Hwang Se-Eun, Jang Yoon-A, Lim Kyung-Min, Jung Ji-Won, Lee Jong Hyuk
College of Pharmacy, Chung-Ang University, Seoul, Republic of Korea.
Expert Rev Pharmacoecon Outcomes Res. 2025 Jun;25(5):813-821. doi: 10.1080/14737167.2025.2487468. Epub 2025 Apr 2.
To compare the accessibility indicators for new drugs in South Korea with those in the United States, Europe, and Japan, and examine the structure of pharmaceutical expenditures in South Korea.
Patient accessibility and budget impacts of new drugs were analyzed using two independent datasets. Accessibility was evaluated for 171 drugs approved between 2013 and 2022 based on reimbursement rates, time to listing post-approval, and international comparisons. Budget impact analysis covered 226 new drugs listed from 2012 to 2021, assessing expenditure patterns with an emphasis on risk-sharing agreements and financial implications for the National Health Insurance budget.
Among the 171 new drugs approved between 2013 and 2022, 67.8% were reimbursed as of 1 January 2024. Approval-to-reimbursement timelines varied by drug type and pricing pathway, with drugs listed via the weighted average price pathway receiving faster reimbursement than those evaluated through pharmacoeconomic evaluation. Between 2012 and 2021, new drugs constituted 8.5% of total pharmaceutical expenditures, with oncology drugs incurring the highest annual expenditure per product. Expenditure on new drugs peaked in 2019 but declined thereafter.
While South Korea has effectively controlled pharmaceutical expenditures, allocations for new drugs remain low compared to other major countries.
比较韩国与美国、欧洲和日本的新药可及性指标，并研究韩国的药品支出结构。
使用两个独立数据集分析新药的患者可及性和预算影响。基于报销率、获批后上市时间以及国际比较，对2013年至2022年期间获批的171种药物的可及性进行了评估。预算影响分析涵盖了2012年至2021年上市的226种新药，评估了支出模式，重点关注风险分担协议以及对国民健康保险预算的财务影响。
在2013年至2022年期间获批的171种新药中，截至2024年1月1日，67.8%已获得报销。获批至报销的时间线因药物类型和定价途径而异，通过加权平均价格途径上市的药物比通过药物经济学评估的药物报销速度更快。2012年至2021年期间，新药占药品总支出的8.5%，肿瘤药物的单产品年度支出最高。新药支出在2019年达到峰值，但此后有所下降。
虽然韩国有效控制了药品支出，但与其他主要国家相比，新药的拨款仍然较低。
