Authored by Kate Constan
Art by Amber Briscoe
The families of Alzheimer’s Disease patients share a simple wish: more time and more clarity for their loved ones. Until recently, this seemed impossible. The cruel disease proceeds at its own pace, robbing people of their health, cognition, and autonomy. This year, that changed: a new drug for Alzheimer's emerged, one that could allow for previously unheard-of improved outcomes.
Lecanemab–marketed as Leqembi–is a breakthrough in the world of neurological drug development. It is the first, and currently only, treatment clinically proven to slow the progression of Alzheimer’s, helping to preserve memory and function [1]. On biological and societal levels, Leqembi is significant.
Leqembi’s efficacy was proven through an 18-month study using 1,795 early-stage Alzheimer’s patients [2]. “Lecanemab in Early Alzheimer’s Disease” by van Dyck et al. was published in its final form in the first days of 2023. Results showed a marked slowing of disease progression in patients treated with Lecanemab, but researchers noted “adverse effects” in the brain and cardiovascular system, mentioned little impact on late-stage patients, and urged for a longer longitudinal study [2]. Nonetheless, (and under pressure from advocacy groups), the FDA granted accelerated approval for Leqembi on January 6, 2023, and granted the drug traditional approval seven months later [3].
Leqembi is an intravenously administered drug that works as an antibody targeting amyloid plaques, which are believed to be responsible for Alzheimer's [2]. Specifically, Leqembi targets and breaks down harmful clumps of proteins called Aβ protofibrils in the brain, leading to slower plaque buildup, and thus, a slower progression of the disease [2]. This allows for an extended period of normal cognitive function for patients. While this by no means is a cure, it buys time for many patients hoping to stave off worsening symptoms.
Developed through a collaboration between Eisai Co. (Tokyo, Japan) and Biogen (Cambridge, Massachusetts), Leqembi was a product of international collaboration, which reflects Alzheimer’s status as a global health crisis. The drug has been granted initial approval for use in both countries [4].
Alzheimer’s Disease treatment is a powerhouse industry. The 6.5 million Americans suffering from Alzheimer’s are estimated to have the highest impact on the economy of any disease: $321 billion [5]. This figure is expected to top $1 trillion by 2050 [5]. With this staggering expense, lucrative possibilities for addressing it emerge.
With a scientific breakthrough and a staggering number of people affected by the disease, it is easy to assume that Alzheimer’s care will vastly transform. However, Leqembi’s value is overshadowed by high costs and serious medical risks.
Unfortunately, some advances in healthcare are accessible only to those who can afford it. Currently, a Leqembi prescription and associated testing cost over $26,500 per year, leaving it inaccessible for uninsured Americans [6]. Medicare leaves gaps, not covering all aspects of Leqembi treatment, which includes testing and follow-up appointments. There are powerful and effective drugs that go unused due to cost barriers. Further, these barriers intersect with racial disparities. The elevated prevalence of dementia and reduced income levels among elderly Black and Hispanic individuals in the United States, compared to their white counterparts, could exacerbate inequities [7].
Eisai argues that the cost of Leqembi reflects its “social value” [8]. While Alzheimer’s detrimental impacts on society are undeniable, this argument is weak in the face of the families struggling to provide their loved ones with adequate treatments.
But even if expenses did not limit access to Leqembi, other problems remain. Leqembi is not recommended for individuals who are already in advanced stages of illness; only 15-20% of diagnosed Alzheimer’s patients show mild enough symptoms to qualify [2]. Even for those who do qualify, there are continued considerations: the possible side effects may be staggering in severity and scale.
Slowing the symptoms of Alzheimer’s is valuable, but how valuable? Atwood et al. titled a 2023 paper about Leqembi “Playing Russian Roulette with Alzheimer’s Disease Patients,” citing serious vascular consequences including stroke [9]. Other side effects include ARIA, or “Amyloid Related Imaging Abnormalities,” which usually present as asymptomatic but can lead to swelling and brain bleeds, introducing issues like confusion and seizures [9]. Perhaps the most alarming warning comes from David Rind, the Institute for Clinical and Economic Review’s Chief Medical Officer. Rind: “People are as dug in on this as almost anything I've ever seen in medicine” and that he doesn’t “think it's healthy” [10]. While breakthroughs in medicine often draw speedy approval and wide press acclaim, our priority must always be health and safety. The hopes of a patient and their family for more time and clarity might trump their fear of risks. As with any medication, Leqembi forces patients to consider the price they might pay for the possibility of better health that they seek. Each patient must consider if the ends justify the means.
