EU Roadmap for Empowered marKet Access
EU Roadmap for Empowered marKet Access
Anticipate. Align. Generate. Succeed. EUREKA!
EUREKA is our structured, strategic evidence-based roadmap designed to support Health Technology Developers (HTDs) in navigating the Joint Clinical Assessment (JCA) process. From early development to launch, EUREKA supports strategic decision-making, optimizes evidence generation, and ensures alignment with both EU and national requirements while meeting HTD's internal objectives. Whenever adopted, at the early or later stage of product development, EUREKA equips teams with the tools and insights to meet JCA expectations, ensure internal alignment and secure timely market access.
EUREKA builds on key synergies across the following workstreams:
PICO Strategy:
A systematic three-step approach to anticipate and respond to JCA scoping while keeping HTD's strategic focus:
PICO Prediction: Forecasts Member State expectations to mirror PICO survey outcomes.
PICO Consolidation: Refines the list into a manageable, JCA-relevant scope.
PICO Prioritization: Defines strategic focus areas for EU and national submissions.
PrecursorSLR
A living evidence database that powers anticipatory insights and adapts to changes during the PICO scoping phase, ensuring HTDs are always one step ahead.
Evidence Generation Plan
Aligns clinical and real-world data strategies with PICO priorities, leveraging existing data, opportunities for new evidence generation, and JCA expectations.
Indirect Treatment Comparisons (ITCs)
Robust, methodologically sound ITCs integrated to address comparator gaps and reinforce the clinical value narrative.
JCA Dossier Development
A cohesive, compelling dossier that brings together the entire strategy and evidence package, tailored for a successful and streamlined JCA submission.
PICO Strategy:
A systematic three-step approach to anticipate and respond to JCA scoping while keeping HTD’s strategic focus:
PICO Prediction: Forecasts Member State expectations to mirror PICO survey outcomes.
PICO Consolidation: Refines the list into a manageable, JCA-relevant scope.
PICO Prioritization: Defines strategic focus areas for EU and national submissions.
PrecursorSLR
A living evidence database that powers anticipatory insights and adapts to changes during the PICO scoping phase, ensuring HTDs are always one step ahead.
Evidence Generation Plan
Aligns clinical and real-world data strategies with PICO priorities, leveraging existing data, opportunities for new evidence generation, and JCA expectations.
Indirect Treatment Comparisons (ITCs)
Robust, methodologically sound ITCs integrated to address comparator gaps and reinforce the clinical value narrative.
JCA Dossier Development
A cohesive, compelling dossier that brings together the entire strategy and evidence package, tailored for a successful and streamlined JCA submission.
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