Disparities in access to novel infusion treatment for Alzheimer's disease revealed

Adoption of lecanemab, a novel infusion treatment for Alzheimer's disease (AD), has been disproportionately higher among patients who are male, white, from urban areas, and have higher socioeconomic status, new research suggests.

The findings, published in the peer-reviewed JAMA Network Open, highlight how certain populations are more likely to access potentially breakthrough new therapies than others, the researchers write.

Lecanemab was the first disease-modifying therapy to receive broad Medicare coverage for AD in July 2023. Its approval and use remain controversial because of its limited effectiveness in slowing cognitive decline and its high rate of serious side effects, such as brain bleeding. The drug is costly, with a price tag of $26,000 per year and an estimated additional $7,000 per year in ancillary costs.

"This drug is contributing to increased Medicare spending for everyone, while only being provided to a select few," said Frank Zhou, a medical student at the David Geffen School of Medicine at UCLA, who led the study. "These findings should alert policymakers that despite patient assistance programs by the drug manufacturer to improve access to the therapy, stark disparities in uptake have still occurred. As we prepare for the likely future launch of more efficacious and safer therapies in this field, we must think harder about how to ensure equitable access to all patients who could benefit from and desire such treatment."

The researchers analyzed all Medicare fee-for-service beneficiaries who had received lecanemab between July 1, 2023 and March 31, 2024. They compared the demographics of these lecanemab users with a broader population of patients possibly eligible for the drug by having diagnosed AD or mild cognitive impairment (MCI). Demographic variables for comparison included age, sex, race and ethnicity, urban/rural status, and a proxy variable for socioeconomic status, which was marked as "higher" if a patient was neither eligible for the Part D low-income subsidy or for dual Medicare-Medicaid. Within each demographic category, the uptake rate of lecanemab was calculated by dividing the number of lecanemab users by the number of patients with AD or MCI.

Patients who used lecanemab were more likely to be male, white, from urban areas, and with higher socioeconomic status than those who did not, the researchers found. Of the 1,725 lecanemab users, 48.5% were male, 90.5% were White, 88.0% were urban residents, and 98.7% had higher socioeconomic status. In contrast, among all 842,192 patients with diagnosed AD or MCI, only 36.4% were male, 82.0% were White, 82.1% were urban residents, and 75.3% had higher socioeconomic status.

Uptake rates of lecanemab were much higher for patients who were male (0.27% vs. 0.19% for female), white (0.23% vs. 0.09% for Asian/Pacific Islander, 0.04% for Black, 0.07% for Hispanic), from urban areas (0.22% vs. 0.14% for rural areas), and with higher socioeconomic status (0.27% vs. 0.01% for lower socioeconomic status).

We found that lecanemab adoption was 6-fold higher among white versus Black patients and 24-fold higher among those with higher versus lower socioeconomic status. While these findings may be related to the drug's annual cost of $26,000 per year and extensive testing and visit requirements, they also reflect a broader and recurring historical pattern of inequities in access to breakthrough therapies in the United States."

Dr. John N. Mafi, associate professor-in-residence in the UCLA division of general internal medicine and health services research and the study's co-senior author

A limitation to the study was that data for Medicare Advantage beneficiaries were unavailable, the researchers write. In addition, patients with AD and MCI were identified via diagnosis codes, which can misdiagnose or underestimate the prevalence of those conditions, can't distinguish between different severities of AD, and can't account for other medication eligibility criteria.

"Lecanemab is a costly therapy with marginal clinical benefits and significant safety risks, and any decision to start using the therapy should be carefully discussed with one's doctor," Zhou said. "Given these significant issues with the therapy, Medicare should also analyze real-world data from its own registry of lecanemab users to decide if continued coverage of this therapy is appropriate. This is especially salient given that there are likely better uses for our limited Medicare dollars, for example caregiver care for dementia patients."

Study co-authors are Dr. Utibe Essien and Dr. Catherine Sarkisian of UCLA, Jeffrey Souza and Dr. Bruce Landon of Harvard University, and Cheryl Damberg of RAND. The study was primarily funded by grants from the National Institute on Aging at the National Institutes of Health.