Leqembi is still in its nascence and as it is used more widely, more data will become available about its accessibility and possible detrimental influences [2]. Reductions in cost and adverse effects should be addressed quickly and thoroughly. Despite criticism, though, Leqembi is still worth celebrating. While the cost and side effects are alarming, the development of this drug indicates a path forward for the treatment of neurodegenerative diseases.
References
U.S. FDA Commissioner (2023, January 6). FDA grants accelerated approval for alzheimer’s disease treatment. U.S. Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-alzheimers-disease-treatment
van Dyck, C. H., Swanson, C. J., Aisen, P., Bateman, R. J., Chen, C., Gee, M., Kanekiyo, M., Li, D., Reyderman, L., Cohen, S., Froelich, L., Katayama, S., Sabbagh, M., Vellas, B., Watson, D., Dhadda, S., Irizarry, M., Kramer, L. D., & Iwatsubo, T. (2023). Lecanemab in early alzheimer’s disease. New England Journal of Medicine, 388(1), 9–21. https://doi.org/10.1056/nejmoa2212948
U.S. FDA Commissioner, FDA converts novel alzheimer’s disease treatment to traditional approval. U.S. Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/fda-converts-novel-alzheimers-disease-treatment-traditional-approval
LEQEMBI® Intravenous Infusion (Lecanemab) approved for the treatment of alzheimer’s disease in Japan. (2023, September 25) Biogen. https://investors.biogen.com/news-releases/news-release-details/leqembir-intravenous-infusion-lecanemab-approved-treatment
University of Southern California Executive Master of Health Administration. (2023, June 23). The most expensive medical diseases and procedures. USC EMHA Online. https://healthadministrationdegree.usc.edu/blog/most-expensive-disease-to-treat-infographic/#:~:text=One%20way%20the%20U.S.%20could,reducing%20incidents%20of%20that%20disease.&text=Alzheimer%27s%20disease%20costs%20%24321%20billion,top%20%241%20trillion%20by%202050
Arbanas, J. C., Damberg, C. L., Leng, M., Harawa, N., Sarkisian, C. A., Landon, B. E., & Mafi, J. N. (2023). Estimated Annual Spending on Lecanemab and Its Ancillary Costs in the US Medicare Program. JAMA internal medicine, 183(8), 885–889. https://doi.org/10.1001/jamainternmed.2023.1749
Cubanski, J., &; Neuman, T. (2023, July 6). New alzheimer’s drugs spark hope for patients and cost concerns for Medicare. KFF. https://www.kff.org/policy-watch/new-alzheimers-drugs-spark-hope-for-patients-and-cost-concerns-for-medicare/
Inc., E. (2023, January 6). Eisai’s approach to U.S. pricing for LEQEMBITM (LECANEMAB), a treatment for early alzheimer’s disease, sets forth our concept of “societal value of medicine” in relation to “Price of medicine.” PR Newswire: press release distribution, targeting, monitoring and marketing. https://www.prnewswire.com/news-releases/eisais-approach-to-us-pricing-for-leqembi-lecanemab-a-treatment-for-early-alzheimers-disease-sets-forth-our-concept-of-societal-value-of-medicine-in-relation-to-price-of-medicine-301715694.html
Atwood, C. S., & Perry, G. (2023). Playing Russian Roulette with Alzheimer's Disease Patients: Do the Cognitive Benefits of Lecanemab Outweigh the Risk of Edema, Stroke and Encephalitis?. Journal of Alzheimer's disease : JAD, 92(3), 799–801. https://doi.org/10.3233/JAD-230040
Allen, A. (2023, August 1). The real costs of the new alzheimer’s drug, leqembi - and why taxpayers will foot much of the bill. CBS News. https://www.cbsnews.com/news/alzheimers-drug-leqembi-cost-patients-taxpayers/