Use of real-world evidence in cancer drug funding decisions in Canada: a qualitative study of stakeholders’ perspectives
- The study emphasizes the need for a cultural shift, enhanced data infrastructure, investment in capacity building, and stakeholder collaboration for effective use of Real-World Evidence (RWE) in drug funding decisions.
- Cancer drug costs are escalating, with some offering substantial benefits while others provide marginal improvements. Assessing overall costs and benefits is crucial for resource allocation.
- Clinical trials, particularly randomized controlled trials (RCTs), have limitations in generalizability due to highly selected populations, and do not revisit cost-effectiveness or clinical effectiveness post-market.
- RWE, derived from postmarket evaluations rather than traditional RCTs, could provide valuable insights into clinical effectiveness, safety, cost-effectiveness, and budget impacts in real-world settings.
- The Canadian Real-World Evidence for Value of Cancer Drugs (CanREValue) Collaboration aims to develop an RWE framework for cancer drug funding in Canada by incorporating views and experiences from Canadian and international stakeholders.
- The study aims to inform the CanREValue framework to ensure it meets end users' needs and facilitates RWE integration into cancer drug funding decisions.
The costs of cancer drugs are rising rapidly. Although some new drugs provide substantial therapeutic improvements, others confer only marginal survival benefits or improve only quality of life. Assessment of the overall costs and benefits of cancer drugs is essential for resource allocation. Drug funding decision-makers typically rely on data from clinical trials to supply clinical and economic evidence.
However, randomized controlled trials (RCTs) have highly selected populations, limiting their real-world generalizability. Funding decisions are not revisited, and cost-effectiveness and clinical effectiveness are not re-assessed, after a drug enters the Canadian market. Decision-makers have little information on whether drug investments yield expected outcomes. Real-world evidence (RWE) — evidence from postmarket evaluations not derived from traditional RCTs— could fill these gaps with information on clinical effectiveness, safety, cost-effectiveness and budget impact outside of the highly controlled trial environment.
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