HealthDay News — Medicare launched a formal process on Monday that will determine whether the agency will cover Aduhelm, the newly approved Alzheimer disease drug with a high price tag and unproven benefits that have prompted widespread controversy.
The Medicare announcement came the same day that leaders of two House committees that are investigating Aduhelm’s approval asked drugmaker Biogen to turn over all documents on how it developed and priced the drug. Biogen was also asked to turn over records on any of its dealings with U.S. Food and Drug Administration officials, the Associated Press reported.
A final decision on coverage is not likely until next spring, the U.S. Centers for Medicare & Medicaid Services said. At the moment, Medicare is making case-by-case calls on whether to cover Aduhelm, which is given intravenously in a doctor’s office and costs $56,000 a year per patient.
“We want to consider Medicare coverage of new treatments very carefully in light of the evidence available,” CMS Administrator Chiquita Brooks-LaSure said in a statement that acknowledged the toll of Alzheimer disease, the AP reported. “Our process will include opportunities to hear from many stakeholders, including patient advocacy groups, medical experts, states, issuers, industry professionals, and family members and caregivers of those living with this disease.”
A 30-day public comment period began Monday, and there will be two public hearings on the drug, the AP said.