Major hospital systems Cleveland Clinic and Mount Sinai will not prescribe the pricey and controversial Alzheimer’s drug Aduhelm (aducanumab) due to concerns over its efficacy and safety, the New York Times reported.
The decision by the two systems is the latest controversy surrounding the drug that was granted accelerated approval by the Food and Drug Administration last month. Experts have been concerned about the drug’s high price tag of $56,000 a year and potentially minimal benefits for Alzheimer’s disease patients.
Cleveland Clinic told the Times that it was concerned about the safety and efficacy of the drug, which targets amyloid plaques that may progress Alzheimer’s disease.
The system added that physicians could still prescribe Aduhelm to patients, but they will have to go elsewhere to get the drug administered intravenously.
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Mount Sinai will also not prescribe the controversial drug. An official from the system told the Times that the decision was spurred by the FDA’s decision to probe interactions between agency staff and the drug’s manufacturer Biogen.
Cleveland Clinic and Mount Sinai did not immediately return a request for comment on the decisions.
The decisions by two of the largest hospital systems in the U.S. marks the latest controversy stemming from the FDA’s accelerated approval.
The agency also narrowed the label for Aduhelm so that it can only be prescribed for patients with a milder form of Alzheimer’s.
Aduhelm’s price tag of $56,000 a year has also been concerning to experts, noting that it could strain Medicare’s budget. The Centers for Medicare & Medicaid Services announced earlier this week that it is starting the process to determine national Medicare coverage of the drug.