Center for Observational and Real-world Evidence, Merck & Co., Inc., Kenilworth, NJ, USA.
J Med Econ. 2020 Dec;23(12):1653-1660. doi: 10.1080/13696998.2020.1840216. Epub 2020 Nov 5.
V114 is an investigational 15-valent pneumococcal conjugate vaccine (PCV) containing the 13 serotypes in 13-valent PCV (PCV13) plus two additional serotypes. This study quantified the health and economic burden of invasive pneumococcal disease (IPD) and acute otitis media (AOM) caused by V114 types among children in the United States.
A Markov model estimated the number of V114-type IPD and AOM cases and costs in a hypothetical, unvaccinated US birth cohort over 20 years. Three time periods were analyzed using time-specific epidemiological data to determine the number of IPD and AOM cases associated with all 15 serotypes in V114. The time periods were: (1) pre-PCV7 (1999); (2) pre-PCV13 (2009); (3) post-PCV13 (2017). Costs were estimated from a societal perspective (2018 US dollars) and discounted at 3%.
The model estimated 18,983 IPD cases and 5.4 million AOM cases associated with V114 serotypes pre-PCV7, 4,697 IPD cases and 3.0 million AOM cases pre-PCV13, and 948 IPD cases and 0.2 million AOM cases post-PCV13. Total discounted costs associated with V114 serotypes were $1.7 billion pre-PCV7, $730 million pre-PCV13, and $75 million US dollars post-PCV13.
Post-meningitis sequelae, cases of non-bacteremic pneumonia, and direct non-medical costs were not included.
IPD and AOM cases and costs were estimated in a hypothetical US birth cohort followed for 20 years at three time periods. In all three periods, the serotypes targeted by V114 contributed to significant morbidity and costs. New pediatric pneumococcal vaccines must continue to retain serotypes in licensed vaccines to maintain disease reduction while extending coverage to non-vaccine serotypes.
V114 是一种研究性的 15 价肺炎球菌结合疫苗(PCV),包含 13 价 PCV(PCV13)中的 13 种血清型和另外两种血清型。本研究量化了 V114 型在美国儿童中引起侵袭性肺炎球菌病(IPD)和急性中耳炎(AOM)的健康和经济负担。
采用马尔可夫模型估算了 20 年内,假设未接种疫苗的美国出生队列中由 V114 型引起的 IPD 和 AOM 病例数和费用。使用特定时间的流行病学数据分析了三个时间段,以确定与 V114 中所有 15 种血清型相关的 IPD 和 AOM 病例数。这三个时间段是:(1)PCV7 前(1999 年);(2)PCV13 前(2009 年);(3)PCV13 后(2017 年)。成本从社会角度(2018 年美元)进行估算,并贴现 3%。
模型估计 V114 血清型引起的 IPD 病例数为 18983 例,AOM 病例数为 540 万例,与 PCV7 前相关;IPD 病例数为 4697 例,AOM 病例数为 300 万例,与 PCV13 前相关;与 PCV13 后相关的 IPD 病例数为 948 例,AOM 病例数为 20 万例。与 V114 血清型相关的总贴现成本为 PCV7 前 17 亿美元,PCV13 前 7.3 亿美元,PCV13 后 7500 万美元。
未包括脑膜炎后遗症、非菌血症性肺炎病例和直接非医疗费用。
在三个时间段内,对假设的美国出生队列进行了 20 年的随访,估计了 IPD 和 AOM 病例数和成本。在所有三个时期,V114 针对的血清型都导致了严重的发病率和费用。新的儿科肺炎球菌疫苗必须继续保留在许可疫苗中的血清型,以保持疾病减少,同时扩大对非疫苗血清型的覆盖范围。