Context: Since FDA approval in 2017, CAR-T therapies have transformed treatment for hematologic malignancies; however, most CAR-T infusions occur in inpatient academic centers, limiting access for over 41% of eligible patients. Expanding delivery to community outpatient settings may improve access and reduce costs by minimizing hospital stays. Current data on outpatient administration remain scarce.

Objectives: To retrospectively evaluate the feasibility and cost-effectiveness of outpatient CD19-directed CAR-T therapy for non-Hodgkin lymphoma in a community setting. While safety and efficacy are well-established, this analysis aimed to demonstrate that outpatient administration offers comparable outcomes with significant cost savings and reduced financial burden. Secondary objectives included assessment of toxicity, response, and survival in patients receiving axicabtagene ciloleucel (axi-cel), brexucabtagene autoleucel (brexu-cel), lisocabtagene maraleucel (liso-cel), or tisagenlecleucel (tisa-cel).

Design: Retrospective cohort study of outpatient CAR-T therapy between 2019-2024. Patients were monitored for hospitalization, toxicity, and treatment outcomes. Observers were not blinded.

Setting: Oncology Hematology Care, a community-based, independent practice in Cincinnati, Ohio.

Patients: 54 patients: 8 follicular, 40 diffuse large B-cell, 5 mantle cell, and 1 nodal marginal zone lymphoma. CAR-T products included axi-cel (n=23), brexu-cel (n=5), liso-cel (n=10), and tisa-cel (n=16). One patients received prophylactic dexamethasone in 2024. Median age was 67 (range 33–86); 34 male, 20 female. At treatment, 48.1% had stage III and 51.9% stage IV disease.

Interventions: All patients received lymphodepletion followed by CAR-T cell infusion on day 0, with daily outpatient monitoring for 28 days. In 2024, one patient received prophylactic dexamethasone prior to infusion. Chart review was captured demographics, baseline characteristics, incidence and severity of toxicity, number of days hospitalized, treatment response, and survival outcomes. Main outcomes measures: Primary endpoints were the rate of hospitalization within 30 days following CAR-T administration and the associated length of stay. Secondary endpoints included the incidences of

CRS and ICANS, as well as key efficacy measures such as objective response rate (ORR), progression-free survival (PFS), overall survival (OS).

Results: Median hospital stay was 6 days compared to 15 days in ZUMA-1. CRS occurred in 57.5% (0 grade 3 or 4); ICANS in 34.0% (2 grade 3, 4 grade 4). No treatment-related deaths. ORR was 77.78%. Median PFS: 10.6 months; OS: 16.5 months.

Conclusions: Based on CMS data and the ZUMA-1 trial, the median inpatient stay for CAR-T therapy is approximately 15 days, with Medicare reimbursing an average of $498,700 per admission. This includes the high cost of the CAR-T product and the intensive inpatient care needed to manage toxicities like CRS and ICANS. In contrast, a typical 7-day inpatient hospital stay costs Medicare only $13,000 to $18,000. Over the past five years, our center has demonstrated a cost savings of around $78,000 to $108,000 per patient with just a 6-day inpatient stay without compromising safety or efficacy. In fact, CAR-T stays are 2.5 times longer and are nearly 30 to 40 times more expensive. Outpatient CAR-T administration has therefore emerged as a viable, cost-effective alternative that maintains clinical outcomes while significantly reducing financial burden for patients and the healthcare system. These promising results underscore the need for larger prospective studies to confirm long-term benefits.

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2025
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