韩国抗癌药物滞后现象的实证分析。
An Empirical Analysis of Anti-Cancer Drug Lags in South Korea.
作者信息
Lee Sung Kyung, Lee Jong Hyuk
机构信息
Korea Institute for Industrial Economics and Trade, Sejong, Republic of Korea.
College of Pharmacy, Chung-Ang University, Seoul, Republic of Korea.
出版信息
Inquiry. 2025 Jan-Dec;62:469580251363855. doi: 10.1177/00469580251363855. Epub 2025 Aug 11.
This study attempts to examine how cancer drug lags in South Korea, along with submission-to-approval and approval-to-reimbursement decision time spans, have evolved over the last decade, from 2013 to 2022. For the same set of cancer drugs, the drug lags observed in South Korea were compared with those of United States, European Union, and Japan. Multivariate linear regression and multivariate Cox regression analyses were performed to conduct quantitative analyses. Compared with the 3 other advanced medicine agencies, South Korea (Ministry of Food and Drug Safety [MFDS]) displays an average delay of 1 to 2 years in submission and approval over the sample period. However, the average review processing time is much shorter than the submission and approval lags, and the MFDS fares even better than the European Union (European Medicines Agency [EMA]) in terms of reviewing efficiency. Notable progress has been made in addressing delays in the reimbursement decision process, roughly cut in half over the period, whereas other lags are rather elongated. The multivariate regression results confirm that the variations in approval delays in South Korea are largely associated with submission delays. The fact that South Korea fares poorly in submission and ensuing approval lags compared to other nations and regions with advanced medicine agencies mirrors the reality that South Korea is still not yet being considered as one of the most preferred testing grounds for innovative cancer drugs. The findings highlight that the goal of regulators should be geared towards ensuring more equitable access to oncology drugs in a timely manner for the Korean population.
本研究试图考察2013年至2022年这过去十年间,韩国癌症药物的滞后情况,以及提交申请至获批和获批至报销的决策时间跨度是如何演变的。对于同一组癌症药物,将韩国观察到的药物滞后情况与美国、欧盟和日本的进行了比较。进行了多元线性回归和多元Cox回归分析以进行定量分析。与其他三个先进医学机构相比,韩国(食品药品安全部[MFDS])在样本期内的提交申请和获批平均延迟1至2年。然而,平均审评处理时间远短于提交申请和获批的滞后时间,并且MFDS在审评效率方面甚至比欧盟(欧洲药品管理局[EMA])表现更好。在解决报销决策过程中的延迟方面取得了显著进展,在此期间大致缩短了一半,而其他滞后时间则有所延长。多元回归结果证实,韩国获批延迟的差异在很大程度上与提交申请延迟有关。与拥有先进医学机构的其他国家和地区相比,韩国在提交申请及随后的获批滞后方面表现不佳,这反映出韩国仍未被视为创新癌症药物最理想的试验地之一这一现实。研究结果凸显,监管机构的目标应是确保韩国民众能及时、更公平地获得肿瘤药物。