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CARVYKTI® (ciltacabtagene autoleucel)
Medical Information
CARVYKTI - Healthcare Resource Utilization: Outpatient/Inpatient Administration
Last Updated: 08/05/2026
SUMMARY
- Johnson & Johnson does not recommend the use of CARVYKTI in a manner that is inconsistent with the approved labeling.
- Janakiram et al (2026)1
published a retrospective observational cohort study evaluating healthcare resource utilization (HCRU) and healthcare costs following outpatient (OP) vs inpatient (IP) administration of CARVYKTI in patients with relapsed/refractory multiple myeloma (RRMM) who received 1 to 3 prior lines of therapy (LOTs), using electronic medical records (EMRs) from the Loopback Analytics database between February 28, 2017, and June 30, 2025. - Janakiram et al (2026)2
published a retrospective cohort study evaluating HCRU following OP vs IP administration of CARVYKTI in patients with RRMM who received at least 4 prior LOTs, using open claims data from February 28, 2022 to June 30, 2024.
HCRU and Healthcare Costs Following OP vs IP CARVYKTI Administration in the Loopback Analytics Database
Study Design/Methods
- The index date was defined as the date of CARVYKTI infusion, and the baseline period was defined as the 12-month period prior to the index date.
- The follow-up period was defined as the period from the index date to the earliest of 30 days after infusion, end of clinical activity, death, or end of data availability.
- Outcomes were assessed from the index date until the earliest of 90 days after infusion, end of clinical activity, death, or end of data availability.
- Inclusion criteria
- CARVYKTI after 1-3 prior LOTs on or after April 5, 2024 (Food and Drug Administration [FDA] approval date), with LOT classification performed using a previously reported algorithm for RRMM applicable to EMR data
- ≥18 years of age as of index date
- ≥12 months of data availability prior to index date
- Known setting of CARVYKTI administration (ie, OP or IP)
- Exclusion criteria
- No lymphodepleting chemotherapy
- Clinical trial participation during the CARVYKTI LOT
- Diagnosis of amyloidosis prior to index date
- Chimeric antigen receptor T-cell (CAR-T) administration prior to index date
- Outcomes: all-cause and MM-related HCRU and associated imputed costs during the 30-day and 90-day post-infusion periods.
Results
Treatment Disposition and Baseline Characteristics
- A total of 99 patients with RRMM treated with CARVYKTI after 1-3 prior LOTs were included in the study (IP, n=62; OP, n=37).
- In the IP vs OP cohorts, the median age was 67.0 vs 70.0 years, female patients comprised 45.2% vs 54.1%, Medicare beneficiaries comprised 50.0% vs 73.0%, mean Quan-CCI scores were 3.2 vs 2.7, and CRAB symptoms were reported in 29.0% vs 45.9% of patients; most patients were nonfrail (75.8% vs 59.5%).
- Details of HCRU after CARVYKTI infusion in the IP and OP cohorts are presented in Table: HCRU During the First 30 and 90 Days After Infusion.
- Adjusted analyses comparing HCRU between the OP and IP cohorts during the 30-day and 90-day post-infusion periods are presented in Tables: Adjusted IRR for the Number of IP Days and Adjusted IRR for the Number of OP Days.
