Mass General Brigham is the latest big-name health system to announce it will not be treating its patients with Biogen’s Aduhelm, the controversial Alzheimer’s disease drug cleared by the Food and Drug Administration in June.
“Like all other drugs used within Mass General Brigham,” the treatment was evaluated on a clinical, economic and operational basis by a multidisciplinary internal panel, the system wrote in an online statement.
“This decision was based on the current data regarding aducanumab’s safety and efficacy,” the system wrote. “We understand that this may be difficult news for some of our patients. However, we fully support continued evaluation of this medication and should new data become available we will re-evaluate this decision.”
In a statement, Biogen said it was "disappointing" that the health system had "chosen to deny patients" the choice to receive an FDA-approved treatment that is currently "the only Alzheimer's disease treatment that addresses a defining pathology of the disease."
"Biogen will continue to advocate on behalf of patients and support access to Aduhelm for all appropriate patients," the drugmaker said in the statement. "If any patient is denied access to care, we encourage them to contact us for assistance."
Mass General Brigham’s decision follows similar calls from Cleveland Clinic and Mount Sinai, which announced as early as July that it would not be prescribing Aduhelm to their patients.
The Cleveland Clinic said at the time that it was concerned about the drug’s safety and efficacy, noting that physicians could still prescribe Aduhelm to patients but that it would need to be administered elsewhere.
Mount Sinai’s decision was spurred by the FDA’s decision to probe interactions between agency staff and the drug’s manufacturer Biogen, the system said at the time. The outside scrutiny has only amplified since then, with two House committee chairs demanding earlier this month that the regulator produce additional information justifying its accelerated approval.
Blues plans and the Department of Veterans Affairs have also said they would not be including the treatment on their formularies, citing efficacy concerns and a “risk of significant adverse drug events.”
Biogen’s Aduhelm comes with an eyebrow-raising price tag of $56,000 per year, which has raised concerns among experts who noted that the cost could strain Medicare’s budget.