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Published online by Cambridge University Press: 03 December 2021
This study is the first to analyze and compare the distinctive market access process of new medical technologies focused on technical fee creation in South Korea and Japan. The purpose of this study is to derive implications for each country through analysis and comparison of the market access process and propose improvements of new medical technology adoption program by referring the United States’ incentive program for innovative technology.
Identification and review the published articles and health polices, and reports related to the medical procedure (medical technologies) coding and payment rule in South Korea, Japan and the United States.
In Korea, for the rapid introduction of new medical technologies, a One-Stop Service program (aka parallel review process) is operated that simultaneously conducts regulatory approval and new health technology assessment (nHTA) process. In Japan, the Sakigake designation program aims to give patients better access to innovative pharmaceuticals, medical technologies, and regenerative medicines by streamlining the approval and pricing process but it doesn't provide immediate coverage after approval. Medicare Coverage for Innovative Technology (MCIT) is one of the incentive programs for innovative technology which aims to improve patient access to new medical technologies through rapid market access process in the United States. Medical technologies designated a Breakthrough Device receive immediate Medicare Coverage for 4 years by MCIT.
It is recommended for Korea and Japan to actively implement the accelerated patient access process and grant affordable premium prices for the innovative medical technologies. MCIT can be considered as a breakthrough for innovative medical technology adaption.