Outpatient Cilta-Cel Administration May Reduce Health Care Utilization in RRMM

Key Takeaways:

• Patients in the outpatient cohort spent less time in inpatient settings than the inpatient cohort. When admitted to an inpatient setting, outpatient participants experienced a median length of stay of 6 days as opposed to the 15 days experienced by inpatient participants.
• Neither a median treatment-free interval (TFI) nor a median overall survival (OS) was reached. Rates of TFI and OS were similar between the cohorts, indicating both care settings as effective in treating patients with relapsed or refractory multiple myeloma (RRMM).
• Both cohorts had comparable rates of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), showing that outpatient settings are sufficient in managing adverse events (AEs).

Ciltacabtagene autoleucel (cilta-cel) has demonstrated high efficacy in treating RRMM, earning approval from the US Food and Drug Administration (FDA) in 2022 to treat patients with heavily treated RRMM who received at least 4 prior lines of therapy.

While clinical trials are traditionally held in inpatient settings, outpatient settings may offer a lower-cost alternative. Researchers sought to compare outcomes and health care resource utilization (HCRU) within inpatient and outpatient settings for patients with RRMM.

Study Population and Patient Characteristics

Researchers used the Komodo Research Database to identify patients with RRMM who received cilta-cel between February 2022 and June 2024. The study size was categorized into 2 cohorts: patients treated in an inpatient setting and those treated in an outpatient setting.

The study included 242 total patients who were treated after at least 4 lines of therapy. Out of this population, 61.2% (148) received cilta-cel in an inpatient setting, and 38.8% (94) received cilta-cel in an outpatient setting.

Outpatient HRCU vs Inpatient HRCU

During the 3 months following cilta-cel administration, patients in the outpatient cohort had lower rates of inpatient days per-patient-per-month than the inpatient cohort, 2.4 days vs 6.6 days. Additionally, the outpatient cohort had higher rates of outpatient days per-patient-per-months than the inpatient cohort, 8.5 days vs 5.4 days. After 4 months, no significant difference was observed in HCRU between care settings.

Within 30 days of initial treatment, 68.1% (64) of patients in the outpatient cohort were admitted into an inpatient setting. The median time between infusion of cilta-cel and inpatient admission was 6 days, and the median length of stay was 6 days as well.

For the inpatient cohort, 92.6% of patients were discharged within 30 days of receiving the cilta-cel regimen. The median length of stay for these patients was 15 days.

Comparable Outcomes Between Care Settings

The clinical outcomes assessed in the study were TFI and OS. A median was not reached for either of these measurements.

After 6 months, the inpatient cohort had an estimated TFI of 92%, and the outpatient cohort had an estimated TFI of 97.5%.

After 6 months, the inpatient cohort had an OS of 96.4%, and the outpatient cohort had an OS of 98.9%. At the 12-month follow-up, the OS was 92.5% for the inpatient cohort and 94.9% for the outpatient cohort.

Manageable Safety Profiles in Both Settings

Rates of AEs were similar between cohorts. Within 30 days of cilta-cel administration, CRS occurred in 69.6% of inpatient participants and 63.8% of outpatient participants. Most events were low grade, with 2% in inpatient and 1.1% in outpatient experiencing a grade 3 or higher.

Among the overall population, one-fifth of patients suffered from ICANS (21.6% inpatient; 20.2% outpatient). Again, most incidences were low grade; events of a grade 3 or higher occurred among 2.7% of inpatient participants and among 3.2% of outpatient participants.

Pancytopenia was common between both cohorts, occurring in 79.7% of inpatient participants and 75.5% of outpatient participants. Tocilizumab occurred in 16.9% of inpatient participants and in 11.7% of outpatient inpatient participants.

Outpatient Settings to Relieve Health System Burden

The findings from this study highlight outpatient utilization as a way to reduce HRCU and care costs. Care in outpatient settings proved sufficient for many patients in the study. Rates of inpatient stays were significantly lower among the outpatient cohort, freeing up space for more vulnerable patients. Furthermore, similar rates of AEs contribute to safety profiles that can be managed in either setting.

Additionally, increasing outpatient utilization could lower overall care costs, largely due to less days spent in inpatient settings. It is estimated that outpatient settings could reduce care costs by approximately $19 000.

According to the researchers, “Collectively, these findings contribute to the growing real-world evidence demonstrating that cilta-cel can be administered safely in the OP setting without compromising patient safety when appropriate safeguards are in place. The development of risk assessment tools and mitigation strategies may further support and optimize OP administration.”

Reference

Janakiram M, Fan L, Ghosh S, et al. Real-world healthcare resource utilization and clinical outcomes among patients with relapsed/refractory multiple myeloma receiving ciltacabtagene autoleucel after four or more prior lines of therapy in inpatient versus outpatient settings. J Med Econ. 2026;29(1):871-884. doi:10.1080/13696998.2026.2640811