Presentation (CTI)

OBJECTIVES: The EU HTA Regulation (HTAR) promised cooperation without uniformity: common assessments that still respect national methodological traditions. This study investigated whether early implementation of the Joint Clinical Assessment framework reflects that pluralism or whether convergence toward a single national HTA tradition is emerging within operational guidance and assessment practice.
METHODS: A comparative policy analysis was conducted using published HTA methodological guidance, implementing regulations, and peer-reviewed comparisons between EUnetHTA Joint Actions and national HTA processes. Particular attention was paid to evidence appraisal standards, indirect treatment comparison (ITC) requirements, subgroup expectations, endpoint assessment, and approaches to uncertainty. Findings were compared against established international standards, including ISPOR and NICE methodological frameworks.
RESULTS: The analysis identified a measurable convergence toward methodological conventions historically associated with the German AMNOG/IQWiG framework. Areas of convergence included stricter approaches to indirect comparisons, increased emphasis on subgroup analyses, narrower acceptance of surrogate outcomes, and more restrictive evidence requirements. Published comparative evidence suggests that earlier EUnetHTA Joint Action assessments were frequently more methodologically inclusive than corresponding national German assessments. The emerging trajectory therefore appears to represent not merely harmonisation, but a movement toward a more restrictive evidence paradigm. This raises concerns regarding the accommodation of methodological diversity across Member States and therapeutic areas.
CONCLUSIONS: Convergence buys consistency at the price of flexibility. To accommodate diverse evidence-generation environments, governance should anchor JCA methodology in internationally recognised standards rather than allow implicit drift toward any single national model.