Preda Alin, Ta An, Vinand Elizabeth, Purdel Veronica, Zdrafcovici Ana Maria, Ilic Aleksandar, Perdrizet Johnna
Pfizer Romania, Bucharest, Romania.
Cytel, London, United Kingdom.
J Med Econ. 2025 Dec;28(1):696-708. doi: 10.1080/13696998.2025.2499333. Epub 2025 May 14.
Despite the inclusion of pneumococcal conjugate vaccines (PCV) in the pediatric national immunization program (NIP) since 2017, Romania continues to face a substantial clinical, economic, and societal burden of pneumococcal disease. Higher-valent vaccines, such as 20-valent PCV (PCV20), offer broader serotype coverage versus the current standard of care (13-valent PCV; PCV13) with the potential to reduce disease burden. To test this, we conducted a cost-effectiveness analysis of switching from PCV13 or a potential future comparator (15-valent PCV; PCV15), both under a 2 + 1 schedule, to PCV20 under a 3 + 1 schedule in the Romanian pediatric NIP.
A population-based, multi-cohort Markov model with a target population of children aged <2 years was utilized to estimate the cost and health impact of PCV20 versus lower-valent comparators over 10 years. The model adopted a Romanian societal perspective, encompassing both direct and indirect costs, with an annual cycle. Sensitivity and scenario analyses were conducted to assess the robustness of the model and its assumptions.
In the base-case analysis, PCV20 demonstrated dominance versus PCV13 and PCV15 (i.e. was more effective and less costly), with total predicted cost-savings of 79,123,267 and 206,623,098 Romanian Leu, respectively, plus reduction in pneumococcal disease cases by 246,245 and 223,914, respectively. The majority of sensitivity and scenario analyses of both pairwise comparisons were aligned with the base case.
The results of this analysis indicate that PCV20 implementation into the Romanian pediatric NIP would greatly reduce pneumococcal disease burden and would be a cost-effective approach versus PCV13 or PCV15 from a societal perspective over 10 years.
尽管自2017年起肺炎球菌结合疫苗（PCV）已被纳入罗马尼亚国家儿童免疫规划（NIP），但该国仍面临肺炎球菌疾病带来的巨大临床、经济和社会负担。与当前的标准治疗方案（13价PCV；PCV13）相比，更高价的疫苗，如20价PCV（PCV20），能提供更广泛的血清型覆盖，有可能减轻疾病负担。为验证这一点，我们对罗马尼亚国家儿童免疫规划中从PCV13或未来可能的对照疫苗（15价PCV；PCV15）（均采用2+1接种程序）转换为PCV20（采用3+1接种程序）进行了成本效益分析。
利用一个以2岁以下儿童为目标人群的基于人群的多队列马尔可夫模型，估计10年内PCV20与低价对照疫苗相比的成本和健康影响。该模型采用罗马尼亚社会视角，涵盖直接和间接成本，以年为周期。进行了敏感性分析和情景分析，以评估模型及其假设的稳健性。
在基础案例分析中，PCV20相对于PCV13和PCV15表现出优势（即更有效且成本更低），预计总成本节约分别为79,123,267罗马尼亚列伊和206,623,098罗马尼亚列伊，肺炎球菌疾病病例分别减少246,245例和223,914例。两种两两比较的大多数敏感性分析和情景分析结果与基础案例一致。
该分析结果表明，在罗马尼亚国家儿童免疫规划中实施PCV20将大大减轻肺炎球菌疾病负担，从社会角度来看，与PCV13或PCV15相比，在10年内将是一种具有成本效益的方法。
