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

Abstract

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.

Harnessing Real-World Evidence for the Development of Novel Cancer Therapies

“…Harnessing the potential of RWE will require close cooperation between key [13]. Similarly, in Europe, efforts to optimize treatment benefits and leverage RWE for personalized medicine are supported by public/private projects.…”

The Past, Present, and Future of Economic Evaluations of Precision Medicine at the Committee for Economic Analyses of the Canadian Cancer Trials Group

“…Multiple jurisdictions are exploring the role of RWE to examine the external validity of clinical trial evidence and enable life-cycle assessment of pharmaceuticals (i.e., assessment at different points of marker approval) [ 12 ]. In Canada, the Canadian Real-world Evidence for Value of Cancer Drugs (CanREValue) Collaboration is one such initiative developing a general framework for the generation and use of RWE to enable life-cycle reassessment to inform ongoing oncology drug funding decisions [ 13 ]. In precision medicine, RWE methods to concentrate clinical trial data with systems-generated RWE are being examined by the Canadian Network for Learning Healthcare Systems and Cost-Effective ‘Omics Innovation (CLEO).…”

Deliberative Appraisal Processes in Health Technology Assessment

“…For example, changing the current Adoption Feasibility criteria of the framework to Implementation and Sustainability which could consider factors such as "drug utilization, budget impact analysis, and an assessment of if and how the funding algorithm has changed since the initial review" was suggested as a modification to the deliberative framework that would allow for its use for questions of reassessment. 81 Furthermore, the collaborative proposed 3 separate recommendation categories in response to a reassessment review: status quo, revisit funding criteria or pricing, do not continue funding, and/or delist.…”