Korean Guidelines for Pharmacoeconomic Evaluation (Second and Updated Version)
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The first version of the Korean guidelines for pharmacoeconomic evaluation was published by Health Insurance Review and Assessment Service (HIRA) in 2006. Since the introduction of the first version, domestic experience with the application of the recommendations has accumulated, and methodologies in certain areas have progressed considerably. Based on these experiences, HIRA initiated a guidelines revision project to address the need for revisions. The purpose of this study is to share the process used to complete these guideline revisions and to provide the contents of the revised guidelines. In developing the current revision, meetings with the advisory committee and working-level meetings with pharmaceutical companies were held several times to reach as much of a consensus as possible, and the results of a survey of pharmaceutical companies and decision makers regarding the existing guidelines were considered. The second version of the guidelines clarified the level of data requirement (‘must’, ‘recommended’, ‘preferred’) based on the data availability, the information needs of the decision makers and the strength of the evidence. The recommended perspective economic studies should take has been modified and additional guidance has been provided on QALY measurement. Manuals for systematic reviews and indirect comparisons have been published, and a standardized reporting format for expert opinions has been added. Sections on preferred methods for evaluations, sensitivity analysis, modelling and time horizon have been elucidated. The revised guidelines clarify the expression of the recommendations, making them more user-friendly, and provide more specific guidance to improve the quality and comparability across submissions.
KeywordsDecision Maker Advisory Committee Societal Perspective Indirect Comparison Surrogate Outcome
This study has been financially supported by HIRA in Seoul, The Republic of Korea. SeungJin Bae led the Guideline Development Team at HIRA. SooOk Lee and Sunmee Jang were members of the team, both of whom were employed by HIRA. Eun Young Bae has served as a member of the DREC since 2011 and the economic subcommittee of the DREC since 2009, and was the principal investigator of the first version of the Korean guidelines for pharmacoeconomic evaluation.
Conflicts of interest
No author has conflicts of interest or financial arrangements that could have potentially influenced the described research.
All authors participated in the design of the study. SeungJin Bae and SooOk Lee reviewed the submitted dossiers, conducted the survey and did the literature review. SeungJin Bae and Eun Young Bae drafted the manuscript. Sunmee Jang critically edited and commented on the manuscript. All authors read and approved the final manuscript. SeungJin Bae is the guarantor for the overall content of this article.
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