Presentation (CTI)

OBJECTIVES: The European Health Technology Assessment (EU HTA) Regulation introduces Joint Clinical Assessments (JCA) to streamline clinical evidence evaluation across Europe. However, national HTA systems remain fully responsible or value appraisal, reimbursement decisions and price setting. Understanding cross-country differences is therefore critical for evidence generation and market access strategy. This work aims to compare HTA frameworks in Germany, Austria and Switzerland with regard to process structure, evidence requirements, assessment outcomes and pricing implications.
METHODS: A structured review of legislation, HTA guidelines and assessment procedures was conducted and complemented by expert input. Findings were synthesized qualitatively.
RESULTS: Marked heterogeneity exists across DACH HTA systems. In Germany, marketing authorization implies immediate reimbursement within the statutory health insurance system, with the AMNOG benefit assessment serving to regulate the reimbursed price. By contrast, Austria and Switzerland operate positive‑list systems in which reimbursement is contingent upon inclusion in the Austrian Reimbursement Code or the Swiss Specialties List. Accordingly, HTA outcomes directly drive reimbursement decisions and scope of use. Consequently, the focus of the benefit assessments differs across countries. Germany emphasizes relative added benefit over an appropriate comparator defined by the G-BA to rationalize price differentiation. In contrast, Austria and Switzerland apply more access‑oriented appraisal criteria focusing on therapeutic relevance, economic considerations, and patient populations for whom reimbursement can be justified. Strategically, health technology developers must therefore align evidence generation and value narratives in early clinical development not only to demonstrate incremental benefit for pricing purposes, but also to substantiate reimbursement eligibility and access conditions in positive‑list systems.
CONCLUSIONS: Early alignment of evidence generation with country-specific HTA objectives, combined with a carefully sequenced launch strategy that accounts for external price referencing and proactive stakeholder engagement, is critical to optimize access and value realization across the DACH region.