“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 treatments in 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.