College of Pharmacy, Sungkyunkwan University, Suwon, Gyeonggi-do, South Korea.
Clin Ther. 2011 Jul;33(7):926-32. doi: 10.1016/j.clinthera.2011.05.089. Epub 2011 Jun 29.
Medical costs in South Korea have risen, in part due to increased demand and consumption of pharmaceutical products by an aging population and also because of the introduction of newer, more expensive drugs. In an effort to stabilize the financing of health insurance and alleviate the financial burden on individuals, the government implemented a policy changing the national health insurance drug-listing system from a negative list system to a positive list system (PLS).
The goal of this study was to compare differences in drug-listing rates for new chemical entities (NCEs) and incrementally modified drugs (IMDs) after South Korea introduced the PLS in December 2006. Parameters significantly affecting NCE and IMD listings were also identified.
New drug-listing data for 2007 and 2008 were obtained from the databases of the Health Insurance Review Agency and the Ministry of Health and Welfare. Descriptive analyses on the reimbursement rate and logistic regression analysis were conducted. Statistical significance was tested for all results, and P < 0.05 was considered statistically significant.
A total of 150 reimbursement applications (79 for NCEs, 71 for IMDs) were examined for this study. The overall drug-listing rate was lower than before the introduction of the PLS. Drug reimbursement rates for NCEs (50.6%) were lower than those for IMDs (74.6%) (P = 0.0025). However, the price negotiation rate was 85.0% for NCEs compared with 73.6% for IMDs (P = 0.1847). The time required for both reimbursement and drug pricing was significantly longer for NCE than for IMD listings (P < 0.05). Cost-effectiveness and budget impact were 2 significant variables affecting the listing of NCEs. However, no significant variable was identified for IMDs.
The PLS challenges the drug-listing system by decreasing the drug-listing rate and lengthening the period for reimbursement determinations. These effects were more pronounced for NCE listings than for IMD listings.
韩国的医疗费用有所上涨，部分原因是人口老龄化导致对药品的需求和消费增加，以及推出了更新、更昂贵的药物。为了稳定医疗保险的融资并减轻个人的经济负担，政府实施了一项政策，将国家健康保险药品清单系统从负面清单系统改为正面清单系统（PLS）。
本研究旨在比较韩国于 2006 年 12 月引入 PLS 后，新化学实体（NCE）和改良药物（IMD）的药品上市率差异。还确定了对 NCE 和 IMD 上市有显著影响的参数。
从健康保险审查和评估机构以及卫生福利部的数据库中获取 2007 年和 2008 年的新药上市数据。对报销率进行描述性分析和逻辑回归分析。对所有结果进行统计学检验，P<0.05 被认为具有统计学意义。
本研究共审查了 150 份报销申请（79 份 NCE，71 份 IMD）。总体药品上市率低于 PLS 引入前。NCE（50.6%）的药品报销率低于 IMD（74.6%）（P=0.0025）。然而，NCE 的价格谈判率为 85.0%，而 IMD 为 73.6%（P=0.1847）。NCE 的报销和药品定价所需时间明显长于 IMD（P<0.05）。成本效益和预算影响是影响 NCE 上市的 2 个重要变量。然而，IMD 没有确定显著变量。
PLS 通过降低药品上市率和延长报销决策时间来挑战药品上市系统。这些影响在 NCE 上市方面更为明显。
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