Using real-world data for coverage and payment decisions: the ISPOR Real-World Data Task Force report

Area of Science:

• Health economics and outcomes research
• Real-world evidence generation
• Health policy and decision-making

Background:

• Growing demand from health decision-makers for real-world (RW) outcomes data to inform coverage and payment policies.
• Initiative by the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) to address the need for a structured approach to RW data.
• Establishment of a Task Force on Real-World Data to develop a guiding framework.

Framework:

• Definition of RW data as information not from traditional randomized controlled trials (RCTs).
• Categorization of RW data by outcome type (clinical, economic, patient-reported), evidence hierarchies, and data sources (registries, claims, surveys, etc.).
• Identification of key issues including importance, limitations, evidence requirements, research practices, decision-making processes, costs, modeling, and stakeholder dialogue.

Implementation:

• Task Force comprised of experts from academia, industry, and health insurance.
• Systematic review and iterative drafting process with external reviewer and ISPOR membership feedback.
• Development of a comprehensive report addressing critical aspects of RW data utilization.

Implications:

• RW data are indispensable for informed coverage and reimbursement decisions.
• The value of RW data is context-dependent, requiring careful consideration of types and applications.
• Policymakers must acknowledge the benefits, limitations, and methodological challenges of RW data, balancing costs and benefits of data collection.