Rethinking Evidence Planning in JCA Era

The Joint Clinical Assessment (JCA) changes the question behind evidence planning. It is no longer whether the available evidence can support a strong HTA submission, but whether companies are generating the evidence that assessors are likely to need. As of September 2026, the European Commission has published four JCA reports, on tovorafenib, lurbinectedin, tarlatamab and onasemnogene abeparvovec. The sample is small, yet it covers single-arm studies, direct RCTs and broad multi-PICO cases, and it already challenges four long-held assumptions: rarity of indication does not lower the evidence bar, meeting the PICOs does not settle the assessment, several comparative methods can be accepted when justified, and national HTA does not have to wait for the JCA. 

The consequence is that pivotal design, comparator sets and dossier preparation are decided years before submission, with Clinical, Regulatory, HEOR/RWE, Medical and Market Access working from shared evidence priorities. The JCA also brings fixed assessment timelines and a single evidence lock at dossier submission. Readiness becomes a standing organisational capability, not a project.