Estimating the Clinical and Economic Impact of Switching from the 13-Valent Pneumococcal Conjugate Vaccine (PCV13) to the 10-Valent Pneumococcal Conjugate Vaccine (PCV10) in Italy

Abstract

Background: Invasive and non-invasive pneumococcal diseases are significant health and economic burdens, especially in children and the elderly. Italy included the 7-valent (PCV7) and 13-valent pneumococcal conjugate vaccine (PCV13) in the National Immunization Program in 2007 and 2010, respectively, allowing a dramatic reduction in the burden of pneumococcal disease. In the era of budget constraints, decision-makers may consider switching from the higher-valent, more costly PCV13, to the lower-cost PCV10. This study estimated the potential public health and economic impact of changing vaccine programs from PCV13 to PCV10 in Italy. Methods: A decision-analytic forecasting model estimated the impact of PCV programs. Real-world surveillance data were used to forecast serotype distribution and disease incidence among children and the elderly over a specified 5-year time horizon. Costs and outcomes included estimates of cases and deaths avoided, quality-adjusted life years (QALYs) gained, and total costs from a payer perspective, discounted at an assumed rate of 3.0%, and robustness validated through several scenarios and sensitivity analyses. Results: A switch from PCV13 to PCV10 would increase invasive pneumococcal disease (IPD) cases by 59.3% (4317 cases) over a 5-year horizon, primarily due to serotypes 3 and 19A. Pneumonia increased by 8.3% and acute otitis media (AOM) by 96.1%. Maintaining a PCV13 program would prevent a total incremental 531,435 disease cases (1.02M over a 10-year time horizon) and 641 deaths due to invasive pneumococcal disease (IPD), with €23,642 per QALY gained over 5 years versus PCV10. One-way and probabilistic sensitivity analyses showed that a PCV13-based program remained cost-effective in 99.7% of the simulations in Italy as parameters varied within their plausible range; percent vaccinated had the most impact. Conclusions: Maintaining the PCV13 strategy would provide substantial public health and economic benefits in Italy and is cost-effective. Switching from PCV13 to PCV10 would increase the incidence of pneumococcal disease primarily linked to re-emergence of serotypes 3 and 19A.

Prevalence of Pneumococcal Serotypes in Community-Acquired Pneumonia among Older Adults in Italy: A Multicenter Cohort Study

“…In 2017, the Italian Immunization Plan 2017–2019 recommended pneumococcal vaccinations for individuals aged ≥65 years with a single dose of PCV13 followed by PPV23 [ 15 ]. Despite these recommendations, the vaccination uptake remains low in both at-risk and older adults [ 16 ].…”

Cost-effectiveness analysis of replacing the 10-valent pneumococcal conjugate vaccine (PCV10) with the 13-valent pneumococcal conjugate vaccine (PCV13) in Brazil infants

“…The model structure has been described in detail elsewhere. 26 , 27 , 30 Briefly, the model uses retrospective country-level observed surveillance data on serotype-specific pneumococcal disease to estimate prospective serotype disease behavior. Therefore, for vaccine serotypes contained in both PCV10 and PCV13, as well as non-vaccine serotypes, the model predicts future disease behavior from retrospective real-world data in the population dependent on which vaccine is being evaluated.…”

“…Age-specific all-cause mortality rates per 100,000 for each age group were taken from IBGE 2018 data. 30 Age-specific case-fatality rates (CFR) for bacteremia, meningitis, and hospitalized pneumonia were taken from the most recent year of Novaes et al 33 which calculated CFR from the number of deaths/confirmed cases for each clinical syndrome registered in the SIH-SUS. The analysis used CFR from SIH-SUS for hospitalized pneumonia and meningitis ( Table 1 ).…”

“… 28 Other examples are reported for Canada, demonstrating that switching to PCV10 from PCV13 was estimated to result in higher net costs due to increases in disease caused by uncovered serotypes; 29 as well as Italy, which concluded that Switching from PCV13 to PCV10 would increase the incidence of pneumococcal disease primarily linked to reemergence of serotypes 3 and 19A. 30 Therefore, the aim of this study was to build upon previous cost-effectiveness analyses conducted in Brazil and to incorporate other critical evaluation factors, such as life-year and QALY outcomes, historical local serotype behavior, current epidemiology, serotype replacement, and herd effects. We evaluated the cost-effectiveness and budget impact of replacing PCV10 with PCV13 over a 5-y period in Brazil for vaccination of children up to 2 y of age after the implementation of a universal PCV10 program.…”

Reply letter to “response to article by Johnna Perdrizet et al.” by Gomez and colleagues

“…The cost-effectiveness model used for this Brazil study uses the same assumptions as many other peer-reviewed studies, including country examples for Mexico, Colombia, Finland, Netherlands, Canada, Malaysia, Italy, and Australia. 5–10 This scientific methodology used for pneumococcal disease serotype trends has been recognized and is a strength of this study because we were able to show with numerous predictions from multiple countries the possible range of outcomes when switching to PCV13. These trendlines serve as a proxy for what Brazil can expect for a PCV13 NIP infant program and ultimately capture variations in uptake, antimicrobial resistance, underlying serotype dynamics, indirect effect, and historical schedules observed in other countries.…”