Expert Guidance Through Complex Regulations

The Swiss market access pathway involves distinct stages, from Swissmedic's Marketing Authorization (MA) to the Federal Office of Public Health's (BAG) reimbursement decisions and Specialties List (SL) inclusion. These processes are governed by specific timelines and detailed requirements.

We provide comprehensive guidance through each phase:

• Swissmedic MA Process: Understanding the nuances of quality, safety, and efficacy assessment, including standard and fast-track procedures. We help you prepare robust dossiers to meet Swissmedic's stringent standards.
• BAG Reimbursement (P&R) Process: Navigating the critical evaluation against the WZW criteria (Wirksamkeit, Zweckmässigkeit, Wirtschaftlichkeit – Efficacy, Appropriateness, Economical). We ensure your submission effectively demonstrates your product's value.

Strategic Insights for Optimal Pricing & Reimbursement

Achieving a favorable price and reimbursement status is paramount. The Swiss system employs a dual-pillar approach for innovative drugs:

• Foreign Price Comparison (APV): We provide strategic insights into how your product's price compares to those in the nine reference European countries, helping you position your pricing effectively.
• Therapeutic Cross-Comparison (TQV): We assist in building a compelling case for your product's benefits and cost-effectiveness against existing therapies on the SL.

Furthermore, we guide you on leveraging opportunities such as the Innovation Bonus for significant therapeutic advancements and understanding the role of Managed Entry Agreements (MEAs) in managing budget impact through confidential rebates.

Seamless Entry to Accelerate Patient Access

Our goal is to streamline your market entry, minimizing delays and ensuring patients can access your innovative therapies quickly. We provide:

• Proactive Planning: Anticipating challenges and preparing comprehensive documentation to meet all submission requirements.
• Stakeholder Engagement: Understanding the roles of key bodies like the Federal Medicines Commission (EAK) and how their recommendations influence BAG decisions.
• Post-Listing Management: Advising on ongoing price reviews (triennial reviews) and managing the impact of generic and biosimilar entry, including strategies to navigate the differentiated deductible.

Our Collaborative Approach: Sur Access & Our Partners

Navigating the Swiss market entry requires a dual approach: robust regulatory approval and compelling HTA/reimbursement dossiers. We are proud to partner with leading experts in Swiss regulatory affairs and corporate services. This strategic collaboration ensures a seamless, integrated process from regulatory submission to successful reimbursement and compliant local establishment.

Sur Access' Focus: HTA & Value Demonstration

• Developing and refining your product's value story specifically for the Swiss context.
• Strategic guidance on evidence generation to meet Swiss HTA requirements for Effectiveness, Appropriateness, and Economic Efficiency (WZW criteria).
• Preparation of comprehensive HTA dossiers, focusing on robust clinical and economic arguments for reimbursement.
• Support for economic assessments required by the FOPH, including the development of budget impact models (BIMs) and analyses that demonstrate cost-effectiveness within the Swiss framework of International Price Comparison and Therapeutic Cross-Comparison.
• Strategic engagement planning with key market access stakeholders (FOPH/BAG, payers, clinicians).
• Support for price negotiations based on robust value arguments and FOPH's pricing methodologies.

Our Partners' Focus: Regulatory Submissions & Company Establishment

• Strategic advice and comprehensive services for regulatory approval with Swissmedic.
• Management of the entire lifecycle of your products from initial marketing authorization applications to maintenance (variations, renewals).
• Ensuring compliance with all Swissmedic regulations and preparing all necessary documentation modules.
• Founding Company Seat: To obtain market access for your medicinal product in Switzerland, your company must have a legal entity (a branch or subsidiary) established in Switzerland. Together with our partners, we assist you in finding an attractive location for your establishment and facilitate all necessary legal and administrative formalities.

Together, we provide an end-to-end solution, ensuring your product meets all regulatory standards while simultaneously building a strong economic and clinical case for reimbursement and establishing a compliant local presence in Switzerland.