Data Sheet 1_Burden of respiratory syncytial virus disease in infants and the potential value of maternal immunization in Greece.pdf

ObjectiveThe objective was to assess the burden of respiratory syncytial virus (RSV) and evaluate the cost-effectiveness of maternal vaccination using the bivalent RSV prefusion F-protein (RSVpreF) vaccine to prevent RSV infections among Greek infants.
MethodsA Markov model was adapted from the perspective of a public payer to simulate the health and economic outcomes of RSV from birth to 1 year of age. Key inputs for the model, including vaccine efficacy, utility values, epidemiological data, and direct medical costs [prices in euros (€), 2024], were obtained from official sources. Model main outcomes were medically attended RSV cases, RSV-related deaths, quality-adjusted life-years (QALY) gained, direct medical costs and incremental cost-effectiveness ratios (ICER).
ResultsThe model analysis estimated that the annual number of RSV medically attended cases would be 21,935, with 22% requiring hospitalization, 32% managed in the emergency department (ED), and the remaining cases treated in outpatient settings. Furthermore, 11 RSV-related deaths were estimated. These cases represent a significant economic burden, with direct medical costs of ~€26 million. With a year-round maternal RSVpreF vaccination coverage of 19.5%, over 1,200 RSV medically-attended cases could be prevented annually. Vaccination benefits translated to 31 additional QALYs compared with no vaccination. Thus, the model analysis indicated that RSVpreF vaccination is a cost-effective strategy, resulting in an ICER of €8,280 per QALY gained compared to no vaccination.
ConclusionAdministering maternal RSVpreF vaccination year-round can provide protection to infants against RSV from birth. From a payer perspective, maternal RSVpreF vaccination has been evaluated as a cost-effective alternative compared to no intervention, underscoring its value as a preventive strategy against RSV in Greece.

研究目标：本研究旨在评估呼吸道合胞病毒（respiratory syncytial virus, RSV）的疾病负担，并评估采用二价呼吸道合胞病毒预融合F蛋白（RSVpreF）疫苗开展孕产妇接种，以预防希腊婴儿RSV感染的成本效益。
研究方法：本研究从公共支付方视角适配马尔可夫模型（Markov model），模拟婴儿从出生至1岁期间的RSV感染健康与经济结局。模型关键输入参数包括疫苗效力、效用值、流行病学数据以及直接医疗成本（以2024年欧元计价），均来源于官方公开数据源。模型主要结局指标包括：需医疗干预的RSV感染病例数、RSV相关死亡数、质量调整寿命年（quality-adjusted life-years, QALY）增益、直接医疗成本及增量成本效果比（incremental cost-effectiveness ratios, ICER）。
研究结果：模型分析估算，年度需医疗干预的RSV感染病例数为21935例，其中22%需住院治疗、32%在急诊室（emergency department, ED）处置，剩余病例于门诊医疗机构就诊。此外，估算RSV相关死亡病例11例。此类感染带来显著经济负担，直接医疗成本约2600万欧元。当孕产妇全年RSVpreF疫苗接种覆盖率达19.5%时，每年可减少超过1200例需医疗干预的RSV感染病例。与未接种方案相比，接种可额外获得31个质量调整寿命年。综上，模型分析显示RSVpreF疫苗接种为具有成本效益的干预策略，相较于未接种方案，其增量成本效果比为每获得1个QALY 8280欧元。
研究结论：全年开展孕产妇RSVpreF疫苗接种，可使婴儿自出生起获得RSV感染防护。从支付方视角来看，孕产妇RSVpreF疫苗接种相较于无干预方案，被评估为具有成本效益的替代选择，凸显其作为希腊RSV预防策略的应用价值。