Key Takeaways
- CAR T-cell therapy can be safely implemented in community oncology settings with appropriate infrastructure and protocols.
- Early engagement of a multidisciplinary team is critical to establishing standardized protocols and ensuring program success.
- Payer coverage and reimbursement remain a significant barrier, alongside the need for strong caregiver involvement and patient understanding and adherence to monitoring requirements.
In a retrospective review of a community practice-based outpatient chimeric antigen receptor (CAR) T-cell therapy program (not affiliated with a healthcare or academic system) researchers found patients could receive the treatment for relapsed hematologic malignancies safely, which demonstrates community oncology practices can provide a viable solution to expand access and reduce geographic barriers.1
“While nearly 85% of patients with cancer in the United States are managed in community treatment settings, fewer than 15% receive CAR T-cell therapy outside of academic centers, reflecting a significant misalignment between access to care and CAR T-cell availability,” the researchers reported in Frontiers in Oncology.
Over six months, the practice implemented its program and onboarded the product following a series of steps, “designed to ensure optimal safety, feasibility, and compliance with regulatory and accreditation standards,” the researchers reported.
The steps taken:
- Clearly defined scope of service and catchment area
- Collaboration with key multidisciplinary stakeholders
- Ensuring sufficient infrastructure and standard operating procedures
- Forged external partnerships
- Provided training and education for the clinical care team and administrative staff
- Provided training and education for the patient and their caregiver
- Achieve qualification as a treatment site
- Ensuring timely and adequate reimbursement for services rendered.
“A critical initial step is early engagement with a small working group of key participants, including physicians, pharmacists, nursing staff, and contracting/billing personnel to develop standardized protocols and define workflows,” according to the research. “Early considerations such as staffing needs, expertise in cell therapy, infrastructure, contracting and billing, post-infusion monitoring, and adverse event management are foundational to a program’s safe and efficient launch.”
Kashyap Patel, CEO of Carolina Blood and Care Associates, created a playbook for executing outpatient CAR T-cell therapy in a community oncology practice, offering different options based on administration model types. His recommendations follow similarly to the steps in this study.
“Success requires careful attention to the unique characteristics of each care environment, robust planning and preparation, comprehensive training programs, and ongoing quality improvement efforts,” he said in the Comprehensive T-Cell and Bispecific Therapy Administration Playbook and Radioligand Therapy (RLT) and Theragnostic Program Implementation Model.
Planning and preparation, while the key to success, is also a financial and resource barrier for some community practices. The onus is also on caregivers, who play an important role in monitoring the health of the patient, and the patient, who must understand and buy-in on the stringent monitoring procedures.
Despite clinical success, payers remain a significant barrier, as well. This highlights “the urgent need for policy reform to enable community-based delivery of advanced therapies,” the researchers concluded.
References
- Simmons GL, Cross S, Pittos EC. Advancing access to CAR T-cell therapy: insights and real-world experience from a community oncology practice. Front Oncol. 2026;16:1712533. doi:10.3389/fonc.2026.1712533
