Presentation (CTI)

OBJECTIVES: Is a Joint Clinical Assessment (JCA) a submission to prepare or a capability to build? Eighteen months of first-wave experience suggested the former framing is the costlier mistake. This analysis examined JCA as a multi-year enterprise operating model rather than a dossier event.
METHODS: A structured synthesis of first-wave practitioner experience traced where assessment challenges originated and where effort concentrated across the evidence lifecycle, from early development through the post-submission period, drawing on complete oncology dossiers, contributed workstreams, and structured peer exchange. Observations were generalised into organisational-capability patterns.
RESULTS: Many of the most consequential assessment challenges originated years before dossier preparation — in comparator and PICO planning, data collection, and analytical design — while many of the most resource-intensive activities occurred after submission. Readiness measured by dossier completion proved misleading: organisations with complete dossiers still struggled where they lacked capability in evidence strategy, comparator planning, analytical preparedness, traceability, governance, and operational responsiveness. Fragmented ownership across market access, health economics and outcomes research, clinical development, statistics, regulatory affairs, and medical writing produced inconsistent standards, duplicated effort, and variable readiness. The first wave pointed toward an enterprise operating model and progressive capability maturity — from reactive practice toward an integrated centre of excellence — supported by benchmarking, performance indicators, and a multi-year transformation pathway.
CONCLUSIONS: JCA success is determined long before, and long after, the submission itself. Treating JCA as an enterprise capability — with consolidated ownership, capability benchmarking, and a staged maturity roadmap — is what converts one-off effort into repeatable performance.