JCA is an EU-level assessment of clinical evidence for health technologies and is one of several recent EU regulations affecting market access. Its implementation will be phased in through 2030, when this will be mandatory for all newly licensed pharmaceuticals and some medical devices.  

On June 9, the HTA Coordination Group (HTA CG) published the first JCA report, a major milestone for the new initiative. This is the first time that stakeholders could see an actual output and how the formalized methodological demands of the process are applied in practice. Further assessments from the initial JCA rollout for oncology medicines and/or advanced therapeutic medicinal products are expected in the coming months. As expected, the report details only a clinical assessment, presenting evidence and noting gaps and uncertainties: no conclusions are drawn on relative benefit versus comparators, nor recommendations with respect to health system access.  

This first assessment focused on Ojemda™ (tovorafenib, Ipsen) for pediatric low-grade glioma harboring BRAF mutations which has progressed after ≥1 systemic treatments. This drug received conditional marketing authorization in the EU in April 2026, supported by an uncontrolled phase II clinical study. Future confirmation of regulatory approval will be dependent on results of a phase III randomized controlled trial.   

Initial Insights  

• The evidentiary and organizational demands on manufacturers are as high as anticipated.  For example, in this case of a biomarker-defined indication within a rare disease, the scope included eight “PICOs” (individual requests for comparative data in a patient group). Despite the final report including data for only one PICO, it was over 150 pages, with the manufacturer’s submission running to many more. JCA submissions will usually require technically complex statistical analyses to generate comparative data versus non-trial comparators, as demonstrated within this assessment. Adding to the technical and organizational complexity, submission finalization and technical engagement with the JCA assessors runs alongside the European Medicines Agency process, including finalization of the regulatory indication.  

• The depth and rigidity of JCA outputs matches that suggested by the guidance, regardless of context. The assessment identified multiple points of uncertainty and risk of bias, and noted where there was insufficient information for evidence interpretation. As expected, evaluation criteria were not moderated by contextual considerations around unmet need, such that supported conditional regulatory approval. Carer and clinician input may have influenced assessment scope but did not guide flexibility in evidence evaluation.  

What is Still Unknown? 

EU countries have incorporated consideration of JCA outputs into the clinical assessment component of national health technology assessment (HTA), but it remains to be seen if and how contextual aspects will influence the end appraisal and decision for reviewed products. It is also unknown how described evidence uncertainty will be interpreted in national HTA recommendations, especially in light of any contextual considerations, and whether evidence will be considered at national level if not submitted or not considered valid within the JCA report.  

Relatedly, there is an open question over national interpretation either where established national HTA is usually more stringent in evidence demands (e.g., around endpoints), or alternatively, where more sophisticated analysis to estimate comparative benefit would not usually play a role in decision-making. For example, in this first JCA report, an estimate of comparative progression-free survival was included in the report, derived from an unanchored Matching-Adjusted Indirect Comparison analysis, albeit with strong caveats of uncertainty. Whether this specific outcome measure and technical approach is considered in future market-level assessments and decision-making will be informative for manufacturers for future evidence planning.  

Phase III data is a condition for full regulatory approval in Europe of Ojemda. Re-assessment upon availability of new data is an established part of HTA in many key markets. The JCA process makes provision for re-assessment if significant new evidence is available, but plans for this are not explicitly mentioned in this first JCA report. Manufacturers will want to understand if and how European-level re-assessment will be conducted, to inform launch strategies and accompanying evidence generation planning.  

Finally, with a multi-national English-language technical assessment of clinical data now available, JCA may be influential beyond EU markets. We will be keen to track any reference or implicit impact of the JCA on assessments and negotiations worldwide. 

What This Means for Global Market Access Strategy 

This assessment confirms the need for early comprehensive planning and investment in the evidence package for any EU market launch. This first report highlights many methodological demands, including beyond the trial, specifically the importance of ensuring that comparative non-trial datasets are suitable for analysis and submission-ready. 

The opportunity for Joint Scientific Consultation (JSC), as offered to accompany JCA, or Early Scientific Advice, will also need to be understood given the limited JSC slots. Further, manufacturers should consider whether the consultation output is feasible for implementation within the timelines and multiple design considerations of a global trial program.    

More broadly, as evidence barriers for EU access are maintained or even raised as now demonstrated, there are important implications for market launch sequencing or feasibility which manufacturers should consider: 

• Generation of JCA-compatible evidence packages may be justifiable only for some assets. 

• Commercialization strategies will need to weigh the consequences of no EU launch, vs. an under-evidenced launch, vs. a launch with evidence but still potentially limited in access and price (without dramatic change at national level in Europe). 

• This will play out especially for products where the US price is particularly exposed to EU market prices through the US’s international reference pricing policy (Most-Favored Nation) 

Dive Deeper  

Manufacturers need to understand the changing landscape of evidence demands in Europe, including what this means for asset/portfolio pricing and access opportunities. Our teams bring deep, cross-market expertise in evidence generation planning, HTA engagement, and market access and commercial strategy across the US and globally. To learn more about how we can support your work, connect with us.