The FDA’s approval of aducanumab has given Alzheimer’s physicians a new treatment option, but little guidance on how to put it into practice. Clinicians are debating issues such as when to prescribe, who qualifies, and how to ramp up capacity (see Part 3 of this story). They also have to figure out how to communicate the potential risks and benefits to patients and their families, and how long to keep patients on drug. Biogen’s post-market study may answer these questions, but the nine-year timeframe means this is no help for clinicians now. Around the world, physicians are preparing to enter a challenging new phase of Alzheimer’s care.
- Clinicians say they will offer aducanumab to patients despite doubts.
- One quandary is when to stop treatment.
- Other countries are closely watching developments in the U.S.
To Prescribe or Not to Prescribe?
Beyond the logistical challenges of bringing monthly infusions into clinical practice lie ethical ones. Some clinicians doubt the value of aducanumab for their patients. Nonetheless, all clinicians Alzforum contacted said they would offer their patients the option to take it. “I believe that patients and families have a right to this treatment now that it is approved, and also that they should receive accurate information from knowledgeable providers about the risks and benefits to help their decision-making,” Suzanne Craft at Wake Forest School of Medicine in Winston Salem, North Carolina, wrote to Alzforum (full comment below).
Even outspoken critics of the FDA approval are taking this approach. David Knopman at the Mayo Clinic in Rochester, Minnesota, who had urged the FDA to demand a confirmatory trial before approving, told Alzforum, “If my patients and their families express interest, I will discuss the pros and cons with them.” Ditto for the National Institute on Aging’s Madhav Thambisetty, who as a fellow AdComs member had advised against approval but more recently wrote about his first physician consult discussing aducanumab with a son and his dad, whose disease was likely too advanced to benefit from the treatment.
Jason Karlawish at the University of Pennsylvania, Philadelphia, described his reluctance to prescribe aducanumab in an editorial prior to June 7. The approval is now forcing his hand because he also believes in respecting an Alzheimer’s patients’ autonomy. “After discussion with a patient and family about this drug, if they want to take it, I’ll prescribe it,” Karlawish told Alzforum. He noted that the clinical conversation would be quite unusual. “In clinical practice we don’t routinely begin with the point that the drug may not have a benefit,” Karlawish said.
Read the full article on the Alz Forum Website – https://www.alzforum.org/news/research-news/little-data-go-clinicians-are-left-figure-out-way-forward#comment-41416