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. 2023 Aug;12(4):1133-1157.
doi: 10.1007/s40120-023-00492-7. Epub 2023 May 15.

Predicting the Societal Value of Lecanemab in Early Alzheimer's Disease in Japan: A Patient-Level Simulation

Affiliations

Predicting the Societal Value of Lecanemab in Early Alzheimer's Disease in Japan: A Patient-Level Simulation

Ataru Igarashi et al. Neurol Ther. 2023 Aug.

Abstract

Introduction: Alzheimer's disease (AD), a neurodegenerative disorder that progresses from mild cognitive impairment (MCI) to dementia, is responsible for significant burden on caregivers and healthcare systems. In this study, data from the large phase III CLARITY AD trial were used to estimate the societal value of lecanemab plus standard of care (SoC) versus SoC alone against a range of willingness-to-pay (WTP) thresholds from a healthcare and societal perspective in Japan.

Methods: A disease simulation model was used to evaluate the impact of lecanemab on disease progression in early AD based on data from the phase III CLARITY AD trial and published literature. The model used a series of predictive risk equations based on clinical and biomarker data from the Alzheimer's Disease Neuroimaging Initiative and Assessment of Health Economics in Alzheimer's Disease II study. The model predicted key patient outcomes, including life years (LYs), quality-adjusted life years (QALYs), and total healthcare and informal costs of patients and caregivers.

Results: Over a lifetime horizon, patients treated with lecanemab plus SoC gained an additional 0.73 LYs compared with SoC alone (8.50 years vs. 7.77 years). Lecanemab, with an average treatment duration of 3.68 years, was found to be associated with a 0.91 increase in patient QALYs and a total increase of 0.96 when accounting for caregiver utility. The estimated value of lecanemab varied according to the WTP thresholds (JPY 5-15 million per QALY gained) and the perspective employed. From the narrow healthcare payer's perspective, it ranged from JPY 1,331,305 to JPY 3,939,399. From the broader healthcare payer's perspective, it ranged from JPY 1,636,827 to JPY 4,249,702, while from the societal perspective, it ranged from JPY 1,938,740 to JPY 4,675,818.

Conclusion: The use of lecanemab plus SoC would improve health and humanistic outcomes with reduced economic burden for patients and caregivers with early AD in Japan.

Keywords: Alzheimer’s disease; CLARITY AD; Cost-effectiveness; Economic burden; Japan; Lecanemab; Patient-level simulator; Quality-adjusted life years; Willingness-to-pay.

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Conflict of interest statement

Ataru Igarashi received consultant fee from Eisai Co., Ltd. Mie Kasai Azuma and Kiyoyuki Tomita are employees of Eisai Co., Ltd. Quanwu Zhang is an employee of Eisai Inc. Weicheng Ye, Aditya Sardesai, Henri Folse, and Ameya Chavan are current employees of Evidera, a healthcare research firm that provides consulting and other research services to pharmaceutical, device, government, and non-government organizations. Eisai Inc. provided funding to Evidera for conducting the analysis and preparing the manuscript. Amir Abbas Tahami Monfared is an employee of Eisai Inc. He serves as Associate Editor for the Journal of Alzheimer’s Disease and did not receive any fees or honoraria.

Figures

Fig. 1
Fig. 1
Amyloid positron emission tomography standard uptake value ratio and Clinical Dementia Rating Sum of Boxes. ACE Archimedes condition-event, AD Alzheimer’s disease, CDR-SB Clinical Dementia Rating Sum of Boxes, PET positron emission tomography, SoC standard of care, SUVr standard uptake value ratio
Fig. 2
Fig. 2
One-way sensitivity analyses results. AD Alzheimer’s disease, CDR-SB Clinical Dementia Rating Sum of Boxes, HR hazard ratio, MCI mild cognitive impairment; societal value of lecanemab ¥15,000,000

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