| 30-Day Post-Infusion Period | 90-Day Post-Infusion Period | |||
|---|---|---|---|---|
| OP Cohort (n=37) | IP Cohort (n=62) | OP Cohort (n=37) | IP Cohort (n=62) | |
| Median follow-up duration months (mean ± SD) | 1.0 (1.0±0.2) | 1.0 (1.0±0.1) | 3.0 (2.6±0.8) | 3.0 (2.8±0.5) |
| All-cause HCRU | ||||
| IP stays | ||||
| ≥1 IP stay, n (%) | 22 (59.5) | 62 (100.0) | 24 (64.9) | 62 (100.0) |
| Median number of days PPPM (mean ± SD) | 3.9 (4.7±5.2) | 13.7 (14.7±5.0) | 1.7 (2.7±3.7) | 5.0 (7.6±5.2) |
| OP visits | ||||
| ≥1 OP visit, n (%) | 37 (100.0) | 60 (96.8) | 37 (100.0) | 61 (98.4) |
| Median number of days PPPM (mean ± SD) | 15.7 (13.8±8.9) | 4.9 (5.9±3.6) | 10.0 (11.0±8.3) | 5.1 (5.7±4.0) |
| MM-related HCRUb | ||||
| IP stays | ||||
| ≥1 IP stay, n (%) | 20 (54.1) | 62 (100.0) | 22 (59.5) | 62 (100.0) |
| Median number of days PPPM (mean ± SD) | 2.0 (4.0±4.8) | 12.8 (14.2±5.0) | 1.7 (2.5±3.7) | 5.0 (7.4±5.2) |
| OP visits | ||||
| ≥1 OP visit, n (%) | 36 (97.3) | 57 (91.9) | 37 (100.0) | 59 (95.2) |
| Median number of days PPPM (mean ± SD) | 6.9 (9.8±7.6) | 3.9 (4.4±2.6) | 6.4 (6.8±6.1) | 3.2 (3.8±2.6) |
| Abbreviations: HCRU, healthcare resource utilization; ICD-10-CM, International Classification of Diseases, 10th Revision, Clinical Modification; IP, inpatient; MM, multiple myeloma; OP, outpatient; PPPM, per patient per month; SD, standard deviation. a bMM-related medical claims are defined as those associated with an ICD-10-CM diagnosis of MM (C90.0). | ||||
| Outcome | Adjusted IRRa (95% CI) | P Value |
|---|---|---|
| All-cause | ||
| 0-30 days | 0.31 (0.21-0.42) | <0.001b |
| 0-90 days | 0.37 (0.20-0.57) | <0.001b |
| MM-related | ||
| 0-30 days | 0.27 (0.17-0.38) | <0.001b |
| 0-90 days | 0.36 (0.18-0.57) | <0.001b |
| Abbreviations: CCI, Charlson Comorbidity Index; CRAB, hypercalcemia, renal impairment, anemia, and bone lesions; HCRU, healthcare resource utilization; IP, inpatient; IRR, incidence rate ratio; MM, multiple myeloma; OP, outpatient. aThe model adjusted for age (reference group: ≥70 years), sex, race (reference group: White), payer type (reference group: Medicare), year of index (reference group: 2024), Quan-CCI score, frailty index score in 3 months prior to infusion (reference group: nonfrail), and having ≥1 CRAB symptom in the month prior to infusion. bStatistical significance. | ||
| Outcome | Adjusted IRRa (95% CI) | P Value |
|---|---|---|
| All-cause | ||
| 0-30 days | 1.88 (1.40-2.56) | <0.001b |
| 0-90 days | 1.49 (1.01-2.21) | 0.044b |
| MM-related | ||
| 0-30 days | 1.76 (1.25-2.46) | <0.001b |
| 0-90 days | 1.29 (0.89-1.82) | 0.172 |
| Abbreviations: CCI, Charlson Comorbidity Index; CRAB, hypercalcemia, renal impairment, anemia, and bone lesions; HCRU, healthcare resource utilization; IP, inpatient; IRR, incidence rate ratio; MM, multiple myeloma; OP, outpatient. aThe model adjusted for age (reference group: ≥70 years), sex, race (reference group: White), payer type (reference group: Medicare), year of index (reference group: 2024), Quan-CCI score, frailty index score in 3 months prior to infusion (reference group: nonfrail), and having ≥1 CRAB symptom in the month prior to infusion. bStatistical significance. | ||
HCRU Following OP vs IP CARVYKTI Administration in the Komodo Research Database
Study Design/Methods
- The study utilized open claims data from the Komodo Research Database, covering the period from January 1, 2016 to June 30, 2024.
- The index date was defined as the date of CARVYKTI infusion on or after February 28, 2022 (date of CARVYKTI FDA approval).
- The baseline period was defined as the 12-month period prior to the index date.
- The follow-up period was defined as the period from the index date to the earliest of 30 days after infusion, end of clinical activity, death, or end of data availability.
