Tahami Monfared Amir Abbas, Ye Weicheng, Sardesai Aditya, Folse Henri, Chavan Ameya, Kang Kang, Zhang Quanwu
Eisai Inc., 200 Metro Blvd, Nutley, NJ, 07110, USA.
McGill University, Epidemiology, Biostatistics, and Occupational Health, Montreal, QC, Canada.
Neurol Ther. 2023 Jun;12(3):795-814. doi: 10.1007/s40120-023-00460-1. Epub 2023 Mar 16.
Alzheimer's disease (AD) is a progressive neurodegenerative disorder associated with memory, cognitive, and behavioral deficits, and brings significant economic burden on caregivers and healthcare systems. This study aims to estimate the long-term societal value of lecanemab plus standard of care (SoC) versus SoC alone, corresponding to a range of willingness-to-pay (WTP) thresholds based on the phase III CLARITY AD trial readouts from both the US payer and societal perspectives.
An evidence-based model was developed to simulate the effects of lecanemab on disease progression in early AD using interconnected predictive equations based on longitudinal clinical and biomarker data derived from the Alzheimer's Disease Neuroimaging Initiative (ADNI). The model was informed with the results of the phase III CLARITY AD trial and published literature. Key model outcomes included patient life-years (LYs), quality-adjusted life-years (QALYs), and total costs of both the direct and indirect costs of patients and caregivers over a lifetime horizon.
Patients treated with lecanemab plus SoC gained an additional 0.62 years of life versus SoC alone (6.23 years vs. 5.61 years). The mean time on lecanemab was 3.91 years, and the treatment was associated with an increase in patient QALYs of 0.61 and an increase in total QALYs of 0.64 when both patient and caregiver utilities were considered. The model estimated that the annual value of lecanemab for the US payer perspective was US$18,709-35,678 ($19,710-37,351 for societal perspective) at the WTP threshold of $100,000-200,000 per QALY gained, respectively. Scenario analyses of patient subgroups, time horizon, input sources, treatment stopping rules, and treatment dosing were conducted to explore the impact of alternative assumptions on the model results.
The economic study suggested that lecanemab plus SoC would improve health and humanistic (quality of life) outcomes and reduce economic burden for patients and caregivers in early AD.
阿尔茨海默病(AD)是一种进行性神经退行性疾病,与记忆、认知和行为缺陷相关,给护理人员和医疗保健系统带来了巨大的经济负担。本研究旨在根据美国支付方和社会视角的III期CLARITY AD试验结果,估计lecanemab联合标准治疗(SoC)与单纯SoC相比的长期社会价值,对应一系列支付意愿(WTP)阈值。
开发了一个基于证据的模型,使用来自阿尔茨海默病神经影像倡议(ADNI)的纵向临床和生物标志物数据的相互关联的预测方程,模拟lecanemab对早期AD疾病进展的影响。该模型参考了III期CLARITY AD试验的结果和已发表的文献。关键模型结果包括患者生命年(LYs)、质量调整生命年(QALYs)以及患者和护理人员一生的直接和间接成本的总成本。
与单纯SoC相比,接受lecanemab联合SoC治疗的患者多获得了0.62年的生命(6.23年对5.61年)。lecanemab的平均治疗时间为3.91年,当同时考虑患者和护理人员的效用时,该治疗使患者QALYs增加了0.61,总QALYs增加了0.64。该模型估计,在美国支付方视角下,每获得一个QALY的WTP阈值为100,000 - 200,000美元时,lecanemab的年度价值为18,709 - 35,678美元(社会视角为19,710 - 37,351美元)。对患者亚组、时间范围、输入来源、治疗停止规则和治疗剂量进行了情景分析,以探讨替代假设对模型结果的影响。
这项经济研究表明,lecanemab联合SoC将改善早期AD患者的健康和人文(生活质量)结果,并减轻患者和护理人员的经济负担。