Similarities and Differences Between the National Institute for Health and Care Excellence (NICE) and European Union Joint Clinical Assessment (EU JCA) Clinical Systematic Literature Review Requirements
Author(s)
Sneha Bhadti, MSc, Susan O'Connell, PhD, Neil Webb, BSc.
Source Health Economics, Oxford, United Kingdom.
Source Health Economics, Oxford, United Kingdom.
OBJECTIVES: A clinical systematic literature review (SLR) is crucial for evaluating efficacy and safety evidence and is a requirement for submissions to the European Union Joint Clinical Assessment (EU JCA) and National Institute for Health and Care Excellence (NICE). The objective of this study is to compare the clinical SLR requirements of NICE and the EU JCA.
METHODS: A review of published NICE and EU JCA guidance documents was conducted. Clinical SLR requirements were extracted and compared across predefined domains.
RESULTS: NICE and EU JCA SLR requirements broadly align, particularly in their emphasis on transparent reporting. Both require detailed documentation of search strings, including justification for filters used, and the inclusion of PRISMA diagrams. However, there are several important differences. Specifically, the EU JCA mandates searches of MEDLINE and CENTRAL, while NICE additionally requires Embase and the Cochrane Database of Systematic Reviews. Conference abstracts and posters are excluded from the JCA SLR but included in NICE SLRs. While both processes require quality assessment of included studies, the JCA specifies RoB1 for randomised trials, while NICE allows flexibility in the choice of appraisal tool. Timeline expectations also differ: the JCA requires searches to be completed within 3 months prior to submission, versus a 6-month window allowed by NICE.
CONCLUSIONS: The differences between the NICE and EU JCA SLR requirements likely reflect the distinct purpose and scope of each process. The JCA serves the EU, whereas NICE focuses on the UK only. Differences in processes may represent a pragmatic approach to capturing relevant and informative evidence within strict EU JCA timelines, while also promoting consistent reporting across assessments for easier interpretation and comparison. Understanding the similarities and differences between the NICE and EU JCA requirements could be leveraged to maximise the EU JCA outputs when preparing country specific HTA submissions, including those to NICE.
METHODS: A review of published NICE and EU JCA guidance documents was conducted. Clinical SLR requirements were extracted and compared across predefined domains.
RESULTS: NICE and EU JCA SLR requirements broadly align, particularly in their emphasis on transparent reporting. Both require detailed documentation of search strings, including justification for filters used, and the inclusion of PRISMA diagrams. However, there are several important differences. Specifically, the EU JCA mandates searches of MEDLINE and CENTRAL, while NICE additionally requires Embase and the Cochrane Database of Systematic Reviews. Conference abstracts and posters are excluded from the JCA SLR but included in NICE SLRs. While both processes require quality assessment of included studies, the JCA specifies RoB1 for randomised trials, while NICE allows flexibility in the choice of appraisal tool. Timeline expectations also differ: the JCA requires searches to be completed within 3 months prior to submission, versus a 6-month window allowed by NICE.
CONCLUSIONS: The differences between the NICE and EU JCA SLR requirements likely reflect the distinct purpose and scope of each process. The JCA serves the EU, whereas NICE focuses on the UK only. Differences in processes may represent a pragmatic approach to capturing relevant and informative evidence within strict EU JCA timelines, while also promoting consistent reporting across assessments for easier interpretation and comparison. Understanding the similarities and differences between the NICE and EU JCA requirements could be leveraged to maximise the EU JCA outputs when preparing country specific HTA submissions, including those to NICE.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HTA298
Topic
Clinical Outcomes, Health Technology Assessment, Study Approaches
Topic Subcategory
Systems & Structure
Disease
No Additional Disease & Conditions/Specialized Treatment Areas