- Inclusion criteria
- CARVYKTI after ≥4 prior LOTs on or after February 28, 2022
- ≥1 diagnosis for multiple myeloma (MM; International Classification of Diseases, 10th Revision, Clinical Modification [ICD-10-CM]: C90.0) on or prior to index date
- Received lymphodepleting therapy agents (≥1 claim for cyclophosphamide, fludarabine, or bendamustine) in the 14 days prior to or the 30 days after index date
- ≥18 years of age as of index date
- ≥12 months of clinical activity prior to index date
- Exclusion criteria
- ≥1 diagnosis of amyloidosis (ICD-10-CM: E85.x) prior to index date
- Clinical trial participation on or prior to index date (ICD-10-CM: Z00.6; Healthcare Common Procedure Coding System [HCPCS]: S9988, S9990, S9991, S9992, S9994, S9996)
- Outcomes: treatment-free interval (TFI; defined as the time between the infusion date and initiation of a next LOT or death) and overall survival (OS; defined as the time from
- infusion to death)
Results
Treatment Disposition and Baseline Characteristics
- A total of 242 patients (IP, n=148; OP, n=94) were enrolled in the study.
- In the IP vs OP cohorts, the median age was 64.0 vs 64.0 years, female patients comprised 47.3% vs 42.6%, Medicare beneficiaries comprised 52.7% vs 53.2%, the median line of CARVYKTI therapy was 6.0 vs 5.0, mean Quan-CCI scores were 5.1 vs 5.1, and CRAB symptoms were reported in 82.4% vs 79.8% of patients; most patients were prefrail or mildly frail (66.9% vs 61.7%).
Adverse Events and Management Strategies
- Clinical events and associated management strategies within 30 days post-infusion are presented in Table: Adverse Events and Management Strategies After Infusion.
| Characteristic | IP Cohort (n=148) | OP Cohort (n=94) | Adjusted OR, 95% CI, P Valuea,b |
|---|---|---|---|
| Clinical events, n (%) | |||
| Pancytopenia | 118 (79.7) | 71 (75.5) | 0.80 (0.42; 1.52), 0.491 |
| Cytokine release syndromec | 103 (69.6) | 60 (63.8) | 0.72 (0.41; 1.27), 0.258 |
| Grade 1-2 | 95 (64.2) | 55 (58.5) | 0.75 (0.44; 1.30), 0.304 |
| Grade ≥ 3 | 3 (2.0) | 1 (1.1) | 0.42 (0.04; 4.31), 0.462 |
| Grade unspecified | 5 (3.4) | 4 (4.3) | 1.27 (0.32; 4.99), 0.732 |
| Fever | 77 (52.0) | 57 (60.6) | 1.45 (0.84; 2.48), 0.180 |
| ICANSc | 32 (21.6) | 19 (20.2) | 0.99 (0.51; 1.92), 0.966 |
| Grade 1-2 | 18 (12.2) | 5 (5.3) | 0.41 (0.14; 1.19), 0.101 |
| Grade ≥ 3 | 4 (2.7) | 3 (3.2) | 1.33 (0.27; 6.57), 0.723 |
| Grade unspecified | 10 (6.8) | 11 (11.7) | 1.93 (0.76; 4.91), 0.167 |
| Death | 2 (1.4) | 1 (1.1) | - |
| Management strategies, n (%) | |||
| Tocilizumab | 25 (16.9) | 11 (11.7) | 0.60 (0.28; 1.31), 0.198 |
| Dexamethasone | 18 (12.2) | 13 (13.8) | 1.13 (0.51; 2.48), 0.769 |
| IVIG | 16 (10.8) | 8 (8.5) | 0.70 (0.27; 1.83), 0.465 |
| Abbreviations: CI, confidence interval; CRAB, calcium elevation, renal insufficiency, anemia, and bone lesions; ICANS, immune effector cell-associated neurotoxicity syndrome; IP, inpatient; IVIG, intravenous immunoglobulin; OP, outpatient; OR, odds ratio. aAn OR <1 indicates that the OP cohort had lower odds of the event compared to the IP cohort.bModels were adjusted for age, sex, Quan-Charlson Comorbidity Index, frailty index score, race, calendar year of infusion, insurance type, and presence of CRAB symptoms in the 12 months prior to infusion.cHighest grade was reported. | |||
All-Cause HCRU Outcomes
- All-cause HCRU outcomes, including IP and OP utilization, intensive care unit (ICU) admissions, emergency department (ED) visits, and admission-related outcomes across prespecified post-index time periods for the IP and OP cohorts, are summarized in Table: All-Cause HCRU Outcomes by Care Setting and Post-Index Time Period.
