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MirageNews.com

On January 11th, the Centers for Medicare and Medicaid Services (CMS) announced that it proposes to cover Food and Drug Administration (FDA)-approved monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease, including aducanumab, under Coverage with Evidence Development (CED) in CMS-approved randomized controlled trials. At this time, aducanumab is the only monoclonal antibody directed against amyloid with FDA approval and AGS has expressed its concern about aducanumab in letters to the FDA.^1,2

In its letter to CMS providing input on issues to consider during the national coverage analysis that is the precursor to the agency making a national coverage determination (NCD), the American Geriatrics Society (AGS) recommended that CMS limit the NCD to aducanumab given that this is the only treatment that the FDA has approved.³ AGS continues to believe that it is premature for CMS to issue a coverage determination for other monoclonal antibodies directed against amyloid in the pipeline before FDA approval.

Although we are still reviewing the proposal, “AGS is very supportive of CMS’ focus on ensuring that we have adequate safety and efficacy data for underrepresented, disproportionately affected, or understudied populations so that we are able to conclude with certainty that this treatment is safe to generalize to the Medicare population,” noted AGS President Peter Hollmann, MD, AGSF. “AGS, and our members, understand the heavy toll of Alzheimer’s disease and other dementias on patients, caregivers, and their families. We are supportive of Medicare payment for treatments that have been shown to have clinical benefit for patients and remain hopeful that federal and private sector investments in research will lead to the discovery of efficacious, disease-modifying treatments for Alzheimer’s disease and other dementias.”

AGS is in the process of reviewing the proposed NCD and will be submitting comments to CMS by the February 10th deadline. CMS will make its final decision in April 2022.

[1] American Geriatrics Society. Letter to FDA on Review of Biogen’s Drug Aducanumab for Alzheimer’s Disease. June 2, 2021. Accessed January 24, 2022. https://www.americangeriatrics.org/sites/default/files/inline-files/American%20Geriatrics%20Society_Letter%20to%20FDA%20Biogen%20Drug%20for%20Alzheimer%27s%20%28June%202021%29%20FINAL%20%281%29.pdf.

[2] American Geriatrics Society. Food and Drug Administration’s Label of Biogen’s Aducanumab. September 30, 2021. Accessed January 24, 2022. https://www.americangeriatrics.org/sites/default/files/inline-files/Joint%20Letter%20to%20FDA%20on%20Aducanumab%20Label%20%289%2030%2021%29_FINAL.pdf

[3] American Geriatrics. Society. Comments on National Coverage Analysis for Aducanumab for Treatment of Alzheimer’s Disease. August 11, 2021. Accessed January 24, 2022. https://www.americangeriatrics.org/sites/default/files/inline-files/CMS%20Letter%20on%20Beta%20Amyloid%20PET%20coverage%20071921%20-%20FINAL.pdf.