Maria Monserrat Reyes-Lozano, MD
Tecnológico de Monterrey, Escuela de Medicina y Ciencias de la Salud TecSalud
Mexico
Andrés Gómez-De León, MD
Member, ISCT SCA LRA Committee
Universidad Autónoma de Nuevo León, Facultad de Medicina y Hospital Universitario Dr. José Eleuterio González
Mexico
We Are Failing to Deliver CAR-T Cell Therapy Equitably: How Do We Move Forward?
The 10th anniversary of the first commercial approval for a chimeric antigen receptor T cell (CAR-T) product is almost here. A milestone that invites both celebration and honest reflection about its current reach.
In 2017, tisagenlecleucel became the first CAR-T therapy to receive authorization by the Food and Drug Administration (FDA) in the United States, marking the start of a new era in immunotherapy. Since then, growing evidence of their efficacy in phase 2 and phase 3 trials has led to the approval of six other CAR-T products for hematological malignancies, including B-cell acute lymphoblastic leukemia (B-ALL), diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma, follicular lymphoma, and multiple myeloma.
Yet, a decade after this turning point, the gap between what this technology can do and who it actually reaches has become a defining inequity in modern medicine. A recent cross-sectional analysis of health technology assessments (HTA) across the G20 countries found that fewer than half (48%) of all FDA-approved CAR-T drug-indication pairs are publicly reimbursed across participating countries. Strikingly, of this set of countries, six (Argentina, India, Indonesia, Mexico, South Africa, and Turkey) face a complete lack of access to commercial CAR-T products (1).
This failure in global access is structural, multilayered, and demands coordinated action. A recent review by Diego Clé and collaborators from the University of São Paulo identifies four commonly cited structural domains that limit equitable access to CAR-T therapy in resource-limited settings (2). These include exorbitant costs and lack of reimbursement, regulatory immaturity, manufacturing logistics, and clinical and Good Manufacturing Practices infrastructure.
However, Alex Ge and colleagues reported a striking finding; in the G20 countries, almost half (124/252) of CAR-T-indication pairs were not accessible, not because HTA bodies rejected them, but because manufacturers never submitted applications for evaluation in the first place (1). This pattern likely reflects commercial skepticism about funding approval following regulatory authorization and questions the future of commercial CAR-T product implementation in low and middle-income countries (LMICs), which are home to over 80% of the world’s population. Because this analysis is restricted to G20 economies, its gaps likely represent a conservative floor, as access in LMICs beyond the G20 is generally even more limited.
A Path Forward
Solutions exist, and several are already being implemented. Alongside Clé and colleagues, a recent perspective by Ana Hidalgo Simon and Claire Booth, two experts in academic ATMP development, propose closer and earlier collaboration between academic institutions and regulatory agencies as a key step toward sustainable ATMP implementation (3).
On cost and reimbursement, academic and noncommercial manufacturing programs represent one of the most promising strategies. Leading this effort is Spain's academic CAR-T, offered at approximately one-third of the commercial price and available to the public through a hospital-exemption pathway. Comparable homegrown programs are already underway in India, Turkey, and Brazil. Another strategy to address the economic burden is to adopt outcome-based and risk-sharing payment models. In these arrangements, reimbursement is tied to whether the patient actually responds to treatment rather than a single lump-sum payment at the time of infusion.
Regulatory adaptation is equally critical. In Latin America, Brazil's health regulatory agency ANVISA established in 2020 the first national ATMP-specific framework and in 2023 launched a public call to integrate locally developed advanced therapies into its public health system, promoting academic-regulatory collaboration and local development. Similarly, the European Medicines Agency (EMA)’s Academic Pilot, launched in 2022, offers dedicated regulatory support to academic and nonprofit developers, providing a model for reducing the regulatory burden on noncommercial innovators (2,3).
Finally, decentralized, point-of-care manufacturing offers a structural solution to both logistical and regulatory bottlenecks, reducing transportation dependencies and enabling local quality oversight. A recent academic experience in Uruguay and Mexico adds to the growing body of evidence from other LMICs, confirming the feasibility of locally produced, lower-cost CAR-T therapy with outcomes comparable to international standards (4).
Ten years of CAR-T therapy have produced extraordinary science. The next 10 must close the gap. The tools, models, and evidence are increasingly available. What remains is the political, regulatory, and financial action to deliver them equitably. ISCT is uniquely positioned to accelerate this transition by promoting capacity building, advocating for manufacturer accountability and supporting regulatory capacity in underserved regions. ISCT’s moment to lead is now. Will we answer the call?
REFERENCES
- Ge, A. Y., Feldman, W. B., Kaiser, M. F., Rejeski, K., Iacoboni, G., Narula, G., Chan, J. Y., Dickinson, M. J., Kesselheim, A. S., & Cliff, E. R. S. (2026). Global access to commercial CAR T-cell therapies: a cross-sectional study of health technology assessment across the G20 countries. Blood, 147(14), 1521–1531. https://doi.org/10.1182/blood.2025030872
- Clé, D. V., Donadel, C. D., & Calado, R. T. (2025). CAR-T in resource-limited regions. Blood Global Hematology, 2(1), 100051. https://doi.org/10.1016/j.bglo.2025.100051
- Hidalgo Simon, A., & Booth, C. (2025). Advancing ATMPs for orphan diseases: redefining the roles of pharmaceutical companies and academia. Blood Immunology & Cellular Therapy, 2(1), 100023. https://doi.org/10.1016/j.bict.2025.100023
- Salazar-Riojas, R., Alvarado-Navarro, D. M., Chávez-Estrada, Y. O., Hernández-Navarro, A. K., Ake-Uc, M. B., Moncada-Saucedo, N. K., Jaime-Pérez, J. C., Quezada-Ramírez, S. I., Rodriguez-Zuñiga, A. C., Gómez-Almaguer, D., & Gómez-De León, A. (2025). Decentralized Point-of-Care Manufacturing of CD19 Chimeric Antigen Receptor T Cells in Mexico. JCO global oncology, 11, e2400581. https://doi.org/10.1200/GO-24-00581
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