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

Abstract

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 phaseIII 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. A disease simulation model was used to evaluate the impact of lecanemab on disease progression in early AD based on data from the phaseIII 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 DiseaseII 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. Over a lifetime horizon, patients treated with lecanemab plus SoC gained an additional 0.73LYs compared with SoC alone (8.50years vs. 7.77years). Lecanemab, with an average treatment duration of 3.68years, 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 (JPY5-15 million per QALY gained) and the perspective employed. From the narrow healthcare payer's perspective, it ranged from JPY1,331,305 to JPY3,939,399. From the broader healthcare payer's perspective, it ranged from JPY1,636,827 to JPY4,249,702, while from the societal perspective, it ranged from JPY1,938,740 to JPY4,675,818. 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.