What the first Joint Clinical Assessment (JCA) report tells us about the next era of integrated evidence planning and access strategy
The publication of the first Joint Clinical Assessment (JCA), assessing tovorafenib in relapsed or refractory pediatric low-grade gliomas1, marks an important milestone for the EU health technology assessment (HTA) process. For the first time, stakeholders have a tangible example of how the JCA framework works. The report shows how consolidated PICOs (target patient population, intervention, comparator, and outcomes of interest) translate into evidence expectations, but also how difficult those expectations may be to meet. In the assessment of tovorafenib, the absence of comparative data meant that seven of eight PICOs could not be assessed. That does not necessarily imply a failure of evidence planning; rather, it highlights that the evidence demanded through JCA may extend beyond what is feasible within clinical development, particularly in oncology and rare disease where comparator arms may be unethical and alternative relevant data is not available.
The JCA is not intended to produce a single European view of product value. National reimbursement decisions will still reflect local priorities, comparators, and thresholds. So, despite the harmonizing ambition of JCA, any tension between the “due consideration” national decision-makers will give a JCA report and their own local interpretation of the evidence remains to be seen. That makes access strategy more complex than simply preparing for a JCA submission. It requires early evidence strategy and pragmatic choices about where to invest, where uncertainty can be reduced credibly, and where residual risk may need to be acknowledged and managed to secure market access.
“The publication of the first JCA is an exciting milestone – and a valuable learning opportunity. The report highlights challenges in generating evidence to address PICOs, particularly in settings with small populations and limited comparative data. It also raises important questions around how to assess the risk of evidence gaps and prioritize activities to build the right evidence package. Experience with JCA will evolve, but the imperative is already clear: early evidence planning is needed to anticipate JCA requirements and challenges.”
- Alison Howell, PhD, Senior Director, Value Demonstration
Are all PICOs created equally?
The tovorafenib report highlights the mismatch that can emerge between the breadth of JCA evidence expectations and the practical limitations that may be encountered in evidence generation. PICO scoping can surface very different evidence needs across markets, and all PICOs matter in the sense that they reflect the totality of what EU Member States want to understand. But PICOs are unlikely to carry equal strategic weight. If one comparator is central to major markets and another reflects a less influential local standard of care, evidence planning may not need to weigh them equally. The challenge is not simply to map every evidence need, but to understand which are most likely to shape successful access.
This is especially relevant in orphan and ultra-rare conditions, where single-arm trials may be the only feasible way to generate evidence. The first JCA report illustrates how difficult it can be to develop robust comparative data to support multiple PICOs in these settings. In that context, evidence limitations may say as much about the condition and the published evidence base as they do about the product’s comparative effect. The tovorafenib JCA report is an important first example of this in a very specific rare pediatric condition with limited data and few well-established treatments. A broader test of how JCA evidence expectations play out may come when the framework is applied to therapies in more common diseases, where comparator choices are more entrenched and the evidence base is broader.
Prioritizing comparative evidence where it matters most
If the first JCA report tells us anything, it’s that comparative evidence planning needs to consider trade-offs. A useful starting point is to ask two questions:
- how relevant is a comparator to decision making in key markets,
- and how robust is the supporting evidence base?
For the comparators most likely to shape access, the priority is to understand the current evidence landscape and identify the methodological approach most likely to generate credible comparative evidence while keeping uncertainty to a minimum. The goal may not always be to eliminate uncertainty entirely. In some cases, decision-makers might be better able to engage with uncertainty around imperfect evidence than with a complete absence of comparative data. Where a comparator is less likely to influence broader access, or where the evidentiary and practical barriers are high, the more proportionate response may be to document the residual risk clearly and focus effort elsewhere.
This has implications well beyond JCA submission preparation. It points to the need for earlier coordination across clinical development, epidemiology, health economics and outcomes research, market access, and real-world evidence teams, so that integrated evidence plans are shaped around likely decision drivers rather than revisited too late. The first JCA report does not answer every strategic question. However, it does reinforce that access-informed integrated evidence planning must be done early and throughout development, grounded in a realistic view of what is both important and achievable.
This urgency is not limited to oncology medicines and ATMPs, which are already subject to JCA. The later application of JCA to orphan drugs from 2028, and to all other products from 2030, should not be seen as a reason to defer planning. For products approaching EMA submission in those timeframes, the window to influence trial design, comparator strategy and uncertainty management may be now. Evidence strategy decisions being made today will shape how well future evidence packages support both JCA requirements and national access decision-making.
For teams planning pipeline evidence, the most valuable lesson from the first JCA report may be that not every anticipated evidence request will matter equally, and not every evidence gap can be closed. The real strategic task is early decision-making around which evidence questions are most likely to be needed by relevant stakeholders to shape access – and which uncertainties will need to be managed.
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Article written by Alison Howell, PhD, Senior Director, Value Demonstration, Fortrea Consulting
References
- Member State Coordination Group on Health Technology Assessment, Joint Clinical Assessment Summary Report of Tovorafenib, Version 1.0, European Union, Brussels, 2026. Last accessed 17th June 2026. https://health.ec.europa.eu/document/download/1aa5dab6-6c43-4692-91b9-c50e96a6679a_en?filename=hta_jca_mp_202406_tovorafenib_summary-report_en.pdf
- European Commission. Joint clinical assessments. European Commission website. Accessed June 17, 2026. https://health.ec.europa.eu/health-technology-assessment/implementation-regulation-health-technology-assessment/joint-clinical-assessments_en
- European Commission. Implementing the EU Health Technology Assessment Regulation: Joint Clinical Assessment for Medicinal Products. Published January 2025. Accessed June 17, 2026. https://health.ec.europa.eu/document/download/ced91156-ffe1-472d-85eb-aa6a91dd707e_en
- Fong H, Garau M. One Europe, one assessment? Unpacking the European Joint Clinical Assessment. Office of Health Economics. May 28, 2026. Accessed June 17, 2026. https://www.ohe.org/insights/one-europe-one-assessment-unpacking-the-european-joint-clinical-assessment/
Frequently Asked Questions
Q: What is a Joint Clinical Assessment (JCA)?
A: A Joint Clinical Assessment (JCA) is a central component of the EU Health Technology Assessment (HTA) Regulation (EU) 2021/2282, in which EU Member States collaboratively evaluate the relative clinical effectiveness and safety of a new health technology (e.g., a medicinal product or medical device) based on a single, shared review of clinical evidence. This EU-level assessment focuses only on clinical outcomes—such as how a therapy compares to existing standards of care—and is intended to support, but not replace, national HTA decisions on pricing and reimbursement, helping to reduce duplication and improve consistency across countries.2,3,4