Potential Impact of Joint Clinical Assessment (JCA) on Health Technology Assessment Timelines in Ireland

OBJECTIVES: One of the main aims of the European Joint Clinical Assessment (JCA) process is to reduce duplication of HTA processes and improve patient access to innovative technologies in Europe. Currently in Ireland, health technology developers (HTDs) can submit a rapid review (RR) dossier at Committee for Medicinal Products for Human Use (CHMP) opinion. A requirement to include the JCA report may therefore delay the start of the Irish HTA process. This research explores the potential impact JCA development may have on the initiation of HTA processes in Ireland.

METHODS: RR submission and CHMP opinion dates for each National Centre for Pharmacoeconomics (NCPE) assessment published in 2023 were identified from publicly available sources. The average duration between CHMP opinion and the anticipated publication of the JCA report was estimated from the JCA Implementing Act and standard European Medicines Agency timelines. Alternative JCA timeline scenarios were explored to estimate the potential impact of a delay on the initiation of NCPE processes

RESULTS: For n=77 assessments published by NCPE, the average time between positive CHMP and RR submission was 427 days (median= 152 days). If the gap between positive CHMP and JCA report is 75 days, 16 (21%) of RR submissions would have been delayed with an average delay of 33 days. If the gap is 60 days, 15 submissions would have been affected, (average delay = 31 days). If the gap is 90 days, 18 submissions would have been affected (average delay =39 days).

CONCLUSIONS: The requirement to consider the JCA report could delay the submission of RR. Based on 2023 data, 1 in 5 submissions may be affected. However, further clarification is needed on how the JCA report will be included in the HTA process in Ireland and the potential impact it will have on patient access.