Korean Guidelines for Pharmacoeconomic Evaluations: Updates in the Third Version

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 circumstanc...

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Bibliographic Details
Published in:Applied health economics and health policy 2022-07, Vol.20 (4), p.467-477
Main Authors: Bae, Eun-Young, Hong, Jihyung, Bae, SeungJin, Hahn, Seokyung, An, Hyonggin, Hwang, Eun-joo, Lee, Seung-min, Lee, Tae-jin
Format: Article
Language:English
Subjects:
Clinical trials
Committees
Compliance
Costs
Decision making
Discount rates
Health Administration
Health care industry
Health Economics
Health insurance
Impact analysis
Leading Article
Market shares
Medicine
Medicine & Public Health
Meetings
Pharmaceutical industry
Pharmacoeconomics
Pharmacoeconomics and Health Outcomes
Public Health
Quality of Life Research
Revisions
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Summary: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.
ISSN:1175-5652
1179-1896
DOI:10.1007/s40258-022-00721-4