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加拿大抗肿瘤药品评审中利益相关者的作用及启示
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| 篇名： | 加拿大抗肿瘤药品评审中利益相关者的作用及启示 |
| TITLE： | Role of stakeholders in Canadian oncology drug review and its enlightenment |
| 摘要： | 目的 为完善我国抗肿瘤药品医保谈判过程中利益相关者的参与机制提供参考。方法基于利益相关者理论，结合文献研究、案例分析（以本妥昔单抗报销审查为例）等方法，对加拿大抗肿瘤药品评审流程及利益相关者的参与机制和作用开展分析，并提出对我国相关工作的建议。结果与结论加拿大抗肿瘤药品报销审查程序大致由提交前规划阶段、正式申请提交阶段、审查阶段以及形成报销建议阶段4个环节组成，而药品厂商、患者代表咨询组织、临床审查专家咨询组以及省级咨询小组等作为利益相关者，通过向加拿大国家卫生技术评估局提供建议和反馈参与抗肿瘤药品的报销评审过程。众多利益相关主体的参与提高了加拿大抗肿瘤药品评审的透明度，使抗肿瘤药品报销结果更趋于科学化、合理化和精准化。笔者建议我国应明确抗肿瘤药品医保谈判过程中利益相关者责、权、利的界定及参与机制，重视患者在抗肿瘤药品医保谈判过程中的作用，完善信息公开并提高谈判机制和流程的透明度，从而提高利益相关者的参与度。 |
| ABSTRACT： | OBJECTIVE To prov ide reference for improving the participation mechanism of stakeholders in the process of medical insurance negotiation for oncology drug in China. METHODS Based on the stakeholder theory ，combined with literature research，case analysis （taking the review of reimbursement of Bentuximab as an example ）and other methods ，analysis and research were conducted on the Canadian oncology drug review process and the participation mechanism and role of stakeholders. The suggestions were put forward for our country. RESULTS & CONCLUSIONS Canadian oncology drug reimbursement review process was composed of four stages ：the pre-submission planning stage ，the formal submission stage of application，the review stage，and the stage of forming reimbursement recommendations. As the role of stakeholders ，drug manufacturers ，patient representative advisory group ， clinical review expert advisory groups and provincial advisory groups participated in the reimbursement review process of oncology drug by providing suggestions and feedback to CADTH. The participation of stakeholders had improved the transparency of the review of oncology drugs in Canada and made the reimbursement results of oncology drugs more scientific ，reasonable and accurate. In China ，it is recommended to define rights ，responsibilities and interests as well as the participation mechanism of stakeholders in the medical insurance negotiation process ，attach importance to the role of patients in the medical insurance negotiation process of oncology drug ，improve information disclosure and increase the transparency of the negotiation mechanism and process so as to increase the participation of stakeholders. |
| 期刊： | 2022年第33卷第09期 |
| 作者： | 王苑如，谢金平，胡紫馨，邵蓉 |
| AUTHORS： | WANG Wanru ，XIE Jinping ，HU Zixin，SHAO Rong |
| 关键字： | 抗肿瘤药品；利益相关者；医保谈判；卫生技术评估；加拿大 |
| KEYWORDS： | oncology drug ；stakeholders；medical insurance negotiation ；health technology assessment ；Canada |
| 阅读数： | 174 次 |
| 本月下载数： | 3 次 |
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