Factors Impacting Premium Reimbursement Price Determination of Medical Technologies in South Korea
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Objectives: There is little transparency about South Korea’s Value Appraisal Standard (VAS) pro cess, which determines premium reimbursement prices for new medical technologies based on VAS scores. The primary objective of this study was to analyze VAS evaluation cases to investigate and identify the key factors that influence VAS scores of medical technologies. Methods: We collected VAS evaluation cases from Medical Device Expert Evaluation Committee (MDEEC) monthly re view results between January 2015 and August 2024. Data was extracted from MDEEC review re sults and supplemented with additional sources. Regression analysis was conducted to identify key factors influencing the VAS process, and sensitivity analysis was performed to assess the robustness of the findings. Results: A total of 35 VAS evaluation cases are included in this study. The study found that the VAS is underutilized, with only a small proportion of medical technologies being evaluated through this process. The multiple regression model revealed that medical technologies recognized for added value in clinical guidelines, textbooks, or foreign reimbursement coverage de terminations were associated with significantly higher VAS scores (p<0.001). These results were consistent in sensitivity analysis. In contrast, direct clinical factors, such as the level of evidence and the number of submitted studies, did not significantly influence VAS scores. Conclusion: Clinical guidelines/textbooks recommendations or foreign reimbursement coverage determinations for added value recognition are critical predictors of VAS scores. This study highlights that practical re forms are necessary to improve transparency and bring evidence requirements in line with global best practice to facilitate effective utilization of the VAS process.
Abstract
Objectives: There is little transparency about South Korea’s Value Appraisal Standard (VAS) pro cess, which determines premium reimbursement prices for new medical technologies based on VAS scores. The primary objective of this study was to analyze VAS evaluation cases to investigate and identify the key factors that influence VAS scores of medical technologies. Methods: We collected VAS evaluation cases from Medical Device Expert Evaluation Committee (MDEEC) monthly re view results between January 2015 and August 2024. Data was extracted from MDEEC review re sults and supplemented with additional sources. Regression analysis was conducted to identify key factors influencing the VAS process, and sensitivity analysis was performed to assess the robustness of the findings. Results: A total of 35 VAS evaluation cases are included in this study. The study found that the VAS is underutilized, with only a small proportion of medical technologies being evaluated through this process. The multiple regression model revealed that medical technologies recognized for added value in clinical guidelines, textbooks, or foreign reimbursement coverage de terminations were associated with significantly higher VAS scores (p<0.001). These results were consistent in sensitivity analysis. In contrast, direct clinical factors, such as the level of evidence and the number of submitted studies, did not significantly influence VAS scores. Conclusion: Clinical guidelines/textbooks recommendations or foreign reimbursement coverage determinations for added value recognition are critical predictors of VAS scores. This study highlights that practical re forms are necessary to improve transparency and bring evidence requirements in line with global best practice to facilitate effective utilization of the VAS process.