Advanced Therapy Medicinal Products (ATMPs) in Switzerland

ATMPs represent a groundbreaking frontier in healthcare, offering the potential for curative, one-time treatments for devastating rare diseases and other severe conditions. Switzerland, with its patient-centric approach and commitment to innovation, presents both unique opportunities and specific complexities for manufacturers seeking market access.

Navigating the Future of Medicine in a Unique Landscape


At Sur Access, we understand that ATMPs challenge traditional market access models due to their:


  • High Upfront Costs: Reflecting immense R&D investment and personalized nature.
  • Limited Long-Term Data: Often approved with shorter follow-up periods due to high unmet medical need.
  • Small Patient Populations: Especially for ultra-rare indications, requiring tailored strategies.
  • Complex Reimbursement Pathways: Demanding innovative payment and data collection models.


Why Switzerland for ATMPs?


Switzerland is at the forefront of embracing ATMP innovation, driven by:


  • High Unmet Medical Need Focus: A healthcare system highly attuned to providing access for severe and life-threatening conditions with no adequate alternatives.
  • Proactive Regulatory & Reimbursement Frameworks:
  • Swissmedic's ATMP Division (est. 2022) & Innovation Office: Dedicated units providing a single point of contact for streamlined regulatory guidance and accelerated pathways.
  • Early Access Programs: Facilitating rapid patient access under specific conditions.
  • Fast Track MA & P&R: Mechanisms to expedite both marketing authorization and reimbursement.
  • Willingness for Innovative Models: A clear openness to Managed Entry Agreements (MEAs), including Payment-for-Performance (P4P) models, to mitigate financial risk and link reimbursement to clinical outcomes.
  • Robust Data Infrastructure: Supported by rare disease registries (e.g., Swiss Rare Disease Registry), crucial for long-term outcome validation and sustained reimbursement.


Our Expertise in Swiss ATMP Market Access


Sur Access specializes in guiding manufacturers through Switzerland's unique ATMP landscape. We provide strategic, end-to-end support to ensure your groundbreaking therapy reaches the patients who need it most.

Our services for ATMPs in Switzerland include:


  • Early Strategic Planning:
  • Pre-submission Dialogue & Scientific Advice: Guiding engagement with Swissmedic to align on regulatory data requirements from the outset.
  • Early FOPH/BAG Engagement: Preparing for and facilitating crucial early dialogues with the Federal Office of Public Health to discuss reimbursement potential and innovative pricing models.
  • Value Proposition Development: Crafting a compelling value story that addresses efficacy (Wirksamkeit), appropriateness (Zweckmässigkeit), and cost-effectiveness (Wirtschaftlichkeit) for the Swiss context.
  • Pricing & Reimbursement Strategy:
  • Developing robust pricing strategies, anticipating external price referencing and internal therapeutic cross-comparisons.
  • Designing and negotiating Managed Entry Agreements (MEAs) and Payment-for-Performance (P4P) models tailored to your ATMP and the Swiss system.
  • Supporting the submission of comprehensive reimbursement dossiers (Spezialitätenliste applications).
  • Real-World Evidence (RWE) Integration: Advising on strategies for long-term data collection, patient registries, and RWE generation to validate value and secure ongoing reimbursement.
  • Launch & Post-Launch Support: Ensuring smooth implementation and monitoring of your market access strategy post-approval.