OBJECTIVES: Centers capable of delivering Advanced Therapy Medicinal Products (ATMPs) may not be available in every country, due to the typically small patient numbers and the complexities related to the delivery of such therapies. Cross-border access to treatment can be hampered by the limitations of existing European cross-border legislation. Therefore, we propose a standardized approach to (i) map the clinical and financial responsibilities along the treatment pathway, (ii) select the most optimal legislative route(s) to cover treatment related costs, and (iii) identify the remaining gaps that remain to be tackled on a national level.

METHODS: We performed exploratory desk research followed by semi-structured interviews carried out with all stakeholders involved (patients, hospitals, physicians, industry and payer) to collect input and feedback on the usefulness, completeness and feasibility of our proposed approach.

RESULTS: Our cross-border treatment pathway includes pre-administration, administration and post-administration care. At each step, the clinical and financial responsibilities should be determined, depending on where the step needs to be executed (abroad vs. in home country), and on the resources required to execute this step. After it is clear for which steps the patient will need to travel abroad, the optimal legislative route(s) can be determined so that treatment-associated costs (e.g. product, treatment, travel cost...) are broadly covered. Finally, the appropriate authorization route can be determined so that all necessary authorization requests can be submitted through a national procedure.

CONCLUSIONS: Our standardized approach can be used to clarify relevant clinical, financial, and authorization responsibilities of cross-border healthcare for ATMPs upfront. This improves transparency and predictability, and ultimately enables more equitable access to highly innovative treatments.