Operating a community-based CAR T-cell therapy program presents significant financial and logistical challenges, oncologists in outpatient settings say. Beyond drug pricing, expenses include staffing, safety protocols, and accreditation demands that smaller clinics often find difficult to meet.
Dr. Graff, who leads a community oncology practice, highlights how safety protocols require substantial resources. Her team uses checklists for physician teams, patient education materials, and home monitoring equipment, including six-hour phone check-ins during critical dosing periods. The practice also keeps tocilizumab, an anti-inflammatory medication for cytokine release syndrome (CRS), on hand at a cost of $11,000 to $13,000 per dose—even with biosimilars—while maintaining at least two doses at all times. Overnight monitoring and off-hours clinic visits further stretch budgets, especially for physician-owned groups.
Some clinics opt out of bispecific antibody therapies due to the operational complexity. Dr. Graff describes these treatments as a stepping stone for community oncologists, explaining that their safety profile, though still requiring caution, is more manageable than often believed. The CRS and neurotoxicity risks for bispecifics, she notes, have a narrower window than anticipated, making them a practical lead-in to full CAR T programs.
Accreditation remains a major hurdle. The Foundation for Accreditation of Cellular Therapy (FACT) is testing probationary or preliminary accreditation for new entrants, but Dr. Patt notes FACT has already begun piloting probationary or preliminary status for practices entering the space, though she believes more support is still needed. Clear documentation of safety measures could help justify temporary accreditation for practices with strong track records, though the FACT application process itself adds to expenses. High staff turnover and the fast pace of therapy advancements also demand continuous training, Dr. Graff conducts quarterly sessions for nurses and advanced practice providers to ensure teams stay current.
The financial burden is most visible in emergency situations. When a patient experiences an overnight adverse reaction that doesn’t need hospitalization, her team opens the clinic immediately instead of directing them to the ER. This approach keeps patients out of hospitals but creates additional staffing costs that smaller practices may struggle to cover. For physician-owned groups, these unexpected expenses can become a dealbreaker, leading some to avoid bispecific therapies entirely.
Dr. Graff notes that even when practices meet the requirements, the ongoing demands of maintaining a CAR T program often outweigh the benefits. The need for around-the-clock readiness, combined with the high cost of specialized medications and infrastructure, makes scaling these treatments difficult outside well-funded institutions.
