WASHINGTON — Medicare’s proposal to restrict access to a controversial Alzheimer’s drug has quickly reignited a long-simmering debate over how best to address ongoing, systemic inequities in Alzheimer’s care experienced by Black and Hispanic patients.
Medicare on Tuesday put forth a draft plan to only cover Aduhelm for patients enrolled in a randomized clinical trial. Biogen, the company behind the drug, and major Alzheimer’s patient groups all panned the proposal, saying it would make it harder for vulnerable populations to access the medicine. The Alzheimer’s Association called it “shocking discrimination.”
They note that only a limited number of people can enter a clinical trial, and that those clinical trials are likely to occur at major medical institutions, which are more often located in wealthy, white areas of the country. Lower-income patients, too, might struggle to access the drug if they can’t drum up nearly $30,000 to pay for it out of pocket.
There is good reason to highlight those concerns. Black and Hispanic people are significantly more likely to develop Alzheimer’s than white people but are far more often excluded from clinical trials. And even when they can participate, Black individuals were 35% less likely to be diagnosed with Alzheimer’s, despite the fact that they are estimated to be twice as likely as white individuals to develop the condition, according to a 2021 study.
But STAT spoke to several of the nation’s top researchers on the racial disparities in Alzheimer’s disease and they uniformly argued that increasing access to the new therapy would only have a minimal impact on addressing health inequities. Several even praised Medicare’s proposal because, they said, it would help gather needed data on how well Aduhelm works in people of color.
“Many of us who actively work in inclusive dementia spaces are in broad agreement: [Medicare’s] decision to cover Aduhelm in clinical trials is the best incentive to determine whether it even works in women and people of color,” tweeted Jonathan Jackson, executive director of the Community Access, Recruitment, and Engagement Research Center at Massachusetts General Hospital, who added in an interview with STAT that regulators “absolutely did make the right decision” given the lack of representation of people of color in Biogen’s original clinical trial.
The debate underscores the rift in the Alzheimer’s community over the best way to address these persistent inequities. Advocacy organizations see any effort to keep patients waiting for the drug as creating a two-tiered system. But academics STAT spoke to felt that advocacy organizations’ efforts would be better spent addressing more systemic issues, like overcoming the obstacles that keep Black and brown people out of Alzheimer’s clinical trials or from receiving a proper Alzheimer’s diagnosis.
Several also vociferously criticized the advocacy organizations’ statements about health equity.
“It’s painful that it feels like the strongest advocacy and the most outraged response is to defend a pharmaceutical company,” said Jennifer Manly, a professor of neuropsychology in neurology at Columbia University. “It feels like a betrayal,” she added.
“It sounds a little performative and I don’t hear any action behind the real issues of inequity in Alzheimer’s management,” said Sharon Brangman, distinguished service professor of geriatrics medicine at SUNY Upstate Medical University, who noted she was not criticizing any one advocacy organization. “I really am past the point with all the performative clamoring about equity.”
People on both sides of the debate think the other side is missing the bigger picture.
Those up in arms about Medicare’s proposal insist the decision sets such a broad precedent that it’s really not about accessing Aduhelm at all. They insist the decision would set a precedent that would allow Medicare to make patients chose between enrolling in a clinical trial, paying out of pocket for the drug, or foregoing the drug altogether, despite those drugs already being FDA approved and typically covered by Medicare.
“We think this is bigger,” said Harry Johns, CEO of the Alzheimer’s Association. “We think it would be an error — a grand error — to let this go.”
Johns also noted his organization has multiple initiatives aimed at addressing systemic inequities in Alzheimer’s disease.
Meanwhile, others say groups need to focus on bigger issues, like addressing lack of primary care doctors in urban and rural areas who can identify suspected risk factors for Alzheimer’s disease like uncontrolled high blood pressure and diabetes, or making sure people of color are included in clinical trials.
“It’s kind of like saying everyone should have a Rolls Royce when we don’t even have people in Kias yet,” said Brangman. “We have to go back to the basics.”
Several researchers noted that there’s hardly any data testing Aduhelm in communities of color. Nearly 80% of the participants in Biogen’s Phase 3 trials were white.
“If this trial didn’t even have communities of color, then the findings aren’t even generalizable to us,” said Joyce Balls-Berry, an associate professor of neurology at Washington University School of Medicine.
Researchers like Columbia’s Manly have raised concerns that Biogen’s Phase 3 trial may have underreported risks of adverse events like microhemorrhages because the trial did not include more Black participants, who experience a higher rate of certain risk factors associated with those adverse events, like vascular disease. They admitted, however, those concerns are hypothetical, given the lack of data.
It’s not the first time researchers have butted heads with Alzheimer’s advocacy groups, especially the Alzheimer’s Association.
A heated debate erupted in 2017 after the Alzheimer’s Association worked to develop a new definition of Alzheimer’s disease alongside the National Institute on Aging. They defined the condition based on confirmed presence of certain biomarkers, like plaques in the brain, rather than symptoms like memory or thinking changes.
Health equity researchers argued the definition negatively impacted communities of color who didn’t have access to the technology needed to diagnose the disease that way, and made it harder for researchers studying these populations to get research funding, explained Jackson, the MGH researcher.
“There was a very impassioned debate … that cautioned against this change,” said Jackson. “Health equity was not well served by that pivot.”
The question now is who officials at the Centers for Medicare and Medicaid Services will listen to.
Alzheimer’s advocacy organizations, many of which have received funding from major drug makers like Biogen, have already pledged to ratchet up the pressure on Medicare to walk back its decision before it’s finalized in April. They’re also not the only groups slamming Medicare. Biogen said in a statement that the decision would “significantly limit patient access to an FDA-approved treatment, especially for underserved patients.”
The entire controversy poses a unique challenge for President Biden, and especially CMS Administrator Chiquita Brooks-LaSure, both of whom have publicly pledged to help tackle the issue of health disparities.
“It’s just hard to believe that this president and the people who work in his administration would accept such an approach that would so negatively affect so many people in so many ways,” said Johns of the Alzheimer’s Association, who pledged the group would be “relentless” in pushing Medicare to reverse its decision.
But Medicare officials were aware of advocates’ concerns before issuing Tuesday’s draft decision, and did so anyway. Several organizations, including the Alliance for Aging Research and National Minority Quality Forum, had raised the issue long before this week’s proposal.
Medicare officials defended the proposal in a press call Tuesday evening, pointing out that they are requiring trials to be “representative of the national population” diagnosed with Alzheimer’s disease, meaning they must enroll a sizable portion of Black and Hispanic patients.
“Given the disappointing lack of inclusion of underserved populations in past trials, we are requiring a representative patient population in this trial,” said Tamara Syrek Jensen, the director of its coverage and analysis group at CMS. “We think this is important for this disease.”