PIN6 EPIDEMIOLOGIC AND ECONOMIC IMPACT OF ROUTINE VACCINATION OF INFANTS AGAINST ROTAVIRUS GASTROENTERITIS IN GERMANY: A PRELIMINARY ANALYSIS

EPIDEMIOLOGIC AND ECONOMIC IMPACT OF ROUTINE VACCINATION OF INFANTS AGAINST ROTAVIRUS GASTROENTERITIS IN GERMANY:A PRELIMINARY ANALYSIS Hammerschmidt T, Forster J, Huppertz HI, Heininger U, Roos R, Standaert BA GlaxoSmithKline, Munich, Germany, St. Josefs-Hospital, Freiburg, Germany, Prof.-Hess Children’s Hospital, Bremen, Germany, University-Children’s Hospital Basel, Basle, Switzerland, Hospital Munich-Harlaching, Munich, Germany, GlaxoSmithKline Biologicals, Rixensart, Belgium OBJECTIVES: Rotavirus gastroenteritis (RVGE) is among the most common reasons for physician consultations during the first year’s of life. RVGE can be prevented by vaccination. The objective was to analyse the clinical and economic impact of universal rotavirus vaccination of infants in Germany. METHODS: A Markov model was developed and calibrated to reflect observed epidemiological data. In the model, a cohort of 670,000 newborns was followed over five years. Routine vaccination with the oral vaccine RotarixTM was compared with no vaccination. Efficacy derived from a European phase-III trial (eTrack102247/ NCT140686) demonstrated 87% efficacy against RVGE of any severity, 96% against severe RVGE and 100% against hospitalisation due to RVGE. Total costs to society were 432 € per outpatient, 2,085 € per community-acquired hospitalization, and 478 € for nosocomial RV cases. Utility values were 0.546 for mild, 0.339 for severe, 0.312 for hospitalized, and 0.501 for nosocomial cases. Cost/effects were discounted by 4.0%/1.5%. Sensitivity analyses were conducted on costs 15%, utilities 15%, efficacy (95%CI), discounting and vaccine price (within pharmacy mark-up differences anticipated with a larger packsize). RESULTS: In the cohort, 182,820 community-acquired cases (140,785 presenting to physicians and of those 33,081 were hospitalized) and 19,848 nosocomial cases occurred resulting in costs of 128.2 mio. €. The overall number of cases could be reduced by 82.0%. Approximately 4 children had to be vaccinated to prevent one RV case and 21 children had to be vaccinated to prevent one community-acquired, hospitalized case. Cost-effectiveness was 3,770 € per QALY. Cost/QALY was below 15.000 € for all sensitivity analyses, the cost/QALY being most sensitive to variations in cost assumptions. At higher costs, lower vaccine price and without discounting, vaccination was costsaving. CONCLUSION: Rotavirus causes a considerable burden of disease and associated costs. Universal vaccination of infants is a cost-effective approach to reducing this socio-economic burden.