Mapping the use of real-world evidence across the EU Health Technology Assessment Regulation

Short summary

This publication maps how real-world evidence can support JSC, JCA and national HTA submissions. It is particularly relevant for Delta-Dossiers because RWE generated for the JCA context may need to be localized, supplemented, updated or re-analyzed for national HTA requirements.

Key takeaways

• RWE can support PICO simulations, disease characterization, prognostic factors, effect modifiers and external control arms.
• EU HTAR guidance on the use of RWE remains limited.
• National HTA bodies apply different requirements and acceptance levels for RWE.
• After or in parallel with JCA, HTDs need to assess whether RWE is usable for national Delta-Dossiers.
• For Germany, local standard-of-care comparators, subgroups and clinical practice patterns may become decisive.

Relevance for JCA, AMNOG and Delta-Dossiers

RWE can help address evidence gaps between the European JCA and national assessment. In Germany, the critical question is whether real-world data fit the appropriate comparator therapy, local clinical practice, subgroup logic and patient-relevant endpoints.

Full text and DOI

• PubMed
• PubMed Central full text
• DOI: 10.3390/jmahp14020020

Related insights

• Individualised treatment comparators in JCA
• EU HTA in Germany