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估计在西班牙,与预防新生儿和婴儿呼吸道合胞病毒感染的标准治疗方法相比,nirsevimab的经济合理价格:一项成本效用模型研究。

Estimating the economically justifiable price of nirsevimab versus standard of practice for the prevention of respiratory syncytial virus infections in neonates and infants in Spain: a cost-utility modelling study.

作者信息

Gil-Prieto Ruth, Pérez-Martín Jaime, Díaz Aguiló Ariadna, Soudani Samira, Platero-Alonso Leticia, López-Belmonte Juan Luis, de la Cuadra-Grande Alberto, Casado Miguel Ángel, Álvarez Aldean Javier

机构信息

Department of Medical Specialties and Public Health, University Rey Juan Carlos, Madrid, Spain.

General Directorate of Public Health and Addictions, Murcia, Spain.

出版信息

BMJ Public Health. 2025 Jul 31;3(2):e002441. doi: 10.1136/bmjph-2024-002441. eCollection 2025.

Abstract

INTRODUCTION

Respiratory syncytial virus (RSV) causes great morbidity and mortality among newborns. Nirsevimab represents a prophylactic alternative used in Spain for a universal prophylaxis strategy of all infants. The aim of this study was to estimate the economically justifiable price (EJP) of nirsevimab in Spain, being the price to consider nirsevimab efficient compared with the standard of practice (administration of palivizumab in eligible infants and no intervention in all other).

METHODS

An economic model based on a decision tree was developed to conduct a cost-utility analysis. The RSV epidemiology, RSV-related health events, clinical variables, resources consumption, costs and utilities were derived from the scientific literature and agreed by a multidisciplinary advisory board. The analyses included the universal immunisation of all infants with nirsevimab, considering both payer and societal perspectives. The EJPs were estimated considering the following willingness-to-pay (WTP) thresholds: €0/quality-adjusted life-year (QALY), €22 000/QALY and €30 000/QALY. Alternative scenarios (including immunisation strategy targeted at high-risk infants), deterministic and probabilistic sensitivity analyses were also conducted.

RESULTS

The prophylaxis with nirsevimab in all infants averted 215 878 RSV events, 9 deaths, avoided 1307 QALYs lost and reduced €48.4 and €17.3 million in direct and indirect costs. For a payer perspective, at those WTP thresholds, the EJPs resulted in €222.27, €320.52 and €356.25, raising to €281.47, €379.72 and €415.45 for a societal perspective. The robustness of the model and its results was confirmed by alternative scenarios and sensitivity analyses.

CONCLUSIONS

Nirsevimab reduces RSV-related health events, leading to cost savings and avoided QALY loss associated with RSV infection in infants compared to the previous standard of practice. This study provides a range of cost-effective prices that would lead nirsevimab to be an efficient intervention, or even dominant (achieves better outcomes and produces cost savings), compared with the standard of-practice for RSV prevention, being key for decision-making in public health.

摘要

引言

呼吸道合胞病毒(RSV)在新生儿中导致了很高的发病率和死亡率。尼塞韦单抗是西班牙用于所有婴儿普遍预防策略的一种预防性替代药物。本研究的目的是估计尼塞韦单抗在西班牙的经济合理价格(EJP),即与实践标准(对符合条件的婴儿使用帕利珠单抗,对所有其他婴儿不进行干预)相比,认为尼塞韦单抗有效的价格。

方法

开发了一个基于决策树的经济模型来进行成本-效用分析。RSV流行病学、RSV相关健康事件、临床变量、资源消耗、成本和效用均来自科学文献,并经多学科咨询委员会认可。分析包括所有婴儿使用尼塞韦单抗进行普遍免疫,同时考虑支付方和社会视角。考虑以下支付意愿(WTP)阈值来估计EJP:0欧元/质量调整生命年(QALY)、22000欧元/QALY和30000欧元/QALY。还进行了替代方案(包括针对高危婴儿的免疫策略)、确定性和概率敏感性分析。

结果

所有婴儿使用尼塞韦单抗进行预防可避免215878例RSV事件、9例死亡,避免1307个QALY损失,并减少4840万欧元和1730万欧元的直接和间接成本。从支付方角度看,在这些WTP阈值下,EJP分别为222.27欧元、320.52欧元和356.25欧元,从社会角度看则升至281.47欧元、379.72欧元和415.45欧元。替代方案和敏感性分析证实了模型及其结果的稳健性。

结论

与之前的实践标准相比,尼塞韦单抗可减少与RSV相关的健康事件,从而节省成本并避免婴儿因RSV感染而导致的QALY损失。本研究提供了一系列具有成本效益的价格,与RSV预防的实践标准相比,这些价格将使尼塞韦单抗成为一种有效的干预措施,甚至是主导性措施(取得更好的结果并节省成本),这对公共卫生决策至关重要。

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