decision memo released on January 11, 2022, thereby allowing for flexibility in study design for anti-amyloid monoclonal antibodies that have been approved by U.S. Food and Drug Administration (FDA) through the traditional approval process for the treatment of AD.

CMS will cover monoclonal antibodies targeting amyloid for the treatment of Alzheimer disease (AD) that receive traditional approval from the FDA under coverage with evidence development (CED) when individuals with Medicare participate in CMS-approved studies, including prospective comparative studies with a variety of study designs (e.g., longitudinal comparative studies, clinical trials, registry data). For drugs in this class that have received an accelerated FDA approval or for which the FDA has not determined the drug to have shown a clinical benefit, CMS will cover FDA- or NIH-approved trials under CED.

There is currently only 1 monoclonal antibody that has been granted FDA approval for the treatment of AD. Aduhelm (aducanumab-avwa; Biogen Inc.) is an amyloid beta-directed antibody indicated for the treatment of AD. The FDA label notes that treatment with Aduhelm should be initiated in patients with mild cognitive impairment or mild dementia stage of disease. This indication was approved under accelerated approval based on reduction in amyloid beta plaques observed in patients treated with Aduhelm. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s). Other amyloid-directed monoclonal antibodies (lecanemab, donanemab) are in development for the treatment of AD.

CMS will hold a stakeholder call on this final NCA decision memo on April 11, 2022. To register for the call, click here. A Fact Sheet that briefly summarizes the NCA decision memo is available here.

Centers for Medicare & Medicaid Services (CMS). Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease (CAG-00460N). National Coverage Analysis (NCA) Decision Memo. April 7, 2022. Available at: click here. Accessed April 8, 2022.