CMS, FDA present united front against criticism of Aduhelm coverage decision

Leaders of the Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) sought to present a united front a day after CMS approved narrow Medicare coverage of the Alzheimer’s disease drug Aduhelm.

FDA Commissioner Robert Califf, M.D., and CMS Administrator Chiquita Brooks-LaSure issued a joint statement Friday to address criticism of CMS’ decision that Medicare only cover Aduhelm and similar products for beneficiaries in a qualifying clinical trial. Critics have charged CMS is trying to undermine the FDA’s approval decisions as the agency cleared the drug last year via accelerated approval.

“The work of both of our agencies is critical to ensure that medical products are available to people across the country,” the agency leaders said in a statement.

Aduhelm was approved by FDA to treat amyloid plaques that could contribute to cognitive impairment caused by Alzheimer’s disease. The FDA granted accelerated approval to Aduhelm despite misgivings from agency advisers over its efficacy. 

The drug, manufactured by Biogen and co-developed by Eisai, launched with a $56,000 price tag that was later reduced by half at the end of 2021. 

CMS proposed earlier this year to offer Medicare coverage for the class of drugs that treats amyloid plaques but only to beneficiaries in a qualifying clinical trial. So far, Aduhelm is the only one approved in the class. 

The agency finalized the coverage proposal Thursday but did broaden what trials are eligible for reimbursement. CMS originally proposed that it would only cover drugs when administered in specific trials it approves, but it will instead also cover the drugs when administered in an FDA application trial or studies conducted by the National Institutes of Health. 

The agency also created another pathway that more broadly covers the drug if it gets traditional FDA approval.

But the decision did not quell criticism from the pharmaceutical industry and advocacy groups that CMS is undermining the FDA. 

“CMS has further complicated matters by taking the unprecedented step of applying different standards for coverage of medicines depending on the FDA approval pathway taken, undermining the scientific assessment by experts at FDA,” said Nicole Longo, spokeswoman for the drug lobby group Pharmaceutical Research and Manufacturers of America.

The joint statement from CMS and FDA said both agencies aim to use reliable data to ensure effective treatments are delivered to patients. 

The FDA’s decision is based on a “careful evaluation of the available data and a determination that the medical product is safe and effective for its intended use,” the statement said. 

CMS, on the other hand, can conduct its own review to determine whether the product is “reasonable and necessary for use in the Medicare population,” the statement added.

The agencies both share a common goal to advance innovative medical products. 

“Our agencies remain committed to using our distinct set of authorities to ensure the continued availability of medical products that meet our respective standards to care for the people we serve,” the leaders said.