As we move into 2026, EU Joint Clinical Assessments (JCAs) are shifting from policy concept to operational reality.
The HTA Coordination Group has now adopted its 2026 Work Programme, with an expectation of around 50 JCAs next year. These will be primarily for oncology medicines and advanced therapy medicinal products, with high-risk medical devices entering scope for the first time.
On the surface, this looks like a straightforward scale-up. In practice, it marks the first time the JCA system will be tested at volume — and the first time many organisations will experience what it actually requires.
The workload is not the main issue
Fifty JCAs is a large number, but volume alone is not the real challenge. The more significant shift is how early decisions are now being fixed.
Under the EU HTA Regulation, JCAs lock in:
- populations
- comparators
- outcomes
through a consolidated PICO process at EU level. Once set, these assumptions shape not only the JCA report but also how national HTA bodies interpret clinical value downstream.
Early experience already suggests that many practical risks surface well before the formal JCA clock starts.
Where teams are feeling pressure
Across conversations over the past year, a small number of pressure points come up consistently.
PICO uncertainty
Different standards of care across Member States mean multiple plausible comparators. Evidence that appears robust in one context can become fragile when stretched across several PICOs.
Compressed timelines
The 100-day dossier window sits late in the EMA process, when teams are already stretched. Unresolved evidence gaps at that stage are difficult to address.
Patient evidence expectations
Patient input is increasingly expected, but requirements around relevance, traceability and methodological quality remain uneven. Evidence that is persuasive elsewhere is not always usable in a JCA context.
Internal coordination
JCA cuts across medical, HEOR, regulatory, market access and affiliates. Where ownership and roles are unclear, preparation quickly becomes reactive.
None of this is about doing more work. It is about doing the right work early enough.
Why 2026 matters even for later programmes
For many organisations, orphan medicines do not formally enter scope until 2028. It is tempting to treat JCA as a future problem. That approach carries risk.
How JCAs are being implemented now — how PICOs are consolidated, how evidence is interpreted, how patient input is handled — will shape expectations well before orphan products enter scope. By the time those programmes arrive, patterns will already be established.
A quieter shift in mindset
What appears to be changing is not the regulation itself, but how it needs to be approached.
JCA is less a single submission event and more a readiness question:
- Are likely PICOs understood early?
- Are evidence gaps visible in time to act on them?
- Is patient evidence planned with HTA use in mind?
- Do teams share a common view of what “good” looks like?
These are not questions that can be answered in the final year before submission.
Looking ahead
2026 is likely to be the year when early preparation begins to separate programmes that feel controlled from those that feel rushed.
For teams with EU launches on the horizon, this is a sensible moment to take stock — without urgency — and ask whether current ways of working are genuinely aligned with how JCAs are unfolding in practice.
This article was originally published in the Rare Focus newsletter and has been adapted for swii.ch.