glossary
What is JCA?
The Joint Clinical Assessment (JCA) is an EU-level evaluation of the clinical effectiveness and safety of a new medicine. It provides a single, standardized clinical assessment intended for use by all EU member states. The JCA focuses solely on clinical evidence, not on pricing, reimbursement, or country-specific economic evaluations, which remain the responsibility of individual national HTA bodies.
Why is JCA important in pharmaceutical strategy?
JCA helps harmonize clinical assessments across EU countries, reducing duplication of effort and providing a consistent scientific foundation for national decision-making. While it does not determine reimbursement or pricing, its findings influence national HTA evaluations and support evidence-based access decisions.
How does JCA differ from national HTA assessments?
Unlike national HTAs, which evaluate both clinical and economic factors for reimbursement purposes, the JCA exclusively assesses clinical evidence. Each EU member state still performs its own appraisal of economic value, cost-effectiveness, and local budget impact before making funding decisions.
How can pharmaceutical companies engage with JCA?
Companies can engage with JCA by providing high-quality clinical data, responding to requests for clarification, and seeking scientific advice during the assessment process. Early preparation ensures that the evidence submitted aligns with JCA requirements, facilitating smoother national HTA reviews and accelerating patient access across Europe.