Market Access

Market Access is an additional hurdle which the pharmaceutical company has to pass after regulatory approval. The objective is to prove the additional therapeutic benefit vs. a local standard therapy and to align the reimbursed price of a pharmaceutical with this additional benefit. Therefore, it is crucial for the pharmaceutical company to include the needs of payor authorities into their clinical development program.
Since 2000 a new process in Germany requires a modified Health-Technology Assessment followed by an appraisal of the Federal Taskforce of Physicians, Sick Funds, and Hospitals (G-BA). Companies have to provide a so called "Value Dossier" at the time of market launch. The objective is to document the “additional therapeutic benefit” vs. an “appropriate standard therapy” as platform for price negotiations. The content of the Value Dossier is linked to the Regulatory File. The price negotiated in Germany is reference for about 25 other international markets, particularly, in Europe.

We support you with:

• Review of market situation at time of launch re. "additional therapeutic benefit" and "appropriate standard therapy"
• Best clinical study plan for the given scenario
• Planning, reviewing and compilation of a Value Dossier
• Input of medical, regulatory, payor stakeholders
• Planning of Scientific Advice Meetings with G-BA and / or BfArM, Federal Association of Sick Funds, Federal Board of Arbitration

• Regulatory Strategy
• Regulatory Procedures
• Advanced Therapies
• Orphan Drug Development
• Paediatric Development
• Medical Devices
• Borderline Products
• Authority Meetings
• Electronic Submissions
• Market Access & Value Dossier
• Small & Medium Enterprises
• Medical Writing
• Project Management
• Due Diligence

• Business Development