Aduhelm

I’ve posted about this monoclonal antibody treatment for Alzheimer’s disease before; I’m a retired geriatrician, after all. Tonight, I submitted my comment regarding this treatment to CMS (Centers for Medicaid and Medicare Services). Tomorrow is the deadline for public comments regarding the manufacturer’s appeal for unlimited approval of the drug. As it stands today, the drug has been approved by Medicare for use in Alzheimer’s Disease patients who are part of a study protocol. My comments appear below.

I submit this comment regarding Aduhelm as a retired Internist/Geriatrician and former medical director of Managed Care Medicaid and Medicare Advantage plans in Austin, Corpus Christi and Houston, Texas. I commend CMS for providing an approval pathway for this treatment that allows for further research and study. It is clear to me that the data submitted by its manufacturer, Biogen, do not persuasively demonstrate that this monoclonal antibody treatment delays disease progression, reverses loss of cognitive abilities, or improves executive function.

Until there is clinical trial evidence that shows that biological endpoints like these are actually achieved, drugs like Aduhelm are promising but not proven. That is, they deserve further study, but they do not merit approval for patients outside of a well-designed study. Mine, of course, is just one of many skeptical voices. The last time that I reviewed the situation, neither Europe, nor Japan nor Canada had approved this treatment for much the same reasons that I mentioned above.

I think that what is in the best interests of our citizens, our healthcare for older adults, and American society at large is that Biogen demonstrate the unequivocal efficacy and safety of their innovative treatment. If they can do that, then we can have the discussion regarding cost vs benefit. Monoclonal antibody treatments for chronic diseases are expensive. Herceptin, Avastin, and similar treatments typically cost $30-$60 thousand per year. And, their efficacy in cancer treatments has been the subject of considerable ethical debate. If Herceptin adds five months of life to a patient who is battling Ovarian cancer, for example, what is that benefit worth? Five million dollars? Ten? Sixty?

I do not know the answer to such questions, I know only that we must have a way to quantify not just the cost but also the benefit. For now, I support CMS’s decision to limit this treatment to individuals who are part of a well-designed clinical trial.

Thank you,

Leslie L. Cortes, MD