Developing a framework to incorporate real-world evidence in cancer drug funding decisions: the Canadian Real-world Evidence for Value of Cancer Drugs (CanREValue) collaboration
Developing a framework to incorporate real-world evidence in cancer drug funding decisions: the Canadian Real-world Evidence for Value of Cancer Drugs (CanREValue) collaboration
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DOI：
10.1136/bmjopen-2019-032884
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发表时间：
2020-01-01
期刊：
影响因子：
2.9
通讯作者：
Isaranuwatchai, Wanrudee
中科院分区：
文献类型：
--
作者：
Chan, Kelvin;Nam, Seungree;Isaranuwatchai, Wanrudee
背景肿瘤治疗正变得越来越昂贵，并对世界各地药物计划的可负担性和可持续性提出了挑战。在评估新药时，卫生技术评估组织依靠临床试验来为资金决策提供信息。然而，临床试验无法评估总生存期，也无法在现实世界中推广证据。因此，政策制定者对基于临床试验的药物资助决定是否最终产生预期的结果和资金价值几乎一无所知。（CanREValue）合作，由研究人员，咨询人员，决策者，付款人，患者和护理人员组成，正在为加拿大各省开发和测试一个框架，以一致和综合的方式为癌症药物资助生成和使用真实世界证据（RWE）。战略CanREValue合作建立了五个正式的工作组（WG）重点关注加拿大癌症药物资助决策中RWE生成和使用的具体过程。不同的RWE WG为：（1）计划和药物选择;（2）方法;（3）数据;（4）重新评估和采用;（5）参与。这些工作组正在合作制定RWE评估框架，通过多省RWE项目验证该框架，并帮助将最终的RWE框架整合到加拿大医疗保健系统中。决策者改进筹资建议和使用新的筹资机制/加拿大各地的支付者，以确保医疗保健系统提供临床福利和物有所值。
BackgroundOncology therapy is becoming increasingly more expensive and challenging the affordability and sustainability of drug programmes around the world. When new drugs are evaluated, health technology assessment organisations rely on clinical trials to inform funding decisions. However, clinical trials are not able to assess overall survival and generalises evidence in a real-world setting. As a result, policy makers have little information on whether drug funding decisions based on clinical trials ultimately yield the outcomes and value for money that might be expected.ObjectiveThe Canadian Real-world Evidence for Value of Cancer Drugs (CanREValue) collaboration, consisting of researchers, recommendation-makers, decision makers, payers, patients and caregivers, are developing and testing a framework for Canadian provinces to generate and use real-world evidence (RWE) for cancer drug funding in a consistent and integrated manner.StrategyThe CanREValue collaboration has established five formal working groups (WGs) to focus on specific processes in the generation and use of RWE for cancer drug funding decisions in Canada. The different RWE WGs are: (1) Planning and Drug Selection; (2) Methods; (3) Data; (4) Reassessment and Uptake; (5) Engagement. These WGs are acting collaboratively to develop a framework for RWE evaluation, validate the framework through the multiprovince RWE projects and help to integrate the final RWE framework into the Canadian healthcare system.OutcomesThe framework will enable the reassessment of cancer drugs, refinement of funding recommendations and use of novel funding mechanisms by decision-makers/payers across Canada to ensure the healthcare system is providing clinical benefits and value for money.