Cleveland Clinic, Mount Sinai Received’t Give Biogen’s New Alzheimer’s Drug


Two large hospitals refuse to operate

Biogenic Inc.’s

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new Alzheimer’s treatment, Aduhelm, the most recent break that emerged from the controversial approval of the drug by the Food and Drug Administration last month.

The Cleveland Clinic and Mount Sinai Health System in New York said they would not give patients Aduhelm, also called aducanumab, amid a debate about the drug’s effectiveness and whether the FDA lowered its standards for approving the drug .

The hospitals’ move is due to the fact that some health insurances are also restricting access to therapy – an unusual, if by no means universal, resistance to a drug for a devastating disease like Alzheimer’s for which there are few effective treatments.

While some doctors endeavored to prescribe the newly approved drug, others criticized the FDA for clearing the drug before studies showed it worked. Critics also raised concerns about whether the drug’s modest utility in studies is worth the risks of side effects such as cerebral hemorrhage that require regular medical monitoring.

“Clinical studies have failed to prove the effectiveness of Aduhelm … while documenting significant risks such as brain swelling and bleeding,” said a North Carolina spokeswoman for Blue Cross and Blue Shield.

Federal officials recently began a month-long review of whether Medicare covers Aduhelm and under what circumstances. The vast majority of patients expected to receive the drug are on Medicare, the government’s insurance program for the elderly and disabled.

The Cleveland Clinic will not run the drug in its pharmacy or give infusions to patients after a review of the available scientific evidence by a multidisciplinary panel of experts, a hospital spokeswoman said.

Doctors at the Cleveland Clinic, the spokeswoman said, can still prescribe the drug, but patients will have to get their IVs in an off-site facility.

The FDA approved Aduhelm in June based on two large but inconclusive studies.


Jessica Rinaldi / press pool

Aduhelm is given as a monthly infusion, typically in an outpatient medical center. Biogenic the drug cost $ 56,000 a yearalthough one health researcher said it will likely cost more for a typical patient.

“Based on the latest data on safety and efficacy, we have decided not to wear aducanumab at this time,” said the Cleveland Clinic. The hospital announced that it will reconsider the decision as soon as more data is available.

Mount Sinai said it won’t pour in Aduhelm until it sees the results of a U.S. government investigation into the interactions between FDA staff and Biogen during the review process. The investigation, requested last week by Acting FDA Commissioner Janet Woodcock,

has raised concerns about the integrity of the permit process, said Mount Sinai.

“Medical decisions should be based on science and data, so it is disappointing that patients with Alzheimer’s disease reportedly do not have access to Aduhelm in some facilities,” said a Biogen spokeswoman. “Biogen remains 100% behind Aduhelm and the clinical data that supported the approval.”

Jason Karlawish, an Alzheimer’s specialist at the University of Pennsylvania, said the decision of some health systems not to give Aduhelm indicates a loss of confidence in the FDA’s decision-making.

“It is very disturbing that we are starting to hear health systems relying on the FDA to send signals that they do not trust the FDA,” said Dr. Karlawish in an interview. “I have to trust the system that brings drugs to the pharmacy so that I can safely prescribe them.”

The New York Times had previously reported that the two hospital systems would not give Aduhelm to patients.

In June it is FDA approved helmet based on two large but inconclusive studies of its effects in slowing cognitive decline in people with mild Alzheimer’s symptoms.

The agency granted approval using a regulatory mechanism that allows drugs to be approved before they are definitively proven to be effective.

Doctors at Cleveland Clinic can still prescribe Aduhelm, but patients must receive their IV fluids in an off-site facility.


aaron josefczyk / Reuters

The FDA approval was up made about the objections by some of its own statisticians and members of an external committee of experts convened by the agency to discuss the drug. Three of the external consultants resigned in protest of the FDA’s decision.

The FDA then has narrowed its recommendation who should get the drug, to Alzheimer’s patients in the early stages of the disease.

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

Before considering administering the drug, Mount Sinai wants to ascertain the integrity of the agency’s interactions with Biogen and confirm the agency’s expedited approval of Aduhelm, the spokeswoman said.

In addition, the hospital system is waiting for guidelines on “best practices” for Aduhelm to be written by its own experts, as well as a standard review required for Aduhelm to be included in its list of available drugs, the spokeswoman said.

“Only when all of this is certain will we think again,” said the spokeswoman.

Sam Gandy, a Mount Sinai professor of Alzheimer’s research, said he and his colleagues were ready to prescribe Aduhelm to certain patients, even though only one of Biogen’s two clinical studies appeared to show the drug worked.

Dr. Woodcock’s request for an investigation, however, questioned whether the drug had even been adequately evaluated and approved, said Dr. Gandy. In the days that followed, the group decided to wait for the exam to complete before considering IVs.

“I am ready to consider the possibility that the FDA has the leeway for approval [Aduhelm] on this accelerated approval route, but not if I cannot trust the integrity of the process, ”said Dr. Gandy in an interview. “We still want to do what is best for our patients, but we just don’t want to make a decision that we cannot uphold.”

The resistance of some hospitals and insurers to Aduhelm may not affect Biogen, which, according to the analyst project, could eventually generate billions in sales with the drug.

A whole series of “academic medical centers etc. can remain on the sidelines and” [the] Math can still work, “Evercore ISI analyst Umer Raffat said in a research note.

Some skeptical doctors said they would not refuse Aduhelm to interested patients.

Write to Joseph Walker at [email protected]

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