NAA issues ethical guidelines on controversial Alzheimer’s drug

A recently released position statement from the American Academy of Neurology (AAN) provides guidance for neurologists to counsel patients with Alzheimer’s disease (AD) and their families about the controversial drug aducanumab (Aduhelm)

The statement includes ethical considerations and recommendations for informed consent, and the AAN notes that neurologists must ensure that patients understand all of the issues and uncertainties surrounding aducanumab use.

Dr Winston Chiong

“Neurologists and other clinicians want to provide the best care for patients and families, especially for a disease as difficult as Alzheimer’s disease. We hope that this statement can be a guide for clinicians in communicating with patients and families to carefully review decisions. on the use of aducanumab, ”said Winston Chiong, MD, PhD, Center for Memory and Aging, University of California, San Francisco and member of the Ethics, Law and Humanities Committee of the AAN. Medscape Medical News.

The statement was posted online on November 17 in Neurology.

Open and honest communication

As stated previously Medical News, the United States Food and Drug Administration (FDA) approved aducanumab, an anti-amyloid agent, based on two studies that were both terminated prematurely due to futility.

In subsequent post-hoc analyzes of the available data, one of these studies indicated a statistically significant, albeit small, benefit with high-dose aducanumab, while the other study continued to show no benefit.

The clinical significance of the low statistical benefit in the single trial for daily function is unclear, and aducanumab has also been associated with brain inflammation and bleeding in more than a third of patients who received the FDA-approved dose, which requires regular brain MRI monitoring. .

All of this should be communicated to patients, advises the AAN.

Patients should also be aware that although aducanumab reduces beta-amyloid plaques in the brain that are markers of AD, it is not clear whether this offers a significant benefit.

ANA Adds Equally Important To Tell Patients And Families That Aducanumab Does Not Restore Cognitive Function And There Is Not Enough Data To Offer It To People With Moderate Dementia or advanced or those without signs of beta-amyloid plaques.

It is also important to note that very few participants in the aducanumab trials were Hispanic, black, or Aboriginal.

“Informed consent conversations with patients from under-represented populations in clinical trials should include disclosure of the lack of safety and efficacy data in these groups,” the authors note.

“New territory” for neurologists

“There are two aspects of aducanumab that are relatively new territory for us as neurologists,” Chiong said. Medscape Medical News.

One is the controversy over the evidence for the drug. “In the statement, we tried to help clinicians communicate uncertainty about the potential risks and benefits of aducanumab,” Chiong said.

The other is the high cost of the drug and how it will be covered.

Aducanumab is priced at $ 56,000 per year, which does not include the cost of the drug infusion, required repeated imaging, and medical management.

The AAN estimates that the annual costs of prescribing aducanumab can exceed $ 100,000 per year. With Medicare typically covering 80%, patients and families should be made aware that the full costs of treatment may not be covered.

“When it comes to cost, we probably don’t think often enough about what prescribing a drug means for a patient’s finances and for the healthcare system,” said Chiong.

“In particular, when patients are on Medicare, we can assume that their health care costs will be sufficiently covered, but since aducanumab is so expensive, its use is likely to impose very significant costs on individual patients as well as on the patient. Medicare program, ”Chiong said.

In a press release, AAN President Orly Avitzur, MD, said: “It is understandable that a new drug for Alzheimer’s disease has generated so much interest, because although its approval has been controversial , it always offers a glimmer of hope for patients and their families. . “

“Using ethical principles to create this position statement, the American Academy of Neurology aims to help neurologists and other physicians transparently counsel patients and their families with the goal of providing the highest quality care centered on the patient, ”Avitzur said.

This statement has been endorsed by the Committee on Ethics, Law, and the Humanities, a joint committee of the AAN, the American Neurological Association, and the Child Neurology Society.

This research did not have targeted funding. Chiong received personal compensation for serving on the Neuroethics Working Group of the National Institutes of Health BRAIN Initiative, and his institution received research support from the National Institutes of Health. A complete list of author disclosures is available with the original article.

Neurology. Published online November 17, 2021. Full text

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