Columnist Phil Gutis imagines the nightmare of a very early cancer diagnosis — and wonders why patients with Alzheimer's are left to live out a very similar scenario thanks to regulatory and insurance decision-makers' calls on the early-stage-treatment options that could slow or stop the disease from worsening.
A few years ago, I listened to my doctors and grudgingly scheduled myself a colonoscopy – one of the most dreaded parts of hitting middle age. Thankfully, I don’t recall much of the process, other than the doctors found a few polyps that were removed and tested.
After a few days, the doctor called to say the polyps were cancerous. They added that Medicare would not pay for treatment because the polyps were too small and the necessary medicine was too expensive.
All of this news was delivered with a tone that said I shouldn’t worry, that the cancer would likely progress slowly, and in a decade or two, when I was really sick and possibly dying from colon cancer, I could return. At that point they would try to treat me with chemotherapy and other expensive drugs, which would then be covered by Medicare.
Now, of course, none of this actually happened. My polyps tested negative for cancer cells and I was told to do a follow up colonoscopy in ten years.
However, the potential nightmare scenario I outlined is all too real when it comes to patients facing an Alzheimer’s or dementia diagnosis.
In 2022, the Centers for Medicare and Medicaid Services made a decision to severely restrict coverage of Aduhelm, the first-ever disease-modifying drug for Alzheimer’s to be approved by the Food and Drug Administration, and all other drugs within this class of treatments.
In its decision, CMS acknowledged that Aduhelm and other drugs in its class could be covered under law by Medicare but the agency said it was not yet convinced that the drug was “meaningful and necessary.”
The potential nightmare scenario I
outlined is all too real when it comes to
patients facing an Alzheimer’s
or dementia diagnosis.
Speaking at a post-decision conference call two years ago, Lee A. Fleisher, CMS Chief Medical Officer and Director of Clinical Standards and Quality, had this to say: “As we think through Medicare coverage, it is important to remember that we are talking about a drug for mild cognitive impairment. This drug is directed at patients who were recently healthy and who may not have outward signs of dementia.”
In my hypothetical colonoscopy experience, if the doctors had found cancerous polyps during my colonoscopy, wouldn’t I have been considered “recently healthy” until that point?
Isn’t the point of a colonoscopy to find out if there is a sign of cancer, or other issue?
So theoretically, aren’t most people who are getting a routine colonoscopy assumed to be “healthy” … until they aren’t?
After all, the National Institutes of Health says that doctors use a colonoscopy as a screening tool to test for diseases when one has no symptoms.
“Screening may find diseases at an early stage,” NIH writes, “when a doctor has a better chance of curing the disease.” (Emphasis added.)
I believe my analogy shows how ridiculous the CMS decision not to cover Aduhelm was. The agency has decided to cover lecanemab — now on the market as Leqembi, another disease-modifying drug that won full FDA-approval in July 2023 — but has said it will only pay for the drug if prescribing doctors participate in what is known as a registry, which will collect information about the efficacy of the drug.
In a news release, the Alzheimer’s association said it believes that the requirement of registry is an unnecessary barrier for people seeking coverage. Some physicians, the Association explained, are reluctant to participate in registries because of time considerations.
“Registries are important tools to gather much needed real-world evidence to transform and improve patient care,” the Association said. “But, registries should not be a requirement for coverage of a FDA-approved treatment.”
While the recent moves by CMS are notable and welcome, the agency needs to change its coverage decision to lift all barriers to access these life-changing drugs. It is time for them to completely stop discriminating against people living with Alzheimer’s, and to treat the disease as they would any chronic, incurable condition.
It is true that we have – somewhat shockingly – won important victories in our fight with CMS. But until they lift all barriers against access, those of us living with Alzheimer’s will not stop raising our voices against continued discrimination against people living with cognitive diseases.
Phil Gutis is a former New York Times reporter and current Being Patient contributor who was diagnosed with early onset Alzheimer’s. This article is part of his Phil’s Journal series, chronicling his experience living with Alzheimer’s and his participation in the aducanumab clinical trial.