| HCRU | IP Cohort (n=148) | OP Cohort (n=94) | Adjusted IRR (95% CI), P Valueb,c |
|---|---|---|---|
| 1-30 days post-index | |||
| Median duration of follow-up, months (mean ± SD) | 1.0 (1.0±0.1) | 1.0 (1.0±0.1) | - |
| ≥1 IP day, n (%) | 146 (98.6) | 64 (68.1) | - |
| Median number of days (mean ± SD) | 13.55 (14.57±5.78) | 4.84 (5.20±5.67) | 0.36 (0.29; 0.43), <0.001d |
| Median time to first admission, days (mean ± SD) | - | 6.0 (6.1±2.8) | - |
| 1-3 days post-index, n (%) | - | 10 (10.6) | - |
| 4-6 days post-index, n (%) | - | 26 (27.7) | - |
| 7-9 days post-index, n (%) | - | 23 (24.5) | - |
| 10+ days post-index, n (%) | - | 5 (5.3) | - |
| Median LOS of first admission, days, (mean ± SD) | - | 6.3±2.8 (6.0) | - |
| ≥1 IP re-admission, n (%) | 16 (10.8) | 11 (11.7) | - |
| Median LOS of re-admission, days (mean ± SD) | 5.5 (6.8±4.9) | 8.0 (9.3±5.8) | - |
| Median time from discharge to re-admission, days (mean ± SD) | 3.5 (6.4±7.1) | 8.0 (8.7±4.1) | - |
| 1-3 days post-discharge, n (%) | 8 (5.4) | 1 (1.1) | - |
| 4-6 days post-discharge, n (%) | 4 (2.7) | 3 (3.2) | - |
| 7-9 days post-discharge, n (%) | 0 (0.0) | 2 (2.1) | - |
| 10+ days post-discharge, n (%) | 4 (2.7) | 5 (5.3) | - |
| ≥1 OP day, n (%) | 136 (91.9) | 94 (100.0) | - |
| Median number of days (mean ± SD) | 4.84 (5.58±3.90) | 13.55 (13.27±5.28) | 2.38 (2.09; 2.75), <0.001d |
| ≥1 ICU admission, n (%) | 41 (27.7) | 29 (30.9) | - |
| ≥1 intermediate ICU admission, n (%) | 23 (15.5) | 18 (19.1) | - |
| ≥1 ED visit, n (%) | 6 (4.1) | 7 (7.4) | - |
| 1-3 months post-index | |||
| Median duration of follow-up, months (mean ± SD) | 3.0 (2.9±0.5) | 3.0 (2.7±0.7) | - |
| ≥1 IP day, n (%) | 146 (98.6) | 64 (68.1) | - |
| Median number of days (mean ± SD) | 4.95 (6.61±5.65) | 1.65 (2.40±3.73) | 0.37 (0.28; 0.48), <0.001d |
| ≥1 OP day, n (%) | 143 (96.6) | 94 (100.0) | - |
| Median number of days (mean ± SD) | 4.62 (5.42±3.15) | 7.91 (8.45±4.39) | 1.43 (1.26; 1.63), <0.001d |
| ≥1 ICU admission, n (%) | 44 (29.7) | 29 (30.9) | - |
| ≥1 intermediate ICU admission, n (%) | 25 (16.9) | 18 (19.1) | - |
| ≥1 ED visit, n (%) | 26 (17.6) | 23 (24.5) | - |
| 4-6 months post-indexe | |||
| Median duration of follow-up, months (mean ± SD) | 3.0 (2.9±0.5) | 3.0 (2.7±0.8) | - |
| ≥1 IP day, n (%) | 13 (9.8) | 9 (12.5) | - |
| Median number of days (mean ± SD) | 0.00 (0.54±2.56) | 0.00 (0.35±1.26) | 0.94 (0.22; 3.87), 0.972 |
| ≥1 OP day, n (%) | 133 (100.0) | 68 (94.4) | - |
| Median number of days (mean ± SD) | 2.97 (4.03±3.03) | 3.30 (4.09±3.21) | 0.96 (0.76; 1.20), 0.712 |
| ≥1 ICU admission, n (%) | 3 (2.3) | 6 (8.3) | - |
| ≥1 intermediate ICU admission, n (%) | 1 (0.8) | 5 (6.9) | - |
| ≥1 ED visit, n (%) | 20 (15.0) | 12 (16.7) | - |
| 7+ months post-indexf | |||
| Median duration of follow-up, months (mean ± SD) | 6.8 (7.9±5.2) | 7.0 (7.4±4.5) | - |
| ≥1 IP day, n (%) | 20 (16.8) | 7 (12.1) | - |
| Median number of days (mean ± SD) | 0.00 (0.30±1.20) | 0.00 (0.21±0.95) | 0.46 (0.12; 1.70), 0.328 |
| ≥1 OP day, n (%) | 112 (94.1) | 52 (89.7) | - |
