Unit of PharmacoEpidemiology & PharmacoEconomics (PE(2)), Department of Pharmacy, University of Groningen, Groningen, The Netherlands.
Vaccine. 2012 Jun 29;30(31):4691-700. doi: 10.1016/j.vaccine.2012.04.072. Epub 2012 May 2.
Respiratory syncytial virus (RSV) infection is one of the major causes of respiratory illness in infants, infecting virtually every child before the age of 2 years. Currently, several Phase 1 trials with RSV vaccines in infants are ongoing or have been completed. As yet, no efficacy estimates are available for these vaccine candidates. Nevertheless, cost-effectiveness estimates might be informative to enable preliminary positioning of an RSV vaccine.
A decision analysis model was developed in which a Dutch birth cohort was followed for 12 months. A number of potential vaccination strategies were reviewed such as vaccination at specific ages, a two- or three-dosing scheme and seasonal vaccination versus year-round vaccination. The impact of the assumptions made was explored in various sensitivity analyses, including probabilistic analysis. Outcome measures included the number of GP visits, hospitalizations and deaths, costs, quality-adjusted life years and incremental cost-effectiveness ratios (ICERs).
Currently, without vaccination, an annual number of 28,738 of RSV-related GP visits, 1623 hospitalizations, and 4.5 deaths are estimated in children in the age of 0-1 year. The total annual cost to society of RSV in the non-vaccination scenario is €7.7 million (95%CI: 1.7-16.7) and the annual disease burden is estimated at 597 QALYs (95%CI: 133-1319). In case all infants would be offered a potentially safe and effective 3-dose RSV vaccination scheme at the age of 0, 1 and 3 months, the total annual net costs were estimated to increase to €21.2 million, but 544 hospitalizations and 1.5 deaths would be averted. The ICER was estimated at €34,142 (95%CI: € 21,652-€ 87,766) per QALY gained. A reduced dose schedule, seasonal vaccination, and consideration of out-of-pocket expenses all resulted in more favorable ICER values, whereas a reduced vaccine efficacy or a delay in the timing of vaccination resulted in less favorable ICERs.
Our model used recently updated estimates on the burden of RSV disease in children and it included plausible utilities. However, due to the absence of clinical trial data, a number of crucial assumptions had to be made related to the characteristics of potential RSV vaccine. The outcomes of our modeling exercise show that vaccination of infants against RSV might be cost-effective. However, clinical trial data are warranted.
呼吸道合胞病毒（RSV）感染是婴儿呼吸道疾病的主要病因之一，几乎每个孩子在 2 岁之前都会感染 RSV。目前，正在进行或已经完成了几项针对婴儿 RSV 疫苗的 1 期临床试验。然而，这些候选疫苗还没有疗效估计。尽管如此，成本效益估计可能有助于初步定位 RSV 疫苗。
本研究开发了一种决策分析模型，该模型对 12 个月的荷兰出生队列进行了随访。审查了一些潜在的疫苗接种策略，例如在特定年龄接种疫苗、两剂或三剂方案以及季节性接种与全年接种。在各种敏感性分析中，包括概率分析，探讨了假设的影响。结果测量包括 GP 就诊次数、住院次数和死亡人数、成本、质量调整生命年和增量成本效益比（ICER）。
目前，如果不接种疫苗，预计 0-1 岁儿童每年会有 28738 次与 RSV 相关的 GP 就诊、1623 次住院和 4.5 次死亡。在非疫苗接种情况下，RSV 给社会造成的年度总成本为 770 万欧元（95%CI：170-1670 万欧元），疾病负担估计为 597 个质量调整生命年（95%CI：133-1319 个质量调整生命年）。如果所有婴儿都在 0、1 和 3 个月时接种潜在安全有效的 3 剂 RSV 疫苗接种方案，预计每年的净成本将增加到 2120 万欧元，但可以避免 544 次住院和 1.5 次死亡。ICER 估计为 34142 欧元（95%CI：21652-87766 欧元）/每获得一个质量调整生命年。减少剂量方案、季节性接种和考虑自付费用都会导致更有利的 ICER 值，而疫苗效力降低或接种时间延迟则会导致不太有利的 ICER 值。
我们的模型使用了最近更新的儿童 RSV 疾病负担估计数据，并纳入了合理的效用值。然而，由于缺乏临床试验数据，许多与潜在 RSV 疫苗特性相关的关键假设都必须做出。我们的建模结果表明，婴儿接种 RSV 疫苗可能具有成本效益。然而，需要临床试验数据。
