Bini Chiara, Marcellusi A, Cazzato D, Muzii B, Soudani S, Bozzola E, Midulla F, Baraldi E, Bonanni P, Boccalini S, Orfeo L
Centre for Economics and International Studies-Economic Evaluation and Health Technology Assessment, Faculty of Economics, University of Rome "Tor Vergata", via Columbia 2, 00133, Rome, Italy.
Department of Pharmaceutical Sciences-DISFARM, University of Milan, via G. Colombo, 71, 20133, Milan, Italy.
Clin Drug Investig. 2025 Jun;45(6):347-361. doi: 10.1007/s40261-025-01437-8. Epub 2025 May 3.
Respiratory syncytial virus (RSV) is a major global cause of childhood respiratory infections, globally linked to significant morbidity and mortality, particularly leading in hospitalizations and death among infants below 1 year of age. A cost-effectiveness analysis was conducted to estimate the economically justifiable price (EJP) of nirsevimab, a new prophylaxis strategy protecting all infants against RSV lower respiratory tract infections (LRTIs), compared with a strategy consisting of palivizumab, protecting only high-risk infants and no preventive intervention for others.
A static decision tree model previously published to evaluate the clinical and economic burden of RSV in Italy was used to determine the EJP of nirsevimab for the prevention of RSV medically attended lower respiratory tract infections (RSV-MA-LRTIs) in all infants experiencing their first RSV season, to become a cost-effective alternative compared with palivizumab only in high-risk infants and no preventive intervention for others. The EJP was estimated considering three different willingness-to-pay (WTP) thresholds. The National Health Service (NHS) perspective was considered in the base-case. Direct costs considered in the analysis were acquisition and administration costs of prophylaxis, costs of managing RSV infection (inpatient and outpatient care, and emergency department visits) and costs of handling complications following hospitalization per RSV event. Indirect costs were evaluated in the scenario analysis as productivity loss due to premature death for RSV infection. A discount rate of 3.0% was applied only to mid-long-term costs and outcomes.
From the NHS perspective, over the first RSV season, nirsevimab in an all-infants population could be a cost-effective approach compared with palivizumab only in high-risk infants, with an EJP equal to €267, €365, and €400 considering a WTP threshold of €0, €22,000, and €30,000 per QALY saved, respectively. Considering only the palivizumab-eligible population, the model estimated that nirsevimab could be a cost-effective approach with an EJP equal to €3,467, €3,633, and €3,694 considering a WTP threshold of €0, €22,000, and €30,000 per QALY saved, respectively.
A prophylaxis strategy against RSV infection targeting all infants with nirsevimab could represent a cost-effective option for both NHS and societal perspectives, and supports the implementation and the equity of RSV prevention for all infants.
呼吸道合胞病毒（RSV）是全球儿童呼吸道感染的主要病因，在全球范围内与显著的发病率和死亡率相关，尤其导致1岁以下婴儿住院和死亡。进行了一项成本效益分析，以估计nirsevimab（一种保护所有婴儿免受RSV下呼吸道感染（LRTIs）的新预防策略）的经济合理价格（EJP），并与仅由帕利珠单抗组成的策略进行比较，后者仅保护高危婴儿，而对其他婴儿不进行预防干预。
使用先前发表的用于评估意大利RSV临床和经济负担的静态决策树模型，来确定nirsevimab预防所有经历首个RSV季节的婴儿发生RSV所致需就医的下呼吸道感染（RSV-MA-LRTIs）的EJP，使其成为与仅用于高危婴儿的帕利珠单抗相比且对其他婴儿不进行预防干预时具有成本效益的替代方案。考虑了三个不同的支付意愿（WTP）阈值来估计EJP。在基础案例中采用了国家医疗服务体系（NHS）的视角。分析中考虑的直接成本包括预防措施的采购和管理成本、RSV感染管理成本（住院和门诊护理以及急诊科就诊）以及每次RSV事件住院后处理并发症的成本。在情景分析中，间接成本评估为因RSV感染过早死亡导致的生产力损失。仅对中长期成本和结果应用3.0%的贴现率。
从NHS的角度来看，在首个RSV季节，对于所有婴儿使用nirsevimab与仅对高危婴儿使用帕利珠单抗相比可能是一种具有成本效益的方法，考虑每挽救一个质量调整生命年（QALY）的WTP阈值分别为0欧元、22,000欧元和30,000欧元时，EJP分别为267欧元、365欧元和400欧元。仅考虑符合使用帕利珠单抗条件的人群，模型估计，考虑每挽救一个QALY的WTP阈值分别为0欧元、22,000欧元和30,000欧元时，nirsevimab可能是一种具有成本效益的方法，EJP分别为3,467欧元、3,633欧元和3,694欧元。
针对所有婴儿使用nirsevimab预防RSV感染的策略，从NHS和社会角度来看都可能是一种具有成本效益的选择，并支持对所有婴儿实施RSV预防措施及其公平性。
