CMS sticks to its guns, limiting coverage of Biogen's Aduhelm to clinical trials

Bad news for Biogen: Medicare didn't change its mind.

After accepting more than 10,000 bits of input during a public comment period over the last three months, the Centers for Medicare & Medicaid Services held to its original decision to limit coverage of the company’s Alzheimer’s disease treatment Aduhelm—and other drugs like it—to clinical trials.

The agency's final national coverage determination reinforces a January proposal, but with a few small tweaks based on the feedback CMS received.

“We know that there is potential for promise with this treatment,” said Dr. Lee Fleisher, CMS Director of the Center for Clinical Standards and Quality, said in a conference call. “However, there’s not currently enough evidence of clinical benefit to say that it is reasonable and necessary for people with Medicare.”

Biogen and others lobbying on its behalf—advocacy groups, legislators and others—were hoping for a very different result. The Aduhelm launch has been dismal thus far, and the CMS coverage limits are part of the reason why.

While BIogen had high hopes for megablockbuster sales of the drug, it brought in only $3 million in 2021 after its June rollout. The company has since slashed the list price in half, from its original $56,000, and started laying off employees in a companywide retrenchment.

As part of the decision, the CMS said that if the FDA offers full approval to any of the drugs in the anti-amyloid class—rather than accelerated approval based on biomarker evidence, as Aduhelm has now—CMS will provide rapid access and coverage to that approved drug.

Tamara Syrek Jensen, the Director of the Coverage and Analysis Group at the CMS’s Center for Clinical Standards and Quality said that the final coverage decision was altered from the proposed version from January, but only slightly.

Instead of covering only CMS-approved trials, Medicare will now support any FDA-cleared trial or NIH trial of anti-amyloid treatments, she said.

The tweaks, however, will not open Aduhelm to more patients.

“It’s status quo,” Jensen said. “If a drug is approved under the traditional approval (process), it could open it quite wide.”

Since the CMS handed down its original guidelines, many advocacy groups have argued that coverage should be extended to a drug that’s been approved by the FDA, as Aduhelm is, even if that approval came under the agency's less rigorous accelerated pathway. Meanwhile, many medical experts contend that the benefits and risks of Aduhelm are uncertain.  

Among those weighing in were Senators Shelley Moore Capito (R-West Virginia) and Susan Collins (R-Maine) who sent a letter (PDF) to the CMS urging it not to follow through with its plan to restrict Aduhelm.

Fleischer admitted that the CMS making a determination on an FDA approved drug was unusual.

“National coverage determination on classes of drugs is a relatively rare process for CMS,” Fleischer said. “However, we were driven by unique circumstances, including multiple requests from stakeholders, to open up a coverage determination for this class of drugs. I can confidently say that science, evidence and stakeholders’ input led our team through this process.”