The Biden administration on Thursday finalized a decision to significantly limit Medicare coverage of a controversial new Alzheimer’s drug amid a fierce debate over its effectiveness.
The Centers for Medicare and Medicaid Services (CMS) said that it would limit coverage of the drug, known as Aduhelm, to people who are participating in a clinical trial, which can help scientists further study the drug.
The drug, made by Biogen, drew controversy when it was approved by the Food and Drug Administration (FDA) despite widespread doubts about whether it worked. The price of the drug has also drawn an outcry, at $28,200 per year, though it was initially even higher.
The CMS is largely finalizing its initial decision to limit coverage of the drug, made in January, despite an intense lobbying campaign from some advocates pushing for broader coverage and pointing to the dire situations of people with Alzheimer’s.
“There is the potential for promise with this treatment; however, there is not currently enough evidence of demonstrating improved health outcomes to say that it is reasonable and necessary for people with Medicare,” said Lee Fleisher, CMS chief medical officer.
“In arriving at this final decision, we looked at the very unique circumstances around this class of treatments and made a decision that weighed the potential for patient benefit against the significance of serious unknown factors that could lead to harm,” he added.
He noted that future related drugs could receive broader coverage if they demonstrate benefit for patients.
In November, Medicare announced a significant increase in premiums, in part citing the costs from the pricey new Alzheimer’s drug.
That was announced before Biogen halved the price of the drug, from $56,000 annually to $28,200. Secretary of Health and Human Services Xavier Becerra directed Medicare to reconsider its premium increase after Biogen lowered the price, though Medicare has not yet announced a final decision on the premiums.
The FDA’s approval of the drug in the first place, which prompted three members of an agency advisory panel to resign in protest, has also drawn scrutiny, including an investigation from the House Energy and Commerce and House Oversight Committees.
Updated at 5:30 p.m.
