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 required 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.
CMS doomed them
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. The cost of delayed treatment to multitudes more Alzheimer's patients, high as it is, pales in comparison to the irreparable loss CMS imposed with its delay.
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.
While there has been some concern around the FDA approval of Aduhelm, all I can say is that it worked for me.
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. The field of Alzheimer's drug development is littered with failures. Because it was a blind trial, for 16 months I didn't know whether I was receiving Aduhelm or a placebo. But I did know that the worst of the fog I'd been experiencing had lifted. 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. Indeed, prior to Leqembi’s traditional approval, Aduhelm and Leqembi were the only FDA-approved drugs that Medicare refused to cover.
Singled out
In other words, Alzheimer's patients are being singled out. This life-threatening disease is being treated differently than cancer, differently than heart conditions, differently than HIV/AIDS.
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, was diagnosed with early-onset Alzheimer's in 2016.
First Published: August 9, 2023, 9:30 a.m.
