One persistent challenge for CAR T-cell therapies is that traditional HTA models are often not fit-for-purpose to capture the characteristics of CAR T-cell therapy (e.g., as a one-time treatment).^{133, 152}T2EVOLVE is a consortium working to accelerate the process of developing CAR T-cell therapy in the European Union (EU) to support patient access to this type of technology, while providing guidance on costs and implementation for EU healthcare systems.¹⁵³

In collaboration with the ASCERTAIN and JOIN4ATMP projects, T2EVOLVE are working on value-based, flexible assessment and reimbursement approaches that can capture the long-term patient benefit and support sustainable innovation for CAR T-cell therapies. JOIN4ATMP has a dedicated work program focused on value assessment, pricing and reimbursement schemes for CAR T-cell therapy. Its aim is to use real-world data to map hurdles in the commercial uptake of Advanced Therapy Medicinal Products (ATMPs), including CAR T-cell therapies. The initiative (currently ongoing) seeks to propose ways for manufacturers to improve their interactions with HTA bodies throughout the R&D process and propose alternative pricing and reimbursement schemes.¹⁵⁴