Background Oncology 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.
Objective The 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.
Strategy The 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.
Outcomes The 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.
- real-world evidence
- real-world data
- health technology assessment
- drug approval
- regulatory approval
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Correction notice This article has been corrected since it was published. The last name for the author, Claire de Oliveira, has been amended.
Contributors KC, WI, BE, CdO, AC, SG, JH and JB devised the project, the main conceptual ideas and proof outline. SN wrote the manuscript with critical feedback from all authors (KC, WI, BE, CdO, AC, SG, JH, REM, WFD, JB, MT).
Funding This work was supported by the Canadian Institutes of Health Research (Grant #HRC-154126).This study was supported by the Canadian Centre for Applied Research in Cancer Control (ARCC). ARCC is funded by the Canadian Cancer Society Grant # 2015-703549
Competing interests None declared.
Patient consent for publication Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
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