Who Pays For New Alzheimer’s Drug? Medicare’s Own Demo Might Tell Us
Experts are backing an idea to test cost and treatment implications of prescribing Aduhelm through a payment pilot under the Center for Medicare and Medicaid Innovation. Separately, an FDA advisor who recently resigned over the drug said there's "no good evidence" it works.
Roll Call:
Medicare Demo Emerges As Coverage Option For Alzheimer’s Drug
The decision on how to cover an expensive and controversial new Alzheimer’s drug could be settled by letting Medicare run its own trial to study payment and treatment implications. Aduhelm, from drugmakers Biogen and Eisai, won accelerated approval from the Food and Drug Administration earlier this month despite objections from the agency’s advisory committee. While clinical trials proved the drug significantly reduced amyloid beta plaques in the brain — which are associated with the disease — the drug failed to show evidence that it slowed progression of the disease itself. (Clason, 6/22)
The New York Times:
Many Alzheimer’s Experts Say Use Of Aduhelm Should Be Sharply Limited
A new drug for the treatment of Alzheimer’s disease should be given to a much narrower group of patients than the federal approval permits, Alzheimer’s experts — including those who strongly supported approval of the medication — said on Monday. Since the Food and Drug Administration approved the controversial and expensive drug, Aduhelm, made by Biogen, this month, much discussion has focused on the fact that many scientists, and the F.D.A.’s own independent advisory committee, say the evidence does not convincingly show that the drug works. (Belluck, 6/21)
Fox News:
FDA Adviser Who Resigned Over Alzheimer's Drug Says 'No Good Evidence' It Works
One of the FDA advisory panel members who resigned after the agency granted Biogen’s Alzheimer’s drug Accelerated Approval has said "the drug showed no good evidence that it worked." Dr. Aaron Kesselheim, professor of medicine at Harvard Medical School and faculty member at Brigham and Women’s Hospital, spoke to CBS about his stepping down, with a resignation letter blasting the Aduhelm approval as "probably the worst drug approval decision in recent U.S. history." The agency’s decision, which was met with mixed reviews and marked the first approval of an Alzheimer’s drug in nearly two decades, came after the Peripheral and Central Nervous System Drugs Advisory Committee said in November that it was not reasonable to consider clinical benefit of the drug based on one successful study. (Rivas, 6/21)
In related news —
Stat:
BIO’s Chief On The FDA Commissioner Rumors, Drug Pricing, And IP Rights
Everyone wants to know whether Michelle McMurry-Heath, the newly minted president of the Biotechnology Innovation Organization, will be President Biden’s pick to lead the Food and Drug Administration. And whether, quite frankly, she wants the job. So STAT asked her just that — and asked, too, about the FDA’s controversial decision to approve Aduhelm for Alzheimer’s, and whether the drug industry should have gotten behind a high-profile, bipartisan drug pricing package it has opposed vehemently. (Florko, 6/21)
Stat:
Biogen Isn’t The Only Drug Company That Will Profit From Aduhelm
Biogen’s expecting to make billions from its newly approved Alzheimer’s drug Aduhelm. But it won’t be the only one making money: the complex brain scans that help doctors decide whether a patient is a good fit for the pricey therapy will also bring in money for PET scan manufacturers and imaging drug makers, too. If the use of those scans skyrockets, it’ll open up a new market for the companies that make the machines and the drug companies that manufacture the imaging drugs needed for those screenings. (Cohrs, 6/22)
