Cleveland Clinic and Mount Sinai to Not Give Biogen’s New Alzheimer’s Drug

The Cleveland Clinic will not transport the drug to its pharmacy or provide infusions to patients after a review of the available scientific evidence by a multidisciplinary panel of experts, a spokesperson for the hospital said.

Doctors at the Cleveland Clinic, the spokesperson said, can still prescribe the drug, but patients will need to receive their infusions at an outside facility.

Aduhelm is given as a monthly infusion, usually in an outpatient medical center. Biogen priced the drug at $ 56,000 per year, although a health researcher said it would likely cost more for a typical patient.

“Based on the current data regarding its safety and effectiveness, we have decided not to offer aducanumab at this time,” the Cleveland Clinic said. “However, we support further research in this area, and when more data becomes available, we will re-evaluate this drug for use in our patients.”

A spokesperson for Biogen said patients who have been denied access to Aduhelm should contact Biogen for help.

“Medical decisions should be based on science and data, so it is disappointing that patients living with Alzheimer’s disease cannot access Aduhelm at some facilities,” the spokesperson said. “Biogen continues to 100% back Aduhelm and the clinical data that supported the approval. “

The New York Times reported earlier that hospital systems were not going to administer Aduhelm to patients.

In June, the FDA approved Aduhelm based on two large but inconclusive studies on its effect on slowing cognitive decline in people with mild symptoms of Alzheimer’s disease.

The FDA granted the approval using a regulatory mechanism that allows drugs to be authorized before they are definitively proven effective, claiming that the drug was reasonably likely to provide benefit by reducing levels of a protein. sticky called amyloid of the brain.

The FDA’s approval came over objections from some of its own statisticians and members of an external expert panel convened by the agency to provide advice on the drug. Three of the outside advisers resigned from the committee to protest the FDA’s decision.

The FDA subsequently restricted its recommendation for who should get the drug to patients with early-stage Alzheimer’s disease.

Acting FDA Commissioner Janet Woodcock earlier this month called for an investigation by an internal government oversight agency into interactions between FDA staff and Biogen during the review process leading to approval. and whether there had been any communications inconsistent with FDA policies.

A spokeswoman for Mount Sinai said the hospital system will not infuse Aduhelm while its experts continue to deliberate on the drug and await the findings of the government investigation into the FDA’s interactions with Biogen.

Before Mount Sinai reconsiders the administration of the drug, he wants to be assured that the investigation confirms the integrity of the agency’s interactions with Biogen and that the agency’s expedited approval of Aduhelm be reaffirmed, a declared the spokesperson.

In addition, the hospital system is awaiting the drafting of “best practice” guidelines for Aduhelm by its own experts, as well as a standard review needed to add Aduhelm to its formulary of available drugs, the spokesperson said.

“It is only after all of this is in place that we will reconsider,” the spokeswoman said. “These conditions must be met before we address the issue of infusion on our campuses.”

Write to Joseph Walker at [email protected]