An Empirical Analysis of Anti-Cancer Drug Lags in South Korea.

Abstract

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.