Case Study: Named Patient Program
EU NPP Serves as a Bridge to Commercial Supply
Continuity Before Launch.
The Challenge
A global pharma company had secured FDA approval for a treatment for pediatric and adult patients with an ultra-rare genetic metabolic disorder — but commercial availability in Europe was still months away.
With clinicians requesting access for patients in urgent need, the sponsor required a chargeable, compliant Name Patient Programme (NPP) that could operate across multiple EU markets, each with different funding mechanisms, licensing processes, and regulatory expectations. They needed a partner who could move quickly, simplify complexity, and ensure no interruption to care while the commercial launch progressed.
Our Approach
Tanner built a simple, compliant access pathway tailored to European requirements, combining global coordination with local regulatory expertise. We established a secure, end-to-end supply chain, supported clinicians with import licensing and documentation, and worked with treatment centers to secure funding and justify medical need.
In key markets, Tanner implemented free-of-charge supply policies to avoid delays and maintained close communication with sites to ensure uninterrupted access throughout the pre-launch period.
