study reports (18 studies), 1 SAS® database pooling data from 16 studies and 1 SAS® database composed of 1 study. While pooling data from these different sources, several issues had to be faced: 1) the need to harmonize data between studies; 2) the fact that some variables were not collected in some studies, and 3) the fact that for 6 studies, part of the data were available only as summarized data. After taking into account all these issues, an exploitable database was obtained whose strengths are its large sample size (35 studies comprising 7923 patients), its range of study settings and designs (phase I to IV across numerous countries) and the time period encompassed (1990 to 2007). CONCLUSIONS: Pooling data from various sources raised several problems, not all of them resolvable. However, this work allowed to obtain an exploitable database with undisputable strengths i.e. sample size, large range of study settings and design and time period encompassed. Once constituted, this database became a valuable tool in evaluating the safety profile of the virosomal aluminium-free hepatitis A vaccine, and will constitute a valuable database to answer further safety questions in the future.
OBJECTIVES:Many pharmacoeconomic studies have applied the decision analytic model or Markov model (collectively termed as static models) to evaluate the costeffectiveness of pneumococcal conjugate vaccines without taking herd effect into account. The objective of the study is to carry out a cost-effectiveness analysis of 13-valent pneumococcal conjugate vaccine PCV13 in Taiwan using a transmission dynamic model (TDM) to circumvent static models. METHODS: We develop an age-structured TDM populated with parameters from the Taiwanese National Health Insurance Research Database (NHIRD), Centers for Disease Control, government websites and public available sources to evaluate the clinical and economic impact of PCV13. Pneumococcal diseases included in the TDM are invasive pneumococcal diseases (IPD), hospitalized pneumonia and acute otitis media (AOM). One-way deterministic and multivariate probabilistic sensitivity analyses based on 5000 Monte Carlo simulations are performed to explore model uncertainties. Confidence intervals for ICER and cost-effectiveness acceptability curves (CEAC) are calculated for further inferences. RESULTS: In the base-case analysis, 4-dose scheduled universal infant PCV13 vaccination is expected to prevent 5,112 cases of IPD, 535,607 cases of all-cause hospitalized pneumonia, 726,986 cases of AOM, and 420 deaths over a 10-year time horizon. The vaccination program is estimated to yield an incremental cost-effectiveness ratio (ICER) of US$38,045 and US$18,299 from payer and societal perspectives. One-way sensitivity analyses indicated that ICER is most sensitive to vaccine price and recovery rate of pneumonia. Ninety-five percent confidence interval of ICER is US$10,186 to US$34,563 by multivariate probabilistic sensitivity analyses in societal perspective. CONCLUSIONS: With a WHOrecommended cost-effectiveness t...