A new position statement , issued by the American Academy of Neurology (AAN), provides guidance for neurologists in counseling patients with Alzheimer’s disease (AD) and their families, about the controversial drug aducanumab.
The document contains ethical considerations as well as recommendations for informed consent. Additionally, the AAN recommends that neurologists ensure that patients understand all of the uncertainties and issues concerning the use of aducanumab.
“Neurologists and other clinicians strive to provide the best possible care to patients and families, particularly for a disease that is as difficult as Alzheimer’s. This statement is meant to be a guideline for clinicians to communicate effectively with patients and their families in order that they can make informed choices about the use of aducanumab.” Winston Chiong, MD, University of California San Francisco Memory and Aging Center and a member of AAN’s Ethics, Law, and Humanities Committee, told Medscape Medical News.
The statement was made public online on on 17 November in Neurology.
Open, Honest Communication
As previously reported Medical News, the US Food and Drug Administration (FDA) approved the anti-amyloid drug, aducanumab, following two studies that were both abandoned prematurely due to ineffectiveness.
In subsequent post-hoc analyses of available data, one of those studies revealed an statistically significant, but small, benefit with high-dose of aducanumab. The other study continued to show no benefits.
The clinical significance of the small statistical benefit in the single trial for daily function isn’t clear and also, the drug was associated with inflammation of the brain and bleeding from the brain in more than one-third of patients who received the FDA-approved dose which requires regular brain MRI monitoring.
The AAN suggests that all of this information is communicated to patients.
Patients should also be aware that while aducanumab reduces beta-amyloid plaques within the brain that are indicative of AD It is not clear whether this provides any meaningful benefit.
The AAN says it’s equally important to tell patients and their families that aducanumab is not able to restore cognitive function and that there is insufficient data to recommend it to patients with moderate or advanced dementia, or to those without evidence of beta-amyloid plaques.
It’s also important to remember that very few participants in the trials of the drug Hispanic, Black or Indigenous.
“Informed consent conversations with patients of groups that are not represented in clinical trials must include a discussion about the lack of efficacy and safety information for these populations,” the authors note.
“New Territory” for Neurologists
“There are two aspects to the drug called aducanumab that are fairly new territory for neurologists.” Chiong told Medscape Medical News.
One is the debate surrounding the evidence supporting the drug. “In the statement, we’ve tried to assist clinicians in communicating the uncertainty surrounding aducanumab’s potential risks and potential benefits of aducanumab,” Chiong said.
The other is the high cost of the drug and how it will be paid for.
Aducanumab costs $56,000 annually. This doesn’t include the cost to infuse the drug, repeat imaging, or medical management.
The AAN estimates that the cost of prescribing aducanumab may top $100,000 per year. Patients and their families should be aware that Medicare covers only 80% of the treatment cost.
“Regarding cost we don’t think about enough about what prescribing a drug affects a particular patient’s financial situation and for the health system,” said Chiong.
“In particular patients on Medicare may believe that their healthcare expenses will be sufficient to be covered. But, because aducanumab’s cost is so high, it’s likely that individual patients will have to pay very substantial costs.” Chiong stated.
In a press release, AAN President Orly Avitzur, MD, said, “It is easy to see why a brand new Alzheimer’s disease treatment is so popular and excitement, as even though its approval has been a source of controversy however, it provides some hope for patients and their families.”
“By using ethical principles to create this position statement, the American Academy of Neurology aims to assist neurologists and other doctors effectively counsel patients and their families with a goal of providing the highest quality patient-centered care,” Avitzur said.
The Ethics Humanities Committee, Law and Humanities is a joint committee of the AAN, American Neurological Association, and Child Neurology Society, approved this statement.
This study did not receive targeted funding. Chiong received compensation for his work on the Neuroethics Work Group of the National Institutes of Health BRAIN Initiative. His institution also received research funding from National Institutes of Health. A complete list of author disclosures can be found in the original article.
Neurology. Published online November 17 2021. Full text
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