Health Insurance Review and Assessment Service, Wonju, South Korea; College of Pharmacy, Ewha Womans University, Seoul, South Korea.
Department of Statistics, Ewha Womans University, Seoul, South Korea.
Clin Ther. 2020 Jul;42(7):1222-1233. doi: 10.1016/j.clinthera.2020.05.006. Epub 2020 May 31.
The South Korean government in 2014 introduced various policies to enhance accessibility of pharmaceuticals. This study sought to examine whether positive reimbursement recommendations of pharmaceuticals have increased since 2014.
Industry submissions evaluated from January 2007 to December 2018 were identified, and characteristics relevant to reimbursement recommendations were extracted. Logistic regression analyses with robust SEs were used to quantify the likelihood of positive recommendations for pharmaceuticals, after controlling for relevant factors influencing the recommendations.
During the study period, 355 (72.9%) of 487 submissions were positively recommended; the drugs evaluated after 2014 (77.8%) were significantly more likely to receive positive reimbursement recommendations than the drugs evaluated before 2014 (69.5%). In the multivariable logistic regression analysis, several factors (labeled a noncancer drug, priced less than alternatives, considered clinically superior, and having budget impact >10 billion South Korean won) were significantly associated with positive recommendations (P < 0.05). When considering interaction effects between evaluation year and other variables, only the interaction between comparative clinical benefit and evaluation year was significant. Specifically, clinically noninferior drugs evaluated after 2014 had 2.85 times the odds of receiving positive recommendations compared with the clinically noninferior drugs evaluated earlier.
Recently evaluated drugs are more likely to receive positive reimbursement recommendations, especially those drugs whose comparative clinical benefits are noninferior.
韩国政府于 2014 年出台了多项政策，以提高药品的可及性。本研究旨在考察自 2014 年以来，药品的正面报销推荐是否有所增加。
确定了 2007 年 1 月至 2018 年 12 月期间评估的行业提交材料，并提取了与报销推荐相关的特征。使用稳健标准误的逻辑回归分析来量化在控制了影响推荐的相关因素后，药品获得正面推荐的可能性。
在研究期间，487 份提交材料中有 355 份（72.9%）获得了正面推荐；与 2014 年之前评估的药物相比（69.5%），2014 年之后评估的药物（77.8%）更有可能获得正面的报销推荐。在多变量逻辑回归分析中，一些因素（非癌症药物、价格低于替代药物、被认为具有临床优势、预算影响超过 100 亿韩元）与正面推荐显著相关（P<0.05）。在考虑评估年度与其他变量之间的交互效应时，只有比较临床效益与评估年度之间的交互效应是显著的。具体来说，与 2014 年之前评估的具有临床非劣效性的药物相比，2014 年之后评估的具有临床非劣效性的药物获得正面推荐的可能性增加了 2.85 倍。
最近评估的药物更有可能获得正面的报销推荐，尤其是那些具有临床非劣效性的药物。
