Authors: Jacob Sebastian Vinzens, Ingo Hantke, Claire Helen Blaney, Maud Brijs, Matthias P. Schönermark.
Tuesday 11th Nov 2025
Poster Presentation: 10:30 - 13:30
Discussion Period: 12:30 - 13:30
OBJECTIVES
This research explores how European market access strategies must adapt to the requirements of the Joint Clinical Assessment (JCA) dossier, focusing on the integration of Member State PICO (Population, Intervention, Comparator, Outcome) input and national evidence requirements. The aim is to identify strategic approaches for dossier development that support accelerated patient access across diverse EU markets such as Germany, France, Netherlands, Belgium and Ireland.
METHODS
A review of the JCA dossier template, recent regulatory guidance, and stakeholder perspectives was conducted to assess how launch strategies and evidence generation must align with JCA content requirements. Emphasis was placed on the operationalisation of PICO input, evidence selection, and the transparent justification of methodological choices within the dossier.
RESULTS
Effective JCA dossier development requires early and systematic incorporation of consolidated PICO questions, reflecting both EU-level and Member State-specific priorities. The dossier’s structure mandates clear articulation of the medical condition, target population, and care pathways, with the option of strategically highlighting regional differences. Evidence selection and synthesis must address each PICO, with justifications for any gaps or deviations, and provide detailed tabular listings of studies by PICO question, including direct and indirect evidence. Methods for information retrieval, data analysis, and synthesis must adhere to the HTA Coordination Group guidance and key national requirements, with explicit rationale for any methodological adaptations. The results section must present relative effectiveness and safety by PICO, ensuring all relevant comparators and outcomes are already addressed as per Member State requirements.
CONCLUSIONS
To achieve accelerated patient access, manufacturers must embed Member State PICO input and evidence requirements into the strategic planning and content development of the JCA dossier. This necessitates cross-functional coordination, proactive engagement with HTA bodies, and flexible evidence generation plans that anticipate both EU and national expectations, ensuring the dossier robustly supports diverse European market access pathways.
