Introduction
A Joint Scientific Consultation (JSC) has been established to provide advice on evidence requirements for the Joint Clinical Assessment (JCA)1. However, due to the number of JSC slots being limited to a maximum of 17 per year (2026)2 and the expected annual demand for JSC of ~50 products a year3, some eligible products might not participate in the JSC. Indeed, in 2025, 10/17 products submitted to JSC were not accepted for consultation4.
Beyond the JSC, manufacturers planning for HTAs in Europe can also obtain scientific advice though national bodies such as the National Authority for Health (HAS) in France, Federal Joint Committee(G-BA) in Germany, and National Institute for Health and Care Excellence (NICE) in England.
Authors: Kacper Swierk, BSc, MSc; Higia Vassoler, BSc, MSc
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.
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.