PURPOSE: There is increasing interest from all stakeholders in the potential for real-world evidence (RWE) to inform decisions made by healthcare payers and providers, but data quality has been raised as a key barrier. This often arises due to the disconnected collection of healthcare data. US healthcare systems have better data collection processes than the EU and drug approval is generally earlier, so US real world data (RWD) could be collected that is useful to jurisdictions outside the US. This workshop will explore whether US RWD, which is often seen as being non-transferable due to differences in healthcare organisation, can be useful to inform decisions in other countries.

DESCRIPTION:

Workshop attendees will hear from stakeholders involved in the EU/Canadian RWE4Decisions multi-stakeholder learning network about the challenges they have seen in using RWE for evaluation of highly innovative medicines, how US RWD has been used by industry to inform determination of value in EU Member States and HTA body’s reflections on use of such data.

Dr Facey will moderate the session, with an introductory presentation that outlines four main challenges associated with development of robust RWE (10 minutes).

Dr Ray will present case studies of where US real world data has been used in other jurisdictions and reflect on how it was assessed (12 minutes)

Dr Lambert will present the new CADTH RWE framework and consider what it says about data transferability and implications for Canada (12 minutes)

Dr Jaksa will present case studies showing how RWD from the US has been evaluated by NICE appraisal committee in England (12 minutes).

Polls during the workshop will ascertain how US data has been used in HTA submissions in other jurisdictions. These outcomes will be used to generate discussion and share experiences.