Presentation (CTI)

OBJECTIVES: From January 12th, 2025, oncology products & ATMPs submitted to the European Medicines Agency must undergo Joint Clinical Assessment (JCA). Whilst reimbursement remains a national decision, member states are required to consider the JCA report. However, the extent of consideration is likely to vary widely between member states. This study explores whether population size correlates with the level of current JCA implementation in each member state, based on a qualitative review of HTA documents and policy publications to determine engagement.
METHODS: Population data for all EU member states was obtained from the World Health Organisation (2023). The respective HTA website for each country was reviewed to assess their level of engagement with the JCA process as low, moderate or high. This qualitative assessment was based on indicators such as assessor/ co-assessor role, changes to dossier template or timelines in current HTA process, and additional policy documentation on JCA. A comparison of engagement levels with population size determined the impact of population size in shaping JCA implementation across member states.
RESULTS: Among the five most populated member states, 80% show moderate engagement towards JCA, including publication of national implementation plans and updates to methods guidance. In contrast, the five least populated member states all show low engagement towards JCA at present, with markets such as Liechtenstein often lacking formal HTA systems at the national level.
CONCLUSIONS: Member states are increasingly showing engagement with the JCA process following its introduction in January 2025. Member states with smaller populations generally demonstrate low levels of engagement, likely driven by resource constraints. Despite this, the HTA Coordination Group estimates 17 oncology and 8 ATMP JCAs will be conducted in 2025, supporting a view that member states will continue increasing their participation in JCA over the coming years, regardless of population size.