In April the Centers for Medicare and Medicaid Services should decide whether it will cover the new and costly Alzheimer’s drug Aduhelm for those on Medicare. In January it issued a proposed coverage determination that would allow Medicare coverage for Alzheimer’s patients only if they are enrolled in a qualifying clinical trial. In other words, the agency seeks more scientific evidence that the drug really works before paying for it.
The FDA approved the drug last summer, but its decision was controversial. Three members of the FDA’s advisory committee resigned in protest, and 10 members of the committee voted against approval while the eleventh voted “uncertain.”
FDA’s decision last summer did not mean that the Medicare agency would automatically approve and pay for it especially because the estimated cost of the drug is about $28,000 a month. That cost will eventually find its way into higher premiums for Medicare beneficiaries whether or not they have or ever are diagnosed with Alzheimer’s disease.
What may be just as crucial as its high price tag is that the drug may not benefit Alzheimer’s patients. For example, it was tested only on patients with early or mild cognitive impairment, but the public needs to know if it works on patients who have more severe disease.
Furthermore, it wasn’t tested in large numbers of people of color. Fewer than 1% of Black people participated in the clinical trials — 11 to be exact — along with 67 Hispanics and 1,285 white people. That small number, though, has not stopped the groups that advocate for Alzheimer’s patients, from capitalizing on the current interest in the kind of health care received by America’s minority populations.
“We know that lack of coverage will further deepen health inequities,” noted one press release from the Alzheimer’s Association. Another said that CMS’s draft decision “is shocking discrimination against everyone with Alzheimer’s disease especially those who are already disproportionately impacted by this fatal disease, including women, Blacks, and Hispanics.” The press release noted that the CMS proposed decision meant “access to treatment would now only be available to a privileged few” and would exacerbate and create “further health inequities.”
Whether those groups are genuinely concerned about the health and access to care obtained by people of color is not clear. “Health equity is not gaining access to dangerous drugs,” said Dr. Adriane Fugh-Berman, a professor of pharmacology at Georgetown University Medical Center. “What is ironic and sad is that the drug was not tested in Black people. Fewer than 1% of Black people were in these trials.”
Both the Alzheimer’s Association and USAgainstAlzheimer’s, another advocacy group, are lobbying hard to persuade the Medicare agency to give full approval for the use of the new drug, which could become just another of several Alzheimer’s drugs approved over the years that later did not pan out, in effect wasting a lot of money and giving false hope to patients.
But like most of the so-called disease advocacy groups that have “good guy” reputations, these two Alzheimer’s groups have close ties to the drug manufacturers that make the pharmaceuticals. It is well-known among journalists but not necessarily among patients and the public that groups like the American Diabetes Association, the American Heart Association, as well as the Alzheimer’s groups receive gobs of money from drugmakers.
Those groups are hardly neutral sources. The 2021 annual report of the Alzheimer’s Association shows that Biogen, the maker of Aduhelm, gave between $250,000 and $499,999 to the group. So did Eisai, Biogen’s Japanese partner and Indianapolis-based Eli Lilly, which also has an Alzheimer’s drug in the pipeline.
I don’t have a crystal ball that reveals or even hints at how CMS will rule in April. But I have seen examples through the years of how money talks in the drug industry and the desperation of families for cures willing to try anything at any price. The question on the table with Aduhelm is whether millions of Medicare beneficiaries should bear the cost of higher Medicare premiums for yet another Alzheimer’s drug that may not work.
