ArticleHealth economics review2018
Understanding the adoption of new drugs decided by several stakeholders in the South Korean market: a nonparametric event history analysis.
Article in Health economics review, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
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Who cites it
8 citing papers in PubMed.
- Patent challenges without entry? Reassessing first generic exclusivity under the patent-linkage system in South Korea.Globalization and health · 2026Article
- Effects of Osteoporosis Medication Use on Reprocedure Rates Following Vertebral Augmentation: A Nationwide Cohort Study.Clinics in orthopedic surgery · 2025Article
- Public perceptions of high-cost cancer drugs and the implications for reimbursement decisions.Health economics review · 2025Article
- Which factor reduces pharmaceutical expenditure, number of entrants or price variance? Updated generic drug markets in South Korea.Health economics review · 2024Article
- Longitudinal study of the impact of three major regulations on the Korean pharmaceutical industry in the last 30 years.Health research policy and systems · 2022Article
- Is greater generic competition also linked to lower drug prices in South Korea?Health economics review · 2020Article
- The speed of adoption of new drugs and prescription volume after the amendments in reimbursement coverage: the case of non-vitamin K antagonist oral anticoagulants in South Korea.BMC public health · 2020Article
- Marketing and Pricing Strategies of Blockbuster Drugs in the South Korean Market: A 15-Year Retrospective Cohort Study for Choline Alfoscerate.Frontiers in pharmacology · 2020Article
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1 author.
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Abstract
backgroundRegulatory approval and reimbursement decisions are necessary if new drugs are to become accessible in a timely manner. However, the process of regulatory approval and the establishment of reimbursement decisions varies across countries. This study aims to analyze the duration between regulatory approval and reimbursement decision for new drugs and to evaluate various factors affecting the timely availability of new medicines in the Korean market. The duration was subdivided into regulatory approval-reimbursement application and reimbursement application-reimbursement decision. We used pharmaceutical approval data to identify new medicines, retrieved documents from the pharmaceutical benefits committee to collect information on reimbursement decision, and applied a non-parametric event history model.
resultsA total of 128 new medicines applied for reimbursement decision, including 85 drugs between 2007 and 2013 and 43 drugs between 2014 and 2016. Delays in access to new medicines occurred at various levels, and various factors affected in different durations. In proportional hazard model, the second period shortened all durations in the models. Biologics and clinically improved drugs were the factor that delayed the duration of regulatory approval-reimbursement application, while uncertain drugs in clinical effectiveness and ATC J or L delayed the duration of reimbursement application-reimbursement decision.
conclusionsThe duration between regulatory approval and reimbursement decision has decreased, and the main cause of the delay has changed. For instance, the proportion of reimbursement trial-reimbursement decision in the total duration was 62.9% (18.39 months out of 29.24 months) in the first period, while the proportion of regulatory approval-reimbursement trial in the total duration was 64.2% (8.6 months out of 13.40 months) in the second period. A series of policies to reinforce access to medicines after 2014 has been effective for the timely availability of new medicines, including both prompt reimbursement application decided by manufacturers and timely review process by the authorities.
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