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In our recent work supporting Joint Clinical Assessment (JCA) submissions and readiness projects, along with 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.
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:
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:
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:
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:
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:
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:
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:
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:
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.
