FROM JCA EVIDENCE PACKAGE TO NATIONAL REIMBURSEMENT: HOW EUROPEAN HTA BODIES ASSESS INDIRECT TREATMENT COMPARISONS
Author(s)
Mona Huhn, MSc1, Lena Stein, MSc1, Victor Rechard, MSc2, Kathrin Bogner, PhD1, Stefanie Wüstner, PhD1.
1AMS Advanced Medical Services GmbH, Mannheim, Germany, 2AMS Advanced Medical Services GmbH, Nantes, France.
1AMS Advanced Medical Services GmbH, Mannheim, Germany, 2AMS Advanced Medical Services GmbH, Nantes, France.
OBJECTIVES: For European Joint Clinical Assessment (JCA) of medicinal products, multiple PICOs requested by different member states (MS) may require various indirect comparisons (ITCs). While EU methodological and practical guidelines address the appropriate ITC method choice and reporting requirements, the appraisal and use of ITCs remain within the national health technology assessment (HTA) procedures. We aimed to compare national HTA guidance on ITCs and identify implications for JCA preparation using case studies.
METHODS: We reviewed HTA method guidelines for 10 MS (Germany, France, Spain, Italy, Portugal, Netherlands, Poland, Slovakia, Sweden, Norway) and extracted recommendations on ITCs, such as network meta-analysis (NMA), population-adjusted ITCs (PAICs), e.g., matching-adjusted indirect comparison (MAIC), and on non-randomized evidence. We compared these to EU-level guidance and NICE technical support documents. To capture methodological and evidentiary standards not fully specified in the national guidance, we examined 4+ HTA case studies in which ITCs played a major role, across countries.
RESULTS: Countries show high congruence regarding evidence hierarchy: Direct comparisons are preferred, followed by NMAs and Bucher ITCs. Methodological limitations of PAICs in unconnected networks are often highlighted, although rarely leading to outright rejection. The extent of guidance varies substantially across MS - from very limited information (e.g., Italy) to detailed reporting requirements (e.g., Norway). Many national method guidelines reference European guidelines (60%) and/or NICE guidance (30%) for evidence synthesis (including ITCs). Case studies showed differences not only in submitted ITCs, largely reflecting country-specific comparator needs, but also in their appraisal and decision relevance. While JCA requires systematic identification of clinical data on comparators and ITC feasibility assessment when no direct evidence is available, this is not necessarily required in national HTA procedures, including Germany.
CONCLUSIONS: Robust ITC planning for JCA requires EU-level methodological alignment and early anticipation of national uncertainty regarding the need for, appraisal and decision relevance of ITCs.
METHODS: We reviewed HTA method guidelines for 10 MS (Germany, France, Spain, Italy, Portugal, Netherlands, Poland, Slovakia, Sweden, Norway) and extracted recommendations on ITCs, such as network meta-analysis (NMA), population-adjusted ITCs (PAICs), e.g., matching-adjusted indirect comparison (MAIC), and on non-randomized evidence. We compared these to EU-level guidance and NICE technical support documents. To capture methodological and evidentiary standards not fully specified in the national guidance, we examined 4+ HTA case studies in which ITCs played a major role, across countries.
RESULTS: Countries show high congruence regarding evidence hierarchy: Direct comparisons are preferred, followed by NMAs and Bucher ITCs. Methodological limitations of PAICs in unconnected networks are often highlighted, although rarely leading to outright rejection. The extent of guidance varies substantially across MS - from very limited information (e.g., Italy) to detailed reporting requirements (e.g., Norway). Many national method guidelines reference European guidelines (60%) and/or NICE guidance (30%) for evidence synthesis (including ITCs). Case studies showed differences not only in submitted ITCs, largely reflecting country-specific comparator needs, but also in their appraisal and decision relevance. While JCA requires systematic identification of clinical data on comparators and ITC feasibility assessment when no direct evidence is available, this is not necessarily required in national HTA procedures, including Germany.
CONCLUSIONS: Robust ITC planning for JCA requires EU-level methodological alignment and early anticipation of national uncertainty regarding the need for, appraisal and decision relevance of ITCs.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HTA241
Topic
Health Technology Assessment, Study Approaches
Disease
No Additional Disease & Conditions/Specialized Treatment Areas