Things are looking bleak for Aduhelm

It's now almost five months since Aduhelm was conditionally approved by the FDA.  Considering how many people in the United States are afflicted by the disease, are patients flocking to it?  Hardly.  Insurance companies are balking at paying the very high price (low to mid $50k/yr, depending on various factors, but not including the cost of regular MRIs), some hospitals are balking at providing it, and both the Senate and House are investigating what it means for the future of Medicare solvency.  So very few people are receiving Aduhelm.

But that's no all.  The Sept 9 issue of JAMA (formerly the Journal of the American Medical Association) carried a letter by Dr. Timothy S. Anderson, an assistant professor of medicine at Boston's Beth Israel Medial Center, claiming that the population on which the treatment was tested is substantially different from the population for which it has been approved.  What's that about?

During the small, phase 1 trial of aducanumab, researchers noted that the treatment caused microhemorrhaging of the brain in some patients.  (You will know this if you read Beating the Dementia Monster.)  This was not believed to be a great risk but still increased the risk to the patient.  Therefore, the criteria for accepting participants in the phase 3 trial were designed to exclude people with a higher risk of more serious adverse consequences from microhemorrhages.  These criteria included cardiovascular disease, prior stroke, and use of blood thinners.  This was obviously done for the safety of the trial participants.  But how did this decision affect the trial results?  

Well, guess what.  An estimated 92 per cent of Medicare patients with cognitive decline would have been excluded by these criteria.  But they are not explicitly excluded from the population for whom the treatment has been approved.  This suggests that the treatment may not have been tested on a population representing ninety per cent or more of people who might receive the treatment.

Opposition to the administration of Aduhelm is growing as noted in this story from the Boston Globe.  In fact, one chain of clinics in Washington DC has banned representatives from Biogen from even setting foot on their property!  Clinics everywhere, as a minimum, are significantly restricting the patients to whom they will administer Aduhelm.  

Philip Scheltens at VU University, Amsterdam, expressed concern that many physicians may not be properly equipped to recognize when someone is or is not an appropriate candidate for Aduhelm treatments.  He noted, “With Aduhelm and others to follow later, we have entered a new era in which treating AD patients becomes more of a precision-medicine approach, in the hands of specialists only.”

But interest in the treatment by desperate Alzheimer's patients is high.  Clinics have begun to emerge simply to provide Aduhelm treatments.  While many clinics and hospitals are reluctant to provide infusion services, and it's not clear that insurance companies are covering it, some believe that, over time, the treatment will be better accepted and funded.