As CAR T evolves, so does the site of care
Author: Caroline Quinn, PharmD, BCOP
For much of its commercial history, chimeric antigen receptor T-cell (CAR T) therapy has been concentrated within inpatient academic medical centers (AMCs), where specialized infrastructure and expertise were needed to support treatment delivery.¹‧² While necessary to ensure the safe adoption of these therapies, this model has created a disconnect between where CAR T is administered and where most patients receive ongoing cancer care.¹
As experience with CAR T grows, stakeholders across the oncology ecosystem are reevaluating long-standing assumptions about where these therapies should be delivered.¹ ² Advances in toxicity management, provider experience and regulatory requirements are making outpatient and community-based administration more feasible.³ ⁴ As a result, managed care organizations are increasingly evaluating how safety, provider readiness, access and cost should inform CAR T site-of-care decisions. While CAR T is a leading example of this transition, the site-of-care policies and care-delivery models developed today may also help shape the delivery of future complex oncology therapies.
Safety and provider readiness
Historically, the risk of severe toxicities, including cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), concentrated CAR T therapy within inpatient AMCs.³ Risk Evaluation and Mitigation Strategy (REMS) requirements further reinforced the need for specialized treatment environments by requiring certified centers with established toxicity management processes.² ⁵
Today, the safety landscape is evolving. Clinical teams have gained substantial experience managing CAR T-related toxicities through standardized treatment algorithms and earlier intervention.⁴ Reflecting this progress, the FDA removed REMS requirements for approved B-cell maturation antigen (BCMA)- and cluster of differentiation 19 (CD19)-directed autologous CAR T products in 2025, citing confidence in established toxicity management practices.⁵ Emerging evidence also suggests that, for carefully selected patients treated at qualified community and outpatient sites, outcomes can be comparable to inpatient care.¹ ³
CAR T also requires specialized infrastructure and care coordination, including cell therapy logistics, laboratory services and higher-acuity care access.¹ ² Community oncology programs are increasingly developing these capabilities through hospital partnerships, remote monitoring and formal escalation pathways.¹ ² As these infrastructure and care-coordination models mature, experience to date suggests that outpatient and community-based CAR T delivery can be implemented safely when appropriate precautionary measures are in place.¹ ³ However, suitability depends on the patient, the product and the treatment site.² For managed care organizations, the focus is increasingly shifting from determining feasibility to defining provider readiness and network participation, including infrastructure requirements, accreditation standards and manufacturer treatment center qualifications.¹ ²
Access and capacity
As CAR T delivery in community and outpatient settings becomes increasingly feasible, attention is shifting to broader access and capacity challenges. Community oncology practices provide the vast majority of cancer care in the United States, yet CAR T therapy remains concentrated within a relatively small number of AMCs.¹ ⁶ As a result, many eligible patients face substantial travel requirements, referral delays, capacity constraints and caregiver burden.¹ These challenges may intensify as CAR T expands into earlier lines of therapy and additional disease states, increasing demand at a limited number of treatment centers.
Addressing these access and capacity pressures has become a key rationale for expanding CAR T care into community and outpatient settings, which may improve access, reduce delays and move treatment closer to where patients receive most of their cancer care.¹ At the same time, shifting appropriate aspects of care beyond AMCs could help preserve specialized capacity for higher-acuity patients as demand for CAR T therapy continues to grow.¹ Collaborative models that link academic centers with community providers will likely be critical to achieving these goals while maintaining appropriate oversight and continuity of care.⁷
Cost and sustainability
If safety, provider readiness and access determine whether outpatient and community-based CAR T delivery is possible, cost determines whether it is sustainable.⁸ Beyond the therapy acquisition cost, inpatient hospitalization and AMC facility charges can substantially affect the total cost of care.³ ⁸ One analysis found average Medicare episode costs of $498,723 for inpatient CAR T delivery compared with $414,393 for outpatient administration.⁹ Across the full episode of care, including pre- and post-administration periods, total costs remained lower for outpatient treatment ($529,188 versus $587,908), despite higher post-treatment costs and readmission rates.⁹ Additional research has demonstrated an approximately 56% reduction in hospitalization and office visit costs associated with outpatient CAR T administration in nonacademic settings.¹⁰
While outpatient and community-based CAR T delivery may reduce total cost of care, reimbursement structures can influence whether providers are willing and able to offer these services.² ⁸ Given the complexity of reimbursement for these high-cost therapies, payment policies may ultimately shape provider participation, treatment access and the long-term viability of alternative site-of-care models.² ⁸
Key takeaways
- Safety and provider readiness: Focus is increasingly shifting from whether outpatient and community-based CAR T delivery is feasible to defining the requirements needed to support it safely.
