加拿大创新药医保准入临床价值评估研究

盛天翊; 蒋蓉; 邵蓉

doi:10.6039/j.issn.1001-0408.2024.24.02

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加拿大创新药医保准入临床价值评估研究

药事管理 | 更新时间：2025-09-24

- 加拿大创新药医保准入临床价值评估研究
- Clinical value assessment of innovative drugs in Canada’s health insurance access
- 中国药房 2024年35卷第24期页码：2972-2976
- 作者机构：
  
  1.中国药科大学国家药物政策与医药产业经济研究中心，南京　211198
  2.国家药品监督管理局药品监管创新与评价重点实验室，南京　211198
- 作者简介：
  
  硕士研究生。研究方向：医药政策与法规。E-mail：13913986700@163.com
  教授，博士生导师。研究方向：医药政策与法规、药事管理、药品监管。电话：025-86185287。E-mail：shaorong118@163.com
- 基金信息：
  
  国家自然科学基金青年项目(72304280)
- DOI：10.6039/j.issn.1001-0408.2024.24.02
  中图分类号： R95
- 收稿日期：2024-05-21，
  
  修回日期：2024-10-27，
  
  录用日期：2024-10-28，
  
  纸质出版日期：2024-12-30
- 稿件说明：
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盛天翊,蒋蓉,邵蓉.加拿大创新药医保准入临床价值评估研究[J].中国药房,2024,35(24):2972-2976.

SHENG Tianyi,JIANG Rong,SHAO Rong.Clinical value assessment of innovative drugs in Canada’s health insurance access[J].ZHONGGUO YAOFANG,2024,35(24):2972-2976.
盛天翊,蒋蓉,邵蓉.加拿大创新药医保准入临床价值评估研究[J].中国药房,2024,35(24):2972-2976. DOI： 10.6039/j.issn.1001-0408.2024.24.02.

SHENG Tianyi,JIANG Rong,SHAO Rong.Clinical value assessment of innovative drugs in Canada’s health insurance access[J].ZHONGGUO YAOFANG,2024,35(24):2972-2976. DOI： 10.6039/j.issn.1001-0408.2024.24.02.

摘要

目的

介绍加拿大创新药医保准入临床价值评估模式，为完善我国创新药临床价值评估体系提供参考。

方法

从评估主体、评估流程、评估维度、评估结果及应用4个方面对加拿大创新药医保准入临床价值评估体系进行梳理，并以贝林妥欧单抗的医保准入临床价值评估过程为例进行深入分析，同时对我国完善相关工作提出建议。结果与

结论

加拿大设置独立的临床价值评估机构加拿大卫生技术评估局承担对创新药的卫生技术评估，以患者需求为导向建立了创新药医保准入临床价值评估体系，审评程序包括意见审查和专家评估等阶段，并将药品按是否为肿瘤药设置了不同的评价维度。其评估依据充分、过程透明，评估结果包括了报销、附条件报销、附期限报销和不报销4种，兼顾了疗效与可及性的平衡。建议我国可从建立创新药临床价值评估专门机构、提高政策预期的清晰度、完善患者获益评估指标、增设药品特殊报销路径4个方面完善创新药医保准入临床价值评估体系。

Abstract

OBJECTIVE

To introduce the clinical value assessment model for innovative drugs in Canada’s health insurance access， providing a reference for improving the clinical value assessment system for innovative drugs in China.

METHODS

The clinical value assessment system for innovative drugs in Canada’s health insurance access was organized from four aspects： the assessment body， the assessment process， the assessment dimensions， and the application of assessment results. A deep analysis was also conducted with the clinical value assessme

nt of health insurance access for blinatumomab as an example. Then the suggestions were proposed for the improvement of relevant work in China.

RESULTS &

CONCLUSIONS

Canada has established an independent clinical value assessment agency， the Canadian Agency for Drug and Technologies in Health （CADTH）， which is responsible for the health technology assessment of innovative drugs. The health insurance access to clinical value assessment system for innovative drugs is built with patient needs as the guide， and the review process includes stages such as opinion review and expert assessment. Different evaluation dimensions are set for oncology and non-oncology drugs， and the assessment is based on sufficient evidence and a transparent process. The assessment results include four types： reimbursement， conditional reimbursement， time-limited reimbursement， and non-reimbursement， balancing efficacy and accessibility. It is suggested that China should strengthen the clinical value assessment system for innovative drugs in health insurance access from four aspects： establishing a specialized institution for the clinical value assessment of innovative drugs， increasing the clarity of policy expectations， including patient benefit assessment indicators， and adding special reimbursement pathways for drugs.

关键词

Keywords

references

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