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.
Highlights
Streptococcus pneumoniae (SP) is associated with significant morbidity and mortality in children, adults, and older adults, but the pneumococcal burden dramatically decreased following vaccine implementation [1]
The clinical impact of switching from the PCV13 to PCV10 forecasted over 5 years and the current serotype distribution are first presented for children ≤2-years-old and adults ≥65 years, since these populations are the most susceptible to pneumococcal disease and form a large proportion of the total burden
Incremental cases, deaths, incremental costs, and Quality Adjusted Life Years (QALYs) under a PCV13 versus PCV10 vaccination program, over a 5 year time horizon were reported for all ages
Summary
Streptococcus pneumoniae (SP) is associated with significant morbidity and mortality in children, adults, and older adults, but the pneumococcal burden dramatically decreased following vaccine implementation [1]. PPSV23 showed many shortcomings, including inconclusive evidence of protection against non-invasive disease, poor immunogenicity in children, especially those under the age of two years, and a rapid decrease of effectiveness with time since administration. To overcome these limitations, pneumococcal vaccines containing polysaccharide covalently conjugated to carrier protein were introduced: in 2000 and in 2010, 7-valent pneumococcal (PCV7) and 13-valent (PCV13) conjugate vaccines, respectively, were licensed in the United States. 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. 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
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