New drug accessibility and budgetary impact in South Korea: policy challenges and implications.

IF 1.8 4区 医学 Q3 HEALTH CARE SCIENCES & SERVICES
Se-Eun Hwang, Yoon-A Jang, Kyung-Min Lim, Ji-Won Jung, Jong Hyuk Lee
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引用次数: 0

Abstract

Background: 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.

Research design and methods: 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.

Results: 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.

Conclusions: While South Korea has effectively controlled pharmaceutical expenditures, allocations for new drugs remain low compared to other major countries.

韩国新药可及性和预算影响:政策挑战和影响。
背景:比较韩国与美国、欧洲和日本的新药可及性指标,并考察韩国的药品支出结构。研究设计和方法:采用两个独立的数据集分析新药对患者可及性和预算的影响。根据报销率、批准后上市时间和国际比较,对2013年至2022年批准的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年期间列出的226种新药,评估了支出模式,重点是风险分担协议和对国家健康保险预算的财政影响。结果:2013 - 2022年获批的171个新药中,截至2024年1月1日报销率为67.8%。审批到报销的时间表因药物类型和定价途径而异,通过加权平均价格途径列出的药物比通过药物经济学评估评估的药物获得更快的报销。2012年至2021年,新药占药品总支出的8.5%,其中肿瘤药物的年度支出最高。新药支出在2019年达到顶峰,但此后有所下降。结论:虽然韩国有效地控制了药品支出,但与其他主要国家相比,新药拨款仍然较低。
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来源期刊
Expert Review of Pharmacoeconomics & Outcomes Research
Expert Review of Pharmacoeconomics & Outcomes Research HEALTH CARE SCIENCES & SERVICES-PHARMACOLOGY & PHARMACY
CiteScore
4.00
自引率
4.30%
发文量
68
审稿时长
6-12 weeks
期刊介绍: Expert Review of Pharmacoeconomics & Outcomes Research (ISSN 1473-7167) provides expert reviews on cost-benefit and pharmacoeconomic issues relating to the clinical use of drugs and therapeutic approaches. Coverage includes pharmacoeconomics and quality-of-life research, therapeutic outcomes, evidence-based medicine and cost-benefit research. All articles are subject to rigorous peer-review. The journal adopts the unique Expert Review article format, offering a complete overview of current thinking in a key technology area, research or clinical practice, augmented by the following sections: Expert Opinion – a personal view of the data presented in the article, a discussion on the developments that are likely to be important in the future, and the avenues of research likely to become exciting as further studies yield more detailed results Article Highlights – an executive summary of the author’s most critical points.
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