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CMS Restricts Medicare Coverage for Aducanumab

Public Citizen News / May-June 2022

By Rhoda Feng

This article appeared in the May/June 2022 edition of Public Citizen News. Download the full edition here.

Despite intense pressure orchestrated by Big Pharma and industry-funded patient advocacy groups, the U.S. Centers for Medicare and Medicaid Services (CMS) in April announced a final national coverage decision under which the Medicare program will cover the drug aducanumab (Aduhelm) only for beneficiaries with Alzheimer’s disease who enroll in a properly designed randomized, controlled clinical trial of the drug.

Public Citizen had previously called for CMS to exclude aducanumab from coverage under the Medicare program because there is a lack of scientific evidence that the drug provides any meaningful benefit to cognitive function. We had also asked the U.S. Food and Drug Administration (FDA) to not approve aducanumab for treatment of Alzheimer’s disease due to lack of evidence of its effectiveness.

“CMS’ science-based action will significantly mitigate the damage done by the FDA’s reckless decision last year to approve aducanumab despite the lack of evidence of benefit and clear evidence of that it can cause serious brain injury,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group.

In 2020, Public Citizen called on the U.S. Department of Health and Human Service’s Office of Inspector General to investigate the unprecedented collaboration between the FDA and Biogen regarding the company’s marketing application for aducanumab. The FDA had approved the drug under the agency’s accelerated approval pathway, and Public Citizen maintains that inappropriately close collaboration between the FDA and Biogen before and after the company submitted its marketing application for the drug dangerously compromised the independence and objectivity of the agency’s review.

In his testimony before an FDA advisory committee in 2020, Carome pointed out that two large studies comparing aducanumab to a placebo were stopped early because a preliminary data analysis showed the drug was not effective. Biogen nevertheless pursued analyses of data from these incomplete studies which were highly susceptible to bias. (One study only suggested possible minimal benefit at a high dose, but the other clearly showed the drug doesn’t work.)

In 2021, the FDA recklessly approved aducanumab for treatment of Alzheimer’s disease despite the nearly unanimous conclusion of an independent panel of experts convened by the agency that there was not sufficient evidence that the drug was effective. At the time, Carome noted that the FDA’s decision “shows a stunning disregard for science and eviscerates the agency’s standards for approving new drugs.” Approving the drug despite the lack of evidence of benefit has raised false hope for millions of Alzheimer’s patients and their families.

In contrast to the FDA, CMS stood its ground in the face of a concerted lobbying campaign by Big Pharma. “CMS’ action is a win for patients, Medicare beneficiaries, the American taxpayer, and evidence-based medicine,” remarked Carome.