신의료기술평가의 주요 이슈와 개선 방안

Abstract

Objectives: This study reviewed the current major issues of New Health Technology Assessment Program (nHTA) in Korea and suggested ways to promote evidence-based approaches to nHTA. Methods: Data covered the list of all applications to nHTA from 2007 when nHTA was introduced to September 30, 2019. A total of 2539 application cases were analyzed. In addition 11 experts who had experience in the nHTA were surveyed and conducted 1:1 non-face-to-face interviews from June 18th to July 5th, 2020. The questionnaire for the expert survey was developed based on the 15 principles of the best HTA practice. Results: Of the 2539 applications, 891 were classified as new technologies, 440 existing technologies, 568 early stage technologies, 243 research stage technologies, and 397 others. Among the 891 new technologies, there were 320 in vitro diagnostic tests, 259 genetic tests, 194 treatments and procedures, and 128 others including one oriental medicine. The average time required for nHTA was 226 days (±96.8), and it took an average of 43.3 days (±22.7) from notification to the applicant to official release of the Ministry of Health and Welfare. Of the 243 cases classified as the research stage technologies, 124 cases were Grade I, which means that the potential benefit of clinical introduction was not significant. About 76% (435/568) of early stage technologies were Grade I. Among 567 cases of new technologies with Scottish Intercollegiate Guidelines Network recommendation grading Grade C was the most common with 236 cases, followed by Grade D 218, Grade B 87, and Grade A 47 in that order. Based on the result of the expert survey, we propose recommendations for improving nHTA. Conclusion: This study based on the analysis of nHTA database and expert survey results can help policy makers and health care professional societies to make better nHTA in Korea.