By Philip S. Gutis
For patients like me in the early stage of Alzheimer’s, recent years have brought two major breakthroughs. One was medical, with the discovery of the first treatments that can actually slow the progression of the disease rather than just ameliorate its symptoms.
The other breakthrough came in July, when the Centers for Medicare and Medicaid Services agreed Medicare would cover one of the treatments, brand-name Leqembi. What’s disturbing is that this decision did indeed require a breakthrough. Had CMS acted within its usual scope of authority, coverage should have been routine.
The FDA granted traditional approval to Leqembi in July after having approved it on an accelerated basis in January. The trials completed in June demonstrated that Leqembi produced clinical benefits as predicted by the accelerated approval data — in this case, slowing cognitive decline in patients by 27%.
We should now be celebrating the arrival of a treatment that reached about 1800 people per day between January and July this year before their disease progressed past the point at which Leqembi is indicated.
The tragedy is that they didn’t. That’s because CMS, departing from all precedent, refused to provide coverage for Leqembi and treatments like it on the strength of the FDA accelerated approval.
That sealed the fate of more than a quarter of a million people. Thanks to CMS, they are doomed to experience the disease running its course unimpeded through progressive cognitive decline, dementia and death.
Leqembi is one of a group of monoclonal antibody treatments that fight Alzheimer’s by reducing the buildup in the brain of amyloid plaque deposits, which have long been associated with the disease. Another, with which I am personally familiar, is Aduhelm. It won FDA accelerated approval in June 2021 — and embarked CMS on its course of denying coverage.
My diagnosis came after months of feeling that something was wrong with my brain. My mind wasn’t right, but I didn’t know what was happening. Hoping for answers, I scheduled an appointment for a cognitive test as part of a clinical trial for Aduhelm. I received a diagnosis of early Alzheimer’s and was accepted into the trial.
My expectations were low. Because it was a blind trial, for 16 months I didn’t know whether I was receiving Aduhelm or a placebo. As it turned out, I had been receiving the medication. After the initial trial ended, I enrolled in an open-label trial extension that allowed me to continue receiving the drug.
That made me one of the lucky few. The CMS decision to effectively block access to an FDA-approved drug was unprecedented.
This CMS decision is unfortunately in line with a disturbing pattern. Medicare has demonstrated consistent bias against people living with Alzheimer’s by refusing to broadly cover the most critical components of basic care.
For the first time, we have treatments that can alter the course of Alzheimer’s, slowing its progression. CMS should no more hesitate to get them to people in the earliest stages of their disease than hesitate to treat a cancer before it spreads.
Philip Gutis, a former New York Times reporter who was diagnosed with early-onset Alzheimer’s in 2016, serves on the board of Voices of Alzheimer’s. This piece originally appeared in the Pittsburgh Post-Gazette.
