Case Study: Named Patient Program
Global Early Access Supports Market Access Strategy
30 Patients. 3 Regions.
The Challenge
A global biopharmaceutical company received FDA approval for a rare liver disease treatment but faced significant delays in securing EMA authorization. With patients urgently awaiting access across Europe, the company needed a compliant, chargeable Early Access Programme (EAP) to bridge the gap to commercial launch, ensuring no patient was left waiting.
The sponsor required a partner who could move fast, manage complexity, and deliver access pathways that balanced speed, compliance, and cost recovery across multiple territories.
Our Approach
Tanner partnered closely with the company to design a robust, regionally tailored EAP that could operate compliantly across the EU, APAC, and LATAM markets. The program’s supply chain was built around Tanner’s global distribution infrastructure, ensuring GDP-compliant handling, quality assurance, and rapid response for urgent cases.
We established a clear pricing and funding framework to maximize patient access prior to commercial availability, while maintaining regulatory integrity. Tanner’s team supported local affiliates in identifying eligible patients, coordinating import license applications, and securing reimbursement from national authorities. Tanner has successfully secured funding and treatment access for 30 patients across key EU markets, a number that continues to grow.
