The Centers for Medicare and Medicaid Services finalized its decision to only cover a contentious, pricey Alzheimer’s drug for patients enrolled in randomized clinical trials, the agency announced Thursday.
The final coverage determination keeps a majority of the agency’s January proposal intact, but slightly loosens the trial requirements for drugs like Aduhelm, which was granted conditional approval by the Food and Drug Administration. Medicare will cover the drug for patients in a randomized, controlled clinical trial conducted either through FDA or the National Institutes of Health — though it does not have to be approved by CMS, per the proposal.
CMS updated its stance on future Alzheimer’s drugs that also target the amyloid proteins thought to cause the disease. Should those drugs go through a traditional approval process, and not the accelerated approval process, patients would not need to be in a randomized, controlled trial.
Instead, they could be in a patient registry, which tracks how patients fare when they receive the drug. Unlike a randomized trial, it doesn’t require any patient to receive a placebo.
“We are really looking for real-world data to ensure that every patient has the same benefits,” said Tamara Syrek Jensen, the head of the coverage and analysis group within CMS’ Office of Clinical Standards and Quality.
The decision goes into effect immediately, meaning that patients who want to receive Aduhelm will need to go through a trial conducted through FDA. Biogen plans to begin screening patients for a post-marketing trial in May, which could meet CMS’ coverage standards.
Background: For the final determination, CMS reviewed more than 10,000 comments and 250 peer-reviewed studies.
At the time it was proposed, critics from the drug industry and patient advocacy groups — some of which receive a small percentage of their funding from pharmaceutical companies — had said that Medicare’s proposed narrow coverage of Aduhelm would effectively prevent most eligible patients from receiving the drug, which has an out-of-pocket cost of roughly $28,000 annually, because of the strict clinical trial requirements.
They have also cited the fact that CMS’ decision functionally overrides the FDA’s approval of the drug. Aduhelm, also known by the scientific name aducanumab, received accelerated approval last summer. The conditional approval requires Biogen to conduct a fourth, post-market randomized trial to prove that the drug benefits patients.
What’s next: Biogen is slated to begin screening patients for its mandated Phase IV trial for Aduhelm next month, in addition to the two ongoing trials it is running on the drug. One of these trials is observational, while the other is a continuation of a late-stage clinical trial.
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