, Volume 29, Issue 11, pp 989-1009
Date: 11 Oct 2012

Rotavirus Vaccine RIX4414 (Rotarix™)

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This article provides an overview of the clinical profile of rotavirus vaccine RIX4414 (Rotarix™) in the prevention of rotavirus gastroenteritis (RVGE) in developing countries, followed by a comprehensive review of pharmacoeconomic analyses with the vaccine in low- and middle-income countries.

RVGE is associated with significant morbidity and mortality among children <5 years of age in developing countries. The protective efficacy of a two-dose oral series of rotavirus vaccine RIX4414 has been demonstrated in several well designed clinical trials conducted in developing countries, and the ‘real-world’ effectiveness of the vaccine has also been shown in naturalistic and case-control trials after the introduction of universal vaccination programmes with RIX4414 in Latin American countries. The WHO recommends universal rotavirus vaccination programmes for all countries.

Numerous modelled cost-effectiveness analyses have been conducted with rotavirus vaccine RIX4414 across a wide range of low- and middle-income countries. Although data sources and assumptions varied across studies, results of the analyses consistently showed that the introduction of the vaccine as part of a national vaccination programme would be very (or highly) cost effective compared with no rotavirus vaccination programme, according to widely used costeffectiveness thresholds for developing countries. Vaccine price was not known at the time the analyses were conducted and had to be estimated. In sensitivity analyses, rotavirus vaccine RIX4414 generally remained cost effective at the highest of a range of possible vaccine prices considered. Despite these favourable results, decisions regarding the implementation of universal vaccination programmes with RIX4414 may also be contingent on budgetary and other factors, underscoring the importance of subsidized vaccination programmes for poor countries through the GAVI Alliance (formerly the Global Alliance for Vaccines and Immunization).

Data Selection

Sources: Medical literature (including published and unpublished data) on ‘RIX4414’ was identified by searching databases since 1996 (including MEDLINE and EMBASE and in-house AdisBase), bibliographies from published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 ‘hospitalisation’ or ‘formularies’ or ‘drug-utilisation’ or ‘meta-analysis’ or ‘therapeuticsubstitution’ or ‘epidemiology’). Searches were last updated 15 Sep 2011.
Selection: Economic analyses in infants and children in developing countries who received rotavirus vaccine RIX4414 (Rotarix™). Inclusion of economic studies was based mainly on the methods section of the analyses. Relevant background data are also included.
Index terms: Rotarix™, RIX4414, monovalent rotavirus vaccine, rotavirus gastroenteritis, developing countries, pharmacoeconomics, cost effectiveness, therapeutic use, tolerability.