With the growing use of regulatory tools such as conditional approvals and breakthrough designations, the traditional bottleneck of regulatory approval is today seen as far less problematic than it was previously. However, the early assessment of new products is also increasingly accompanied by smaller datasets that are often extrapolated for outcomes and survival. This creates enormous challenges for Europe’s HTA bodies, which need to assess these new treatments based on limited quantities of long-term outcomes data. This session will explore how EHDEN can function as a platform to capture longer-term outcomes data and provide alternative reimbursement and assessment approaches to facilitate comparative effectiveness measures.