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Biden Limits Access to FDA-Approved Alzheimer’s Treatment

Alzheimer’s has touched virtually every American’s life in one way or another. Our parents, grandparents, spouses and friends are more like to suffer and die from this degenerative brain disease than from breast cancer and prostate cancer combined. Yet for the past two decades, we’ve been completely without new treatments to stop it.

That changed in the summer of 2021 when the FDA approved a new injectable therapy, aducanumab, shown to reduce amyloid plaques in the brain that are associated with Alzheimer’s disease. Hopes were soon dashed when the high price tag and bungled launch caused a backlash in the medical community. Few hospitals would administer the treatment without Medicare’s guidance, and millions of seniors continued to waste away while the Federal government decided what to do. 

On January 11, 2022 the Centers for Medicare and Medicaid Services (CMS) shocked the world by proposing one of the most restrictive policies in the agency’s history – not only for covering aducanumab, but also for new future treatments like it (and there are several under FDA review). In short, only patients enrolled in clinical trials in a hospital would be eligible for Medicare coverage. The rest would have to cover the treatment’s annual $28,000 price tag out-of-pocket or through private insurance.

The decision appears narrowly written to control costs – and patient advocacy groups are furious. Writing in The Hill, Mario H. Lopez, president of the Hispanic Leadership Fund, explains how the proposal flies in the face of the Biden administration’s commitment to equity:

The consequences of CMS implementing this decision will be severe, especially for more vulnerable populations. Economically disadvantaged people who live in rural settings without access to reliable transportation or health insurance will face yet another obstacle toward accessing potentially life-changing treatment.

Furthermore, Black Americans are about two times more likely than whites to have Alzheimer’s and other dementias, but only one-third more likely to have a diagnosis. Hispanic Americans are about 50 percent more likely than non-Hispanic whites to have Alzheimer’s and other dementias, but only 18 percent more likely to be diagnosed.

The ability to fight Alzheimer’s disease should not be restricted or available only to a privileged few.

Lopez further criticized CMS for proposing unrealistic guidelines for the racial and ethnic make-up of those clinical trials:

The draft policy also states that “the diversity of patients included in each trial must be representative of the national population diagnosed with Alzheimer’s disease.” This is a laudable goal, since Black and Hispanic Americans long have been disadvantaged in clinical trial participation, despite an intense and ongoing public-private effort to increase enrollment. Recent research by the University of Southern California and Gates Ventures found that the situation is even worse with Alzheimer’s; more than 99 percent of eligible patients are never referred to clinical trials.

While promoting equity in policy is good, investing and doing the hard work to achieve real goals are better. Increased targeted outreach to underserved communities — not only patients, but also family members and caretakers — will raise awareness of diagnosis and treatment options. This should include education about participation in clinical trials, which will ensure more complete representation in new Alzheimer’s research. 

The policy won’t be finalized until April, and it’s possible CMS will revise its decision to ensure more seniors can access aducanumab and future Alzheimer’s treatments. Even if the agency withstands the public outcry, it’s hard to imagine its math will hold up. The cost of Alzheimer’s care topped $300 billion in 2020 and is projected to top $1 trillion in the years ahead. Restricting access to the only FDA-approved treatment that could slow the progression of this disease – and with others on the way – is incredibly short-sighted. Still, Lopez ends on a hopeful note:

If implemented, the policy will only deepen the inequities that have been exacerbated by the coronavirus pandemic…

As a candidate for president, Joe Biden listed racial inequality as one of the “four historic crises” facing our country, calling it “the most compelling call for racial justice since the ’60s.” As president, his actions speak louder than words. Restricting access to treatment for this widespread and deadly disease flies in the face of the promised justice. Let’s hope President Biden’s administration changes course on Alzheimer’s treatments.

You can read his article in full here.