Ishiwada Naruhiko, Akaishi Rina, Kobayashi Yasuhiro, Togo Kanae, Yonemoto Naohiro, Matsuo Moe, Kaneko Shinnosuke, Law Amy W, Kamei Kazumasa
Department of Infectious Diseases, Medical Mycology Research Center, Chiba University, Chiba, 260-8673, Japan.
Center for Maternal-Fetal, Neonatal and Reproductive Medicine, National Center for Child Health and Development, Tokyo, 157-8535, Japan.
Infect Dis Ther. 2024 Jul;13(7):1665-1682. doi: 10.1007/s40121-024-01000-6. Epub 2024 Jun 5.
Respiratory syncytial virus (RSV) is one of the major causes of respiratory tract infections among children. Until recently, the monoclonal antibody palivizumab was the only RSV prophylaxis available in Japan. In 2024, the bivalent RSV prefusion F protein-based (RSVpreF) vaccine was approved for the prevention of RSV infection in infants by active immunization of pregnant women. In this study, we assessed the cost-effectiveness of a combined strategy of RSVpreF vaccine and palivizumab in Japanese setting.
Using a Markov model, we evaluated prevented cases and deaths of medically attended RSV infections from birth to age 11 months for each of the three healthcare settings: inpatient (hospitalization), emergency department visits, and outpatient visits. Incremental cost-effectiveness ratios (ICERs) were calculated from economic outcomes (intervention costs, medication costs, and productivity losses) and quality-adjusted life years (QALYs). Further, we calculated the maximum price of RSVpreF vaccine within which the program would be cost-effective.
In comparison with the current prophylaxis (palivizumab alone), a combined prophylaxis of year-round RSVpreF vaccination of pregnant women and palivizumab prescription for premature infants born in < 32 weeks gestational age (wGA) and all infants with high risk prevented 14,382 medically attended cases of RSV (hospitalization, 7490 cases; emergency department, 2239 cases; outpatient, 4653 cases) and 7 deaths, respectively. From a healthcare payer perspective, when the price of RSVpreF vaccine was equal to or less than ¥23,948 (US $182), a combination prophylaxis was cost-effective under the ICER threshold of ¥5 million per QALY. The other combination prophylaxis of year-round RSVpreF vaccination and palivizumab prescription of premature born in < 32 wGA regardless of risk in infants was a dominant strategy (more effective and less costly).
A combined prophylaxis of year-round RSVpreF vaccine and palivizumab could be a cost-effective strategy to protect neonates throughout the infant stage (< 1 years old) in Japan.
呼吸道合胞病毒（RSV）是儿童呼吸道感染的主要病因之一。直到最近，单克隆抗体帕利珠单抗仍是日本唯一可用的RSV预防药物。2024年，基于二价RSV预融合F蛋白（RSVpreF）的疫苗被批准用于通过对孕妇进行主动免疫来预防婴儿的RSV感染。在本研究中，我们评估了RSVpreF疫苗和帕利珠单抗联合策略在日本背景下的成本效益。
我们使用马尔可夫模型，针对三种医疗环境（住院、急诊就诊和门诊就诊）中的每一种，评估从出生到11个月大时因就医的RSV感染而预防的病例数和死亡数。增量成本效益比（ICER）根据经济结果（干预成本、药物成本和生产力损失）和质量调整生命年（QALY）计算得出。此外，我们计算了RSVpreF疫苗的最高价格，在此价格范围内该方案具有成本效益。
与当前的预防措施（仅使用帕利珠单抗）相比，对孕周<32周（wGA）出生的早产儿以及所有高危婴儿进行孕妇全年RSVpreF疫苗接种和帕利珠单抗处方的联合预防措施，分别预防了14382例因就医的RSV病例（住院7490例；急诊2239例；门诊4653例）和7例死亡。从医疗保健支付方的角度来看，当RSVpreF疫苗的价格等于或低于23948日元（182美元）时，在每QALY 500万日元的ICER阈值下，联合预防措施具有成本效益。另一种联合预防措施是对孕周<32周出生的早产儿无论婴儿风险如何都进行全年RSVpreF疫苗接种和帕利珠单抗处方，这是一种占优策略（更有效且成本更低）。
在日本，全年RSVpreF疫苗和帕利珠单抗联合预防措施可能是一种在婴儿期（<1岁）保护新生儿的具有成本效益的策略。
