EU HTA Joint Clinical Assessments: what the first reports mean for market access

The most important practical learning from the first four published JCA reports is the potential gap between the questions that Member States collectively wish to see answered and the evidence available at the time of dossier submission.

The JCA assessment scope is expressed through PICOs: population, intervention, comparator and outcome. In principle, a common assessment scope can provide a more transparent view of European evidence expectations in general. In practice, however, it can also expose where a development programme was not designed to address the full range of clinically relevant populations, comparators and outcomes across Member States. The EU process requires the health technology developer to provide evidence against the final scope, with input from patients and clinical experts which inform the scoping process.

The first four reports illustrate several distinct situations:

• A focused assessment may be supported by direct randomised evidence for relevant PICOs.
• A broader assessment scope may contain multiple PICOs for which the available evidence answers only some questions.
• A developer may seek to address several PICOs through a combination of direct and indirect evidence, such as network meta-analysis, matching-adjusted indirect-comparisons or other indirect-comparison approaches.

None of these situations is inherently good or bad; what matters is whether the evidence is sufficiently robust, relevant and mature for the decision context. PICO coverage should not be confused with evidential strength. A dossier may address many PICOs but retain important uncertainties. Equally, a narrow evidence base may be highly informative for a well-defined population and comparator as in the case of the lurbinectedin JCA summarised in Table 1.

Why is indirect evidence likely to remain important in EU Joint Clinical Assessments?

The first four JCA reports also reinforce a familiar challenge, namely that direct head-to-head trials will not always be available for every relevant national comparator.

Indirect comparisons can therefore be essential. Their credibility, however, depends on transparent assumptions, sufficiently comparable study populations and outcome definitions, appropriate adjustment for prognostic factors, treatment-effect modifiers, and a clear account of residual uncertainties. Where confidence intervals are wide, a non-statistically-significant result should not be interpreted as evidence that treatments are comparable, it may simply reflect limited precision.

For development and evidence teams, the implication is that indirect-comparison feasibility should be assessed early, not as a late-stage technical exercise when the JCA scope is already known. This means understanding likely comparators across major European markets, preserving access to patient-level data where possible, prospectively collecting relevant baseline characteristics, and ensuring that outcome definitions can be meaningfully aligned across studies.

What do the first JCAs tell us about HTA capacity across Europe? 

The first JCA reports and the list of ongoing procedures suggest that a relatively small group of experienced HTA agencies has taken on a substantial share of assessor and co-assessor responsibilities. This is understandable in the early implementation period, when methodological capacity and operational experience are still being built.

It would be premature to draw conclusions from this observation; however, as the volume of JCAs increases, it will be important to monitor how capacity is distributed across Member States, whether methodological practice remains consistent across assessor combinations, and how quickly the process develops a stable and predictable operating model.

What does this mean for global and European market access teams?

The appropriate response is not to run a full internal JCA simulation for every asset. That would be resource-intensive and, for many products, disproportionate. Instead, companies should look to build proportionate JCA readiness into global evidence and launch planning. In practical terms:

• Forecasting plausible European PICO scenarios early in development;
• Mapping comparator relevance across priority Member States;
• Testing whether pivotal-study populations, endpoints and follow-up are likely to support those scenarios;
• Identifying where direct evidence will be unavailable and assessing indirect-comparison feasibility before late-stage development;
• Distinguishing uncertainties that are manageable from those that could materially weaken national value demonstration, and
• Creating stronger collaboration between clinical development, regulatory, biostatistics, HEOR, global market access, regional and local affiliates.

The objective is not to eliminate uncertainty or to generate evidence for every conceivable PICO. It is to make informed choices: which questions can be answered robustly, which uncertainties will remain, and where those uncertainties may influence national HTA conclusions, negotiation dynamics and access timing.

Will JCA speed up patient access in Europe?

It is too early to conclude that JCA will accelerate patient access or lead to greater consistency in national reimbursement outcomes. The first four reports are an important milestone, but the sample is too small to infer definitive trends.

What they do show, however, is that the EU has created a highly visible, common clinical evidence checkpoint. Over time, this may make evidence gaps more transparent, reduce some duplication and encourage earlier alignment between development programmes and European HTA needs. Whether those potential benefits translate into faster or more predictable national access will depend on how Member States use JCA reports within their own HTA, pricing and reimbursement processes.

For manufacturers, the strategic conclusion is clear: JCA should be treated neither as a stand-alone European access route nor as a procedural compliance exercise. It is a new and influential component of the evidence environment. Companies that plan for it early, while retaining strong country-level insight and a genuinely global perspective, will be better placed to navigate the next phase of European market access.