The Aduhelm controversy is not dying down ... at all

Aduhelm continues to be in the news, even with its dramatically lowered price -- $56,000 per year now reduced to $28,200 per year.  These prices do not include the cost of regular MRIs to check for brain hemorrhages.  Patients would still have an annual copay of $5,640.  Since it's not clear that the treatment actually works, should insurance companies be covering it?  Should Medicare cover it?  It depends on who you ask.

My high school classmate, Mike, sent me this article from the WaPo that sums up the situation pretty well, as does this later article from Alzheimer's News Today.  For 2022, Medicare is raising the standard monthly premium from $148.50 to $170.10.  Half of that increase is intended to provide a cushion to pay for anticipated Aduhelm treatments, although, so far, not many people seem interested.

So will Medicare cover it?  To begin with, it's important to understand that we're actually in a phase 4 trial.  Because of the nature of the FDA's provisional approval the treatment got, Biogen is still on the hook to produce real-world data that shows people actually improving when they get it.  That data remains to be collected.  "Improving" doesn't mean they get better or that the progress of the disease is reversed, only that the rate of decline slows.  Biogen wants to do this in a population of paying customers.  

So what does Medicare say about that?  In a recent press release, the Centers for Medicare and Medicaid proposed a system in which they would cover it in a "coverage with evidence development" protocol.  In other words, they will cover people only in the context of participation in a controlled drug trial.  This has ignited a fire storm.

Dr. Matthew S. Schrag, a vascular neurologist at Vanderbilt University Medical Center said, “This drug is an empty promise.  It’s very unlikely to provide beneficial effects.”  Vanderbilt will not offer Aduhelm, nor will Cleveland Clinic, Johns Hopkins, the University of California at Los Angeles or the University of Michigan, all due to lack of evidence of efficacy.

But the Alzheimer's Association is all in on Aduhelm, and they screamed bloody murder. They hyperbolically decried the “shocking discrimination against everyone with Alzheimer’s disease, especially those who are already disproportionately impacted by this fatal disease, including women, Blacks, and Hispanics.”

It seems to me that the Alzheimer's Association is wrong to place so much confidence in Aduhelm at this stage of the game, and I think they are seriously overplaying their hand here.

It will be interesting to see how this all plays out.