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.
Similar content being viewed by others
References
Health Insurance Review and Assessment Service. Guidelines on economic evaluation for pharmaceuticals. 2021. https://www.hira.or.kr/bbsDummy.do?pgmid=HIRAA040055000000. Accessed 20 May 2021.
Bae EY, Lee EK. Pharmacoeconomic guidelines and their implementation in the Positive List System in South Korea. Value Health. 2009;12:S36-41.
Bae SJ, Lee SO, Bae EY, Jang SM. Korean guidelines for pharmacoeconomic evaluation (second and updated version). Pharmacoeconomics. 2013;31:257–67.
Lee TJ, Bae EY, Kang EJ, Bae SJ, Ahn H, Cho M, Han S, Hong J. Recommendations for the revision of pharmacoeconomic guidelines (in Korean). Seoul: Seoul National University; 2019.
HIRA. 2018 TF report for the improvement of economic evaluation system (in Korean). Wonju: Health Insurance Review and Assessment Service; 2018.
KDI Public and Private Infrastructure Investment Management Center. Revisions to guidelines on preliminary feasibility study for projects of public enterprises and quasi-governmental organizations (in Korean). 2nd ed. Sejong: Korea Development Institute; 2018.
Choi JE, Park TK. Estimation of the social discount rate for the public investment projects (in Korean). J Soc Sci. 2015;41(3):145–67.
Lee KB, Song BR, Kahng DJ, Par KA, Kim NJ. Rate of return of PPI projects (in Korean). Sejong: Korea Research Institute for Human Settlements; 2001.
Arrow KJ. Inter-generational equity and the rate of discount in long-term social investment. In: Sertel MR, editor. Contemporary Economic Issues. International Economic Association Series. London: Palgrave Macmillan; 1999. https://doi.org/10.1007/978-1-349-14540-9_5.
Latimer NR, Abrams KR, Lambert PC, Crowther MJ, Wailoo AJ, Morden JP, Akehurst RL, Campbell MJ. Adjusted survival time estimates to account for treatment switching in randomized controlled trials—an economic evaluation context: methods, limitations, and recommendations. Med Decis Mak. 2014;34(3):387–402.
Bae SJ, Bae EY, Lim SH. Sourcing quality-of-life weights obtained from previous studies: theory and reality in Korea. Patient Cent Outcomes Res. 2014;7(2):141–50.
Lee YK, Nam HS, Chuang LH, Kim KY, Yang HK, Kwon IS, et al. South Korean time trade-off values for EQ-5D health states: modeling with observed values for 101 health states. Value Health. 2009;12(8):1187–93.
Kim SH, Ahn J, Ock M, Shin S, Park J, Luo N, et al. The EQ-5D-5L valuation study in Korea. Qual Life Res. 2016;25(7):1845–52.
Vemer P, Ramos IC, Van Voorn GAK, Al MJ, Feenstra TL. AdViSHE: a validation-assessment tool of health-economic models for decision makers and model users. Pharmacoeconomics. 2016;34(4):349–61.
The Canadian Agency for Drugs and Technologies in Health (CADTH). Guidelines for the conomic evaluation of health technologies, 4th edn. 2017. https://www.cadth.ca/guidelines-economic-evaluation-health-technologies-canada-0. Accessed 9 Jan 2022.
The National Institute for Health and Care Excellence (NICE). Guide to the methods of technology appraisal. 2013. https://www.nice.org.uk/process/pmg9/resources/guide-to-the-methods-of-technology-appraisal-2013-pdf-2007975843781. Accessed 9 Jan 2022.
Australian Government: Department of Health. Guidelines for preparing a submission to the Pharmaceutical Benefits Advisory Committee (Version 5.0). 2016. https://pbac.pbs.gov.au/content/information/files/pbac-guidelines-version-5.pdf. Accessed 9 Jan 2022.
ISPOR. Pharmacoeconomic guidelines around the world. https://tools.ispor.org/peguidelines/. Accessed 9 Jan 2022.
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.
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
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.
Ethics approval
Not applicable.
Consent to participate
Not applicable.
Consent for publication
Not applicable.
Availability of data and material
Not applicable.
Code availability
Not applicable.
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.
Supplementary Information
Below is the link to the electronic supplementary material.
Rights and permissions
About this article
Cite this article
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
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s40258-022-00721-4