Presentation (CTI)

OBJECTIVES: EU-HTA aims to provide a common clinical evidence base, however, reimbursement decisions remain country-specific. The national "Delta Dossier"—developed alongside the EU dossier—should therefore not be considered a mere gap-filling exercise. The preparation of the first Delta Dossiers presents an opportunity to identify challenges in aligning EU and German HTA dossiers and derive strategic implications for national Market Access.
METHODS: We qualitatively assessed early Delta Dossier development to identify key challenges arising from the parallel preparation of Delta and EU dossiers and corresponding strategies to enhance alignment between global and national teams.
RESULTS: The level of inter-team collaboration influences the extent to which EU-HTA strategies are developed independently of national considerations. Strategies may evolve further with updated assumptions (e.g. adapted label, new data cuts); early experience shows misalignment risks related to subpopulations, unmet need, and choice of appropriate comparators. Differences in the strategic use of epidemiological data, endpoint relevance, and product positioning in national healthcare systems further limit transferability to the German AMNOG framework. While referencing the EU dossier aims to reduce duplication, national requirements may still necessitate additional analyses and context. Therefore, critical success factors are a structured collaboration framework between global and local teams and the early definition of a national Market Access strategy, followed by a systematic comparison with the anticipated EU approach to identify gaps and risks and create mitigation strategies. This enables timely decisions on additionally required data and continuous alignment of key messages throughout the development process.
CONCLUSIONS: Delta Dossiers remain a central instrument for national Market Access and should be developed as part of an integrated strategy between global and local teams. Early, structured communication and continuous alignment of the Delta and EU dossiers are essential for complying with national requirements and creating a coherent, locally relevant dossier for successful reimbursement.