Mapping methods gaps between EU joint clinical assessments and local health technology assessment decision-making

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.

Full text and DOI

• PubMed
• PubMed Central full text
• DOI: 10.57264/cer-2024-0240