In a new statement from the American Academy of Neurology, researchers suggest that neurologists must make sure Alzheimer’s patients and their families understand that the controversial drug aducanumab does not restore mental function.
The U.S. Food and Drug Administration approved aducanumab(brand name: Aduhelm) based on two studies that were both stopped early because the drug showed no benefits for patients.
The statement explained that a later analysis of data from one of those studies suggested a small benefit, while the other still showed no benefit.
The statement noted that while aducanumab reduces the beta-amyloid plaques in the brain that are markers of Alzheimer’s, it’s unclear whether that provides any meaningful benefits to patients.
There isn’t sufficient evidence to offer the drug to patients with moderate or advanced dementia, or to those without evidence of beta-amyloid in the brain.
It also said the drug carries a risk of brain inflammation and brain bleeds, which occurred in a third of patients in the studies who received the dose approved by the FDA.
The statement said neurologists must inform patients and families about the drug’s potential risks and the need for more frequent monitoring with MRI scans.
Another issue is the lack of racial and ethnic diversity in the clinical trials of aducanumab.
Patients in racial and ethnic minorities need to be told about the lack of safety and effectiveness data for them.
In addition, it warned that pricing and insurance coverage of the drug may cause financial harm to patients and their families.
Aducanumab is priced at $56,000 a year. But the costs of infusing the drug, repeated imaging and medical management may push annual costs to more than $100,000.
Medicare generally covers 80%, so patients and families must be told that the full cost of treatment may not be covered, the statement advised.
The statement said another concern is that availability of aducanumab may lead to lower patient enrollment in clinical trials of more effective treatments.
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The study is published in Neurology. One author of the study is Dr. Winston Chiong.
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