Presentation (CTI)

OBJECTIVES: EU JCA represents an important step towards standardized clinical and safety evaluation. However, procedural harmonization has not transferred assessment authority. Rather, it has created a shared clinical assessment resource for member states to inform national decisions. How assessments are used with regards to how clinical evidence is interpreted, applied and integrated may vary across member states. We examine updates to national HTA guidance and methodologies across EU member states, identifying: 1) How national agencies plan to incorporate JCA outputs in their processes 2) Areas of national methodological and procedural convergence and divergence
METHODS: Targeted review of HTA agency websites and guidance repositories, to identify EU member states national HTA process and guidance documents published since 2024.
RESULTS: National HTA agencies across Europe have adapted guidance, submission requirements and assessment processes in response to JCA implementation. Early national procedural or methodological adaptations have been documented in Italy (AIFA), Denmark (DMC), Germany (G-BA), France (HAS), Norway (NOMA), and Sweden (TLV). Half of the changes are early procedural adaptations to create alignment and half are more explicit integrations of JCA assessment/evidence. For example, in Germany and France formal incorporation of JCA reports into national assessment procedures is outlined to increase alignment with EU-level dossier requirements and reduce duplication across clinical evidence submissions. Other jurisdictions introduced more limited procedural adaptations or simply acknowledged future intent to consider JCA.
CONCLUSIONS: National HTA agencies responses to JCA range from explicit formal integration to early procedural alignment. With 14 ongoing JCAs, three discontinued and one complete the first published report, conducted by NCPE (Ireland) and IQWiG (Germany), will provide critical insights into how JCA outputs are implemented nationally. Continued monitoring of national guidance updates and JCA implementation will determine whether procedural harmonization at the European level successfully addressed persistent divergence in clinical evidence application.