BACKGROUND: Extrapolation of research data from developed countries, without considering the local context can sometimes result in outcomes different from the research setting, emphasizing the need to integrate external research with local context. An example of hepatitis B vaccination in India is presented as a model. OBJECTIVES: To decide whether hepatitis B vaccination should be introduced in India, by integrating pharmaco-economic research data with the local context. METHODS: Detailed literature search was undertaken to identify evidence for: 1) hepatitis B disease burden in India; 2) efficacy and safety of Hepatitis B vaccination; 3) economic implications; 4) feasibility of universal administration; 5) local situation; and 6) expected short and long term outcome. Evidence was sought in the following hierarchy: systematic reviews, randomized trials and case control/cohort studies. RESULTS: A current systematic review1 identified Hepatitis B prevalence as 1.7%; another (Cochrane) review2 reported relative risk of hepatitis B following vaccination as 0.12(0.03-0.44) in per-protocol analysis, suggesting that prevalence could be decreased by 88% through universal vaccination. The cost of vaccine would be approximately 0.15US$ per dose and vaccination cost per child approximately 0.60US$ (1.8US$ for three doses) if added to DPT vaccination administered to infants at 6,10,14 weeks of age; thereby making the intervention highly cost-effective in terms of reduction in disease prevalence (short-term outcome) and hepatitis B morbidity/mortality (long-term outcome). However current national data3 shows that DPT vaccine coverage is only 55.3%; further over one-third of hepatitis B infection is acquired perinatally4 and cannot be prevented through this vaccination schedule. Therefore, integrating local context with research data suggests that the expected 88% reduction in prevalence (from research data) would practically translate to only 37% reduction, whereby hepatitis B vaccination may no longer be cost-effective to reduce disease burden. CONCLUSIONS: It is critical to incorporate local contextual issues when pharmaco-economic outcome data is extrapolated from external research, especially in developing countries.
Mathew, J. (2011). PIN2 INTEGRATION OF PHARMACO-ECONOMIC OUTCOME BASED RESEARCH WITH LOCAL CONTEXT: A MODEL FOR RATIONAL HEALTH CARE DECISION-MAKING IN DEVELOPING COUNTRIES. Value in Health, 12(7), A515. https://doi.org/10.1016/s1098-3015(10)75443-7