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

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.

Cost-effectiveness analysis of lemborexant for treating insomnia in Japan: a model-based projection, incorporating the risk of falls, motor vehicle collisions, and workplace accidents.

BACKGROUND: Lemborexant has demonstrated statistically significant improvements in sleep onset and sleep maintenance compared with placebo and zolpidem tartrate extended release, measured both objectively using polysomnography and subjectively using sleep diaries, in the phase 3 clinical trial SUNRISE 1. This study evaluated the cost-effectiveness of lemborexant compared with suvorexant, zolpidem immediate release (IR), and untreated insomnia. METHODS: A decision-tree model was developed for falls, motor vehicle collisions, and workplace accidents associated with insomnia and insomnia treatments from a Japanese healthcare perspective and with a 6-month time horizon. The model extracted subjective sleep onset latency treatment responses and disutility values for non-responders from SUNRISE 1. Cost-effectiveness was assessed using incremental cost per quality-adjusted life year (QALY) gained. One-way and probabilistic sensitivity analyses were conducted to evaluate the impact of parameter uncertainty on the results. RESULTS: In the base-case analysis, the mean estimated QALYs for lemborexant, suvorexant, zolpidem-IR, and untreated insomnia were 0.4220, 0.4204, 0.4113, and 0.4163, and expected medical costs were JPY 34 034, JPY 38 371, JPY 38 139, and JPY 15 383, respectively. Lemborexant saved JPY 4337 and JPY 4105 compared with suvorexant or zolpidem-IR, respectively, while conferring QALY benefits. The incremental cost-effectiveness ratio (ICER) of lemborexant compared with that of untreated insomnia was JPY 3 220 975 /QALY. Lemborexant was dominant over suvorexant and zolpidem-IR and was cost-effective when compared with untreated insomnia. Sensitivity analyses supported the results' robustness. CONCLUSIONS: In a Japanese clinical practice setting, lemborexant may represent a better investment for treating insomnia in the healthcare system in Japan.

Investigation of Evidence Sources for Health-Related Quality of Life in Cost-Utility Analysis of Pharmaceuticals in Japan.

OBJECTIVE: To provide an overview of how current utility values were obtained in the cost-utility analysis (CUA) for pharmaceuticals in Japan on the basis of methodological guidelines developed in England and Wales, Australia, Canada, France, and Japan by conducting a systematic review of the published literature. METHODS: We searched and reviewed CUAs conducted for pharmaceuticals in Japan, reporting the results as cost per quality-adjusted life-year (QALY). The databases we used were PubMed, EconLit, Centre for Reviews and Dissemination, and the Japan Medical Abstracts Society. The search terms were "QALY" and "Japan" or "cost utility" and "Japan" in the PubMed database, Centre for Reviews and Dissemination, and EconLit. In the search on the Japan Medical Abstracts Society database, we used the term "QALY." RESULTS: In total, 41 CUA articles met the selection criteria and the most common method of obtaining utility values was derived from the published literature (31 CUAs, 168 utility values). Five CUAs were elicited by directly asking the participants regarding their own health state, and four CUAs used "mapping" techniques in which utility values were linked to clinical results. The most commonly used instrument was the EuroQol five-dimensional questionnaire followed by the time-trade-off. A few CUAs mentioned how they selected the literature for the utility values, and some utility values were combined across different sources, using different methods, and obtained from different locations. CONCLUSIONS: Practical methodological guidelines need to be developed to provide standardized methods of presenting the procedure of using utility values from the literature. Although transferability of utility values across jurisdictions has not been discussed fully, this topic should be covered in methodological guidelines and recommend best practices for evaluations.