Department of Research, Health Insurance Review & Assessment Service, Wonju, South Korea.
Clin Transl Sci. 2022 Feb;15(2):433-441. doi: 10.1111/cts.13161. Epub 2021 Sep 29.
This study probed the market share of generic medicines by patients' age and sex, type of medical facilities, route of administration, number of generic brands, market size (drug expenditure), and therapeutic class and investigated factors associated with a high market share of generic medicines in Korea. We analyzed using national health insurance data between 2010 and 2019. The dependent variable was the generic medicine market share, measured as the number of prescriptions and expenditures. Multivariable regression analysis was conducted using the numbers of generic brands, market size by each ingredient and therapeutic class, relative price, the number of prescriptions, and therapeutic class. Total pharmaceutical expenditures have increased due to the high use of single-source drugs. The number of prescriptions and expenditures for generic medicines were 0.3 billion prescriptions and $7.8 billion, respectively, accounting for 46.5% and 46% of the total market. Multivariate analysis showed that the number of prescriptions (>20 thousand) and the market size of main active ingredients (>$1 million) were associated with an increased market share, whereas the number of generic brands (compared to <3) was associated with reduced generic medicine market share. In conclusion, we found that supply policies to promote the market entry of generic medicines by mandating price consistency between generic medicines and off-patent original medicines had limitations in increasing the generic medicine market share. Policy should be put in place both to ensure the timely market entry of generic medicines and to promote the use of cheaper generic medicines.
本研究探讨了患者年龄和性别、医疗设施类型、给药途径、仿制药品牌数量、市场规模(药品支出)以及治疗类别等因素对仿制药市场份额的影响,并调查了韩国仿制药市场份额较高的相关因素。我们分析了 2010 年至 2019 年期间的国家健康保险数据。因变量是仿制药市场份额,以处方数量和支出衡量。使用每个成分和治疗类别的市场规模、相对价格、处方数量和治疗类别对多变量回归分析进行了分析。由于单一来源药物的大量使用,总药品支出有所增加。仿制药的处方和支出分别为 30 亿张和 78 亿美元,分别占总市场的 46.5%和 46%。多变量分析显示,处方数量(>20000 张)和主要活性成分的市场规模(>$100 万美元)与市场份额的增加相关,而仿制药品牌数量(与<3 相比)与仿制药市场份额的减少相关。总之,我们发现,通过要求仿制药和非专利原研药之间的价格保持一致来促进仿制药市场准入的供应政策,在增加仿制药市场份额方面存在局限性。应制定政策,既要确保仿制药的及时入市,又要促进更便宜的仿制药的使用。