Alzheimer’s disease is a neurodegenerative disorder that manifests with the deterioration of brain functions, such as memory, language, judgment, and reasoning – to a point of complete immobility – has made this condition a daunting diagnosis to receive. As of 2022, it is estimated that as many as 6.5 million people have dementia or dementia-related diseases. As Alzheimer’s and Brain Awareness Month comes to a close in June, we must also realize that with no cure in sight and limited accessibility to therapeutics that can slow progression, Alzheimer’s disease remains a tsunami headed straight for our healthcare system.
Researchers estimate the projected costs associated with treating and caring for Alzheimer’s disease patients are expected to reach more than $1 trillion and will affect nearly 13 million people by the year 2050 – just in the United States. Footing that bill are Medicaid/Medicare, private insurers, out-of-pocket costs, and other sources. Some people use their own money to supplement the costs but most of us can’t afford to do that.
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Up until the last few years, there was no viable therapeutic to minimize the progression of early onset Alzheimer’s disease. In 2023, the Food & Drug Administration fully approved Leqembi (lecanemab), a promising new treatment that has shown to lessen the progression of Alzheimer’s disease in its early stages. Donanemab, another drug that works to lessen symptoms of mild cognitive impairment, is expected to be fully approved in the following months. Both drugs are undoubtedly a significant advancement in the fight against a devastating disease.
These medical breakthroughs have given me hope, but I am apprehensive about the looming health disparities they will create. As a social epidemiologist with decades of research defining and intervening on social determinants of disease, I believe the approval of Leqembi and Donanemab raise important ethical, safety, and economic concerns that cannot be ignored by academia, healthcare, and pharmaceutical stakeholders.
Two concerns in particular stand out:
No. 1: Lack of diversity in clinical trials.
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Leqembi was evaluated based on a phase-3 clinical trial, which tested the efficacy and collected any adverse reactions to the drug. The manufacturer’s clinical trial enrolled nearly 950 study participants and of that total only 43 identified as Black. Likewise, Donanemab had 1,182 study participants who were split into two randomized groups: 588 received the drug and 594 received a placebo. In each group, only 17 identified as Black (3% of each group). Yet, Black populations have a two to four times higher risk of developing Alzheimer’s disease than non-Hispanic Whites. Unfortunately, the underrepresentation of many communities is common in most clinical trials where minorities account for less than one-tenth of clinical trial participants. Adequate representation of all communities in clinical trials is a matter of social justice and good science. Whether it is a lack of culturally appropriate outreach efforts, eligibility criteria disproportionately excluding Black populations and other minoritized groups, or participant’s mistrust in our healthcare system, we need everyone all in to really make any progress in our fight to overcome Alzheimer’s disease.
No. 2: Economic burden for the majority of people.
In a news release from the pharmaceutical manufacturers of Leqembi, the price of the drug is set at $26,500 a year with treatments required indefinitely — completely out of reach for most Americans. This does not include the expense of the work-up, the administration of multiple clinic treatment infusions, and the required maintenance of brain imaging. Fortunately, those with Medicare and supplemental insurance will pay much less, but those without insurance or inadequate insurance are left with an unaffordable option. This large price tag limits access to those who are financially disadvantaged and exacerbates existing healthcare inequalities. An additional barrier to consider: Allocation of healthcare resources towards expensive treatments may also divert attention from preventive measures, early diagnosis, and care for Alzheimer’s patients.
The approval of Leqembi, and others to come, undeniably marks a significant milestone in the fight against Alzheimer’s disease. However, it must be recognized as a double-edged sword, bringing both hope and apprehension. Alzheimer’s is a multifaceted disease with various underlying factors, and although both Leqembi and Donanemab target the amyloid protein at different stages of buildup in the brain, we might be overlooking the complexity of its pathogenesis. The diversion of resources away from other research avenues, which could be equally promising and more inclusive of diverse participants, cannot and should not be overlooked.
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Ethical considerations, long-term safety assessment, and equitable access to treatment should remain at the forefront of our medical community, regulators, and researcher’s minds – guiding the responsible integration of Leqembi, Donanemab, and hopefully future life changing treatments into the arsenal of tools to combat Alzheimer’s disease.
