고가 의약품 급여관리제도의 시사점
A Comparative Study on the High-Cost Medicine Reimbursement Management Policy Between Countries
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Objectives: This study aims to compare the domestic and foreign high-priced drug benefit management systems in order to draw implications for the development of the domestic system. Methods: In this study, countries with public health insurance systems and comparable demographic and economic characteristics were carefully chosen. A thorough literature review was conducted to examine the existing state of high-priced drug benefit management systems, and subsequently compare them to the Korean system in terms of access and financial management. Results: We examined the reimbursement systems for high-cost drugs in the United Kingdom, Germany, France, and Italy. These countries commonly utilized the managed entry agreement (MEA) or managed access agreement (MAA), rather than relying solely on specific pricing criteria. To enhance access, specific measures are implemented in each country as follows: the United Kingdom (Patient Access Schemes), Germany (Early Benefit Assessment), France (Autorisation Temporaire d’Utilisation), and Italy (the 5% AIFA Fund). Regarding fiscal management, MEAs/MAAs are also utilized to implement price discount, refund and aggregate limitations based on pharmaceutical companies’ sales. Simultaneously, a performance- based payment system is applied to high-priced drugs with significant clinical uncertainty. Conclusion: The reimbursement systems for high-cost drugs in major countries and Korea exhibit no significant differences. However, it should be noted that the MAA contract clause in the UK and Italy require pharmaceutical companies to supply free medicines to patients facing difficulties in receiving benefits. In the future, it is imperative for stakeholders to collaborate in establishing a patient support system.
Abstract
Objectives: This study aims to compare the domestic and foreign high-priced drug benefit management systems in order to draw implications for the development of the domestic system. Methods: In this study, countries with public health insurance systems and comparable demographic and economic characteristics were carefully chosen. A thorough literature review was conducted to examine the existing state of high-priced drug benefit management systems, and subsequently compare them to the Korean system in terms of access and financial management. Results: We examined the reimbursement systems for high-cost drugs in the United Kingdom, Germany, France, and Italy. These countries commonly utilized the managed entry agreement (MEA) or managed access agreement (MAA), rather than relying solely on specific pricing criteria. To enhance access, specific measures are implemented in each country as follows: the United Kingdom (Patient Access Schemes), Germany (Early Benefit Assessment), France (Autorisation Temporaire d’Utilisation), and Italy (the 5% AIFA Fund). Regarding fiscal management, MEAs/MAAs are also utilized to implement price discount, refund and aggregate limitations based on pharmaceutical companies’ sales. Simultaneously, a performance- based payment system is applied to high-priced drugs with significant clinical uncertainty. Conclusion: The reimbursement systems for high-cost drugs in major countries and Korea exhibit no significant differences. However, it should be noted that the MAA contract clause in the UK and Italy require pharmaceutical companies to supply free medicines to patients facing difficulties in receiving benefits. In the future, it is imperative for stakeholders to collaborate in establishing a patient support system.
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