OBJECTIVES: The European Union Directive (2011/24/EU) requires member states to establish pathways that enable patients to receive reimbursed treatment in another European Union country. These cross-border access pathways are becoming increasingly relevant for highly specialised medical technologies such as proton beam therapy and gene therapy, which are delivered by only a handful of providers across Europe. The objectives of our study were to understand how approvals for reimbursed cross-border treatments in the context of highly specialised treatments work in Germany, and to identify any barriers and practical steps to overcome these. METHODS: We have investigated the case-by-case access decision pathway for German patients to receive highly specialised treatments in another country using secondary research, and awareness surveys with Health Care Practitioners. RESULTS: We found the biggest barrier for cross-border treatment access are delays in the case-by-case approval process caused by (a) low awareness of cross-border access pathways amongst Health Care Practitioners, (b) the lack of well-defined guidelines on how to make the case for medical need, and (c) case-by-case reimbursement negotiations between the sickness fund and the treatment provider in the other country. CONCLUSIONS: To overcome these barriers we suggest manufacturers and/or the provider of the highly specialised treatment to engage with the MDK (Medizinischer Dienst der Krankenkassen - Medical Service of Health Insurance) to define the requirements of the patient dossier, and to agree a checklist to bring a degree of objectivity in to medical need assessment. Additionally, we suggest working with the major sickness funds to negotiate a reimbursement rate, in advance of the first patient being identified for the treatment. Establishing these processes and making Health Care Practitioners aware of them would reduce approval times for German patients to access highly specialised treatments delivered in another EU member state.