Systematic review for new health technology assessment

ABSTRACT

We used a systematic review to evaluate the safety and effectiveness of a new health technology in Korea. The results of the systematic review are being used by the Health Insurance Review and Assessment Service when the Ministry of Health and Welfare introduces new medical technology. The purpose of this study is to introduce this systematic review, which is the main methodology for evaluating the safety and effectiveness of new medical technology, and to share our experience of performing a systematic review to guide the reader in performing a systematic literature review accurately and easily. This paper presents the process of new health technology evaluation using a systematic review. A systematic review involves collecting current available evidence of health technology systematically. According to the evaluation process, in the first meeting of sub-committee, we develop a systematic review protocol including PICO and criteria for inclusion/exclusion. In the second meeting of sub-committee, we search comprehensively for appropriate literature according to the clinical question and to select in a clear and reproducible method. We also assess study quality, considering the internal validity and external validity of the selected literature, and make a table of extracted data. In the third meeting of sub-committee, we extract general information, study characteristics information, and study outcome information, and synthesize the outcomes. In the forth meeting of sub-committee, we finalize the conclusions based on synthesizing the studies. After the subcommittees' assessments, the results are presented to the Committee for New Health Technology. Finally, we report this result to the Ministry of Health and Welfare. The systematic review is useful for helping policymakers make decisions about the introduction of new health technology based on evidence. It enables people to minimize confusion due to weak evidence for health technology. In case of domestically developed technology and technology for rare disease, it is difficult assess health technology due to a lack of evidence, so assessing raw data (charts, results of clinical trials) is needed in addition to a systematic review. Furthermore, the government should support clinical studies to develop evidence on new health technologies with potential benefit, and the introduction of a conditional coverage decision in the new health technology assessment system is necessary to deal with uncertainty.