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I have been living joyfully and purposefully with Alzheimer's disease for over nine years.
And I'm doing so well, in large part, because I've been fortunate to participate in Biogen's clinical trial of the drug aducanumab, now FDA-approved as Aduhelm, for the last seven years. I have no doubt that the medication has slowed my cognitive decline—providing me additional years to enjoy my grandchildren, family and my role as a national Alzheimer's advocate.
In June last year, the FDA approved Aduhelm, the first Alzheimer's disease modifying treatment. This decision offered hope to the 6 million Americans living with Alzheimer's and their 16 million caregivers, who previously watched in despair as dozens of initially promising experimental treatments failed in clinical trials. Until the FDA approved Aduhelm, Alzheimer's was the only condition among the top 10 deadly illnesses which had no medication to prevent, slow, or cure.
But now, the unthinkable is happening. On Jan. 11, another government agency, the Centers for Medicare and Medicaid Services (CMS), issued its preliminary decision that Aduhelm will not be granted full Medicare coverage, a ruling practically without precedent. Only the small subset of Alzheimer's patients who are enrolled in further clinical trials will have access to the medicine.
CMS has simply turned its back on the millions of Americans hoping to see if Aduhelm would work as well for them as it has for me. The sheer cruelty of this decision is beyond words. To live without hope, then to find it—only for it to be abruptly taken away. This CMS decision is unconscionable.
CMS' decision to provide extremely limited coverage will essentially bar many minority and rural patients from accessing the medicine at all, since the teaching hospitals where clinical trials occur tend to be located only in big cities. Yet African Americans develop Alzheimer's at twice the rate of white people—Hispanic Americans at one and a half times the rate of white people.
Today these communities are significantly underrepresented in Alzheimer's clinical trials; a major inhibitor to participation is lack of trust in the American research community. This CMS decision does not dispel that lack of trust, but only serves to reinforce it. Yes, America, institutional racism does exist.
The decision is particularly worrying because it could prevent the further development of three prospective new Alzheimer's drugs whose trials have been granted accelerated approval status by the FDA. CMS' preliminary decision has cast much doubt and confusion in the Alzheimer's research community that Lilly, a developer of one of the three prospective new drugs, announced it will delay its application for approval by at least six months, specifically blaming the uncertainty created by the negative CMS decision.
The CMS decision—if not reversed—will significantly slow the prospects for future drugs for some time.
I, and fellow Alzheimer's patients, do not have time. In six months, hundreds of thousands of individuals will pass the point when a new drug would be beneficial for them.
New functional losses every day remind me that I am very slowly dying. Mine will not be a fast resolution, unlike those who battle aggressive cancers and other diseases. Mine will be a slow death of a thousand cuts and losses. But the end result will be the same.
From each of my parents, I received a gene which significantly increased the risks that I would develop Alzheimer's. I have passed this gene to my son and perhaps to my granddaughter, increasing their risk of developing the disease. I plead not for myself; I plead for them.
Geri Taylor, a registered nurse with a master's degree in public health from Columbia University, has been living joyfully and purposefully with Alzheimer's disease since 2012.
The views expressed in this article are the writer's own.
