Health Day reporter
TUESDAY, July 13, 2021 (Healthday News) – Medicare launched a formal process on Monday that will determine whether the agency will cover Aduhelm, the newly approved Alzheimer’s drug whose high price and unproven benefits have sparked widespread controversy .
The Medicare announcement came on the same day that leaders of two House committees investigating Aduhelm’s approval asked drugmaker Biogen to turn over all documentation on how it developed and fixed the drug. drug price. Biogen has also been asked to turn over records on all of its dealings with U.S. Food and Drug Administration officials, on Associated press reported.
A final decision on coverage is not likely until next spring, the U.S. Centers for Medicare and Medicaid Services said. Right now, Medicare is making case-by-case calls about whether to cover Aduhelm, which is administered intravenously in a doctor’s office and costs $ 56,000 per year per patient.
The recent FDA approval of Aduhelm sparked an unusually intense reaction after the agency went against the recommendation of its independent advisers. Since then, the agency has limited the drug’s recommended use and has requested an investigation by an independent watchdog into its relationship with Biogen.
“We want to take a very careful look at Medicare coverage of new treatments in light of the available evidence,” CMS administrator Chiquita Brooks-LaSure said in a statement acknowledging the toll of Alzheimer’s disease, the PA reported. “Our process will include opportunities to hear from many stakeholders, including patient advocacy groups, medical experts, states, issuers, industry professionals, family members and caregivers of people. living with this disease. “
A 30-day public comment period began Monday, and there will be two public hearings on the drug, the PA mentionned.
Prior to Aduhelm’s approval, Biogen and the FDA reanalyzed Aduhelm’s data together after the company’s studies suggested the drug did not slow mental decline, the PA reported. The collaboration ultimately led to the FDA granting conditional approval for the drug.
Last week, the FDA asked the independent government watchdog to investigate unusual interactions between certain FDA staff and Biogen. This included reports of at least one “off the book” discussion between a Biogen executive and the FDA’s top Alzheimer’s drug reviewer.
Meanwhile, much of the document request from lawmakers includes details of how Biogen came up with the drug’s price. The drug requires monthly IVs and the dosage is based on the patient’s weight. House committee chairs noted that a nonprofit think tank focused on drug pricing has priced the drug at $ 3,000 to $ 8,400 per year, based on its unproven benefits. .
“Although the company has claimed this [$56,000 a year] the price is’ fair ‘and’ justified by the value it should bring, ‘independent analysis determined that a fair price for Aduhelm would be a small fraction of Biogen’s price,’ said committee chairs Carolyn Maloney and Frank Pallone. .
Visit the US National Institute on Aging to learn more about Alzheimer’s disease.
SOURCE: Associated press
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