Two large hospitals have decided against administering Aduhelm for patients following the FDA’s approval of the new Alzheimer’s drug in June.
After the Food and Drug Administration’s (FDA) controversial approval of Aduhelm (aducanumab), two major U.S. healthcare providers say they will not administer the new Alzheimer’s drug to patients.
Following a review of the scientific evidence by a panel of experts at the Cleveland Clinic, the medical center said it won’t be infusing Aduhelm for patients. Cleveland Clinic’s doctors can still prescribe the drug, The New York Times reports, and if prescribed, patients will have to receive monthly infusions of the drug elsewhere.
“Based on the current data regarding its safety and efficacy, we have decided not to carry aducanumab at this time,” Cleveland Clinic’s spokesperson wrote in a statement to Being Patient. “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.”
The Mount Sinai Health System has also decided not to infuse patients with Aduhelm for the time being. “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’s spokesperson wrote in a statement to Being Patient.
The healthcare providers’ decisions come at the heels of a host of controversies surrounding Aduhelm. While some experts have praised the FDA’s accelerated approval of Aduhelm, others have criticized its decision after overwhelming objection from an independent advisory committee. Three of its members later resigned in protest against Aduhelm’s approval.
The FDA’s accelerated approval is a mechanism intended to offer earlier access to drugs for serious diseases, allowing drugs to be green lit when uncertainties remain about their efficacy. In Aduhelm’s case, the agency determined that the drug’s effect on amyloid plaques “is reasonably likely to predict a clinical benefit to patients” and required the drugmaker Biogen to carry out a Phase 4 confirmatory trial. The company has until 2029 to finish that study.
While the anti-amyloid drug is proven to be effective at clearing the hallmark of Alzheimer’s known as amyloid plaques, clinicians say the resulting benefits for patients remain unclear, given the conflicting evidence from its two Phase 3 clinical trials. Even if Aduhelm can slow patients’ decline, experts say the effect is likely modest, and whether or not this justifies the risks and the exorbitant price of Aduhelm treatment remains an open question.
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In response to the decisions from the Cleveland Clinic and Mount Sinai, Biogen’s spokesperson wrote in a statement to Being Patient that it “continues to stand 100% behind Aduhelm and the clinical data that supported approval. If any patient is denied access to care, we encourage them to contact us for help as we remain committed to supporting access to Aduhelm for all appropriate patients.”
Acting FDA Commissioner Dr. Janet Woodcock stated in an interview with STAT News on July 14, 2021 that “the accelerated approval was based on very solid grounds.” She added, “I do believe that will play out over time as people see that was a very appropriate use of that authority, and the right thing to do for patients. Now, was the process done exactly the best that it could be? Possibly not.”
Given the concerns about the integrity of the approval process, Woodcock requested on July 9, 2021 the Office of Inspector General at the Department of Health & Human Services to investigate the interactions between officials from Biogen and the FDA. Dr. Sam Gandy, director of the Mount Sinai Center for Cognitive Health, told The New York Times that Mount Sinai will not consider infusing Aduhelm for patients unless the investigation “affirms the integrity of the FDA-Biogen relationship and goes on to reaffirm” the FDA’s basis for approving the drug.
Meanwhile, at least a half-a-dozen private health insurers say they will not cover Aduhelm because they consider it “investigational,” “experimental,” or because “a clinical benefit has not been established,” according to the Boston Globe. Biogen responded to the news to Being Patient, writing “we are disappointed that this inaccurate characterization is leading some commercial plans to temporarily deny patients access to Aduhelm — however, these plans represent a very small portion of the potential patient population.”
The announcements by private insurers come at a time when the Centers for Medicare and Medicaid Services (CMS) is asking the public to weigh in while it determines whether it will establish a national coverage policy for Aduhelm.