Polistena Barbara, Midulla Fabio, Sotgiu Giovanni, d'Angela Daniela, Di Virgilio Roberto, Spandonaro Federico
Dept. of "Economia e Finanza", University of Rome Tor Vergata, Rome, Italy.
C.R.E.A. Sanità, Rome, Italy.
Infect Dis Ther. 2025 Jul 18. doi: 10.1007/s40121-025-01193-4.
Respiratory Syncytial Virus (RSV) is a leading cause of severe lower respiratory tract infections and is one of the primary causes of hospitalization in high income countries and death among children aged ≤ 1 year in lower income countries where the healthcare systems not always have the resources to provide appropriate intensive care to all infants with severe RSV infection. On the basis of the results of a large programme of clinical trials, the European Medicine Agency has recently approved a Bivalent Stabilized Prefusion F Subunit Vaccine (RSVpreFV) for maternal immunization, with a year-round administration between 24-36 weeks of gestation. The objective of the study is providing an estimation of the efficiency of complementary strategy RSVpreF and monoclonal antibodies for the prevention of RSV among Italian infants.
Using a model (with a cohort framework and a Markov-type process) specifically adapted to the Italian context, the study provided cost-effectiveness and cost-utility assessment of prevention strategies adding the maternal vaccination to the existing immunization opportunities with palivizumab or nirsevimab administered to high risk and unprotected infants.
The complementary strategy RSVpreFV plus palivizumab demonstrates significative health benefits versus palivizumab alone: it would reduce annual hospitalizations by 4097 cases (-25.8%), Emergency Department (ED) admissions not followed by hospitalization by 534 (-18.8%), with 25 years of life recovered, and an increase of 90 Quality Adjusted Life Years (QALYs). The strategy results cost-saving: the complementary strategy saves € 6.0 mil and € 8.4 mil per year in the NHS and in the Societal perspective, respectively; the complementary strategies of maternal vaccination plus nirsevimab also prove to have significant benefits versus the monoclonal antibody alone, providing a decrease equal to 941 annual hospitalizations (-9.0%), 6 years of life recovered, and an increase of 20 QALYs. The strategy saves € 2.6 mil and € 3.1 mil per year in the NHS and in the Societal perspective, respectively.
RSV is a leading cause of severe lower respiratory tract infections and is one of the primary causes of hospitalization in high income countries and death among children aged ≤ 1 year in lower income; bivalent Stabilized Prefusion F Subunit Vaccine (RSVpreFV) for maternal immunization proves to be effective in preventing RSV infections, avoiding severe disease. The modelling exercise shows that the complementary strategy of maternal vaccination with palivizumab or nirsevimab are both dominant (better health outcomes with lower costs) on monoclonal antibodies alone; the sensitivity analysis confirms that the complementary strategies in most of the simulation remain dominant or cost-effective adopting a low threshold for the willingness to pay; finally the complementary strategies are also sustainable, owing to a limited impact on the current national budget for vaccines.
呼吸道合胞病毒（RSV）是严重下呼吸道感染的主要病因之一，在高收入国家是住院的主要原因之一，在低收入国家是1岁及以下儿童死亡的主要原因之一，因为这些国家的医疗系统往往没有足够资源为所有患有严重RSV感染的婴儿提供适当的重症监护。基于一项大型临床试验项目的结果，欧洲药品管理局最近批准了一种用于孕产妇免疫的二价稳定前融合F亚单位疫苗（RSVpreFV），在妊娠24 - 36周期间全年均可接种。本研究的目的是评估补充策略RSVpreF和单克隆抗体在预防意大利婴儿RSV感染方面的效果。
该研究使用了一个专门针对意大利情况进行调整的模型（具有队列框架和马尔可夫型过程），对在现有为高危和未受保护婴儿接种帕利珠单抗或尼塞韦单抗的免疫机会基础上增加孕产妇疫苗接种的预防策略进行了成本效益和成本效用评估。
与单独使用帕利珠单抗相比，补充策略RSVpreFV加帕利珠单抗显示出显著的健康益处：每年可减少4097例住院病例（-25.8%），减少534例未住院的急诊科（ED）就诊病例（-18.8%），挽回25年生命，并增加90个质量调整生命年（QALY）。该策略还节省成本：从国民健康服务体系（NHS）和社会角度来看，补充策略分别每年节省600万欧元和840万欧元；孕产妇疫苗接种加尼塞韦单抗的补充策略与单独使用单克隆抗体相比也显示出显著益处，每年减少941例住院病例（-9.0%），挽回6年生命，并增加20个QALY。从NHS和社会角度来看，该策略分别每年节省260万欧元和310万欧元。
RSV是严重下呼吸道感染的主要病因之一，在高收入国家是住院的主要原因之一，在低收入国家是1岁及以下儿童死亡的主要原因之一；用于孕产妇免疫的二价稳定前融合F亚单位疫苗（RSVpreFV）被证明可有效预防RSV感染，避免严重疾病。建模分析表明，孕产妇接种疫苗与帕利珠单抗或尼塞韦单抗的补充策略相对于单独使用单克隆抗体均具有优势（以更低成本获得更好的健康结果）；敏感性分析证实，在大多数模拟中，采用较低的支付意愿阈值时，补充策略仍具有优势或具有成本效益；最后，由于对当前国家疫苗预算的影响有限，补充策略也是可持续的。
