Analytical approach:
This economic evaluation was based on a published decision analytic model with a five-year time horizon, which was updated with more recent data. The authors stated that the perspectives of both the health care system and society were adopted.
Effectiveness data:
The clinical data came from published studies that were selected. The bulk of evidence for epidemiological parameters was based on a recent prospective, multi-centre, observational study, namely the Rotavirus Gastroenteritis Epidemiology and Viral Types in Europe Accounting for Losses in Public Health and Society (REVEAL) study. A subgroup of 127 Belgian children was used to update the previous model with country-specific and recent epidemiological inputs. The key clinical endpoint was the vaccine efficacy, which was retrieved from a large, double-blind, placebo-controlled, phase III efficacy and safety trial involving over 70,000 children in 11 countries. Assumptions were made for vaccine coverage rates and some other parameters.
Monetary benefit and utility valuations:
Not relevant.
Measure of benefit:
The model outputs were RVGE episodes, hospitalisations, nosocomial infections, consultations with general practitioners or paediatricians, cases not seeking medical care, and deaths due to paediatric RVGE infections. None of these were combined with costs in cost-effectiveness ratios. The benefits were discounted at an annual rate of 1.5%.
Cost data:
The economic analysis included vaccine costs, but not those for its administration as the vaccine was delivered concomitantly with other paediatric vaccines, medical costs, direct non-medical costs, and indirect costs. Medical costs included consultations with health care professionals, laboratory tests, medications, dietary products, over the counter medications, and hospitalisations. Direct non-medical costs included transportation, nappies, and parents’ accommodations and indirect costs included workdays lost by parents to take care of their sick child, childcare, and baby-sitting. Most of the cost data were estimated from the REVEAL study using local tariffs and official sources. The economic analysis also considered the cost per case of nosocomial RVGE infection, which was estimated based on an authors' calculation. Vaccine cost was calculated using the official vaccine price, the Belgian reimbursement rate, and the ceiling co-payment. A 3% annual discount rate was applied to costs, which were in Euros (EUR). The price year was not explicitly reported, but 2007 prices were used to estimate the vaccine cost.
Analysis of uncertainty:
A deterministic sensitivity analysis was undertaken on the key model inputs such as the ratio of patients seeking or not seeking medical care, the vaccination coverage rate, the impact of the extra length of stay due to a nosocomial RVGE infection, incidence rates, hospital costs for hospitalised children, and discount rates. The alternative assumptions were either based on authors’ opinions or were derived from published sources that were not considered in the base-case analysis.