Understanding the adoption of new drugs decided by several stakeholders in the South Korean market: a nonparametric event history analysis

摘要

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.