OBJECTIVES: The EU Joint Clinical Assessment (JCA) will be a centralised procedure for the HTA of new medicines/indications launching within the European Union. Introduction of the JCA will start from 2025 for ATMPs and oncology medicines, before rollout to all centrally approved medicines from 2030. The objective of this research is to identify member state HTA/payer perceptions on the likely impact of the JCA introduction for country level evaluation of the clinical/economic value of new medicines and associated pricing and reimbursement decisions.

METHODS: Primary research has been undertaken with recent former HTA members across the EU. Countries were selected based on four archetypes: 1. High purchasing power (PP) + high population (France, Germany, Italy, Spain); 2. High PP + low population (Belgium); 3. Low PP + high population (Poland); 4. Low PP + low population (Hungary, Portugal).

RESULTS: Perceptions of the value and role of the JCA vary significantly across countries. For countries with higher purchasing power and established HTA processes, the additional value of the JCA is lower, with a high potential for additional data/analysis requests if the JCA outcomes do not align directly with existing assessment frameworks. For member states with lower purchasing power and smaller populations, the JCA has the potential to accelerate access decisions for new medicines, with JCA outcomes more likely to be directly integrated into current evaluation pathways (with reduce risk of additional data/analysis requests).

CONCLUSIONS: Introduction of the JCA is recognised as an important step towards more consistent value assessment and reduced delays to patient access for innovative medicines across the EU. To maximise the value and impact of the new process across the EU (and minimise member state requests for additional data), JCA methods and processes should align with existing HTA standards across larger member states with high purchasing power.