Noto Shinichi, Kieffer Alexia, Soudani Samira, Arashiro Takeshi, Tadera Chiho, Eymere Sebastien, Lemański Tobiasz, Wang Xinyu
Department of Rehabilitation, Niigata University of Health and Welfare, Niigata, Japan.
Health Economics and Value Assessment, Sanofi, Lyon, France.
Infect Dis Ther. 2025 Apr;14(4):847-865. doi: 10.1007/s40121-025-01134-1. Epub 2025 Mar 28.
Respiratory syncytial virus (RSV) is a common cause of lower respiratory tract disease, and the standard prevention strategy in Japan is limited to high-risk infants. Nirsevimab provides protection against medically attended (MA) RSV infection in healthy late-preterm and term infants and was approved in Japan in 2024. This study estimates the cost-effectiveness of universal immunization with nirsevimab in an all-infant population from the Japanese public healthcare payer perspective.
A static decision analytic model, able to track costs and health outcomes in a cohort of infants, was adapted to the Japanese setting. The standard of care, palivizumab, administered to high-risk infants, was compared with nirsevimab administrated to all infants in the first year, and an additional increased dose of nirsevimab (200 mg) in the second season for high-risk infants. Differences in costs and quality-adjusted life years (QALYs) were captured considering RSV-related MA health events requiring inpatient hospitalizations, emergency room visits, and primary care visits, as well as RSV-related complications. Sensitivity and scenario analyses were conducted to explore the robustness and uncertainty of the study.
Assuming a price of ¥45,000 for nirsevimab, universal immunization with nirsevimab was found to be cost-effective with an incremental cost-effectiveness ratio (ICER) of ¥4,537,256/QALY. At the Japanese willingness-to-pay threshold of ¥5,000,000, the economically justifiable price was ¥45,496. Using the societal perspective, the ICER decreased to ¥1,695,635/QALY. Nirsevimab has a substantial public health impact on RSV disease burden, reducing approximately 50% of RSV-associated health events in an all-infant population.
The analysis demonstrated that universal prophylaxis strategy with nirsevimab would significantly reduce the health and economic burden associated with RSV among infants in Japan. At the assumed price, nirsevimab can provide a cost-effective prophylaxis option against RSV infection in an all-infant population not limited to infants born prematurely or with high risk.
呼吸道合胞病毒（RSV）是下呼吸道疾病的常见病因，日本的标准预防策略仅限于高危婴儿。尼塞韦单抗可预防健康的晚期早产儿和足月儿发生需就医的（MA）RSV感染，并于2024年在日本获批。本研究从日本公共医疗支付方的角度评估了在所有婴儿群体中普遍接种尼塞韦单抗的成本效益。
采用一个静态决策分析模型，该模型能够追踪一组婴儿的成本和健康结果，并将其应用于日本的情况。将给予高危婴儿的标准治疗药物帕利珠单抗与第一年给予所有婴儿的尼塞韦单抗，以及第二年给予高危婴儿额外增加剂量（200毫克）的尼塞韦单抗进行比较。考虑到与RSV相关的需住院治疗、急诊就诊和初级保健就诊的MA健康事件以及RSV相关并发症，计算成本和质量调整生命年（QALY）的差异。进行敏感性分析和情景分析以探讨研究的稳健性和不确定性。
假设尼塞韦单抗价格为45000日元，普遍接种尼塞韦单抗具有成本效益，增量成本效益比（ICER）为4537256日元/QALY。在日本5000000日元的支付意愿阈值下，经济上合理的价格为45496日元。从社会角度来看，ICER降至1695635日元/QALY。尼塞韦单抗对RSV疾病负担具有重大的公共卫生影响，可减少所有婴儿群体中约50%的RSV相关健康事件。
分析表明，在日本，采用尼塞韦单抗的普遍预防策略将显著降低婴儿中与RSV相关的健康和经济负担。在假设价格下，尼塞韦单抗可为所有婴儿群体（不限于早产儿或高危婴儿）提供一种具有成本效益的预防RSV感染的选择。
