Journal of Comparative Effectiveness Research (2025); Authors: Grammati Sarri, Lydia Vinals, Lilia Leisle, Ingrid Claverie Chau, David Smalbrugge, Kai Lucassen, Yannis Jemiai
Curated publication page on the peer-reviewed article and its relevance for JCA, national HTA decision logic and Delta-Dossiers.
Short summary
This publication supports the central argument that EU JCA does not create full methodological harmonization across national HTA decision-making. It maps similarities and misalignments between EU HTAR methodological guidance and selected national HTA requirements.
Key takeaways
EU JCA and national HTA systems share the expectation of systematic and transparent evidence assessment.
National requirements continue to differ, particularly in scoping, evidence selection, evidence synthesis, ITCs and non-randomized evidence.
Germany/IQWiG shows close methodological proximity to EU HTAR, but national decision logic remains relevant.
HTDs need evidence packages that can support both JCA and local HTA decision-making.
For Delta-Dossiers, European evidence must remain locally interpretable, supplementable and methodologically usable.
Relevance for JCA, AMNOG and Delta-Dossiers
The publication supports the core Delta-Dossier argument: JCA creates a common clinical evidence base, but it does not replace local assessment perspectives. For Germany, AMNOG as Germany's early benefit assessment framework, IQWiG methods, Germany's Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA), appropriate comparator therapy, subgroups and patient-relevant endpoints remain distinct requirements.