Overall effectiveness of pneumococcal conjugate vaccines: An economic analysis of PHiD-CV and PCV-13 in the immunization of infants in Italy

ABSTRACT

Pneumococcal diseases are associated with a significant clinical and economic burden. The 7-valent pneumococcal conjugate vaccine (PCV-7) has been used for the immunization of newborns against invasive pneumococcal diseases (IPD) in Italy while now, the pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) and the 13-valent pneumococcal conjugate vaccine (PCV-13) are available.

The aim of this analysis was to compare the estimated health benefits, cost and cost-effectiveness of immunization strategies vs. non-vaccination in Italy using the concept of overall vaccine effectiveness.

A published Markov model was adapted using local data wherever available to compare the impact of neonatal pneumococcal vaccination on epidemiological and economic burden of invasive and non-invasive pneumococcal diseases, within a cohort of newborns from the Italian National Health Service (NHS) perspective. A 18-year and a 5-year time horizon were considered for the base-case and scenario analysis, respectively.

PHiD-CV and PCV-13 are associated with the most important reduction of the clinical burden, with a potential marginal advantage of PHiD-CV over PCV-13. Compared with no vaccination, PHiD-CV is found on the higher limit of the usually indicated willingness to pay range (30,000 - 50,000€/quality-adjusted life year [QALY] gained), while the incremental cost-effectiveness ratio (ICER) for PCV-13 is slightly above. Compared with PCV-13, PHiD-CV would provide better health outcomes and reduce costs even at parity price, solely due to its differential effect on the incidence of NTHi acute otitis media (AOM). The analysis on a shorter time horizon confirms the direction of the base-case.

KEYWORDS:

• acute otitis media
• community-acquired pneumonia
• cost-effectiveness analysis
• invasive pneumococcal disease
• overall effectiveness
• pneumococcal vaccine
• PHiD-CV
• Streptococcus pneumoniae

Abbreviations

AOM	=	acute otitis media
CAP	=	community-acquired pneumonia
GP	=	general practitioner
ICER	=	incremental cost-effectiveness ratio
IPD	=	invasive pneumococcal disease
ISTAT	=	Istituto nazionale di statistica (Italian National Statistics Institute)
NHS	=	National Health Service
NVT	=	non-vaccine serotype
NTHi	=	non-typeable Haemophilus influenzae
OVE	=	overall vaccine effectiveness
PCV	=	pneumococcal conjugate vaccine
PCV-7	=	7-valent pneumococcal conjugate vaccine
PCV-13	=	13-valent pneumococcal conjugate vaccine,
PHiD-CV	=	pneumococcal Haemophilus influenzae protein D conjugate vaccine
PPV-23	=	23-valent pneumococcal polysaccharide vaccine
PSA	=	probabilistic sensitivity analysis
QALY	=	quality-adjusted life years
RCT	=	randomized controlled trials
VT	=	vaccine serotype
WHO	=	World Health Organization
WTP	=	willingness to pay

Disclosure of potential conflicts of interest

SC and VF are employees of the GSK group of companies (the manufacturer of PHiD-CV, Synflorix) and SC reports ownership of stocks from this entity. PC reports personal fees and non-financial support from the GSK group of companies during the conduct of the study as well as personal fees and non-financial support from the GSK group of companies, Novartis, Pfizer and Sanofi and grants from Pfizer, unrelated to the present work. LP received grant from the GSK group of companies for the conduct of this analysis and received grants from the GSK group of companies, Fresenius Kabi, Roche, Amgen, Sanofi, Novartis, Gilead, Chiesi, CSL Behring, Janssen-Cilag, Leo Pharma, Merck Sharp and Dohme, Bristol-Myers Squibb, and ViiV Healthcare and personal fees from Fresenius Kabi, outside of the submitted work. SE received research grants from the GSK group of companies, DMG, Novartis Vaccines, Pfizer, Sanofi and Scioderm as well as payment for lectures and advisory board participation from the GSK group of companies, Pfizer, Valeas, and Vifor. GP reports personal fees and non-financial support from the GSK group of companies during the conduct of the study.

Acknowledgments

Authors would like to thank Business & Decision Life Sciences platform for editorial assistance and manuscript coordination, on behalf of GSK. Stephanie Garcia coordinated manuscript development and editorial support. The authors also thank Ombretta Bandi (SEED medical publishers, on behalf of GlaxoSmithKline S.p.A.) for providing medical writing support.

Funding

GlaxoSmithKline S.p.A. (Verona, Italy) funded this study (GSK study identifier: HO-15–16068) and was involved in all stages of study conduct, including analysis of the data. GlaxoSmithKline S.p.A. (Verona, Italy) and GlaxoSmithKline Biologicals SA took in charge all costs associated with the development and publication of this manuscript.

Contributorship

All authors participated in the design or implementation or analysis, and interpretation of the study; and the development of this manuscript. All authors had full access to the data and gave final approval before submission