Journal of Market Access & Health Policy (2026); Authors: Grammati Sarri, Bengt Liljas, Keith R Abrams, Stephen J Duffield, Murtuza Bharmal
Curated publication page on the role of real-world evidence across JSC, JCA, national HTA and Delta-Dossiers.
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.