Two large medical centres in the US have decided against administering Biogen and Eisai's Alzheimer's disease treatment Aduhelm (aducanumab), the latest blow to the rollout of the anti-amyloid antibody, The New York Times reported. Aduhelm gained accelerated approval from the FDA last month, a decision that has been met with widespread criticism, in part due to concerns over the drug's efficacy, as well as communications between Biogen and agency staff during the review process.
In a statement, the Cleveland Clinic said that a panel of its experts had "reviewed all available scientific evidence" on Aduhelm, adding "based on the current data regarding its safety and efficacy, we have decided not to carry [it] at this time." A spokeswoman for the Cleveland Clinic explained that doctors may prescribe Aduhelm to patients, but they would have to go elsewhere to receive the drug. The Cleveland Clinic added "however...when additional data become available, we will re-evaluate this medication for use in our patients."
Meanwhile, Sam Gandy, director of the Mount Sinai Center for Cognitive Health, noted that "Aduhelm will not be considered for infusion into patients on any of its campuses until and unless" an investigation by the inspector general of the US Department of Health and Human Services (HHS), "affirms the integrity of the FDA-Biogen relationship and goes on to reaffirm" the agency's basis for approving the drug. Shares in Biogen fell on Thursday nearly as much as 8% in reaction to the news.
A spokesperson for Mount Sinai explained that the hospital system is also awaiting the production of "best practices" guidelines for Aduhelm by its own experts, as well as a standard review necessary for adding the drug to its formulary of available medicines. "Only after all these are in place will we reconsider," the spokesperson said, adding "these conditions must be met before we take up the question of infusion on our campuses."
Last week, acting FDA Commissioner Janet Woodcock asked the HSS' Office of Inspector General to open up an independent review "as soon as possible" into communications that took place between representatives of Biogen and FDA staff in the period that led up to the approval of Aduhelm. In addition, a joint congressional probe is examining the approval, as well as the drug's $56,000 annual price tag, while the Centers for Medicare & Medicaid Services (CMS) launched a review process to determine whether Medicare will establish a national coverage policy for monoclonal antibodies targeting amyloid.
While a number of Blue Cross Blue Shield health insurance plans, including those in Michigan, North Carolina and Pennsylvania, have said there is currently insufficient evidence of Aduhelm's benefit, other insurers have indicated that they will wait for the Medicare review to complete before reaching a decision. UnitedHealth Group noted on Thursday that it is still reviewing the drug and awaiting input from Medicare. "This has some way to go before we get to real clarity. So I wouldn't guide you to expect a very rapid decision-making on this piece," UnitedHealth CEO Andrew Witty said.
In addition, Humana indicated that it has not finalised coverage for Aduhelm as it awaits guidance from the CMS. For related analysis, see Physician Views Results – Demand for Biogen’s Aduhelm set to be sky high, and FirstImpact Results – How do 50 US neurologists plan to use Aduhelm?
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