Skip to Content

Operationalizing CAR-T Therapy  

Published Date: August 22, 2025

Author: Ginger Blackmond, PharmD | Associate Director of Clinical Initiatives, NCODA
Madelyn Floysand, PharmD; Shawnny Eugene, PharmD, MBA, MS | Oncology, Advocacy, Health Policy & Equity Fellows, NCODA

Background  
Chimeric antigen receptor T-cell (CAR-T) therapy represents a transformative advance in the treatment of hematologic malignancies, offering durable responses in patients with relapsed or refractory disease. Historically, these therapies were administered exclusively in inpatient academic settings due to their complexity, toxicity profile, and infrastructure requirements. The therapeutic landscape is now evolving. In June 2025, the Food and Drug Administration (FDA) eliminated class-wide Risk and Mitigation Strategy (REMS) requirements for CAR-T, reducing post-infusion monitoring and easing restrictions. Coupled with the development of constructs designed for outpatient use, this regulatory change has propelled expanded adoption across cancer centers.  

Practice Perspectives
To better understand this evolution, NCODA has engaged with sites at varying stages of CAR-T program development. These perspectives will highlight strategies that support successful program operations while also revealing barriers and questions faced by cancer centers in the planning phase.  

NCODA’s process begins with targeted site interviews that gather operational, clinical, and financial insights. This approach builds on prior work with bispecific T-cell engagers and the Immunotherapy Hub, where member feedback was distilled into evidence-based best practices and translated into practice-ready materials. The same framework will guide future CAR-T initiatives, ensuring both frontline clinicians and administrative leaders have access to relevant   information that supports safe and effective therapy delivery.  

Challenges 
Operationalizing CAR-T requires robust systems for safety, coordination, and financial sustainability:  

  • Clinical: Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) remain the primary safety concerns. Early recognition protocols, standardized escalation pathways aligned with consensus guidelines, and careful product rollout strategies are central to risk mitigation. Clinical pharmacists play a key role in  
    • Pre-infusion counseling,  
    • Patient education,
    • And post-infusion monitoring,
      while coordinators ensure caregivers are equipped to detect early signs of toxicity.  
  • Operational: Programs must establish reliable triage processes, integration with emergency and intensive care units, and clearly defined admission pathways. Daily evaluations during the highest-risk period and adherence to product-specific workflows are critical for success.  
  • Financial: Payer agreements, case-by-case arrangements, and complex billing workflows remain significant hurdles. Adapting reimbursement processes while maintaining compliance is an ongoing challenge.  

Support from Pharma Partners
Pharmaceutical partners can play a vital role in the broader adoption of CAR-T by collaborating with cancer centers to simplify operational barriers. Opportunities include:  

  • Developing streamlined payer support programs to simplify access and enhance patient affordability.
  • Creating tailored educational resources designed to equip diverse care teams with practical, role-specific knowledge.
  • Providing comprehensive logistical support that eases caregiver responsibilities during intensive monitoring periods.

Continued partnership in these areas will help expand safe and timely access to CAR-T across community and academic practices. 

Looking Ahead
The expansion of outpatient CAR-T delivery holds promise for improving patient- centered care while preserving inpatient resources. Avoiding unnecessary hospitalizations reduces patient burden and system strain. Future innovations, such as allogeneic “off-the-shelf” CAR-T constructs, may further shorten manufacturing timelines and simplify logistics, making readiness even more important. 

NCODA is leveraging its Immunotherapy Hub framework to address these challenges. Insights gathered through interviews, member engagement, and collaborative discussions will inform the development of tools and guidance to support CAR-T implementation. This work will be further advanced through a dedicated CAR-T session at the 2025 NCODA Fall Summit, where an expert pharmacist will share experiences and strategies for success. 

Through proactive collaboration with pharmaceutical partners and member practices, NCODA aims to drive scalable, real-world solutions for CAR-T implementation. By aligning shared goals, developing targeted resources, and elevating best practices through the Immunotherapy Hub, this effort will help ensure that cancer centers are equipped to deliver next-generation cellular immunotherapies while maintaining the highest standards of safety and patient care. 

Additional Resources

Abramson JS, Palomba ML, Gordon LI, et al. Lisocabtagene maraleucel for patients with relapsed or refractory large B-cell lymphoma (TRANSCEND NHL 001): a multicentre seamless design study. Lancet. 2020;396(10254):839-852. doi:10.1016/S0140-6736(20)31366-0. 

Depil S, Duchateau P, Grupp SA, Mufti G, Poirot L. “Off-the-shelf” allogeneic CAR T cells: development and challenges. Nat Rev Drug Discov. 2020;19(3):185-199. doi:10.1038/s41573-019-0051-2. 

Lee DW, Santomasso BD, Locke FL, et al. ASTCT consensus grading for cytokine release syndrome and neurologic toxicity associated with immune effector cells. Biol Blood Marrow Transplant. 2019;25(4):625-638. doi:10.1016/j.bbmt.2018.12.758. 

Locke FL, Ghobadi A, Jacobson CA, et al. Long-term safety and activity of axicabtagene ciloleucel in refractory large B-cell lymphoma (ZUMA-1): a single-arm, multicentre, phase 1-2 trial. Lancet Oncol. 2022;23(1):91-103. doi:10.1016/S1470-2045(21)00566-0. 

Neelapu SS, Locke FL, Bartlett NL, et al. Axicabtagene ciloleucel CAR T-cell therapy in refractory large B-cell lymphoma. N Engl J Med. 2017;377(26):2531-2544. doi:10.1056/NEJMoa1707447. 

US Food and Drug Administration. FDA eliminates CAR-T REMS requirements, ushering in a new era. Published June 26, 2025. Accessed August 14, 2025. https://advisory.avalerehealth.com/insights/fda-eliminates-car- t-rems-requirements-ushering-in-a-new-era.