OBJECTIVES: Spurred by biotechnology advances, development of cell and gene therapies (CGTs) is accelerating. As the adoption of CGTs multiply, novel models for CGT delivery are needed, particularly for expanded access in low- and middle-income countries (LMICs). This study proposes and simulates a model for CGT delivery in LMICs and details a framework for the identities and roles of core CGT stakeholders.

METHODS: Extensive mapping was undertaken to develop the core CGT stakeholder framework (e.g., cell processing facilities, accredited health facilities). We used academic articles and other sources including grey literature, social media, and relevant web pages to inform the proposed delivery model. Model simulations were then undertaken for Brazil, and the Middle East and North Africa (MENA) region, informed by publicly available data sets and articles.

RESULTS: The proposed framework includes four direct (beneficiaries, therapeutic center, treatment coordinators, manufacturers) and two non-direct (payers, regulators) CGT delivery stakeholder types. Our proposed CGT delivery model comprises Hub (experienced academic medical center), Spoke (health care center with less CGT experience that may serve as the home center for patients), and Partner Spoke (supporting facility that enables the function of spokes within the system). In the model, Hubs, Spokes, and Partner Spokes were concentrated in the southeast region of Brazil, where health access and development are most advanced. Facilities were concentrated in major Brazilian cities, especially São Paulo, reflecting the nation’s health inequality. In the MENA region, potential CGT facilities were concentrated in Gulf Cooperation Council countries (e.g., UAE, Saudi Arabia), where large health infrastructure investments have recently been made.

CONCLUSIONS: Our model provides a framework for the roles of core CGT access stakeholders. We believe that further investigation into the practical adoption and implications of such a model is needed and may serve to expand access to CGTs in LMICs.