Updated: 5:08 p.m., Thursday, July 15, 2021
The Alzheimer’s Association, a national organization focused on Alzheimer’s and dementia care and research, is criticizing Cleveland Clinic’s decision not to offer a controversial new Alzheimer’s drug to its patients.
The treatment, Aduhelm, was granted accelerated approval by the Food and Drug Administration (FDA) in June, but some health experts claimed there was not enough clinical evidence that the drug was effective. Aduhelm, also known by its generic name aducanumab, is the first Alzheimer’s therapy approved for use in nearly 20 years.
Cleveland Clinic announced Thursday it agrees with that assessment and that it will not offer the drug to patients.
“Based on the current data regarding its safety and efficacy, we have decided not to carry Aducanumab at this time,” Cleveland Clinic officials said in a statement.
The hospital system will re-evaluate its decision if additional data become available after continued research of the drug, according to the statement.
“We were surprised and disappointed by the hesitancy of Cleveland Clinic to provide patients that access to treatment,” said Kristen Clifford, chief program officer at the Alzheimer’s Association.
Cleveland Clinic officials told Ideastream Public Media that physicians can still prescribe the drug, but patients would have to receive the treatment at a different facility. Clifford disagrees with that decision.
“Not being able to receive treatment at the institution does create a potential access barrier,” Clifford said. “We want to try to address and eliminate those barriers as much as possible so those who could benefit from the treatment have the opportunity to do so.”
Aduhelm removes plaque buildup on an Alzheimer’s patient’s brain, which is thought to help slow down the memory loss process. However, experts have not concluded the treatment is effective, and two different studies had conflicting findings.
An advisory panel did not recommend authorization of the drug for that reason, but the FDA still approved it.
One month later, the FDA then issued updated guidance, clarifying that Aduhelm should only be prescribed in patients in the disease stage studied in the clinical trials: people who have mild cognitive impairment (MCI) or mild dementia.
The national Alzheimer’s Association applauded this clarification, Clifford said.
“We appreciate the FDA’s thoughtful consideration and response to the Alzheimer’s Association and others in the community including physicians, researchers and patients to ensure this treatment is prescribed only to those who may see benefit," Maria C. Carrillo, Alzheimer’s Association chief science officer, said in a statement.
Scientists within the Alzheimer’s Association have reviewed the clinical trial data, Clifford added, and support the authorization of the drug because it could be effective for some patients. There is currently no other treatment that addresses the underlying biology of the disease, she said.
“There is a dire and drastic need for this community for relief and support,” Clifford said. “We believe based on the totality of the science that it should have been approved, also given that unmet need and the devastating toll of the disease.”
Clifford added that she supports additional research into the drug, and her organization is also lobbying the drug’s maker, Biogen, to decrease the price of the drug, which has been set at $56,000 a year.
“We remain outraged. We think the price is simply unacceptable,” she said.
As part of the FDA's accelerated approval, Biogen must conduct another trial, even though the drug is already on the market.
Read the full statement from Cleveland Clinic below:
“A multidisciplinary panel of Cleveland Clinic experts have reviewed all available scientific evidence on this medication. Based on the current data regarding its safety and efficacy, we have decided not to carry Aducanumab at this time. 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.”
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