Presentation (CTI)

OBJECTIVES: Joint Clinical Assessment was sold partly as a way to cut duplicated effort — so is it reducing the burden, or simply moving it? Concerns about evidence requirements, PICO complexity, and workload suggest the latter. This study developed a framework for measuring the administrative burden of EU HTA implementation.
METHODS: A burden-assessment model was developed using regulatory-impact assessment principles, HTA process analysis, and implementation-science methodologies. Potential burden drivers were identified across dossier preparation, evidence generation, PICO development, information requests, stakeholder interactions, and assessment timelines. Candidate metrics were designed to quantify workload, resource utilisation, and procedural complexity.
RESULTS: The analysis identified multiple dimensions of administrative burden extending beyond simple dossier preparation costs. Key burden drivers included the number of PICOs, subgroup analyses, evidence-generation requirements, indirect treatment comparison requests, and iterative information exchanges. Several burden components appear measurable through objective indicators, including submission volume, analytical complexity, response timelines, and resource consumption. Importantly, the study found that burden and duplication are not synonymous. Some activities may increase short-term workload while reducing long-term duplication across Member States. Consequently, administrative burden should be assessed using a lifecycle perspective rather than a single procedural measure. The proposed framework enables comparison between expected and observed implementation impacts and could support future evaluation exercises.
CONCLUSIONS: Burden is among the most policy-relevant yet least measured dimensions of EU HTA — and it is not the same as duplication. Measuring it over the full lifecycle would show where to simplify without sacrificing assessment quality.