高价值创新药准入路径及支付策略的国际案例分析——以丙肝直接抗病毒药物为例  

International Case Study On Access And Payment Strategy Of High Value Innovative Drugs——Taking Direct-acting Antiviral Agents Of Hepatitis C As An Example

作　　者：刘昭 朱雨蕾 郭武栋 张帆 陈金榆 王耀羚 李雪 赵琨 刘跃华 Liu Zhao;Zhu Yulei;Guo Wudong;Zhang Fan;Chen Jinyu;Wang Yaoling;Li Xue;Zhao Kun;Liu Yuehua(Health Development Research Center of National Health Commission,Beijing,100191;Center for Comprehensive Evaluation of Drugs and Health Technology of National Health Commission,Beijing,100191;School of Medical Administration,Nanjing Medical University,Nanjing,211166)

机构地区：[1]国家卫健委卫生发展研究中心,北京100191 [2]国家卫健委药物和卫生技术综合评估中心,北京100191 [3]南京医科大学医政学院,南京211166

出　　处：《中国医疗保险》2020年第9期71-75,共5页China Health Insurance

基　　金：国家医疗保障局医疗保障事业管理中心项目:中国卫生技术评估机制建设研究。

摘　　要：目的:以丙肝直接抗病毒药物(DAAs)为例,梳理高价值创新药的准入路径和支付策略,为我国创新药准入及支付决策提供参考。方法:文献梳理,案例研究。结果:包括澳大利亚、巴西、中国在内的多个国家和地区,基于自身国情,针对创新药运用风险分担协议、专利自愿许可、专利强制许可、专利申请拒绝、联合采购、竞争性谈判以及个人进口等方式,大幅降低了DAAs在区域内的实际支付价格,提高了该药的可及性和可负担性。建议:根据高价值创新药的特性,灵活运用专利相关制度,全面引入竞争,增强支付方的议价能力;积极探索风险分担的模式方法,使支付方和生产方共同承担财务和效果的不确定性后果。Objective:To sort out cases of admittance and payment of Direct-acting antiviral agents(DAAs),with a view to providing reference for the decision-making of innovative drugs in China.Methods:Literature review and case studies.Results:Many countries and regions(including Australia,Brazil,China and so on),based on their own conditions,signifi cantly reduced the actual payment price of DAAs in the region,and improved the accessibility and aff ordability of the drug,through risk-sharing agreements,voluntary patent licenses,patent compulsory licenses,patent application rejections,joint procurement,competitive negotiations,and individual imports.Suggestions:It is recommended to use patent-related policies more fl exibly based on the characteristics of high-value innovative drugs,in order to add more competition and enhance the bargaining power of payers.Developing risk sharing model and method is also recommended,so that payer and producer jointly bear the uncertain consequences of fi nancial and drug eff ect.

关 键 词：创新药 高价值 准入 支付 直接抗病毒药物 

分 类 号：F840.684[经济管理—保险] C913.7[社会学]