Center for Observational and Real-World Evidence, Merck & Co., Inc., Kenilworth, NJ, USA.
Outcomes Research, MSD, Madrid, Spain.
J Med Econ. 2021 Jan-Dec;24(1):1098-1107. doi: 10.1080/13696998.2021.1970975.
V114, a 15-valent pneumococcal conjugate vaccine (PCV15) currently approved in adults in the US, contains the 13 serotypes in PCV13 and two additional serotypes, 22 F and 33 F, which are important contributors to residual PD. This study quantified the health and economic burden of pediatric invasive pneumococcal disease (IPD) associated with V114 serotypes in eight countries in Europe.
A Markov model estimated V114-type IPD cases and costs in hypothetical unvaccinated birth cohorts from Denmark, France, Germany, Italy, Norway, Spain, Switzerland, and the UK over 20 years. Inputs were obtained from published literature. IPD cases and costs were calculated for three time periods using time-specific epidemiological data: (a) pre-PCV7; (b) pre-PCV13; and (c) post-PCV13. Costs were estimated from a societal perspective (2018 Euros) and discounted at 3%.
The model estimated that 4,649 IPD cases in the pre-PCV7 period, 3,248 cases in the pre-PCV13 period, and 958 cases in the post-PCV13 period were attributable to V114 serotypes. Total discounted costs associated with V114 serotypes were €109.1 million (pre-PCV7 period), €65.7 million (pre-PCV13 period), and €18.7 million (post-PCV13 period).
Post-meningitis sequelae, acute otitis media, and non-bacteremic pneumonia were not considered. Direct non-medical costs were not included. Conclusions on effectiveness of V114 or added value over existing infant vaccination programs cannot be drawn.
IPD cases and costs were estimated in hypothetical birth cohorts in eight European countries followed for 20 years during three time periods. Serotypes included in V114 were associated with significant morbidity and costs in pre-PCV7, pre-PCV13, and post-PCV13 periods. Future pediatric pneumococcal vaccines should maintain protection against serotypes in licensed vaccines while extending coverage to additional serotypes to ensure reductions in IPD burden are maintained.
V114 是一种 15 价肺炎球菌结合疫苗（PCV15），目前已获准在美国成人中使用，其中包含 PCV13 中的 13 种血清型，以及另外两种血清型 22F 和 33F，这两种血清型是剩余 PD 的重要贡献者。本研究定量评估了欧洲 8 个国家 V114 血清型相关小儿侵袭性肺炎球菌病（IPD）的健康和经济负担。
使用马尔可夫模型，从丹麦、法国、德国、意大利、挪威、西班牙、瑞士和英国的假设未接种疫苗出生队列中估算了 20 年内 V114 型 IPD 病例和费用。使用来自已发表文献的数据来获取输入。根据特定时期的流行病学数据，使用三个时间段来计算 IPD 病例和费用：（a）PCV7 前；（b）PCV13 前；和（c）PCV13 后。从社会角度（2018 年欧元）估算了成本，并贴现 3%。
该模型估计，V114 血清型在 PCV7 前时期导致 4649 例 IPD 病例，PCV13 前时期导致 3248 例病例，PCV13 后时期导致 958 例病例。与 V114 血清型相关的总折扣成本为 1.091 亿欧元（PCV7 前时期）、6570 万欧元（PCV13 前时期）和 1870 万欧元（PCV13 后时期）。
未考虑脑膜炎后后遗症、急性中耳炎和非菌血症性肺炎。未包括直接非医疗费用。不能得出关于 V114 的有效性或相对于现有婴儿疫苗接种计划的附加值的结论。
在欧洲 8 个国家的假设出生队列中，对 20 年内的 3 个时期进行了随访，估算了 IPD 病例和费用。包含在 V114 中的血清型在 PCV7 前、PCV13 前和 PCV13 后时期与显著的发病率和费用相关。未来的小儿肺炎球菌疫苗应保持对已许可疫苗中血清型的保护，同时扩大覆盖范围，增加其他血清型，以确保维持 IPD 负担的减少。
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