This policy is consistent with Medicare’s coverage determination for monoclonal antibodies directed against amyloid for the treatment of Alzheimer's disease (AD). The Company’s payment methodology may differ from Medicare.US FOOD AND DRUG ADMINISTRATION (FDA) STATUS
In June 2021, aducanumab-avwa (Aduhelm; Biogen) was approved by the FDA for treatment of AD. This indication was approved under accelerated approval based on reduction in amyloid beta plaques observed in patients treated with aducanumab-avwa (Aduhelm). Continued approval for this indication may be contingent on verification of clinical benefit in confirmatory trial(s).
The FDA, under the accelerated approval regulations (21 CFR 601.41), requires that Biogen conduct a randomized controlled trial to evaluate the efficacy of aducanumab-avwa (Aduhelm) compared to an appropriate control for the treatment of AD. The trial should be of sufficient duration to observe changes on an acceptable endpoint in the patient population enrolled in the trial. The expected date of trial completion is August 2029 and final report submission to the FDA is expected by February 2030.
In January 2023, the FDA approved lecanemab-irmb (Leqembi) as the second humanized IgG1 monoclonal antibody directed against amyloid beta for the treatment of AD. Like aducanumab-avwa (Aduhelm), lecanemab-irmb (Leqembi) was approved via the accelerated approval pathway based on amyloid plaque reduction in a Phase 2 clinical trial, and continued approval will be contingent upon verification of a clinical benefit in a confirmatory trial. Lecanemab-irmb (Leqembi) is limited to treating patients with mild cognitive impairment (MCI) due to Alzheimer’s or mild Alzheimer’s dementia as this was the population evaluated in clinical trials, and no safety or effectiveness data are available on initiating treatment earlier or later in the disease course.
In July 2023, the FDA converted lecanemab-irmb (Leqembi), indicated to treat adult patients with AD, to traditional approval. Lecanemab-irmb (Leqembi) is the first amyloid beta-directed antibody to be converted from an accelerated approval to a traditional approval for the treatment of AD.
In July 2024, the FDA approved donanemab-azbt (Kisunla), which is an amyloid beta–directed antibody, as indicated for the
treatment of Alzheimer’s disease. Per the FDA: "Treatment with KISUNLA should be
initiated in patients with mild cognitive impairment or mild dementia
stage of disease, the population in which treatment was initiated in the
clinical trials."
BENEFIT APPLICATION
Subject to the terms and conditions of the applicable Evidence of Coverage, monoclonal antibodies directed against amyloid for the treatment of AD is covered under the applicable medical benefits of the Company's Medicare Advantage products when the requirements for Coverage with Evidence Development listed in this medical policy are met.
Services that are experimental/investigational are excluded for the Company’s Medicare Advantage products. Therefore, they are not eligible for reimbursement consideration.
