Presentation (CTI)

OBJECTIVES: This research assesses how national-level early scientific advice (ESA) in key European countries — French National Authority for Health (HAS), Federal Joint Committee (G-BA) and National Institute for Health and Care Excellence (NICE) — compare to the Joint Scientific Consultation (JSC) regarding Joint Clinical Assessment (JCA) readiness support. Understanding how scope and accessibility compare is particularly relevant for manufacturers, given that demand for JSC surpasses its capacity. As the number of products expected to go through the JCA exceeds the JSC's available slots, manufacturers may have to rely solely on national-level ESA routes.
METHODS: A structured comparison of publicly available ESA guidance documents as of 1 June 2026 was conducted for JSC, HAS, G-BA, and NICE and qualitatively evaluated against the JCA submission requirements across three categories: PICO (Population, Intervention, Comparator and Outcomes) alignment; pivotal study design and statistical analysis advice; and procedural feasibility.
RESULTS: G-BA methodology had the closest alignment with the EU JCA PICO framework, followed by HAS. Pivotal study design and statistical analysis are covered by all national routes; however, NICE had the lowest level of alignment due to a greater focus on economic analysis. In terms of procedural feasibility, HAS is the least accessible due to restrictive eligibility, while G-BA and NICE routes have no to minor eligibility constraints.
CONCLUSIONS: National ESA can support JCA readiness, although it is not a substitute for the multi-HTA approach offered by the JSC. The G-BA appears most aligned with JCA needs, particularly for PICO considerations, pivotal study design and statistical analysis and has low barriers in terms of procedural feasibility. Whereas HAS is limited by more restrictive access, and NICE is limited by more indirect relevance to EU JCA preparation.