Cost-effectiveness analysis of implementing 20-valent pneumococcal conjugate vaccine into the Romanian pediatric national immunization program.

Introduction: 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.

Methods: 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.

Results: 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.

Conclusion: 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.