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Respiratory syncytial virus immunization program for the United States: Impact of performance determinants of a theoretical vaccine

机译：美国呼吸道合胞病毒免疫计划：理论疫苗性能决定因素的影响

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Objectives: To inform strategic decisions on respiratory syncytial virus (RSV) vaccine development and identify critical endpoints likely to drive the vaccine's medical and economic impact. Design: A decision-analysis model populated using healthcare utilization data and costs from the literature; vaccine efficacy and duration based on assumptions. Setting: Vaccination in the physician office setting in the USA. Participants: A hypothetical cohort of newborn infants. Intervention: Vaccination of children at low and high risk of respiratory sequelae with a theoretical RSV vaccine vs palivizumab prophylaxis for children at high risk. Outcome measures: Medical and economic value of RSV vaccination, including cost per quality adjusted life-year (QALY) gained. Results: Using base-case assumptions (efficacy 50% at birth; half-life 12 months), RSV vaccination would prevent 23,069 hospitalizations and 66 deaths per vaccinated birth cohort in the USA. Excluding vaccination costs, direct medical costs for RSV would reduce by $236 million, and income and productivity losses by $134 million. Assuming a vaccine cost per course similar to Rotarix (R) in the USA ($232 including administration fees), the cost per QALY gained would be $93,401 (95% CI: $65,815-$126,060) from the healthcare system perspective and $65,115 (95% CI: $41,003-$93,679) from the societal perspective. The net cost (healthcare system perspective) per life-year saved would be $216,120 (95% CI: $161,184-$263,981); the cost per hospitalization averted would be $19,172 (95% CI: $14,679-$22,093). Aside from efficacy, the vaccine's impact is sensitive to the start of protective immunity and the duration of protection. Conclusions: Development of an RSV vaccine would substantially reduce inpatient hospitalizations and outpatient visits. It would also have an impact on infant mortality. To demonstrate the full medical and economic value of the vaccine, appropriate endpoints or endpoint surrogates for hospitalization, mortality, and total case reductions should be collected during vaccine development. (C) 2013 Elsevier Ltd. All rights reserved.
机译：目标：告知有关呼吸道合胞病毒（RSV）疫苗开发的战略决策，并确定可能推动该疫苗的医疗和经济影响的关键终点。设计：使用医疗保健利用率数据和文献成本填充的决策分析模型;疫苗效力和持续时间基于假设。地点：在美国的医师办公室进行疫苗接种。参与者：新生婴儿的假想队列。干预：理论上RSV疫苗为低和高风险的呼吸性后遗症儿童接种疫苗，而帕利珠单抗预防为高风险的儿童。成果措施：RSV疫苗接种的医学和经济价值，包括每质量调整生命年（QALY）获得的成本。结果：使用基本案例假设（出生时的效率为50％;半衰期为12个月），在美国，RSV疫苗接种将预防23,069例住院和每名接种出生队列的66例死亡。除去疫苗接种费用，RSV的直接医疗费用将减少2.36亿美元，收入和生产力损失将减少1.34亿美元。假设每个疗程的疫苗费用与美国的Rotarix（R）相似（232美元，包括管理费），那么从医疗保健系统的角度来看，每获得QALY的费用将为93,401美元（95％CI：65,815-126,060美元），以及65,115美元（95％CI） ：$ 41,003- $ 93,679）。每个生命年节省的净成本（从医疗保健系统的角度来看）将为$ 216,120（95％CI：$ 161,184- $ 263,981）;避免的每次住院费用为$ 19,172（95％CI：$ 14,679- $ 22,093）。除了功效外，疫苗的影响还对保护性免疫的开始和保护期很敏感。结论：RSV疫苗的开发将大大减少住院病人的住院和门诊就诊人数。这也将对婴儿死亡率产生影响。为了证明疫苗的全部医学和经济价值，应在疫苗开发过程中收集住院，死亡率和总病例数减少的适当终点或终点替代指标。 （C）2013 Elsevier Ltd.保留所有权利。

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