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Aim: To assess treatment patterns, healthcare resource utilization (HCRU), and costs for patients with diffuse large B-cell lymphoma (DLBCL) who did not receive stem cell transplantation in second-line. Patients & methods: An administrative MarketScan® database study to assess DLBCL claims from 01/01/2009-30/09/2020. Results: Most patients (n = 750) received rituximab plus cyclophosphamide, doxorubicin, vincristine and prednisone in first-line (86.8%) and rituximab (39.5%) or bendamustine ± rituximab ± other (16.3%) in second-line. Over half were hospitalized (mean duration: 16.5 (standard deviation [SD]: 25.8) days per patient per year). Mean medical/pharmacy costs were US$141,532 per patient per year (SD: $189,579), driven by DLBCL-related claims. Conclusion: Healthcare resource utilization and costs for DLBCL-related claims were due to hospitalizations and outpatient visits. Novel therapies to reduce clinical and economic burdens are needed.
Assuntos
Linfoma Difuso de Grandes Células B , Humanos , Rituximab/uso terapêutico , Anticorpos Monoclonais Murinos/uso terapêutico , Ciclofosfamida/uso terapêutico , Vincristina/uso terapêutico , Linfoma Difuso de Grandes Células B/patologia , Prednisona/uso terapêutico , Doxorrubicina/uso terapêutico , Transplante de Células-Tronco , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêuticoRESUMO
It is important to consider the total cost of care (TCOC) associated with a therapy and clinical benefit for relapsed or refractory (R/R) large B cell lymphoma (LBCL). We estimated the 1-year TCOC and cost per clinical outcome for patients with R/R LBCL treated with second-line lisocabtagene maraleucel (liso-cel) versus autologous stem cell transplantation (ASCT) using data from the TRANSFORM study (ClinicalTrials.gov NCT03575351). A cost per clinical outcome analysis using a Monte Carlo simulation approach was conducted. Cost inputs were generated from a retrospective microcosting analysis of healthcare resource utilization (HCRU). Patient-level data from an interim analysis (March 2021) were used to derive HCRU and clinical inputs. Clinical inputs included median event-free survival (EFS), median progression-free survival (PFS), objective response rate, and complete response (CR) rate. In the intention-to-treat analysis, the mean (standard deviation) TCOC per patient was $550,864 ($173,087) for liso-cel and $413,200 ($290,802) for ASCT. The cost per clinical outcome model estimated a mean cost for liso-cel versus ASCT per EFS month of $57,295 versus $186,369, per PFS month of $40,949 versus $78,797, per overall responder of $653,965 versus $881,804, and per complete responder of $828,045 versus $1,063,822. This economic model shows reductions in mean estimated TCOC per EFS month, PFS month, overall responder, and complete responder with liso-cel versus ASCT owing to the superior efficacy of liso-cel. Although liso-cel-treated patients incurred greater upfront costs, fewer required subsequent therapy, and they accumulated less downstream costs. These results underscore the importance of considering the durability of response and clinical benefit when assessing total costs.
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Transplante de Células-Tronco Hematopoéticas , Linfoma Difuso de Grandes Células B , Humanos , Transplante de Células-Tronco Hematopoéticas/métodos , Linfoma Difuso de Grandes Células B/terapia , Indução de Remissão , Estudos Retrospectivos , Transplante Autólogo , Estudos Clínicos como AssuntoRESUMO
INTRODUCTION: The objective of this study was to evaluate the cost-effectiveness of lisocabtagene maraleucel (liso-cel) versus other available chimeric antigen receptor T-cell therapies, including axicabtagene ciloleucel (axi-cel) and tisagenlecleucel (tisa-cel), in patients who had received at least two prior therapies from a United States (US) commercial third-party payer perspective. METHODS: To capture this heterogeneity in survival outcomes, we used mixture cure models to extrapolate progression-free survival (PFS) and overall survival (OS). Patient-level data from TRANSCEND NHL 001 for liso-cel and reconstructed patient-level data from ZUMA-1 for axi-cel, JULIET for tisa-cel, and SCHOLAR-1 for salvage chemotherapy, derived using the Guyot method, were used for OS and PFS. The model included adverse events associated with liso-cel, axi-cel, and tisa-cel. RESULTS: Liso-cel was less costly (incremental cost of - $74,980) and marginally more effective (0.002 incremental quality-adjusted life-years [QALY]) than axi-cel and had an incremental cost of $67,925 and 2.02 incremental QALYs over tisa-cel in the base case. Results remained consistent in sensitivity analyses, with the liso-cel OS cure fraction being the main driver of cost-effectiveness compared with both axi-cel and tisa-cel. CONCLUSION: This analysis estimated that liso-cel is cost-effective compared with tisa-cel and axi-cel from a commercial US payer perspective.
