CMS Proposes Medicare Coverage Policy for Monoclonal Antibody–Based Alzheimer Treatment

On January 11 the U.S. Centers for Medicare & Medicaid Services (CMS) released a proposed National Coverage Determination (NCD) decision memorandum that would cover U.S. Food and Drug Administration (FDA)–approved monoclonal antibodies that target β-amyloid for the treatment of Alzheimer disease (AD) through coverage with evidence development (CED). This means that FDA-approved drugs in this class would be covered for people with Medicare only if they are enrolled in qualifying clinical trials.

Aducanumab (Aduhelm; Biogen, Inc. [Cambridge, MA] and Eisai, Co., Ltd. [Tokyo, Japan]) is currently the only monoclonal antibody directed against β-amyloid approved by the FDA for treatment of AD. The FDA issued conditional approval of the drug on June 7, 2021. At that time, Biogen announced that the cost of the drug would be $56,000 per year ($4,300/monthly infusion). Widespread public and scientific media coverage focused on the high cost, as well as on efficacy data and potential side effects. In November 2021, CMS announced that Medicare Part B premiums would be increased by almost 15% in 2022, citing the potential impact of coverage for aducanumab as 1 of 5 factors in projected costs. On December 20, Biogen announced a 50% reduction in the price for aducanumab, to $28,000/year.

The January 11 announcement of the proposed NCD and limited coverage of the drug included a 30-day period for public comment. After reviewing all comments received on the proposed determination, CMS will announce its final decision by April 11, 2022. If the proposed NCD is finalized, CMS will review each submitted clinical trial to determine whether specific criteria are met. All CMS-approved clinical trials would be posted on the CMS Coverage website. In addition to CMS-approved trials, National Institutes of Health (NIH)–sponsored clinical trials would be covered. Medicare patients participating in these trials would be eligible to receive coverage of the drug, related services, and other routine costs, which may include 1 β-amyloid PET scan if required by a clinical trial protocol.

“We believe that any appropriate assessment of patient health outcomes must weigh both harm and benefit before arriving at a final decision,” said Lee Fleisher, MD, CMS Chief Medical Officer and Director of the Center for Clinical Standards and Quality. “Therefore, based on the public comments submitted previously and evidence CMS reviewed, the potential for harm, and important questions that remain, we have determined that coverage with evidence development through clinical trials is the right decision for Medicare patients, clinicians, and caregivers, and we look forward to receiving feedback on the proposal.”