【摘要】 为我国罕见病药物医保准入过程中谈判机制建立和完善的提供借鉴。本研究通过查阅相关的官网,对英国发布的药品价格谈判相关政策进行深入分析,解读药品价格谈判机制在卫生技术评估与英国国民健康保障体系(National Health Service,NHS)报销中的应用。同时,以实证研究法分析英国国家卫生与临床优化研究所(National Institute for Health and Care Excellence,NICE)于2018年发布的罕见病药物报告,探究价格谈判机制的使用情况。英国对高值罕见病药物的谈判机制主要分为3种,即患者用药可及性方案(Patient Access Scheme,PAS)、商业准入协议(Commercial Access Agreements,CAAs)、管理准入协议(Managed Access Arrangements,MAAs),3种协议在使用过程中,都充分考虑了罕用药的特殊性。英国3种价格谈判机制的应用及其灵活性,对现阶段我国正面临的罕见病药物是否纳入医保问题,以及维护医保基金可持续性均有重要的借鉴价值,也为我国药品价格谈判方案的运行提供实践依据。更多还原

【Abstract】 To provide reference for the establishment and improvement of the price negotiation mechanism in the process of medical insurance access for rare diseases in China. Relevant policies on drug price negotiations issued by the UK were in-depth analyzed by inquiring the relevant official website,in order to understand the application of drug price negotiation mechanism in health technology assessment and NHS reimbursement. At the same time,the empirical research method was used to analyze the report of the rare disease drug issued by National Institute for Health and Care Excellence (NICE) in 2018 to explore the use of the price negotiation mechanism.There are three main negotiating mechanisms for high-value orphan drugs in the UK,namely Patient Access Scheme (PAS),Commercial Access Agreements (CAAs),and Management Access Agreements (MAAs). In the process of using these three schemes,the particularity of orphan drugs has been fully considered. The application and flexibility of the three price negotiation mechanisms in the UK have important reference value for the inclusion drugs treating rare diseases into medical insurance and the sustainability of the medical insurance fund,which also provide a practical basis for the operation of Chinese drug price negotiation scheme.更多还原