First EU Joint Clinical Assessment report published, with stakeholders highlighting transparency and process

The publication of the first Joint Clinical Assessment (JCA) report under the EU HTA Regulation has prompted reactions from policymakers, HTA organizations, and industry stakeholders, with discussion focusing on the transparency of the new process, its implementation across Europe, and the challenges that remain as the framework matures.

The Baseline

• The European Commission has published the first Joint Clinical Assessment (JCA) report, covering tovorafenib (Ojemda®) for pediatric low-grade glioma.
• Four documents have been released: the JCA report, summary report, developer dossier, and factual accuracy check comments with responses from the assessor and co-assessor.
• Early stakeholder reactions have highlighted the publication as a milestone for European HTA while drawing attention to transparency, collaboration, and the practical implementation of the new framework.

The European Commission has published the first Joint Clinical Assessment (JCA) under Regulation (EU) 2021/2282 for tovorafenib (Ojemda®), developed by Ipsen for pediatric low-grade glioma. The report follows endorsement of the assessment by the Member State Coordination Group on Health Technology Assessment in April 2026. Alongside the assessment report, the Commission has released a summary report, the developer dossier, and the factual accuracy comments with responses from the assessor and co-assessor. Together, these documents provide the first public example of how the new EU HTA framework is being applied in practice.

The JCA assesses the medicine's relative effectiveness and relative safety in line with the scope defined under the EU HTA Regulation and includes detailed information on the assessment scope, PICOs (population, intervention, comparator, outcomes), stakeholder involvement, and the results of the clinical evaluation. Rather than determining overall clinical added benefit, the report is intended to provide a common evidence base to support national HTA processes, where decisions on added benefit, pricing, and reimbursement remain the responsibility of individual Member States.

The evaluation was conducted by the National Centre for Pharmacoeconomics (NCPE), Ireland, as assessor, with the Institute for Quality and Efficiency in Health Care (IQWiG) acting as co-assessor. The European Commission completed its procedural review on May 19, 2026. Ojemda had previously received a one-year conditional marketing authorization in April 2026 based on the European Medicines Agency's scientific assessment.

While the first JCA represents an important milestone in the implementation of the EU HTA Regulation, early reactions have focused primarily on what the report signifies for European cooperation, evidence generation, and the future operation of the new framework.

Olivér Várhelyi, Commissioner for Health and Animal Welfare, described the publication as “a turning point for patients, healthcare systems and innovation in Europe,” adding that the EU HTA framework will ensure "high-quality scientific assessments are available to all Member States" to support timely and informed decisions on new treatments. He also urged Member States to put the assessments to use "without adding additional requirements, so that innovation can reach patients faster."

Anne Willemsen, Chair of the Joint Clinical Assessment Subgroup and Senior Advisor at Zorginstituut Nederland, similarly highlighted the significance of the publication, stating that:

"European cooperation in HTA is no longer a future ambition; it is now a reality."

Willemsen also acknowledged that implementation remains an ongoing process, noting that "we still have a long journey ahead of us as we continue to refine methodologies, strengthen collaboration, and learn from experience."

The organizations responsible for producing the assessment also emphasized the collaborative nature of the process. Regina Skavron, Head of the EU HTA Division within IQWiG's Drug Assessment Department, described completion of the first assessment as “an exciting yet challenging journey,” undertaken in close collaboration with Irish partners, adding that the JCA “will now start to impact on national healthcare systems, marking the first practical implementation of the EU HTA process.”

Tommaso Osti, Public Health Specialist at the European Commission, likewise reflected on the report as “a major milestone HTA in Europe, but more broadly for public health,” concluding that:

“This first JCA report is therefore more than a document. It is proof that meaningful collaboration across Europe can produce something that no single actor could have achieved alone.”

Industry stakeholders also welcomed the first assessment while highlighting the challenges that remain. EUCOPE also welcomed the publication, with Secretary General Alexander Natz stating that:

"An important milestone has been achieved, and we hope full attention is now directed towards the readiness of EU HTA for orphan medicinal products."

The organization also noted that further work will be needed to harmonize Member State requirements, reduce the burden created by multiple PICOs, strengthen early interaction between developers and assessors, and recognize situations where conventional randomized controlled trials may not be feasible for rare diseases. Many of these implementation questions have also been raised by stakeholders involved in the first wave of JCAs, who have highlighted the evolving nature of the new procedures and evidence expectations.

Other commentators emphasized that the publication marks the beginning of the next phase of the EU HTA process. Smita Sealey, Partner at ZS, observed that "the JCA creates a shared clinical narrative but not a shared value conclusion," suggesting that reimbursement outcomes may continue to differ as individual healthcare systems interpret uncertainty and assess value within their own national contexts.

Benjamin Patton, Strategic Account Manager for Life Science & Healthcare at Clarivate, likewise commented that “everything transitions from EU-level clinical consensus to country-level economic evaluation and pricing.” He noted that the process now moves from EU-level clinical assessment to national appraisal, with local economic evidence and healthcare system priorities continuing to shape reimbursement decisions.

The publication comes as national HTA systems continue adapting to the new framework. Germany, France, Italy, Sweden, Denmark, Norway, and, most recently, Spain, have all introduced changes to incorporate JCA outputs into their national processes, reflecting the shift from a common European clinical assessment to country-specific pricing and reimbursement decisions.

The publication of the JCA for tovorafenib marks the first public demonstration of the new EU HTA framework in practice, offering an early indication of how its methodologies and processes will operate. With 18 JCAs initiated to date, future reports are expected to provide further insight into the framework's implementation across different therapeutic areas and evidence contexts, while highlighting how Member States incorporate JCA outputs into national HTA processes and how evidence expectations evolve over time.