Marcellusi Andrea, Bini Chiara, Muzii Barbara, Soudani Samira, Kieffer Alexia, Beuvelet Matthieu, Bozzola Elena, Midulla Fabio, Baraldi Eugenio, Bonanni Paolo, Boccalini Sara, Orfeo Luigi
Centre for Economics and International Studies-Economic Evaluation and Health Technology Assessment, Faculty of Economics, University of Rome "Tor Vergata", Rome - Italy.
Sanofi, Rome - Italy.
Glob Reg Health Technol Assess. 2025 Jan 29;12:16-28. doi: 10.33393/grhta.2025.3182. eCollection 2025 Jan-Dec.
To describe the seasonal respiratory syncytial virus (RSV) burden in Italy considering the current prophylaxis strategy with palivizumab recommended only for high-risk infants (representing only 4.4% of an estimated birth cohort) and to evaluate the potential benefits of a new prophylaxis strategy targeting all infants with nirsevimab.
A static decision analytic model previously used in the US was adapted to evaluate the RSV-related health and cost outcomes associated with nirsevimab versus standard of care (SoC) for the prevention of RSV medically attended lower respiratory tract infections (RSV-MA-LRTIs). Monthly probabilities of RSV infections, health events, mortality, and complications associated with RSV infections were obtained from the literature. Costs associated with each event were obtained using the available literature and through real-world data analysis of National Hospital Discharge Records.
For one RSV season, in the current SoC, the model estimated 216,100 RSV-MA-LRTIs, 15,121 associated complications, and 16 RSV-deaths-corresponding to an economic burden of approximately €50.5 million related to RSV-MA-LRTIs management, €10.9 million associated with potential complications due to RSV and €3 million in lost productivity due to RSV-deaths. Nirsevimab is expected to prevent 100,208 RSV-MA-LRTIs, 6,969 complications, and 6 deaths due to RSV infections, corresponding to an economic saving of about €23.3, €5, and €1.2 million, respectively.
Nirsevimab is a new prophylaxis strategy that helps to protect all infants against RSV disease and could substantially reduce the clinical and economic burden of RSV in Italy in infants experiencing their first RSV season.
考虑到目前仅推荐帕利珠单抗用于高危婴儿（仅占估计出生队列的4.4%）的预防策略，描述意大利季节性呼吸道合胞病毒（RSV）负担，并评估针对所有婴儿使用尼塞韦单抗的新预防策略的潜在益处。
采用先前在美国使用的静态决策分析模型，评估与尼塞韦单抗相比，预防RSV相关的医疗就诊下呼吸道感染（RSV-MA-LRTIs）的标准治疗（SoC）的RSV相关健康和成本结果。从文献中获取RSV感染、健康事件、死亡率以及与RSV感染相关并发症的月度概率。使用现有文献并通过对国家医院出院记录的真实世界数据分析获得与每个事件相关的成本。
对于一个RSV季节，在当前的SoC中，模型估计有216,100例RSV-MA-LRTIs、15,121例相关并发症和16例RSV死亡——对应于与RSV-MA-LRTIs管理相关的约5050万欧元经济负担、与RSV潜在并发症相关的1090万欧元以及因RSV死亡导致的300万欧元生产力损失。预计尼塞韦单抗可预防100,208例RSV-MA-LRTIs、6,969例并发症和6例因RSV感染导致的死亡，分别对应约2330万欧元、500万欧元和120万欧元的经济节省。
尼塞韦单抗是一种新的预防策略，有助于保护所有婴儿免受RSV疾病侵害，并可大幅降低意大利首次经历RSV季节的婴儿中RSV的临床和经济负担。
