ABSTRACT

Objective: This study aims to provide an up-to-date analysis of the current state of patient access to new drugs in South Korea, focusing on the effect of new review pathways for reimbursement.

Methods: We analyzed patients’ access to new drugs, listing rate and lead time until listing from marketing authorization. New pathways were defined as ‘price negotiation waiver,’ ‘risk-sharing agreements,’ and ‘pharmacoeconomic evaluation exemption.’

Results: The listing rate for drugs increased after the introduction of the new pathways (93.7% vs. 77.9%, p < 0.001). Before the new pathways, the median lead time for listing was 21.0 months (95% CI: 16.9–25.0), while afterward it was shortened to 10.9 months (95% CI: 10.2–11.7) (p < 0.001).

Conclusion: Although it has strengthened national health insurance coverage by positively impacting the rate and lead time, the lead time for the oncology and orphan drugs is substantially longer as compared to other drugs. Expanding the eligibility criteria to include non-life-threatening but rare or intractable diseases, and resolving the system’s operational issues are still necessary.

摘要

目的：本研究旨在提供对韩国患者使用新药的当前状况的最新分析，重点是新的报销途径的效果。

方法：我们分析了患者从市场许可获得新药的机会，上市率和上市前的准备时间。新的途径被定义为“豁免价格谈判”，“风险分担协议”和“药物经济学评估豁免”。

结果：引入新途径后，药物的上市率有所提高（93.7％对77.9％，p <0.001）。在采用新途径之前，上市所需的中位数时间为21.0个月（95％CI：16.9-25.0），而之后缩短至10.9个月（95％CI：10.2-11.7）（p <0.001）。

结论：尽管它通过积极影响费用率和前置时间而加强了国民健康保险的覆盖范围，但与其他药物相比，肿瘤科和孤儿药物的前置时间要长得多。仍需要将资格标准扩展到包括不威胁生命但罕见或难治的疾病，并解决系统的操作问题。