The Use of Real-World Evidence in Health Technology Assessments by the Canadian Agency for Drugs and Technologies in Health
Increasingly real-world data (RWD) are being used to inform decision-making in health technology assessments (HTAs) by providing information (real-world evidence, or RWE) on the value of new medicines. RWD includes data from administrative sources, electronic health records, claims databases, and patient registries, among others.
Inform decisions across the product lifecycle
One of the strengths of RWE is the potential to inform the entire lifecycle of therapy development, by providing insights from pre-clinical research through to reimbursement. While randomized controlled trials (RCTs) are still considered the gold standard for determining clinical efficacy and safety, RWE supplement clinical trial data with long-term safety, effectiveness and real-world treatment patterns among diverse populations. In particular, the demand for RWE from regulatory and reimbursement agencies worldwide is increasing, due to the costs of innovative therapies, and the need to understand comparative- and cost-effectiveness with the current standard of care. In Canada, the richness of the Alberta health system data allows researchers to provide robust evidence to inform these critical decisions, as well as provide insights into earlier life cycle questions, such as pragmatic trial designs.
Real-World Evidence and CADTH HTAs
In Canada, the Canadian Agency for Drugs and Technologies in Health (CADTH) is responsible for completing HTAs and providing recommendations for the reimbursement of new medicines. Medlior completed a review of HTA submissions to CADTH between January 1, 2017 and May 22, 2018 and found that 18 submissions to the Common Drug Review (CDR) and eight submissions to the pan-Canadian Oncology Drug Review (pCODR) included some form of RWE, such as economic cost inputs or indirect treatment comparisons.
Although more work is needed to create a framework for the utilization and evaluation of RWE in HTA submissions, many of the uncertainties noted among HTA appraisal committees can be addressed by utilizing routinely captured real-world data.
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As an independent Canadian consultancy based in Calgary, Alberta, Medlior offers a variety of research services, as well as access to and expertise with Canadian real-world data sources. Our team includes experienced biostatisticians and epidemiologists from academia and the health system to provide insights from Canadian provincial and national data sets, surveys, and patient-reported outcomes to address a variety of research questions. Medlior is experienced with both the UK and Canadian HTA processes and supports the integration of RWE into HTA submissions.
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