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Korean Guidelines for Pharmacoeconomic Evaluations: Updates in the Third Version

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Abstract

The first version of the pharmacoeconomic (PE) guidelines was published in South Korea in 2006. Despite its first revision in 2011, there were still ambiguities in its interpretation. Moreover, methodologies for estimating effectiveness and costs have also evolved since then. Under these circumstances, the Health Insurance Review and Assessment Service published the third version in January 2021. This article reviews the revision process and major changes made in the new edition of the PE guidelines. The revision was processed through reviews of the previous 50 PE submissions, international guidelines, academic literature, and surveys and advisory meetings to obtain stakeholders’ opinions. The analysis perspective has changed from a limited societal perspective to a healthcare system perspective. In addition to the drug with the highest market share, drugs used in clinical trials can be selected as comparators under certain conditions. The discount rate decreased from 5% to 4.5%. Furthermore, the revised guidelines provide more detailed and specific instructions for items including non-inferiority margin, extrapolation, utility elicitation, and uncertainty. Treatment switch and co-dependent technology guidelines are newly included; the budget impact analysis guideline is deleted. Through this revision, transparency and consistency of decision-making is expected to improve.

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Acknowledgments

The authors would like to thank the HIRA staff, who supported the research project, and consultees and anonymous commentators who participated in the consultation and provided insightful comments.

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Authors and Affiliations

  1. College of Pharmacy, Gyeongsang National University, Jinju-si, Gyeongnam, South Korea

    Eun-Young Bae

  2. Department of Healthcare Management, College of Social Science, Gachon University, Seongnam-si, Gyeonggi-do, South Korea

    Jihyung Hong

  3. College of Pharmacy, Ewha Womans University, Seoul, South Korea

    SeungJin Bae

  4. College of Medicine, Seoul National University, Seoul, South Korea

    Seokyung Hahn

  5. College of Medicine, Korea University, Seoul, South Korea

    Hyonggin An

  6. Pharmaceutical Benefit Listing Division, Health Insurance Review and Assessment Service, Wonju-si, Gangwon-do, South Korea

    Eun-joo Hwang & Seung-min Lee

  7. Department of Public Health Science, Graduate School of Public Health, Seoul National University, 1 Gwanak-ro, Gwanak-gu, Seoul, 08826, South Korea

    Tae-jin Lee

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  1. Eun-Young Bae
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  2. Jihyung Hong
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  3. SeungJin Bae
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  4. Seokyung Hahn
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  5. Hyonggin An
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  6. Eun-joo Hwang
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  7. Seung-min Lee
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  8. Tae-jin Lee
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Corresponding author

Correspondence to Tae-jin Lee.

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Funding

This study was supported by Health Insurance Review and Assessment Service.

Conflicts of interest/competing interests

None of the authors have any conflicts of interest.

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Authors’ contributions

All authors contributed to the revision process of the third pharmacoeconomic guidelines. The first draft of the manuscript was written by E-YB and T-JL. JH, SJB, SH, HA, E-JH, and S-ML reviewed and provided critical comments on the manuscript. E-YB revised the manuscript critically. All authors read and approved the final manuscript.

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Bae, EY., Hong, J., Bae, S. et al. Korean Guidelines for Pharmacoeconomic Evaluations: Updates in the Third Version. Appl Health Econ Health Policy 20, 467–477 (2022). https://doi.org/10.1007/s40258-022-00721-4

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  • DOI: https://doi.org/10.1007/s40258-022-00721-4

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