Medicare is stealing time from Alzheimer's patients

Both of my parents died of Alzheimer's disease. When I received my own diagnosis in 2020, at the age of 66, I knew all too well that the progressive, fatal illness would slowly rob me of cognition.

But relative to my parents, I'm lucky. In 2021, the FDA approved the first new Alzheimer's treatment in decades, Aduhelm. I was one of the first Americans to receive it. This year, the FDA approved another new treatment, Leqembi. We're in a moment of hope for patients like me, as we start to see medicines that can slow our cognitive decline and buy us more time.

Aduhelm and Leqembi belong to a class of drugs called monoclonal antibodies, which are proteins that help the body fight disease. Both drugs work by removing the clumps of amyloid that build up in Alzheimer's-afflicted brains.

These medicines — and similar ones in the pipeline — are exciting for the 6.7 million Americans living with Alzheimer's disease. They have the potential to keep us actively engaged with our families, hobbies and careers longer.

But we face a major challenge, caused not by scientific barriers but a bureaucratic one. Medicare has taken the unprecedented step of putting these drugs off limits to the vast majority of patients.

Medicare, of course, is the federal health insurance program for people 65 and older — the demographic group chiefly afflicted by Alzheimer's. Normally, once a treatment has met the FDA's strict standards for safety and effectiveness, Medicare coverage follows. The Department of Veteran Affairs approved Leqembi in March.

Yet the agency that runs Medicare, the Center for Medicare and Medicaid Services, has restricted coverage to just a small group of patients — those who receive Leqembi as part of an approved clinical trial or a physician who collects data for a national registry. The idea is that the drugmaker should provide "additional evidence" of effectiveness, despite having met FDA requirements. In practice, this means that the number of patients who can benefit is tiny — mostly limited to those who live in areas with access to clinical trials. Even then, participants could end up receiving placebos. In an even more baffling maneuver, CMS hasn't set up the registries it says are required to collect data in order for coverage to be assured.

Worse, CMS isn't just stalling on Aduhelm and Leqembi. Its coverage restrictions apply to any monoclonal antibody treatment targeting amyloids. The agency is essentially placing a whole class of drugs, including those yet to be developed, off limits.

So now we have the FDA approval of the drug, the VA providing coverage, but CMS still is stuck in the mud and afraid to do the right thing.

To be sure, these drugs are expensive — Leqembi costs $26,500 per year. Covering them could cost Medicare billions of dollars. Yet CMS doesn't require other FDA-approved drugs — for cancer, heart disease, HIV, or anything else — to clear extra regulatory hurdles. The agency is signaling out Alzheimer's patients for this shoddy and shameful treatment.

And we can't afford to wait. Leqembi and similar medicines are most effective in patients with early-stage Alzheimer's. Delaying treatment costs us time we don't have. The Alzheimer's Association estimates that every day, about 2,000 people progress from the mild stage of disease to the moderate phase. My clock is ticking, and every day it ticks a little bit louder.

As an American of my age, I have a right to health care coverage from Medicare. I trust the FDA, the global gold standard for drug approval. And I'm aware of the risks and uncertainties surrounding these treatments. It's my brain that's on the line here. I should be allowed to decide what's best for it.

I know I'm not alone. The Alzheimer's Association and more than 200 researchers have asked CMS to lift its restrictions. Republicans and Democrats in Congress have called on the agency to provide immediate access to monoclonal antibody treatments for Alzheimer's patients.

It's time for CMS to give us back our hope.

Mike Zuendel, a resident of Des Moines and Telluride, Colo., is a public advocate with Voices of Alzheimer's and the Alzheimer's Association.