경제성평가자료제출생략 트랙으로 진입한 약제에 대한 외국의 치료적 이익 평가 결과 비교

Abstract

This study assessed the additional health benefits of the drugs listed through the Economic Evaluation Exemption Procedure (EEEP) in Korea. We conducted a comparative review of 32 EEEP drugs listed between May 2015 and July 2022, comparing how they were assessed in France, Germany, and Canada. To collect the data, we reviewed the evaluations conducted by the relevant agency in each country and identified if the additional benefit exists and how significant it is. Additionally, the size of the benefit gains assessed by each agency was categorized as “High” or “Low,” allowing us to evaluate the consistency among these countries. In France, only 38% of the 34 drugs compared demonstrated moderate or higher levels of additional benefit. Germany acknowledged substantial benefit improvement in 27% of the 30 drugs assessed, while 73% showed minor, unquantifiable, or no additional benefits. In Canada, 5 out of 22 cases have been identified as providing significant additional benefit. The level of inter-country consistency in the assessment results from these three countries was somewhat limited. Based on the evaluation results in France, Germany, and Canada, the additional benefits of EEEP drugs over existing treatments were not substantial in many cases. Even though the EEEP was introduced to improve accessibility to high-cost drugs for medical conditions with unmet needs, it is necessary to reconsider whether to allow exceptions for drugs with low therapeutic value.