- Access and capacity: As CAR T utilization grows, expanding appropriate treatment settings may help address access barriers while preserving capacity at specialized treatment centers.
- Cost and sustainability: Alternative CAR T care settings may reduce costs, but reimbursement remains a critical factor in sustaining provider adoption.
References:
- Simmons, G. L., Cross, S., & Pittos, E. C. (2026). Advancing access to CAR T-cell therapy: Insights and real-world experience from a community oncology practice. Frontiers in Oncology, 16, Article 1712533. https://doi.org/10.3389/fonc.2026.1712533
- Gatwood, K., Mahmoudjafari, Z., Baer, B., Pak, S., Lee, B., Kim, H., Abernathy, K., Dholaria, B., & Oluwole, O. (2024). Outpatient CAR T-cell therapy as standard of care: Current perspectives and considerations. Clinical Hematology International, 6(2), 11–20. https://doi.org/10.46989/001c.115793
- Hansen, D. K., Liu, Y.-H., Ranjan, S., Bhandari, H., Potluri, R., McFarland, L., De Braganca, K. C., & Huo, S. (2023). The impact of outpatient versus inpatient administration of CAR-T therapies on clinical, economic, and humanistic outcomes in patients with hematological cancer: A systematic literature review. Cancers, 15(24), 5746. https://doi.org/10.3390/cancers15245746
- Oluwole, O. O., Dholaria, B., Knight, T. E., Jain, T., Locke, F. L., Ramsdell, L., Nikiforow, S., Hashmi, H., Mooney, K., Bhaskar, S. T., Morris, K., Gatwood, K., Baer, B., Anderson, L. D., & Hamadani, M. (2024). Chimeric antigen receptor T-cell therapy in the outpatient setting: An expert panel opinion from the American Society for Transplantation and Cellular Therapy. Transplantation and Cellular Therapy, 30(2), 131–142. https://doi.org/10.1016/j.jtct.2023.11.008
- U. S. Food and Drug Administration. (2025, June 27). FDA eliminates risk evaluation and mitigation strategies (REMS) for autologous chimeric antigen receptor CAR T cell immunotherapies [Press release]. https://www.fda.gov/news-events/press-announcements/fda-eliminates-risk-evaluation-and-mitigation-strategies-rems-autologous-chimeric-antigen-receptor
- National Cancer Institute. (n.d.). Bringing research to the community to reduce cancer disparities. https://www.cancer.gov/research/areas/disparities/chanita-hughes-halbert-clinical-trials-community-access
- Association of Cancer Care Centers. (2023). Optimizing care coordination: Part of the Bringing CAR T-Cell Therapy to Community Oncology series. https://cdn.sanity.io/files/0vv8moc6/accc-cancer/947f489d710c3b375b2bba81b65286c503760530.pdf
- Leech, A. A., Neumann, P. J., Cohen, J. T., Jagasia, M., & Dusetzina, S. B. (2020). Balancing value with affordability: Cell immunotherapy for cancer treatment in the U.S. The Oncologist, 25(7), e1117–e1119. https://doi.org/10.1634/theoncologist.2020-0025
- Wu, J., Ghobadi, A., Maziarz, R., Patel, K., Hsu, H., Liu, Z., Sheetz, C., Kardel, P., & Fu, C. (2024). Medicare utilization and cost trends for CAR T cell therapies across settings of care in the treatment of diffuse large B-cell lymphoma. Advances in Therapy, 41(8), 3232–3246. https://doi.org/10.1007/s12325-024-02917-7
- Lyman, G. H., Nguyen, A., Snyder, S., Gitlin, M., & Chung, K. C. (2020). Economic evaluation of chimeric antigen receptor T-cell therapy by site of care among patients with relapsed or refractory large B-cell lymphoma. JAMA Network Open, 3(4), e202072. https://doi.org/10.1001/jamanetworkopen.2020.2072