OBJECTIVES: The logistical practicalities of delivering specialised care, with manufacturing and distribution across wide geographical areas, can be a barrier to the commercialisation of, and patient access to, advanced therapy medicinal products (ATMPs). Hub-and-spoke models – where centres of clinical and/or manufacturing expertise support a network of smaller widespread centres – have been proposed as an approach to ATMP delivery. The aim of this scoping review was to synthesise current literature to understand opportunities for, and barriers to hub-and-spoke delivery of ATMPs and to develop a framework for wider implementation in Europe.

METHODS: A search strategy, using keywords related to ATMPs and distribution models, was executed in Embase, MEDLINE, the Cochrane Library, and the grey literature. Relevant articles were identified by two reviewers in a two-stage screening of 1) titles and abstracts, and 2) full-text content. A standardised data extraction table was used to capture key information from included articles.

RESULTS: Of 405 articles identified, 28 (7%) were passed for data extraction. Articles identified included narrative reviews and descriptions of real-world case-studies. Opportunities identified for hub-and-spoke delivery models included the possibility to use existing networks for other therapies/diseases, and potential to address current geographical inequity in ATMP access. Barriers included establishing sustainable funding necessary infrastructure, potential complications related to cross-border patients, and the need for specialised knowledge to manufacture, handle and administer ATMPs. Based on findings, a framework for the establishment of hub-and-spoke networks in Europe is proposed.

CONCLUSIONS: Overall, the articles identified support the hub-and-spoke model as a feasible approach to ATMP access in Europe. The proposed framework outlines how patients might be managed using this model. Practical considerations for implementation would need to account for varied stakeholders who would need to be involved in delivery, as well as how established infrastructure for other therapies or diseases might be best leveraged.