Two of the largest health systems in the country — Cleveland Clinic and New York City-based Mount Sinai — have refused to administer Biogen's much-debated Alzheimer's drug aducanumab.
Aducanumab, branded as Aduhelm, was cleared by the FDA June 7 using the agency's accelerated approval pathway, marking the first Alzheimer's drug approved by the agency in two decades. The drug is the first treatment approved by the FDA intended to slow cognitive decline from Alzheimer's. The Alzheimer's drugs the FDA previously cleared are aimed at alleviating symptoms rather than slowing the disease's progression.
The approval sparked an intense debate in the pharmaceutical and medical communities, with critics saying there was not enough evidence of clinical benefits to warrant an approval. Three members of the FDA's advisory committee resigned over the approval, and two House committees are investigating the drug's pricing and approval. On July 9, Janet Woodcock, MD, the FDA's acting commissioner, requested the HHS' Office of Inspector General conduct an independent review of the approval.
Two major health systems' rejection of Aduhelm is the latest public display of doubt about the drug.
"A multidisciplinary panel of Cleveland Clinic experts have reviewed all available scientific evidence on this medication," the health system said in a July 15 statement provided to Becker's. "Based on the current data regarding its safety and efficacy, we have decided not to carry aducanumab at this time. However, we support continued research in this area, and when additional data become available, we will re-evaluate this medication for use in our patients."
Cleveland Clinic physicians can still prescribe the drug, but patients will have to go somewhere else to receive it, the system told The New York Times.
Mount Sinai's Aduhelm strategy is focused on three main areas, a spokesperson for the health system told Becker’s.
A group of Mount Sinai Alzheimer’s experts are writing best practices for the drug, and another working group is developing formulary addition protocols. The system is also waiting for the outcome of the ongoing investigations into the drug’s approval.
"The FDA’s approval of Aduhelm has raised serious concerns and questions by clinicians, patients and caregivers, and a cautious approach is required," Mount Sinai said. "Mount Sinai Health System will not administer Aduhelm until the outcome of the FDA Inspector General’s investigation of Biogen is complete. Depending on this outcome, if appropriate, our experts will follow formulary addition protocols and consider best practices for Aduhelm to inform clinical practice."