Lessons from the frontline: Seven myths that could compromise your JCA dossier

In our recent work supporting Joint Clinical Assessment (JCA) submissions and readiness projects, plus insights from stakeholder consultations and early pilots, we’ve seen recurring misconceptions that can quietly undermine dossier quality. 

Here are seven myths that, if left unchallenged, could compromise your JCA dossier - and how to avoid them. 

Myth 1: No additional clinical evidence is needed beyond JCA 

Reality from the field 
Even after a robust JCA submission, national HTA bodies will often require clinical elements that go beyond JCA requirements. These “delta dossiers” capture differences in standard of care, sub-population definitions, locally relevant endpoints, and the most recent data cut-offs (which may emerge after the JCA report has been finalised). 

Why it matters 
Assuming the JCA clinical package will seamlessly transfer into every national dossier risks rejection or delay. Examples: 

• Germany may request additional subgroup analyses or locally defined comparators. 

• France could emphasise different outcomes or require longer follow-up data. 

• Spain and Italy may want evidence tailored to national treatment guidelines or registries. 

In addition to these clinical deltas, most markets will also expect economic models, budget impact analyses, organisational feasibility evidence, and ethical/legal justifications that JCA does not cover. 

How we address this:  

• Map clinical deltas for each priority market alongside JCA prep (comparators, outcomes, cut-offs). 

• Anticipate requests for updated data that will arise between JCA decision and national submission. 

• Align JCA evidence with local HTA expectations early, so adaptations are modular rather than reactive. 

Myth 2: You only need one PICO 

Reality from the Field 
Early assessments for oncology show that products can generate dozens of potential PICOs during scoping, with many still surviving post consolidation. 

Why It Matters 
Planning for only one comparator or sub-population risks evidence gaps when multiple PICOs are retained. 

How we address this: 

• Run early PICO predictions using guidelines, HTAs, and treatment patterns (www.picopredict.com). 

• Validate with affiliates and clinical experts. 

• Prepare flexible evidence packages (ITCs, NMAs) that cover multiple plausible PICOs. 

• Prepare robust defences where PICOs cannot be addressed. 

Myth 3: EMA dossier evidence is sufficient 

Reality from the Field 
Regulatory dossiers often lack the comparator or outcome evidence demanded by JCA scopes. 

Why It Matters 
Assuming EMA = JCA leaves you underprepared for comparative analyses and broader outcome requirements. 

How we address this: 

• Audit EMA data against likely JCA PICOs. 

• Identify RWE or registries to bridge gaps. 

• Plan surrogate or interim outcomes when long-term data are immature. 

Myth 4: Outcomes are interchangeable, so pick the easiest 

Reality from the Field 
JCA demands breadth: survival, PROs, QoL, tolerability, safety. Narrow regulatory endpoints don’t suffice. 

Why It Matters 
Failure to plan for a comprehensive set of outcomes can erode confidence in your dossier. 

How we address this: 

• Integrate PROs and quality of life early. 

• Justify surrogate endpoints transparently. 

• Ensure measurement consistency and external validity. 

Myth 5: The scoping process will catch everything, so you can wait 

Reality from the Field 
Scoping surveys are fast and may not capture late-emerging comparators or outcomes. 

Why It Matters 
Waiting risks insufficient time to close evidence gaps. 

How we address this: 

• Start pre-scoping prep early. 

• Maintain a living evidence landscape. 

• Use Joint Scientific Consultations and structured advice processes to test assumptions. 

Myth 6: Indirect evidence will be a last resort 

Reality from the Field 
Indirect comparisons and RWE are often essential, not optional. 

Why It Matters 
Without high-quality ITCs, comparators missing from your trial arms remain unassessed. 

How we address this: 

• Build ITC/NMA capability early. 

• Source RWE proactively. 

• Be transparent about uncertainty; plan sensitivity analyses. 

Myth 7: Aligning for one “EU clinical story” is enough 

Reality from the Field 
Member States differ in standards of care, outcomes valued, and comparator norms. 

Why It Matters 
Assuming one unified story can backfire when national HTAs diverge. 

How we address this: 

• Maintain a core clinical spine for JCA. 

• Layer national modules for DE/FR/IT/ES/PL/others. 

• Secure early affiliate input. 

Final Thoughts 

JCAs are here, and the first dossiers reveal how demanding the process is. The biggest risk isn’t what you don’t know - it’s what you think you know but misunderstand. By recognising and addressing these myths, and planning for national delta dossiers beyond JCA, you can turn confusion into clarity and readiness into execution.

Written by Mohammed Madkour

Decisive Dialogue 2nd October 2025