Medicare is starting a formal process to decide whether to cover the new Alzheimer’s drug, EduHelm, which costs $56,000 a year and the unproven benefits have prompted widespread criticism and congressional scrutiny.
WASHINGTON – Medicare on Monday began a formal process to decide whether to cover the new Alzheimer’s drug EduHelm, which costs $56,000 a year and unproven benefits have prompted widespread criticism and congressional scrutiny.
The Centers for Medicare and Medicaid Services, or CMS, said a final decision is unlikely until next spring, though a preliminary decision could come in six months. Medicare is currently making a case-by-case determination of whether to cover the drug, which is administered intravenously at a doctor’s office.
Medicare’s announcement came on the same day that Democratic leaders on two House committees asked drugmaker Biogen to turn over a re-evaluation of documents about the drug’s development and pricing, and its dealings with government officials at the Food and Drug Administration.
Although expensive drugs are now fairly common, Eduhelm’s recent approval prompted an unusually rapid response. The FDA went against the recommendation of its external advisers in approving, and the beleaguered agency has since reduced the drug’s recommended use and requested an independent oversight investigation into its dealings with Biogen. Meanwhile, Democrats in Congress are pushing legislation authorizing Medicare to negotiate drug prices.
CMS administrator Chiquita Brooks-Lasur indicated that neither politics nor cost would be part of Medicare’s evaluation.
“We want to consider Medicare coverage of new treatments very carefully in light of the available evidence,” Brooks-Lasur said in a statement. “Our process will include opportunities to hear from a range of stakeholders, including patient advocacy groups, medical experts, states, issuers, industry professionals, and family members and caregivers of people living with this disease.”
The 30-day public comment period began on Monday, followed by two hearings seeking a range of views. The agency’s decision will hinge on whether EduHelm’s evidence meets a legal requirement that covered services, medical equipment and drugs are “appropriate and necessary for the diagnosis or treatment of disease or injury.”
Meanwhile, lawmakers have intensified their investigation into the drug’s approval.
Two committees in the House asked Biogen to submit documents on several issues surrounding EduHelm’s development, including unusual liaisons between company officials and FDA regulators.
Biogen and the FDA re-analyzed EduHelm’s data together after the company’s study suggested the drug was ineffective at slowing mental decline. The collaboration eventually led the FDA to grant conditional approval for the drug against the advice of its outside experts.
Specifically, lawmakers asked Biogen to provide details about a company initiative called “Project Onyx, to persuade the FDA to approve EduHelm.”
Last week, the FDA asked the government’s independent watchdog to investigate unusual interactions between some FDA employees and Biogen. This included reports of at least one “off the books” discussion between a Biogen executive and the FDA’s top Alzheimer’s drug reviewer.
Meetings between pharmaceutical industry representatives and the FDA are typically carefully scheduled and documented. The FDA’s acting commissioner, Dr. Janet Wooddock, asked the Inspector General of the Department of Health and Human Services to investigate whether the agency’s dealings with Biogen violated any government regulations.
Another large part of the lawmakers’ request includes documents that describe how Biogen arrived at the drug’s price, estimated at about $56,000 for the typical patient. The drug requires monthly IVs and the dosage is based on the patient’s weight.
The committee’s chairmen noted that a non-profit think tank focused on pricing the drug, based on its unproven benefits, estimated the drug’s true value to be between $3,000 and $8,400 per year.
“While the company claims that the price is ‘reasonable’ and is ‘confirmed by the price it expects to bring,’ an independent analysis determined that the fair value for EduHelm is a small fraction of Biogen’s price.” There will be a little fraction,” committee chairman Rep. Caroline Maloney and Rep. Frank Pallon.
Maloney heads the Committee on Monitoring and Reform, and Pellone heads the Committee on Energy and Commerce.
In the letter, Biogen has been directed to provide the information by July 26.