, Volume 29, Issue 5, pp 439-454

Rotavirus Vaccine RIX4414 (Rotarix™)

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Abstract

The most common cause of severe diarrhoea in infants and young children is rotavirus gastroenteritis (RVGE), which is associated with significant morbidity, healthcare resource use and direct and indirect costs in industrialized nations. The monovalent rotavirus vaccine RIX4414 (Rotarix™) is administered as a two-dose oral series in infants and has demonstrated protective efficacy against RVGE in clinical trials conducted in developed countries. In addition, various naturalistic studies have demonstrated ‘real-world’ effectiveness after the introduction of widespread rotavirus vaccination programmes in the community setting.

Numerous cost-effectiveness analyses have been conducted in developed countries in which a universal rotavirus vaccination programme using RIX4414 was compared with no universal rotavirus vaccination programme. There was a high degree of variability in base-case results across studies even when conducted in the same country, often reflecting differences in the selection of data sources or assumptions used to populate the models. In addition, results were sensitive to plausible changes in a number of key input parameters. As such, it is not possible to definitively state whether a universal rotavirus vaccination programme with RIX4414 is cost effective in developed countries, although results of some analyses in some countries suggest this is the case. In addition, international guidelines advocate universal vaccination of infants and children against rotavirus. It is also difficult to draw conclusions regarding the cost effectiveness of rotavirus vaccine RIX4414 relative to that of the pentavalent rotavirus vaccine, which is administered as a three-dose oral series. Although indirect comparisons in cost-effectiveness analyses indicate that RIX4414 provided more favourable incremental cost-effectiveness ratios when each vaccine was compared with no universal rotavirus vaccination programme, results were generally sensitive to vaccine costs. Actual tender prices of a full vaccination course for each vaccine were not known at the time of the analyses and therefore had to be estimated.

Various sections of the manuscript reviewed by: J. Bilcke, Center for Health Economics Research and Modelling of Infectious Diseases (CHERMID), Vaccine & Infectious Disease Institute (Vaxinfectio), University of Antwerp, Antwerp, Belgium; M. Jit, Modelling and Economics Unit, Health Protection Agency, London, United Kingdom; D. Panatto, Department of Health Science, University of Genoa, Genoa, Italy; T. Vesikari, Vaccine Research Centre, Medical School, University of Tampere, Tampere, Finland.

Data Selection

Sources: Medical literature (including published and unpublished data) on ‘RIX4414’ was identified by searching databases since 1996 (including MEDLINE, EMBASE and in-house AdisBase), bibliographies from published literature, clinical trial registries/databases and websites (including those of regional regulatory agencies and the manufacturer). Additional information (including contributory unpublished data) was also requested from the company developing the drug.
Search strategy: MEDLINE search terms were ‘rotavirus vaccine’ or ‘RIX4414’ or ‘Rotarix’ and (‘economics’ or ‘health-policy’ or ‘qualityof- life’ or ‘models-statistical’ or ‘health-planning’ or ‘epidemiology’ or ‘guideline in pt’ or ‘practice-guidelines in pt’. EMBASE search terms were ‘rotavirus vaccine’ or ‘RIX4414’ or ‘Rotarix’ and (‘economics’ or ‘health economics’ or ‘economic evaluation’ or ‘health status’ or ‘pharmacoeconomics’ or ‘drug cost’ or ‘drug utilization’ or ‘utilization review’ or ‘health survey’ or ‘practice guideline’ or ‘quality of life’ or ‘treatment outcome’ or ‘cost’ or ‘cost benefit analysis’ or ‘cost control’ or ‘cost effectiveness analysis’ or ‘cost minimisation analysis’ or ‘cost of illness’ or ‘cost utility analysis’). AdisBase search terms were ‘RIX-4414’ or ‘rotavirus vaccine’ or ‘Rotarix’ and (‘health-economics’ or ‘pharmacoepidemiology’ or ‘prescribing’ or ‘hospitalization’ or ‘formularies’ or ‘drug-utilisation’ or ‘meta-analysis’ or ‘therapeuticsubstitution’ or ‘epidemiology’). Searches were last updated 23 March 2011.
Selection: Economic analyses in infants and children who received rotavirus vaccine RIX4414 (Rotarix™). Inclusion of economic studies was based mainly on the methods section of the analyses. Relevant background data on epidemiology and cost of illness are also included.
Index terms: Rotarix™, RIX4414, monovalent rotavirus vaccine, rotavirus gastroenteritis, pharmacoeconomics, cost effectiveness, therapeutic use, tolerability.