The first EU Joint Clinical Assessment (JCA) marks a significant milestone in the implementation of the EU HTA Regulation, offering valuable insights into future evidence requirements and market access decision-making.
Simon-Kucher experts explore the first JCA through the case of tovorafenib in paediatric low-grade glioma. Based on our reverse-engineering analysis, they discuss how PICO scoping and evidence appraisal appear to work in practice and what these early learnings mean for manufacturers preparing future EU HTA submissions.
This recording covers:
- How the assessment scope for tovorafenib was likely defined, including key considerations around PICO selection, comparator choice, and Member State perspectives
- How submitted evidence was appraised across PICOs, from study validity and comparator alignment to the handling of evidence gaps
- What the first JCA report means in practice for manufacturers preparing future HTA submissions
- Which methodological and procedural uncertainties remain, and how they could influence local pricing and reimbursement outcomes
- Practical steps manufacturers can take now to strengthen EU HTA readiness
Watch the recording to gain expert perspectives on the first EU Joint Clinical Assessment and its implications for future evidence generation, market access, and pricing and reimbursement strategies across Europe.
