Coverage With Evidence Development: An Environmental Scan of Funding Programs Leveraging Real-World Evidence to Support Funding Decisions

Key Messages

• Coverage with evidence development (CED) programs provide early access to promising therapies while additional evidence is generated to support a final funding decision. This Environmental Scan sought to identify CED programs globally, specifically where real-world evidence (RWE) is generated to support decision-making. This Environmental Scan reports how 13 jurisdictions (2 Canadian, 11 international) have used CED to support interim patient access to new drugs while gathering data to resolve uncertainties.
• There is variation in how CED is applied between jurisdictions and limited transparency into CED agreement details, financial agreements applied with CED, and the impact of RWE on final funding decisions.
• Real-world data collected from prospective observational studies, disease or drug registries, and administrative health databases are used to generate RWE during interim funding. Jurisdictions apply performance-based or outcomes-based agreements and/or financial agreements as part of CED agreements to support risk-sharing between payers and drug manufacturers.
• CED agreements come with limitations, including the following: outcomes of analysis may not support final funding decision-making, entry and exit criteria may not be established, project timelines may not be clear, agreements may lack transparency, and data collection and evidence generation to address uncertainties may not be feasible in practice.
• CED provides an opportunity for RWE to address evidence gaps while facilitating patient access to new cancer drugs. Lessons learned from other jurisdictions may support careful design of a Canadian CED model.
• CED programs should include defined roles and responsibilities for system partners, drug and indication eligibility criteria, exit plans, deliverables to support final funding decisions, reporting intervals, and timelines. RWE generation plans should include defined research questions, objectives, data collection plans, and end points. Details of CED programs should be made publicly available to ensure transparency and accountability, and to reduce duplication of efforts across jurisdictions.