Alzheimer's patients deserve access to all FDA-Approved drugs

I have early-onset Alzheimer's. And right now, the Biden administration is blocking millions of Americans like me from taking new drugs that can slow the disease's progression.

Back in January, the Food and Drug Administration offered "accelerated approval" to a new Alzhiemer's drug: lecanemab, also known by its brand name, Leqembi. The drug works by clearing the brain of amyloid plaques, which many scientists believe cause, or at least exacerbate, Alzheimer's. It performed well in its phase 3 clinical trial, slowing patients' rate of cognitive decline by 27% over an 18-month period.

I'm currently talking with my doctor about whether I should start the treatment. But even if we decide it's the right choice, actually obtaining the drug will be an enormous challenge.

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That's because, last year, the federal agency that oversees Medicare announced, in an unprecedented decision, that it would refuse to cover any amyloid-targeting Alzheimer's drugs that the FDA approves on an accelerated basis in the future. The only exception is for patients who enroll in government-approved clinical trials.

Finding and enrolling in one of these trials is extraordinarily difficult. So the drugs are effectively out of reach for the millions of Medicare beneficiaries with Alzheimer's.

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This blatant discrimination against Alzheimer's patients needs to end. Medicare officials lack the scientific authority to second-guess the FDA. Patients living with Alzheimer's should be able to access all FDA-approved medications — and it's up to the White House to ensure they can.

I was diagnosed with the disease at 57. Previously, as a city manager for Fayetteville, I had run meetings and retained information with ease. But gradually, I started having issues with my short-term memory. I struggled to process and comprehend what colleagues were saying.

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Alarmed, I talked with my doctor and went through a battery of testing, and was ultimately diagnosed.

Ranks upon ranks of Americans share my predicament. There are more than 6 million Alzheimer's patients in the United States, and by 2050, that number could reach nearly 13 million.4 Every year, about 672,000 Americans — roughly 1,800 people per day — slip from the early stages of the disease, where cognitive impairment is only mild, to the more severe "moderate" stage.

Right now, lecanemab isn't slated for any government-approved trials, which means Americans with early-stage Alzheimer's — the population eligible for the drug based on the FDA label — can't access it through Medicare.

Even if a trial were ongoing, the vast majority of early-stage Alzheimer's patients wouldn't be able to join. Clinical trials generally need only a few hundred, or at most a few thousand, participants. Patients in rural communities would almost certainly live too far away from clinical trial sites, which are generally in urban areas, to participate.

The Centers for Medicare & Medicaid Services — the agency in question — is essentially doubting the FDA, which already determined that the drug is likely to provide a clinical benefit. Not content to trust the actual scientists at the FDA, the bureaucrats at CMS are demanding their own data showing that amyloid-targeting drugs produce a "statistically significant and clinically meaningful difference in decline in cognition and function."

That kind of overreach needs to stop. For patients struggling with Alzheimer's, any drug that slows the progress of the disease could mean additional years with family and friends. CMS is denying patients that precious time.

True, new drugs come with unknown risks. But Americans deserve the freedom to weigh medical risks on their own, and make those decisions with their doctors.

Alzheimer's has already taken so much from me and millions of other Americans. It's crushing that Medicare has stripped us of our autonomy, too.

Jay Reinstein is a retired Fayetteville assistant city manager. He serves on the boards for the NC Alzheimer's Association, Voices of Alzheimer's and the Alliance for Aging Research. He lives in Durham.