디지털 치료기기 개념과 건강보험 적용 가능성 검토

Abstract

This study aims to provide political implications of Digital Therapeutics (DTx) for the coverage of the health insurance program in Korea. The study reviewed foreign policies related to the concept of DTx, DTx support systems, health insurance coverage status, coverage areas, criteria for listing decisions, and pricing methods. To review foreign regulatory status on DTx, this study selected the following six countries focusing on their leadership: the United States with the world-first approval of DTx, the United Kingdom, Germany, Japan having the health insurance coverage for DTx, and Australia announcing a specific national digital health strategy on digital health. First of all, foreign countries were supporting DTx through subsidies, fundraising, or with health insurance coverage. But only six cases supporting DTx with health insurance coverage were observed (one in the UK, four in Germany, and one in Japan). Secondly, health insurance coverage was provided only when the clinical effects were equivalent to those provided by existing technology. In this regard, foreign countries such as Germany and the UK were requiring validation of positive clinical effect of DTx through 1~2 years of real-world testing. The prices of DTx were either determined through closed negotiations between government and manufacturers or based on existing health insurance coverage cases (drugs, treatment materials, and medical services). Finally, this study concluded that the application of domestic health insurance coverage for DTx is available when the clinical effect is proven. From the short-term perspective, the national health insurance coverage is also possible through cost-level reimbursements during a certain period of time being considered as an innovative health technology. However, from the long-term perspective, the application of national health insurance coverage for DTx requires consideration of the value of DTx rather than the cost. The establishment of a committee on the DTx coverage determination or assessment needs to be considered.