A newly released position statement from the American Academy of Neurology (AAN) provides guidance to neurologists about counseling 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 should ensure that patients understand all of the issues and uncertainties surrounding the use of aducanumab.
“Neurologists and other clinicians want to provide the best care to patients and families, particularly for a disease that is as challenging as Alzheimer’s. We hope that this statement can be a guide for clinicians in communicating with patients and families in order to carefully consider decisions about the use of aducanumab,” Winston Chiong, MD, PhD, University of California San Francisco Memory and Aging Center and a member of the AAN’s Ethics, Law and Humanities Committee, told Medscape Medical News.
The statement was published online November 17 in Neurology.
Open, Honest Communication
As previously reported Medical News, the US Food and Drug Administration (FDA) approved the anti-amyloid agent aducanumab based on two studies that were both stopped prematurely for futility.
In subsequent post-hoc analyses of the available data, one of those studies indicated a statistically significant, albeit small, benefit with high-dose aducanumab, while the other study continued to show no benefit.
The clinical importance of the small statistical benefit in the single trial for daily function is unclear, and aducanumab was also associated with brain inflammation and brain bleeds in more than one third of patients who received the FDA-approved dose, which requires regular brain MRI monitoring.
All of this should be communicated to patients, the AAN advises.
Patients should also know that while aducanumab reduces beta-amyloid plaques in the brain that are markers of AD, it remains unclear whether this provides any meaningful benefit.
The AAN adds it’s equally important to tell patients and families that aducanumab does not restore cognitive function and that there is insufficient data to offer it to people with moderate or advanced dementia or to those without evidence of beta-amyloid plaques.
It’s also important to note that very few participants in the aducanumab trials were Hispanic, Black or Indigenous.
“Informed consent conversations with patients of populations underrepresented in clinical trials should include disclosure about the absence 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 told Medscape Medical News.
One is the controversy about the evidence for the drug. “In the statement, we’ve tried to help clinicians communicate the uncertainty over aducanumab’s risks and potential benefits,” Chiong said.
The other is the high cost of the drug and how it will be covered.
Aducanumab has a price tag of $56,000 a year, which does not include the cost of infusing the drug, required repeat imaging, and medical management.
The AAN estimates annual costs of prescribing aducanumab may top $100,000 per year. With Medicare generally covering 80%, patients and families must be told that the full costs of treatment may not be covered.
“Regarding cost, we probably don’t think often enough about what prescribing a drug means for an individual patient’s finances and for the health system,” said Chiong.
“In particular, when patients are in Medicare we might assume their healthcare costs will be sufficiently covered, but because aducanumab is so expensive its use is likely to impose very significant costs on individual patients as well as to the Medicare program,” Chiong said.
In a news release, AAN President Orly Avitzur, MD, said, “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.”
“By 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 a goal of providing the highest quality patient-centered care,” Avitzur said.
This statement was approved by the Ethics, Law, and Humanities Committee, a joint committee of the AAN, American Neurological Association, and Child Neurology Society.
This research had no targeted funding. Chiong has received personal compensation for serving on the Neuroethics Working Group of the National Institutes of Health BRAIN Initiative, and his institution has 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