Abstract
Precision medicine in oncology poses unique challenges to the generation of clinical and economic evidence used for cost-effectiveness analyses that can inform health technology assessment. The conduct of randomized controlled trials for biomarker-specific therapies targeted towards small populations has limitations in regard to feasibility, timeliness, and cost. These limitations result in associated challenges for groups involved in the generation of economic evidence to inform treatment-related decision making, including the Committee of Economic Analysis (CEA) at the Canadian Cancer Trials Group (CCTG). We provide a high-level description and vision about the new paradigm of clinical trial design, generation of economic evidence, and novel approaches to economic evaluations necessary in the space of precision medicine in oncology in Canada. The CEA’s previous approach to precision medicine, including master protocol designs and single-arm studies, is reviewed. Methods and approaches currently under consideration by the CEA and national collaborators, such as the role of real-world and clinical trial evidence in enabling life-cycle assessment of therapies, are explored. Finally, future initiatives being planned in the space of precision medicine at CCTG, such as the incorporation of correlative studies to identify and test high-performing biomarkers in trials, are discussed.
Highlights
Cost-effectiveness analysis is an important component of health technology assessment (HTA)
The difficulty in generating high-quality and rigorous economic evidence in precision medicine in oncology is a common challenge faced by many groups that are involved in the generation of economic evidence to inform decision making, including our group, the Committee of Economic Analysis (CEA) at the Canadian Cancer Trials Group (CCTG)
The work of the CEA within CCTG continues to evolve in the era of modern clinical trial design for precision oncology approaches
Summary
Cost-effectiveness analysis is an important component of health technology assessment (HTA). The difficulty in generating high-quality and rigorous economic evidence in precision medicine in oncology is a common challenge faced by many groups that are involved in the generation of economic evidence to inform decision making, including our group, the Committee of Economic Analysis (CEA) at the Canadian Cancer Trials Group (CCTG) The purpose of this discussion paper, commissioned by the CCTG and supported by the Canadian Agency of Drugs and Technologies in Health (CADTH), is to provide a high-level description and vision about the past, present, and future of the generation of economic evidence in the space of precision medicine in oncology in Canada. We describe future initiatives that are planned in the space of precision medicine at CCTG, with some discussion about important unanswered questions for future explorations
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