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Availability and drug lag of new medicines in South Korea


 
 
 This study aims to capture the availability of new medicines, to measure drug lags for new medicines, and to demonstrate various factors affecting timely availability of new medicines in Korean market.
 
 
 
 We construct two models for the analysis; logistic and Cox model. First, we provide the logistic regression to analyze the availability of new medicines in Korean market. Second, we are interested in the timely availability of new medicines in Korea. Therefore, we calculated the drug lag between the United States and South Korea, and applied an event history model for a statistical estimation.
 
 
 
 There have been 160 NDAs approved by the FDA in the United States between 2007 and 2015. Among 160 new drugs approved in the United States during the study period, 112 NDAs (70%) were also approved by the MFDS in Korea, while 48 new drugs (30%) are not currently available in the Korean market. In addition, we are interested in the order of timing for market approval for 112 NDAs that approved in both countries. Not surprisingly, 95 NDAs (85%) were approved in the United States, and then approved in Korea, while 17 NDAs (15%) were approved in Korea, and then approved in the United States.
 
 
 
 Compared to the United States, a striking drug lag was observed in Korea. For the new drugs approved between 2007 and 2015, the median approval lag ranged from 1.72 years in 2013 to 5.84 years in 2007. Presence of the manufacturers in Korea and medicines belonging to the antineoplastic agents were not only positively associated with the availability in Korea, but also accelerated the time to approval in Korea compared to the reference.
 
 
 
 Compared to the United States, a striking drug lag was observed in Korea. Presence of the manufacturers in Korea were not only positively associated with the availability in Korea, but also accelerated the time to approval in Korea.
