OBJECTIVES: METHODS: To understand the challenges faced by gene/cell therapies, a targeted review of current pricing and reimbursement decisions for marketed gene/cell therapies was conducted, supplemented with expert interviews. Innovative pricing and funding models within the biopharmaceutical industry and across broader industries were identified by conducting a targeted review of materials available in the public domain. A feasibility analysis was conducted to explore in which countries these pricing and funding models might be feasible, and what, if any, healthcare system adaptations would be required. RESULTS: Six distinct challenges were identified and broadly segmented into those associated with payment and funding (e.g., one-off up-front payment required for curative therapies), and those associated with assessing value (e.g., uncertainty around long-term effect). Eight innovative pricing and funding models were identified and described: payment-by-results, partial or full capitation, amortisation, annuity, prize funding, reinsurance, and framework contracting. Payment-by-results and capitation models were found to offer the most feasible solutions for gene/cell therapy pricing and reimbursement in select European countries. Considerable legislative/policy changes were considered necessary for the successful implementation of other models in EU5. CONCLUSIONS: Existing pricing and funding models are insufficient to support a sustainable gene therapy business model. National or regional legislative change may be required to achieve a sustainable solution.