Three major hospitals refuse to administer Biogen Inc.
The Cleveland Clinic, Mount Sinai Health System in New York and Providence in Renton, Wash., Have said they will not give Aduhelm, also known as aducanumab, to patients amid a debate over the drug’s effectiveness and on whether the FDA lowered its standards in approving the drug.
While some doctors were eager to start prescribing the newly approved drug, others criticized the FDA for clearing the drug before studies proved it was effective. Critics have also expressed concerns about whether the drug’s benefits, which appeared modest in studies, are worth the risks of side effects such as brain hemorrhages that require regular monitoring by doctors.
“Clinical studies have failed to demonstrate the effectiveness of Aduhelm … while also documenting significant risks, such as swelling and bleeding in the brain,” said a spokesperson for Blue Cross and Blue Shield of North Carolina , which will not cover the drug for its commercially insured patients.
Federal officials recently began a month-long review to see if Medicare will cover Aduhelm and under what circumstances. The vast majority of patients who should receive the drug benefit from Medicare, the federal insurance program for the elderly and disabled.
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. The hospital said it will reconsider its decision when more data becomes available.
Mount Sinai said he will not infuse Aduhelm until he sees the findings of a US government investigation into interactions between FDA staff and Biogen during the review process. The investigation, which was requested last week by acting FDA commissioner Janet Woodcock, raised concerns about the integrity of the approval process, Mount Sinai said.
“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,” said a spokesperson for Biogen. “Biogen continues to 100% back Aduhelm and the clinical data that supported the approval. “
“We always want to do what’s best for our patients, but we just don’t want to make a decision that we can’t stick to. “
Jason Karlawich, an Alzheimer’s disease specialist at the University of Pennsylvania, said the decision by some health systems not to give Aduhelm suggests an erosion of confidence in FDA decision-making.
“It’s very disturbing that we are starting to hear health systems that depend on the FDA sending signals that they don’t trust the FDA,” Dr. Karlawich said in an interview. “I have to trust the system that puts the drugs in the pharmacy so I can prescribe them with confidence. “
The New York Times reported earlier that the Cleveland Clinic and Mount Sinai 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 agency issued the approval using a regulatory mechanism that allows drugs to be authorized before they are definitively proven effective, saying Aduhelm was reasonably likely to provide benefit by reducing the levels of a sticky protein called amyloid in the brain.
The FDA’s approval came over objections from some of its own statisticians and members of an external expert committee 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.
Dr Woodcock’s request for an investigation last week prompted Mount Sinai not to treat patients with Aduhelm.
A spokeswoman for Mount Sinai said that in addition to completing the investigation, the hospital was awaiting the drafting of “best practice” guidelines for Aduhelm by its own experts, as well as a necessary standard review. to add Aduhelm to its formulary of available medications.
Sam Gandy, Alzheimer’s research professor at Mount Sinai, said he and his colleagues, who set guidelines for Aduhelm, were prepared to prescribe the drug to some patients, although only one of the two studies Biogen clinics appeared to show the drug was working.
Dr Woodcock’s request for an investigation, however, called into question whether the drug was properly evaluated and approved in the first place, Dr Gandy said. Over the next few days, the group decided to wait until the investigation was completed before considering infusions.
“I am prepared to allow the possibility of the FDA having the latitude to approve [Aduhelm] along that fast-track approval path, but not if I can’t trust the integrity of the process, ”Dr Gandy said in an interview. “We always want to do what’s best for our patients, but we just don’t want to make a decision that we can’t stick to. “
Washington neurologist Nancy Isenberg, one of the Providence physicians involved in the decision not to administer Aduhelm, cited the drug’s potential for serious side effects, lack of clear benefits, and high cost as the reasons behind the drug. Politics. Providence, whose system includes 52 hospitals and more than 1,000 outpatient clinics, is also reluctant to prescribe the drug before investigators return the results of an investigation into Aduhelm’s regulatory approval, she said.
“I hope and hope that we can provide safe, effective and affordable treatments” to patients with Alzheimer’s disease, said Dr. Isenberg. “At the same time, that’s not it.
Aduhelm’s resistance to some hospitals and insurers may not affect Biogen, which analysts predict could potentially generate billions of dollars in sales through the drug.
A good number of “university medical centers, etc.” can stay on the sidelines and [the] math can still work, ”said Umer Raffat, Evercore ISI analyst, in a research note.
Some skeptical doctors, he added, said they would not deny Aduhelm to interested patients.
—Melanie Evans contributed to this article.
Write to Joseph Walker at [email protected]
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