AAN: Neurologists must discuss Aduhelm risks with patients, families
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The American Academy of Neurology has issued ethical guidance on Aduhelm that outlines important points for neurologists to communicate to patients eligible for the treatment.
The academy published these considerations in a position statement in Neurology.
“[Aduhelm (aducanumab, Biogen/Eisai)] is not a cure for Alzheimer’s disease, yet since it has been approved by the FDA, patients are asking their doctors if this is an option for them,” position statement author Winston Chiong, MD, PhD, of the University of California San Francisco and a member of the AAN’s Ethics, Law and Humanities Committee, said in a press release. “This is a high-cost drug that was approved by the FDA without convincing evidence of benefits and with known harms, so the purpose of this position statement is to offer ethical guidance on how neurologists can help patients make informed decisions about this treatment.”
Chiong and colleagues noted that the FDA approved Aduhelm based on two studies that were ended early for showing lack of benefits for participants. A later data analysis revealed one of those studies showed a small benefit but the other continued to show no benefit. Although Aduhelm reduces beta-amyloid plaques that signal AD in the brain, it is still unclear whether reduction of these plaques offers patients any significant benefits, the authors noted.
Further, they emphasized the importance of clinicians communicating to patients that the drug does not restore cognitive function and highlighted the “insufficient grounds” to warrant offering it to patients with moderate or advanced dementia or to those without evidence of beta-amyloid presence.
“It is understandable why a new drug for Alzheimer’s disease generates so much interest, because while its approval has been controversial, it still offers a glimmer of hope to patients and their families,” Orly Avitzur, MD, MBA, FAAN, president of the AAN, said in the release. “By using ethical principles to create this position statement, [AAN] aims to help neurologists and other physicians transparently counsel patients and their families with a goal of providing the highest quality patient-centered care.”
According to Chiong and colleagues, Aduhelm poses risks related to brain inflammation, or amyloid-related imaging abnormalities, including brain bleeds. The two studies showed Aduhelm use correlated with brain inflammation and bleeds among one-third of patients who received the FDA-approved dose. Neurologists “must communicate” risks for adverse effects and about the necessity of more frequent monitoring with MRI scans, according to the statement. Further, the clinical trials for Aduhelm lacked racial and ethnic diversity, which raises a significant ethical concern related to depriving individuals from underrepresented groups of relevant information on the benefits and harms of the drug for their racial or ethnic groups. Chiong and colleagues emphasized the importance of telling these patients about the lack of safety and efficacy data for these groups.
Pricing and coverage of Aduhelm may lead to financial harm to patients taking the drug, depending on how Medicare handles individual patient costs, the authors noted. The drug costs $56,000 per year, which does not include costs of infusion, repeated imaging and medical management. The authors estimated that annual costs could exceed $100,000 per year, and because Medicare typically covers 80% of the cost, patients and families should be made aware that total treatment costs may not be covered.
“While many hope that [Aduhelm’s] approval will lead to better treatments in the future, there are also grounds to worry that its availability will hinder enrollment in clinical trials of more effective interventions,” Chiong and colleagues wrote. “In the interim, neurologists, patients and families will face ethical challenges given the incomplete data available to guide aducanumab prescribing, the prospect of worrisome financial conflicts of interest, and the costs and practical burdens that using aducanumab will impose on patients and families.
“Neurologists facing these challenges will be guided best by established ethical principles that they can apply, in turn, to transparently counsel patients and their families,” they added.
Reference:
AAN issues ethical guidance on aducanumab. https://www.aan.com/PressRoom/Home/PressRelease/4937. Published Nov. 17, 2021. Accessed Nov. 18, 2021.
Perspective
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This ethical guidance is important because Aduhelm’s approval doesn’t just raise regulatory and clinical concerns, it raises ethical concerns. Some clinicians have advocated that an “informed consent” approach overlooks the fact that this isn’t just about information delivery, it is about what inevitably should be a shared decision among patients, their loved ones and providers. There is no decision that is as clinically and ethically fraught as this that shouldn’t be shared among these parties.
As the position statement notes, Aduhelm’s approval means that clinicians, patients and their loved ones have no choice but to navigate these uncertain waters together.
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