Medicare and Medicaid deny Alzheimer's medicine coverage, hindering thousands of Tennesseans | Opinion
In January, the government agency in charge of Medicare proposed a rule that would be devastating for the six million Americans living with Alzheimer's disease, a debilitating brain disorder that destroys memory and thinking. In a bid to save money, the Centers for Medicare and Medicaid Services wants to block seniors' access to a whole category of dementia medicines.
The FDA greenlit the first of these treatments, Aduhelm, last year, bringing great hope to patients and their loved ones. But now, CMS has effectively told patients that their condition, which primarily affects seniors, is too expensive to treat.
This is a heart-wrenching letdown for hundreds of thousands of Tennessee patients.
According to the most recent estimate from the non-profit Alzheimer's Association, around 120,000 Tennesseans currently struggle with Alzheimer's. That's roughly equivalent to two-thirds of the entire population of Chattanooga.
By 2025, an additional 20,000 state residents will have developed the devastating illness. To make matters worse, Tennessee has a higher Alzheimer's mortality rate than all but six U.S. states.
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Proposal robs us of hope'
It's bad enough that bureaucrats at CMS, which oversees government health insurance programs, is second-guessing the FDA, which employs thousands of scientists to determine drug safety and effectiveness. This fact alone sets a terrible precedent, under which CMS might choose to deny access to any approved drug it doesn't like the look of.
But the more frightening aspect of the proposed rule is that it would block access not just to this one treatment, but to any present or future Alzheimer's medicine that relies on the same technology.
This is devastating, especially for those of us who know the ravages of Alzheimer's personally. My own mom had Alzheimer's – and my sister is currently suffering from advanced dementia.
Last June, the FDA gave Aduhelm the go-ahead under the agency's "accelerated approval" program. This lets patients with otherwise untreatable diseases access new medicines quickly, while conditioning long-term approval on further trials. Accelerated approval is only granted to medicines that FDA scientists consider extremely promising.
The new drug is based on cutting-edge monoclonal antibody technology, which targets the brain plaques many scientists believe cause Alzheimer's. As it is the first of its kind, approval laid the groundwork for an entire new class of drugs.
As the director of the FDA's Center for Drug Evaluation and Research noted, "the accelerated approval pathway can bring therapies to patients faster while spurring more research and innovation," a process that has been effective in the fight against cancer. In other words, even if this particular drug doesn't live up to its full promise, accelerated approval encourages research into similar treatments.
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Unfortunately, officials at CMS now want to curtail access to any Alzheimer's treatment that relies on monoclonal antibodies with this beta-amyloid target. Their proposal would allow coverage for only a tiny number of Alzheimer's patients enrolled in certain clinical trials. It calls this system "coverage with evidence development," as though it is just waiting on data, ignoring the fact that the agency actually charged with approving drugs -- the FDA -- has already painstakingly evaluated the evidence.
If CMS goes through with its proposal, it would jeopardize future innovation in Alzheimer’s and beyond. One company has already hit pause on their Alzheimer’s treatment. No company can afford to develop Alzheimer's drugs that Medicare won't cover, given that the majority of patients are on Medicare. Companies researching monoclonal antibodies to treat Alzheimer's would simply reallocate research money to less-risky ventures -- and seniors with dementia would bear the brunt.
The CMS proposal to severely reduce access to treatment appears aimed at saving costs. But its approach is short-sighted and unlikely to succeed over the long term.
Alzheimer's already costs the U.S. healthcare system some $300 billion annually, according to the BrightFocus Foundation, which funds disease research. Without a game-changing new treatment, Alzheimer's disease will cost more than $1 trillion annually by 2050. In Tennessee, Alzheimer's drains nearly $7 billion worth of unpaid labor from the state economy every single year.
Hence every new treatment ought to be viewed as an opportunity to reduce these astronomical costs over time, not add to them.
But worse, by denying coverage for a whole class of Alzheimer's drugs to Medicare recipients, CMS would consign millions of Americans to living with or dying from a devastating illness. Already, one in every three seniors dies with Alzheimer's or another dementia, and about 500,000 new cases are diagnosed every year.
CMS won't finalize its proposal until April, which means it still has time to reverse course. Tennessee's 120,000+ Alzheimer's patients and the 357,000 caretakers that look after them can only hope it does.
Saul Anuzis is President of 60 Plus, the American Association of Senior Citizens.
This article originally appeared on Nashville Tennessean: Why crucial Alzheimer's medicine coverage must remain for thousands of Tennesseans.
