摘要
目的:全面总结和分析我国抗肿瘤创新药物政策的发展演变及全生命周期可及性政策实践,为解决实践中存在的问题提供分析基础和框架,并为政策的优化和改进提供科学依据。方法:通过检索北大法宝及政府官方网站,筛选我国国家层面发布的抗肿瘤创新药物政策文件。采用文献回顾法系统梳理国家层面抗肿瘤创新药物政策,深入剖析我国抗肿瘤创新药物政策的类型、内容以及发展阶段。并从全生命周期视角分析抗肿瘤药物可及性提升的政策实践。结果:1984~2023年,我国抗肿瘤创新药物相关政策数量达到136份,呈现出显著的增长趋势,近5年政策数量实现了爆发式增长。政策发展演变划分为早期萌芽阶段(1984~1997年)、初步探索阶段(1998~2008年)、快速发展阶段(2009~2017年)、深化发展阶段(2018年至今)。2018年以来的深化发展阶段初步形成了基于药品全生命周期的政策框架,通过加速市场准入可及、促进临床应用可及、加强支付保障可及等核心维度下的政策实践,保障和提升抗肿瘤创新药物的可及性。结论:我国在抗肿瘤创新药物可及性政策方面取得了显著进展,但仍然面临可及性挑战。未来的政策制定和优化应通过深化供给侧和需求侧政策改革、完善支付分担政策体系,以促进抗肿瘤创新药物可及性的持续改善。
Objective To comprehensively summarize and analyze the evolution of policies for innovative anticancer drugs and accessibility policy practices in China from a drug lifecycle perspective,and provide an analytical basis and framework for policy optimization and improvement.Methods By searching on Peking University Law Database and government official websites,national-level policy documents related to innovative anticancer drugs in China were obtained,which were systematically reviewed by using literature review methods.Based on the drug lifecycle theory,a comprehensive examination of each link of novel anticancer drugs was conducted.Results From 1984 to 2023,the number of policies related to innovative anticancer drugs in China reached 136,showing a significant upward trend,especially in the last five years,with a burst-like increase in policy numbers.The evolution of policy development is divided into the early germination stage(1984~1997),the initial exploration stage(1998~2008),the rapid development stage(2009~2017),and the deepening development stage(2018 to the present).Since 2018,a policy frame based on the drug life cycle of drugs has been initially formed to accelerate the market accessibility,promote clinical accessibility,and strengthen payment accessibility.Conclusion China has made significant progress in accessibility policies for innovative anticancer drugs,while it still confronted with challenges of accessibility.It was proposed to optimize the drug life cycle policy chain by deepening supply and demand side policy reforms,improving the payment sharing policy system.
作者
朱虹
高美香
李雅
陈红微
殷奕茹
冯浩浩
杨嘉安
吴群红
Zhu Hong(School of Humanities and Social Sciences,Harbin Medical University,Harbin,P.R.China)
出处
《中国卫生事业管理》
北大核心
2025年第5期546-551,563,共7页
Chinese Health Service Management
基金
黑龙江省哲学社会科学研究规划项目“基于价值医疗导向的抗癌创新药物可及性问题诊断及政策优化研究”(22GLB125)。
关键词
抗肿瘤创新药物
政策演变
可及性政策
全生命周期
innovative anticancer drugs
policy evolution
accessibility policy
drug lifecycle.
