How to design real-world evidence for EU Joint Clinical Assessment (JCA)

Real-world evidence (RWE) has become a fixture of European market access. Between 2011 – 2021, the proportion of HTA reports drawing on RWE increased eight-fold from 4% to 34%, across more than 100 HTA agencies in 37 countries, including many European HTA bodies¹.  With the EU’s Joint Clinical Assessment (JCA) now in force, and submissions expected to grow from 13 in 2025 to around 50 in 2026², that trajectory is set to steepen.

Each JCA must address multiple Patient/Population, Intervention, Comparison and Outcomes (PICO) requirements, reflecting standards of care across 27 Member States with only 100 days between final PICO communication and submission. A single pivotal trial rarely covers that ground. This creates an important role for RWE, particularly in contextualising PICOs and supporting indirect treatment comparisons (ITCs) where pivotal trial evidence does not fully address JCA requirements.

At the same time, JCA guidance from the HTA Coordination Group explicitly recognises RWE and requires high standards but does not provide clear guidance and especially, limited potential for consultation³.

For manufacturers, the strategic question is no longer whether to use RWE in JCA. It is how to design RWE that can withstand JCA scrutiny.

How pharma is thinking and changing

Deloitte interviewed experts from top 20 pharma companies on this topic. Three signals stood out.

• Early integration is now universal. Every company pointed to the need for earlier evidence planning under JCA. For some, this has meant acceleration; for others a fundamental shift. Around a quarter reported tangible changes in team set-up (closer alignment between clinical, market access and HEOR). A similar share flagged budget increases, though budget itself is rarely the binding constraint.
• Expectations on RWE quality have not softened. The gold standard continues to be randomised, prospective designs with strong confounding control. Notably, none plan to rely solely on data from the country presumed to have submitted a given PICO. Instead, they either use the best available evidence with justification, draw on reweighted multi-country datasets, or flag the gap and address it nationally.
• The vendor model is being stress-tested. Every company works with external RWE vendors, typically through long-term master agreements. JCA is sharpening three vendor requirements in particular: speed-to-data (standard timelines are too slow), IPD and patient-level matching (a visible gap in today’s landscape), and JCA-specific regulatory and analytical expertise.

Use cases: what’s new under JCA

We mapped eight RWE use cases for JCA across three areas. Many will look familiar — but JCA shifts the centre of gravity.

The most familiar sit in the support-the-trial category. External control arms, surrogate endpoint validation and sub-population analyses are long-standing techniques; under JCA their importance is narrower than expected (e.g., “very few reasons to use an ECA” in oncology where in-trial comparators exist or where there is high complexity in rare diseases).

Where JCA genuinely changes the playing field is in evidence planning, generation and synthesis. This is particularly so in PICO contextualisation and justification (a real-world view of EU treatment patterns, today filled by guidelines and market research due to lack of harmonised data). Its impact is felt equally in ITC generation or synthesis from existing RWE to cover PICOs that RCTs have not.

In supplementary information, RWE retains a meaningful but more contained role — it is most valuable for disease-landscape and epidemiology arguments, particularly in oncology.

The pattern is consistent: the techniques are not new but JCA changes which use cases carry the most weight, how quickly they must be delivered, and how transparently they must be defended.

What HTA bodies are signalling

There are some early signals that should be considered directional.

The EU HTA Coordination Group is expected to remain neutral: the substantive call will stay national. Germany (G-BA) is likely to remain conservative, accepting RWE mainly as an exception for ATMPs and rare diseases. France (HAS) is moving from principled opposition toward partial acceptability, with JCA expected to accelerate the trajectory. Shared concerns are consistent across both: bias, data quality, cherry-picking, and methodological heterogeneity across the EU.

The implication: a JCA-ready RWE package will not automatically be a national-ready one.

Companies must design evidence that can be defended in front of the strictest audience in the room.

What this means for manufacturers

JCA is not creating a new RWE playbook: Instead, it is compressing the timeline, raising the bar, and forcing earlier cross-functional alignment. By treating evidence planning as a JCA-day-one activity and building vendor relationships that are optimised for speed, IPD access and JCA-specific expertise, companies can approach JCA as a manageable process more effectively.

The shift from whether to how is, ultimately, a shift in mindset. Those companies that internalise it early will spend less time defending their evidence and more time using it to secure access.

To discuss how to operationalise these insights inside your organisation, please get in touch with the Deloitte Life Sciences Market Access team.

Authors

• Leon Struett, Director, Monitor Deloitte
• Lorenz Abduly, Manager, Monitor Deloitte — Life Sciences Market Access Strategy