Cost-effectiveness of PCV20 to Prevent Pneumococcal Disease in the Pediatric Population - A German Societal Perspective Analysis

Abstract Background The 13-valent pneumococcal conjugate vaccine (PCV13) has been included by Germany’s Standing Committee on Vaccinations for infants since 2009, resulting in major reductions in pneumococcal disease (PD). Higher-valent vaccines may further reduce PD burden. This cost-effectiveness analysis compared PCV20 under 3+1 schedule with PCV15 and PCV13, both under 2+1 schedule, in Germany’s pediatric population. Methods A Markov model with annual cycles over a 10-year time horizon was adapted to simulate the clinical and economic consequences to the German population and compare pediatric vaccination with PCV20 to lower-valent PCVs. The model used PCV13 clinical effectiveness and impact studies as well as PCV7 efficacy studies for vaccine direct and indirect effect estimates. Epidemiologic, utility, and medical cost inputs were obtained from published sources. Benefits and costs were discounted at 3% from a German societal perspective. Outcomes included PD cases, deaths, costs, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs). Results In the base case, PCV20 provided greater health benefits than PCV13, averting more cases of invasive pneumococcal disease (IPD; 15,301), hospitalized and non-hospitalized pneumonia (460,197 and 472,365, respectively), otitis media (531,634), and 59,265 deaths over 10 years. This resulted in 904,854 additional QALYs and a total cost-saving of €2,393,263,611, making PCV20 a dominant strategy compared with PCV13. Compared to PCV15, PCV20 was estimated to avert an additional 11,334 IPD, 704,948 pneumonia, and 441,643 otitis media cases, as well as 41,596 deaths. PCV20 was associated with a higher QALY gain and lower cost (i.e., dominance) compared with PCV15. The robustness of the results was confirmed through scenario analyses as well as deterministic and probabilistic sensitivity analyses. Conclusion PCV20 3+1 dominated both PCV13 2+1 and PCV15 2+1 over the model time horizon. Replacing lower-valent PCVs with PCV20 would result in greater clinical and economic benefits, given PCV20’s broader serotype coverage. Key Summary Points Streptococcus pneumoniae is the leading cause of bacterial pneumonia and global mortality in children. Pneumococcal conjugate vaccines (PCVs) elicit robust and durable immune responses in both pediatric and adult populations. This study examined the cost-effectiveness of PCV20 under a 3+1 schedule in Germany’s pediatric population compared with PCV13 and a secondary comparator (PCV15), both under a 2+1 schedule. PCV20 was estimated to prevent more pneumococcal disease cases and deaths versus PCV13 and PCV15, as well as providing greater quality-adjusted life years and cost savings (i.e., dominant strategy) over 10 years. Implementation of PCV20 under a 3+1 schedule into the German pediatric immunization program would result in greater clinical and economic benefits versus PCV13 and PCV15, both under a 2+1 schedule. Plain language summary Pneumococcal diseases (e.g., ear infections, pneumonia, bloodstream infections) are among the leading causes of illness and death in children worldwide. The pneumococcal conjugate vaccine (PCV) protects against pneumococcal diseases and has significantly reduced the number of newly diagnosed cases. Higher-valent vaccines (which provide coverage for a greater number of disease-causing serotypes) have recently received EC approval for use in adults and EC approval for use in infants is expected soon. This study examined costs and health benefits associated with the 20-valent PCV (PCV20) under a 3+1 (i.e., three primary doses and one booster dose) schedule in Germany’s childhood vaccination program compared with 13-valent PCV (PCV13) and the 15-valent PCV (PCV15), both under a 2+1 (two primary doses, one booster) schedule. PCV20 was estimated to result in greater health benefits from avoiding more cases in pneumococcal diseases and lower costs compared with both PCV13 and PCV15. PCV20, therefore, is considered the best option among the three vaccines for children in Germany.

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