European Launch-Focused Evidence Gaps and Integrated Evidence Generation Plan (IEGP)

A Medical Affairs team needed to develop an integrated evidence generation plan focused on regional and country-level evidence gaps to address the highest-priority needs for European markets.

To identify the highest priority evidence gaps for European success, we conducted up-front research and a cross-functional workshop. We then prioritized evidence gaps based on urgency of need and trade-offs if not prioritized. We then identified country-specific needs, especially those to support local HTA. Local representatives from all high-priority European markets contributed to this effort. Next, we performed 1:1 meetings with KOLs from different countries to validate data needs to support reimbursement and uptake. Finally, we updated the IEGP based on this work and shared with the team to begin data generation.

This uniquely targeted IEGP captured the nuances of evidence needs across the diverse and complex European payer landscape. It ensured that requirements outside of the EU4+UK were considered and further validated by local experts.