| Median number of days (mean ± SD) | 2.32 (2.75±2.35) | 2.41 (2.63±2.08) | 1.05 (0.83; 1.35), 0.740 |
| ≥1 ICU admission, n (%) | 7 (5.9) | 1 (1.7) | - |
| ≥1 intermediate ICU admission, n (%) | 2 (1.7) | 1 (1.7) | - |
| ≥1 ED visit, n (%) | 33 (27.7) | 14 (24.1) | - |
| Abbreviations: CI, confidence interval; CRAB, calcium elevation, renal insufficiency, anemia, bone lesions; ED, emergency department; HCRU, healthcare resource utilization; ICU, intensive care unit; IP, inpatient; IRR, incidence rate ratio; LOS, length of stay; OP, outpatient; SD, standard deviation. aReported among patients with ≥1 day of follow-up in the specified time period and presented per-patient-per-month, unless otherwise specified bAn IRR <1 indicates that the OP cohort had a lower rate of events compared to the IP cohort. cModels were adjusted for age, sex, Quan-Charlson Comorbidity Index, frailty index score, race, calendar year of infusion, insurance type, and presence of CRAB symptoms in the 12 months prior to infusion. dP value<0.05. eIP, n=133; OP, n=72. fIP, n=119; OP, n=58. | |||
- The median follow-up duration was 11.4 months in the IP cohort and 9.2 months in the OP cohort. Clinical outcomes are summarized in Table: TFI and OS Outcomes.
- After adjustment for baseline characteristics, the risks of initiating subsequent treatment or death were lower in the OP cohort vs the IP cohort; however, the differences did not reach statistical significance.
| Outcome | IP Cohort (n=148) | OP Cohort (n=94) | Adjusted HRa (95% CI); P Value |
|---|---|---|---|
| Patients with next treatment or death, n (%) | 22 (14.9) | 7 (7.4) | 0.59 (0.26-1.37); 0.221 |
| Type of progression event | |||
| Line progression, n (%) | 12 (8.1) | 5 (5.3) | - |
| Death, n (%) | 10 (6.8) | 2 (2.1) | - |
| Estimated median TFI, months | NR | NR | - |
| Estimated TFI rate, % | |||
| 6 months | 92 | 97.5 | - |
| 12 months | 87.3 | 92.2 | |
| Patients with death (OS), n (%) | 11 (7.4) | 3 (3.2) | 0.67 (0.18-2.53); 0.552 |
| Estimated median OS, months | NR | NR | - |
| OS rate, n (%) | |||
| 6 months | 96.4 | 98.9 | - |
| 12 months | 92.5 | 94.9 | - |
| Abbreviations: CI, confidence interval; CRAB, calcium elevation, renal insufficiency, anemia, and bone lesions; HR, hazard ratio; IP, inpatient; NR, not reached; OP, outpatient; OS, overall survival; TFI, treatment-free interval. aModels were adjusted for age, sex, Quan-Charlson Comorbidity Index, frailty index score, race, calendar year of infusion, insurance type, and presence of CRAB symptoms. An HR <1 indicates that the OP cohort had a lower rate of events compared to the IP cohort. | |||
Literature Search
A literature search of Ovid MEDLINE®
References
| 1 | Janakiram M, Ghosh S, Alegria V, et al. Healthcare resource utilization and costs in patients with multiple myeloma administered ciltacabtagene autoleucel in outpatient versus inpatient settings after one to three prior lines of therapy. J Comp Eff Res. 2026;15(7):e260052. |
| 2 | |
| 3 |
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