Treatment without borders for Cell & Gene Therapies: Are we there yet?

“Cross border access”, “hub models”, “highly centralised access models” are only a few buzz words to refer to the pathway that enables European Union (EU) citizens to access reimbursed treatmentsin another member state. This pathway is particularly relevant for Advanced Therapy Medicinal Products (ATMPs) like cell & gene therapies where specialist infrastructure, controlled distribution, and stringent quality control across the treatment process require manufacturers to limit treatment delivery to a handful of Centers of Excellence across Europe.

While legislation exists for reimbursed access to treatments in an EU member state out­side of the patients’ own, there are certain challenges in implementation. These challenges result in delays to access and/or patient drop-off.

This whitepaper examines some of the challenges faced by patients, referring physicians, treatment delivery centres, and manufacturers to drive access to cell & gene therapy in another EU member state. These challenges require manufacturers to take a cross-functional perspective involving medical, manufacturing, public policy, market access, and pricing alongside other considerations when designing their treatment delivery model.

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