Department of Health Policy and Management, Sangji University, Wonju, Korea.
Value Health. 2009 Nov-Dec;12 Suppl 3:S36-41. doi: 10.1111/j.1524-4733.2009.00625.x.
This article reviews the change in the reimbursement and pricing system in South Korea, which was the precursor to the eventual implementation of evidence-based decision-making. There has been pressure on Korea's National Health Insurance system to control its skyrocketing expenditures on drugs. As a result, a series of cost-containment policies have been implemented. The idea of economic evidence-based decision-making was first introduced in Korea in 2001 when the government announced cost-effectiveness as one of the criteria for reimbursement decisions. After this announcement, the Health Insurance Review and Assessment Service (HIRA) developed guidelines, which became the standard for economic evaluations. In 2006, the drug listing system for reimbursement was changed from a negative to a positive system under the drug expenditure rationalization plan. Under this new system, only drugs that are proven economically and clinically valuable can be listed, and applicants have to submit economic evaluation studies to support the cost-effectiveness of their drugs. Once new applications are submitted, HIRA reviews them, and the Drug Reimbursement Evaluation Committee (DREC) decides whether or not to recommend the submitted drugs. In its reimbursement decisions, the DREC considers not only cost-effectiveness but also the availability of therapeutic alternatives, the severity of the condition treated, and the impact on the budget, among other measures. After the introduction of the positive list system, 56% of drugs were determined to be appropriate for reimbursement by the DREC. Despite limited human resources, experience, and quality local data, Korea is continuing to make efforts to establish a system of evidence-based decision-making.
本文综述了韩国医保报销和定价体系的变化，这是实行循证决策的前奏。韩国医保系统面临着控制药品支出飞涨的压力。因此，实施了一系列成本控制政策。2001 年，韩国政府宣布将成本效益作为医保报销决策的标准之一，首次提出了基于经济证据的决策理念。此后，韩国医保审查评估服务局（HIRA）制定了相关指南，成为经济评估的标准。2006 年，在药品支出合理化计划下，医保报销药品目录系统由负面清单改为正面清单。在新制度下，只有经过经济和临床验证有价值的药品才能被列入目录，申请人必须提交经济评估研究来支持其药品的成本效益。一旦提交新药申请，HIRA 会进行审查，药品报销评估委员会（DREC）决定是否推荐提交的药品。在医保报销决策中，DREC 不仅考虑成本效益，还考虑治疗替代方案的可及性、治疗疾病的严重程度以及对预算的影响等因素。正面清单制度实施后，DREC 确定 56%的药品适合报销。尽管韩国面临人力资源、经验和高质量本地数据有限的挑战，但仍在继续努力建立循证决策体系。
