Cost-effectiveness analysis of a 20-valent pneumococcal conjugate vaccine for pneumococcal disease prevention in the Slovak pediatric population

BACKGROUND: Slovakia has introduced pneumococcal conjugate vaccines (PCVs) in the national immunization program (NIP) since 2011. Recently licensed for use in the pediatric population in Europe, the 20-valent pneumococcal conjugate vaccine (PCV20) is poised to become a new potential standard of care (SoC) in the pediatric national immunization program (NIP). Therefore, this study aims to assess the cost-effectiveness and the clinical and economic outcomes of the PCV20 compared to PCV13 and PCV15 in Slovakian infants. METHODS: A decision-analytic Markov model was employed to estimate the cost-effectiveness of implementing PCV20 versus two lower-valent PCVs in Slovakian infants aged over 10 years. Health outcomes comprised cases of pneumococcal disease, life years, and quality-adjusted life years (QALY). Economic outcomes included vaccination- and disease-associated costs. Outcomes were evaluated for the entire population to capture full vaccine benefits (indirect effects). Epidemiological inputs were sourced from local surveillance reports or published literature. Direct and indirect vaccine effects (VE) were estimated from vaccine impact, effectiveness, and clinical studies of PCV7 and PCV13. Economic inputs were informed by local studies and 2024 Slovak national reimbursement cost. Comprehensive deterministic sensitivity analysis and scenario analyses were examined. The study assumed a willingness-to-pay threshold (WTP) of €40,377/QALY. RESULTS: Over 10 years, PCV20 3 + 1 was predicted to prevent over 810 invasive pneumococcal disease (IPD) cases, 885,000 pneumonia cases, 6,600 otitis media (OM) cases, and 16,600 disease-associated deaths compared with PCV13 2 + 1. The disease prevention subsequently resulted in €326.7 million direct medical costs savings, 96,430,859 additional QALYs gain and an ICER of €1,349/QALY. Comparable trends were observed versus PCV15 2 + 1, with PCV20 preventing more pneumococcal disease cases, providing greater additional QALYs, and being cost-effective under the prespecified threshold. Results were consistent across base case and scenario analyses. CONCLUSIONS: Implementing PCV20 into the Slovakian pediatric NIP is projected to yield the most significant clinical and economic benefits compared to the two lower-valent PCVs, due to its more extensive protection against a broader range of pneumococcal serotypes. Despite an additional cost of dose and visit, PCV20 was estimated to be cost-effective at the Slovak WTP threshold versus other SoC options over a 10-year time horizon.