Cleveland Clinic, Mount Sinai not administering new Alzheimer’s drug

The Cleveland Clinic and the Mount Sinai Health System, two major health systems in the U.S., have decided they would not administer Biogen’s new Alzheimer’s drug following the Food and Drug Administration’s (FDA) controversial approval. 

The Cleveland Clinic issued a statement on Wednesday saying its panel of experts decided against carrying the drug Aduhelm, also called aducanumab, after having “reviewed all available scientific evidence.”

“Based on the current data regarding its safety and efficacy, we have decided not to carry Aducanumab at this time,” the statement reads. “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.”

A spokesperson for the Cleveland Clinic clarified to The Hill that individual physicians will be allowed to prescribe Aduhelm. But patients would need to have the drug administered intravenously monthly from a different health provider.

Mount Sinai also released a statement saying Aduhelm will not be given out within the health system until the inspector general for the Department of Health and Human Services finishes its investigation of the FDA approval.

“The FDA’s approval of Aduhelm has raised serious concerns and questions by clinicians, patients, and caregivers and a cautious approach is required,” the statement said.

“Depending on this outcome, if appropriate, our experts will follow formulary addition protocols and consider best practices for Aduhelm to inform clinical practice,” it added. 

The systems’ refusal to give out Aduhelm comes after the FDA approved the drug to treat Alzheimer’s last month, despite the agency’s advisory committee overwhelmingly recommending to reject authorization. Three members of that committee resigned following the FDA’s approval of the drug that’s priced at $56,000 per year.

As the first approved drug to treat Alzheimer’s since 2003, Aduhelm aims to remove plaque from the brains of patients.

FDA officials have recognized that Aduhelm did not clearly show that it slowed the disease’s progression in clinical trials. But they said the reduction of plaques leads the drug to be “reasonably likely” to help patients and has the potential to limit cognitive decline. 

Several experts have in turn questioned the drug’s effectiveness in treating Alzheimer’s patients. Most respondents in a survey by Stat and Medscape of almost 200 neurologists and primary care doctors came out against the FDA’s authorization. 

Stat also reported last month that Biogen worked in “a secret campaign” to convince the FDA to back its drug. 

Following the criticism and Stat’s reporting, acting FDA Administrator Janet Woodcock requested a federal investigation into the agency’s authorization of Aduhelm last week. 

The House Energy and Commerce and Oversight and Reform committees both launched investigations into the drug’s FDA approval.

Last week, the FDA also narrowed Aduhelm’s intended use, saying it should only be given to patients with mild Alzheimer’s dementia or mild cognitive impairment. 

–Updated at 12:22 p.m.