On January 11, 2022, the Centers for Medicare and Medicaid Services (CMS) released a proposed decision memo, Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease, proposing to cover FDA-approved monoclonal antibodies directed against amyloid for the treatment of Alzheimer disease (AD) under Coverage with Evidence Development (CED) in CMS approved randomized controlled trials and in trials supported by the National Institutes of Health (NIH).
There is currently only 1 monoclonal antibody that has been granted approval by the Food and Drug Administration (FDA) 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, the population in which treatment was initiated in clinical trials. There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied. 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.
If the proposal is finalized, monoclonal antibodies directed against amyloid for the treatment of AD provided outside of the CMS approved randomized controlled trials and trials supported by the NIH will be nationally non-covered. All trials must be conducted in a hospital-based outpatient setting.
CMS is seeking comments on the proposed decision memo.
Centers for Medicare and Medicaid Services (CMS). Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease (CAG-00460N). Proposed Decision Memo – 01/11/2022. Available at: click here. Accessed January 12, 2022.