ARE EVIDENCE REVIEW REQUIREMENTS SIMILAR ACROSS HEALTH TECHNOLOGY ASSESSMENT (HTA) AGENCIES? A CROSS-SECTIONAL STUDY OF NICE, CDA, IQWIG AND EU JCA
Author(s)
Raju Gautam, PhD1, Khushbu Baranwal, MSc2, Shilpi Swami, MSc1;
1ConnectHEOR, London, United Kingdom, 2ConnectHEOR, Delhi, India
1ConnectHEOR, London, United Kingdom, 2ConnectHEOR, Delhi, India
OBJECTIVES: Evidence reviews are the backbone of HTA submission. We aimed to compare the evidence review requirements of major HTA agencies, including European Union Joint Clinical Assessment (EU JCA).
METHODS: A targeted review was conducted to identify the published guidelines of NICE (UK), CDA-AMC (Canada), IQWiG (Germany), and EU JCA. Information captured focused on evidence review requirements, appraisal methods, and presentation of findings. Similarities and differences were summarized across various domains.
RESULTS: All four agencies prioritize RCTs as gold standard evidence, requiring a PICO/PICOS-framed question, search core biomedical databases/registries and emphasize patient-relevant outcomes (mortality, morbidity, HRQoL, safety). Transparency requirements, including comprehensive documentation of searches and critical appraisal are common across agencies. Some notable differences were observed. While NICE integrates clinical and cost effectiveness to support economic model, IQWiG applies most restrictive approach focusing on demonstration of “added benefit” versus an appropriate comparator. CDA-AMC evaluates comparative effectiveness in Canadian practice with pragmatic acceptance of real-world evidence. The newly introduced EU JCA focuses on a clinical-only relative effectiveness summary for member states. Evidence handling also differs: EU JCA has strictest search timelines (within 3 months) and excludes conference abstracts; NICE is broader accepts grey literature/abstracts; CDA-AMC uses GRADE to present results and may accept lower-certainty evidence to address gaps. NICE, CDA-AMC, and IQWiG requires broad search on Medline, Embase, and Cochrane databases. Nevertheless, EU JCA needs mandatory searches on MEDLINE and CENTRAL. Conference abstracts and posters are included in NICE and CDA-AMC, excluded from EU JCA SLR, but IQWiG requires full access to unpublished clinical study reports. Differences were noted in recommended risk-of-bias tools for quality assessment.
CONCLUSIONS: While NICE, CDA-AMC, and EU JCA share a common methodological foundation, their differences reflect distinct policy contexts across UK, Canada, and EU nations, respectively. These variations have important implications for evidence generation and submission strategies across HTA jurisdictions.
METHODS: A targeted review was conducted to identify the published guidelines of NICE (UK), CDA-AMC (Canada), IQWiG (Germany), and EU JCA. Information captured focused on evidence review requirements, appraisal methods, and presentation of findings. Similarities and differences were summarized across various domains.
RESULTS: All four agencies prioritize RCTs as gold standard evidence, requiring a PICO/PICOS-framed question, search core biomedical databases/registries and emphasize patient-relevant outcomes (mortality, morbidity, HRQoL, safety). Transparency requirements, including comprehensive documentation of searches and critical appraisal are common across agencies. Some notable differences were observed. While NICE integrates clinical and cost effectiveness to support economic model, IQWiG applies most restrictive approach focusing on demonstration of “added benefit” versus an appropriate comparator. CDA-AMC evaluates comparative effectiveness in Canadian practice with pragmatic acceptance of real-world evidence. The newly introduced EU JCA focuses on a clinical-only relative effectiveness summary for member states. Evidence handling also differs: EU JCA has strictest search timelines (within 3 months) and excludes conference abstracts; NICE is broader accepts grey literature/abstracts; CDA-AMC uses GRADE to present results and may accept lower-certainty evidence to address gaps. NICE, CDA-AMC, and IQWiG requires broad search on Medline, Embase, and Cochrane databases. Nevertheless, EU JCA needs mandatory searches on MEDLINE and CENTRAL. Conference abstracts and posters are included in NICE and CDA-AMC, excluded from EU JCA SLR, but IQWiG requires full access to unpublished clinical study reports. Differences were noted in recommended risk-of-bias tools for quality assessment.
CONCLUSIONS: While NICE, CDA-AMC, and EU JCA share a common methodological foundation, their differences reflect distinct policy contexts across UK, Canada, and EU nations, respectively. These variations have important implications for evidence generation and submission strategies across HTA jurisdictions.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
HTA74
Topic
Health Technology Assessment
Disease
No Additional Disease & Conditions/Specialized Treatment Areas