Are Recently Evaluated Drugs More Likely to Receive Positive Reimbursement Recommendations in South Korea? 11-year Experience of the South Korean Positive List System

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Abstract

Purpose: The South Korean government in 2014 introduced various policies to enhance accessibility of pharmaceuticals. This study sought to examine whether positive reimbursement recommendations of pharmaceuticals have increased since 2014. Methods: Industry submissions evaluated from January 2007 to December 2018 were identified, and characteristics relevant to reimbursement recommendations were extracted. Logistic regression analyses with robust SEs were used to quantify the likelihood of positive recommendations for pharmaceuticals, after controlling for relevant factors influencing the recommendations. Findings: During the study period, 355 (72.9%) of 487 submissions were positively recommended; the drugs evaluated after 2014 (77.8%) were significantly more likely to receive positive reimbursement recommendations than the drugs evaluated before 2014 (69.5%). In the multivariable logistic regression analysis, several factors (labeled a noncancer drug, priced less than alternatives, considered clinically superior, and having budget impact >10 billion South Korean won) were significantly associated with positive recommendations (P < 0.05). When considering interaction effects between evaluation year and other variables, only the interaction between comparative clinical benefit and evaluation year was significant. Specifically, clinically noninferior drugs evaluated after 2014 had 2.85 times the odds of receiving positive recommendations compared with the clinically noninferior drugs evaluated earlier. Implications: Recently evaluated drugs are more likely to receive positive reimbursement recommendations, especially those drugs whose comparative clinical benefits are noninferior

Original languageEnglish
Pages (from-to)1222-1233
Number of pages12
JournalClinical Therapeutics
Volume42
Issue number7
DOIs
StatePublished - Jul 2020

Bibliographical note

Funding Information:
This study was supported by the National Research Foundation of the South Korean government (2018R1A5A2025286).

Funding Information:
Dr. Gong is currently employed by the HIRA. Dr. Bae reports grants and personal fees from the Ministry of Food and Drug Administration, the HIRA, the Ministry of Health and Welfare, and MSD Korea. The authors have indicated that they have no other conflicts of interest regarding the content of this article.This study was supported by the National Research Foundation of the South Korean government (2018R1A5A2025286). JG conducted the statistical analysis and interpretation and drafted the article. JG and Dr. Bae conceived the study and designed the analysis. Dr. Lee supervised the statistical analysis of the data. Dr. Lim critically edited the manuscript. All of the authors approved the final version of the article.

Publisher Copyright:
© 2020 The Authors

Keywords

  • South Korea
  • economic evaluation
  • pharmaceutical
  • policy evaluation
  • reimbursement

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