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

Filippo Ansaldi; Sarah Pugh; Daniela Amicizia; Roberto Di Virgilio; Cecilia Trucchi; Andrea Orsi; Alessandro Zollo; Giancarlo Icardi

doi:10.3390/pathogens9020076

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

Pathogens. 2020 Jan 22;9(2):76. doi: 10.3390/pathogens9020076.

Authors

Filippo Ansaldi^{1

2

3

4}, Sarah Pugh⁵, Daniela Amicizia^{1

2

3

4}, Roberto Di Virgilio⁶, Cecilia Trucchi^{2

3}, Andrea Orsi^{1

2

4}, Alessandro Zollo⁶, Giancarlo Icardi^{1

2

4}

Affiliations

¹ Department of Health Sciences, University of Genoa, 16132 Genoa, Italy.
² IRCCS San Martino University Hospital, 16132 Genoa, Italy.
³ Liguria Health Authority, A.Li.Sa., 16121 Genoa, Italy.
⁴ CIRI-IT, Centre of Influenza and other Respiratory Infections, 16132 Genoa, Italy.
⁵ Pfizer, 19426 Collegeville, PA, USA.
⁶ Pfizer, 00188 Rome, 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.

Keywords: cost-effectiveness analysis; impact; pneumococcal infections; pneumococcal vaccines.