摘要：Regulatory 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. A 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. The 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.
关键词：New drug ; Reimbursement decision ; Delay in access ; Event history model
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