Health

EU Joint Clinical Assessment

We partner with pharmaceutical companies preparing for EU Joint Clinical Assessment (JCA) to develop strategies and evidence that meet regulatory requirements and clearly demonstrate product value, supporting successful market access across European markets.

The European healthcare landscape is undergoing a significant shift with the introduction of JCA under the new EU HTA regulation

This collaborative, EU-wide approach to evaluating new medicines and medical devices is designed to streamline access across member states. However, navigating the JCA process can be complex - pharmaceutical and MedTech companies must meet unified evidence requirements and tighter timelines while coordinating with multiple stakeholders.

Strategic support for EU Joint Clinical Assessment (JCA)

Across the clinical development-to-access continuum, we advise clients on how best to incorporate JCA requirements - from clinical trial design and evidence generation to submission and beyond.

We tailor our approach to each product and therapeutic area, anticipating potential PICO criteria and adapting to the latest guidance.

How we support our clients

Strategy & evidence planning

Anticipate payer and EU HTA requirements, optimise clinical evidence positioning across consolidated PICO scopes, and sequence analyses to JCA timelines.

Integrate JCA methodology into development and launch planning by stress-testing PICO scenarios, mapping critical-path risks, and preparing for Joint Scientific Consultations (JSCs).

Support Joint Scientific Consultations (JSCs) with tailored evidence strategies, coordinating cross-functional input and aligning RWE plans with HTA expectations.

Gather insights from affiliates to inform potential cross-market implications and analyse impact on launch strategy.
Value & dossier development

Develop clinically anchored value narratives that clearly articulate efficacy, safety, and unmet need within the JCA framework, while ensuring seamless adaptation for country affiliates.

Translate clinical evidence into structured JCA dossiers that meet HTA Coordination Group requirements, ensuring consistency across SmPC, clinical overview, and ITC outputs.
Evidence generation & statistics

Rapidly identify evidence gaps and provide tailored evidence generation solutions to support JCAs, leveraging our in-house automation capabilities/ tools. Combined with LCP’s expertise in ITCs, NMAs, ECA feasibility, and automated SLRs, this approach delivers robust, decision-relevant evidence that covers all relevant PICOs for EU JCA.

Economic modelling support: While economic evaluation is not part of the JCA process, we develop early economic models to inform strategic planning for future HTA submissions. By integrating clinical trial data, real-world evidence, and scenario-based assumptions, we help support our clients with value narratives and by anticipating payer perspectives.
Intelligence & insights

Consolidating insights from EUnetHTA joint actions and providing ongoing EU-27 intelligence updates and newsletters to ensure teams remain aligned with evolving guidance and best practices

Simulate PICO scenarios to optimise evidence strategy, anticipate comparator and outcome requirements, and align trial design and RWE plans with the evolving scope of EU JCA assessments.

LCP Health brings extensive experience in health technology assessment, data analysis and strategic consulting

We are committed to being your strategic partner across the development-to-access pathway, supporting you at every step to successfully meet JCA requirements and achieve faster, equitable access for patients.