Medicare plans to pay for the new Alzheimer’s drug Aduhelm, federal officials announced on Jan. 11. But in a rare move, the program is proposing to limit its coverage to beneficiaries who are enrolled in approved clinical trials.
The preliminary decision comes seven months after the U.S. Food and Drug Administration (FDA) granted the hotly debated monoclonal antibody treatment accelerated approval on the basis that it can reduce amyloid beta plaques in the brain — a hallmark associated with Alzheimer’s disease — despite scant proof that the medication stops or slows a person’s cognitive decline. The other FDA-approved Alzheimer’s drugs on the market are designed to help manage some symptoms of the disease, not disrupt its progression, making Aduhelm a first-of-its-kind treatment and the first new Alzheimer’s drug to get federal approval since 2003. Medicare will finalize its coverage policy for Aduhelm and future drugs like it by April 11. The public has until Feb. 10 to comment on this proposal.
Officials at the Centers for Medicare & Medicaid Services (CMS) cited potential risks as one reason for limiting coverage of the drug, estimated to cost $28,200 a year, according to Massachusetts-based drugmaker Biogen. “While there may be the potential for promise with this treatment, there is also the potential for harm to patients,” including headaches, dizziness, falls and bleeding in the brain, all of which have been associated with Aduhelm’s use, Lee Fleisher, M.D., chief medical officer and director of CMS’ Center for Clinical Standards and Quality, said in a statement.
“Our foremost goal is to protect beneficiaries from potential harm from an intervention without known benefits in the Medicare population,” Fleisher said during a call with reporters. “As a practicing physician, I cannot overemphasize the need to understand the risks and benefits of a given treatment in order to better inform patients and their families as they make decisions about their care.” Several prominent health systems, including the Cleveland Clinic, Mount Sinai and Mass General Brigham, have refused to use Aduhelm, which is given as a monthly infusion, based on its safety and efficacy data.
Clinical trials key to coverage
If Medicare’s ruling is finalized, researchers will be able to submit their proposed clinical trials to the CMS for approval. National Institutes of Health (NIH)-sponsored clinical trials would also be covered under this proposed policy. Only Medicare beneficiaries who participate in these approved trials would be eligible to get Aduhelm. Other related services would also be paid for, including scans to identify the targeted plaques in the brain. Participation would be limited only to those who have a clinical diagnosis of mild cognitive impairment (MCI) due to Alzheimer’s disease or mild Alzheimer’s dementia to qualify for the trials, plus evidence of amyloid, according to CMS.
Medicare officials emphasized during the press call that any approved trials “must be diverse and representative of the Medicare population with Alzheimer’s disease.” Still, critics of the agency’s initial decision say it restricts the drug’s access “to a privileged few, those with access to research institutions, exacerbating and creating further health inequities,” Alzheimer’s Association CEO Harry Johns said in a statement. The patient advocacy group’s 2021 report found that white Americans are most likely to express interest in Alzheimer’s research trial participation, while Black Americans, who are at higher risk for the disease, are least likely.
Other groups supported Medicare’s decision, including the Alzheimer’s Drug Discovery Foundation, whose cofounder, Howard Fillit, M.D., said in a statement that CMS’ draft ruling “is consistent with the FDA’s decision to grant accelerated approval to Aduhelm.” The FDA gave the green light to Aduhelm on the condition that Biogen conduct a new randomized controlled trial to verify the drug’s clinical benefit.
Before it makes its final decision, the CMS “will have more opportunities to hear from people with Medicare living with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s disease dementia, their family members and caregivers, as well as many other stakeholders, including patient advocacy groups, medical experts, states, payers and industry professionals,” CMS Administrator Chiquita Brooks-LaSure said.
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It’s unclear how many participants will be enrolled in Medicare-approved trials and how many of those patients will have access to Aduhelm, Tamara Syrek Jensen, director of CMS’ Coverage and Analysis Group, told reporters. Drugmaker Biogen said in a statement that “even the largest [randomized controlled trials] in Alzheimer’s disease have been limited to a few thousand patients, of which 30 to 50 percent have been on placebo.” About 1 million to 2 million Americans out of the more than 6 million living with Alzheimer’s are in the early stages of the disease.
Earlier this week, U.S. Department of Health and Human Services Secretary Xavier Becerra instructed the CMS to reassess the 2022 Part B premium, which went up $21.60 per month, to $170.10 — the largest dollar increase ever. The price of Aduhelm, originally listed at $56,000 a year, factored into roughly half that premium hike. Biogen, however, has since cut the cost nearly in half under pressure from health advocates. Medicare officials on Tuesday stressed that the CMS does not consider the cost of a medical drug or device when determining whether it will be covered.
Rachel Nania writes about health care and health policy for AARP. Previously she was a reporter and editor for WTOP Radio in Washington, D.C. A recipient of a Gracie Award and a regional Edward R. Murrow Award, she also participated in a dementia fellowship with the National Press Foundation.