Presentation (CTI)

OBJECTIVES: Although Germany, Austria, and Switzerland share language, culture, and similar health outcomes, their pharmaceutical reimbursement systems differ considerably in structure, timing, and stakeholder engagement. For manufacturers, understanding these differences is critical to optimizing market access strategies across the DACH region.
METHODS: A comparative policy analysis was conducted based on national legislation, HTA guidance, and reimbursement pathways in Germany (AMNOG process), Austria (HVB List and BASG coordination), and Switzerland (SL inclusion via BAG). Key evaluation dimensions included dossier requirements, decision timelines, price negotiation mechanisms, HTA methodology, and transparency. Supplementary insights were drawn from interviews with regional access experts and public payer reports.
RESULTS:

Germany features a rapid post-launch access model with a 6-month free pricing window and value-based price negotiation anchored in added benefit assessments (AMNOG). The process is transparent but politically charged.

Austria operates a pre-launch inclusion system via the EKO (reimbursement list), coordinated by the Main Association of Social Insurance Institutions (Dachverband/HVB). The process is more administratively driven with limited public documentation and no structured added-benefit negotiation.

Switzerland combines clinical and economic evaluation under the Federal Office of Public Health (BAG). Inclusion into the Specialties List (SL) is required before reimbursement. Pricing often refers to international comparators and therapeutic alternatives and allows for negotiations based on cost-effectiveness or budget impact.

CONCLUSIONS: Despite geographic proximity, Germany, Austria, and Switzerland follow fundamentally different reimbursement logics—impacting speed, predictability, and strategic sequencing. Manufacturers must tailor submissions to each market’s regulatory rhythm, pricing culture, and evidentiary expectations. Cross-border learnings are limited by institutional design, but alignment in real-world evidence acceptance and horizon scanning could foster regional efficiencies.