The Atlanta Journal-Constitution
Decision looms that could decide fate of Alzheimer’s drug
Medicare’s potential coverage of expensive drug will be crucial.
Federal officials are wrestling with a decision that could go a long way toward determining the future of the controversial new Alzheimer’s drug, Aduhelm, and whether significant numbers of patients use it.
This month, Medicare, the federal health insurance program for people 65 and older, plans to issue a preliminary decision on whether it will cover the expensive medication. The Food and Drug Administration’s approval of Aduhelm in June has drawn fierce criticism because clinical trials showed the drug had significant safety risks and unclear benefit to patients.
Roughly 80% of potential Aduhelm patients are old enough to receive Medicare, making the program’s coverage decision crucial. Private insurers often follow Medicare’s lead.
Medicare almost always pays for Fda-approved drugs, at least for the medical conditions designated on their label, health policy experts said. But with Aduhelm, Medicare officials have undertaken a monthslong review that could result in no coverage, full coverage or limited coverage.
“It’s truly unprecedented,” said James Chambers, a researcher at the Center for the Evaluation of Value and Risk in Health at Tufts Medical Center in Boston.
Chiquita Brooks-lasure, administrator of the Centers for Medicare & Medicaid Services, declined to discuss the deliberations. “It’s a process our coverage team goes through,” she said. “We will let the scientists continue their work.”
Aduhelm, made by Biogen, is a monoclonal antibody also known by its scientific name, aducanumab. Patients receive it in monthly infusions and also require regular MRI scans to monitor for potentially dangerous side effects, including brain swelling and bleeding.
Last week, after weak sales, Biogen slashed Aduhelm’s price to $28,200 a year from $56,000.
In a statement, Michel Vounatsos, Biogen’s CEO, said, “It is a critical time for the Alzheimer’s disease community as the Centers for Medicare & Medicaid Services (CMS) is considering the possibility of coverage of not only Aduhelm, but also this entire new class of Alzheimer’s disease therapies. We hope our actions today will facilitate patient access to these innovative Alzheimer’s treatments.”
The new price is still much higher than many analysts have said is warranted.
The total cost to Medicare would depend on the terms it sets and how many patients decide to use Aduhelm. About 1.5 million Americans may be eligible because they have mild Alzheimer’s-related dementia.
“While it of course depends on Aduhelm’s utilization, it seems that even at $28,000 a year, Aduhelm would still be one of Medicare’s biggest drug expenses,” Chambers said.
Before Biogen’s price cut, Medicare’s actuarial division, acting without knowing what the coverage decision would be, imposed one of the biggest-ever increases in Medicare Part B premiums for 2022, partly driven by the possibility of Aduhelm coverage.
Medicare’s review comes as Aduhelm faces criticism and hurdles around the world.
Reviewers at the European Union’s drug regulator, the European Medicines Agency, recommended against approving the drug, a decision that Biogen is requesting be reexamined. Leading Canadian Alzheimer’s research organizations earlier said that approving Aduhelm in Canada “cannot be justified.”
Large U.S. medical systems, including Cleveland Clinic, Mount Sinai Health System, Mass General Brigham and the Department of Veterans Affairs have declined to offer Aduhelm.