EU HTA Insights
Current analyses, case studies and expert perspectives on EU HTA, Joint Clinical Assessments and national HTA.
EU HTA Insights covers current developments and examines them through specific JCA procedures and published assessments. The focus is on their practical relevance for evidence strategy, JCA preparation and subsequent national HTA procedures.
Five Theses on EU HTA and National HTA Processes: Why One JCA Requires Different National Evidence Strategies
The Joint Clinical Assessment (JCA) establishes a common European assessment of comparative clinical effectiveness and safety under the EU HTA Regulation. National HTA processes, however, remain decisive for subsequent appraisal, reimbursement and pricing. The first JCA reports and their implementation in Germany and France show that differences in PICO, comparators, endpoints, evidence methods and national evidence appraisal need to be considered early in evidence planning.
Joint Clinical Assessment: What the First Four JCA Reports Reveal About Evidence Assessment
The first four published Joint Clinical Assessment (JCA) reports reveal recurring methodological challenges in European evidence assessment. Key issues include PICO scoping and comparators, indirect treatment comparisons, the selection of prognostic factors and effect modifiers, and the handling of non-randomised evidence and post-hoc analyses. For manufacturers, the critical question is therefore whether the evidence for each PICO can be planned, generated and presented in a methodologically robust and transparent way.
Discontinued JCAs: Why Joint Clinical Assessments are discontinued
Joint Clinical Assessments can be discontinued for different reasons. The cases reviewed to date show two main scenarios: the underlying EMA marketing authorisation application is withdrawn, or the JCA dossier does not meet key requirements for completeness, methodology, transparency and documentation. The cases of Zumrad / sasanlimab, catequentinib, Tacquell and sintilimab illustrate the different reasons why a JCA procedure may not be completed.
EU JCA and national HTA: Where methodological differences begin after the JCA
The Joint Clinical Assessment harmonizes parts of clinical evidence assessment across Europe, but it does not harmonize all methodological requirements of national HTA processes. A comparative analysis of EU HTAR and HTA systems in Germany, France, the Netherlands and Spain identifies common ground in core evidence standards, alongside relevant differences in scoping, indirect comparisons, non-randomized evidence and the handling of uncertainty.
Real-World Evidence in the EU-JCA: Where RWE Can Close Evidence Gaps and Where Its Limits Lie
Real-world evidence can contribute far more to the EU Joint Clinical Assessment than describing epidemiology and treatment patterns. RWE can support PICO scoping, identify prognostic factors and effect modifiers, enable external control arms, and provide additional information for evidence synthesis. At the same time, broader use of RWE increases the methodological requirements for data quality, confounding control, comparability, and analytical justification.