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Linfoma Difuso de Grandes Células B , Humanos , Análise Custo-Benefício , Imunoterapia AdotivaRESUMO
Chimeric antigen receptor (CAR) T-cell therapies demonstrated efficacy in relapsed/refractory large B-cell lymphoma (LBCL) but are associated with cytokine release syndrome (CRS) and neurological events (NE). We wanted to estimate the total cost of CRS and NE management among patients with relapsed/refractory LBCL treated with lisocabtagene maraleucel (liso-cel), axicabtagene ciloleucel (axi-cel), or tisagenlecleucel (tisa-cel) in the third- or later-line setting. An economic decision tree model was developed using clinical and economic data to estimate a weighted average per-patient adverse event (AE) management cost from a United States health care system perspective in 2020 dollars. In 2 predefined analyses, mean expected cost and 95% confidence intervals of the average treated patient were estimated via Monte Carlo simulations, with per-patient costs for each CAR T-cell therapy further stratified by AE and grade. In the base case, the overall weighted average per-patient cost was $18,718, $47,665, and $42,538 for liso-cel, axi-cel, and tisa-cel, respectively. The weighted average per-patient cost per CRS event was $8213, $20,442, and $26,009 for liso-cel, axi-cel, and tisa-cel, respectively; the weighted average per-patient cost per NE was $10,505, $27,223, and $16,528, respectively. Differences in the base-case scenario estimated total mean costs for liso-cel were -$28,947 and -$23,819 compared with axi-cel and tisa-cel, respectively. In the scenario analysis (alternative cost input), differences in the estimated total mean costs were -$24,498 for liso-cel versus axi-cel, and -$19,326 for liso-cel versus tisa-cel. Across the base case and scenario analysis, liso-cel had the lowest weighted average CRS and NE costs per treated patient compared with axi-cel and tisa-cel owing to lower incidence rates and symptom severity. These findings highlight the economic implications of differences in safety among CAR T-cell therapies.
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Imunoterapia Adotiva , Linfoma Difuso de Grandes Células B , Humanos , Imunoterapia Adotiva/efeitos adversos , Síndrome da Liberação de Citocina/etiologia , Síndrome da Liberação de Citocina/terapia , Modelos Econômicos , Método de Monte CarloRESUMO
The use of chimeric antigen receptor (CAR) T-cell therapy after a second relapse of diffuse large B-cell lymphoma (DLBCL) has shown favorable efficacy in clinical trials; however, little is known about health care resource utilization (HCRU) and costs of CAR T cell therapy for patients treated in real-world settings. We assessed treatment patterns, HCRU, costs, and safety in patients receiving CAR T cell therapy for relapsed or refractory DLBCL across 3 US commercial claims databases. Adults with DLBCL treated with CAR T cell therapy were identified in the following 3 claims databases: Optum® Clinformatics® Data Mart, IBM MarketScan® Commercial & Medicare Database, and IQVIA PharMetrics® Plus. Mean total costs were calculated and adjusted to 2019 US dollars. HCRU and costs within 3 months of infusion were stratified by safety events of interest, including neurological events (NEs) and cytokine release syndrome (CRS), identified via unvalidated algorithms designed based on expert medical opinion. A total of 191 patients receiving CAR T cell therapy were identified across the databases; their median age ranged from 56 to 67 years, and 63% to 75% were male. Most patients (88% to 98%) received CAR T cell infusions in the inpatient setting; 30% to 75% received bridging therapy. CRS was reported in 75% to 84% of patients (severe CRS, 15% to 32%), and NEs were reported in 58% to 69% (severe NEs, 25% to 43%). Mean total inpatient hospital days ranged from 17 to 22 days and increased with severe CRS (19 to 27 days) or severe NEs (22 to 29 days). Mean total health care expenditures ranged from $380,000 to $526,000 and were generally higher with severe CRS or NEs (â¼$406,000 to $679,000). HCRU and costs associated with CAR T cell therapy may vary in the real world depending on several factors, including occurrence and severity of adverse events.
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Imunoterapia Adotiva , Linfoma Difuso de Grandes Células B , Aceitação pelo Paciente de Cuidados de Saúde , Adulto , Idoso , Terapia Baseada em Transplante de Células e Tecidos/economia , Síndrome da Liberação de Citocina , Feminino , Humanos , Imunoterapia Adotiva/economia , Linfoma Difuso de Grandes Células B/terapia , Masculino , Medicare , Pessoa de Meia-Idade , Recidiva Local de Neoplasia/etiologia , Receptores de Antígenos Quiméricos/uso terapêutico , Estados Unidos/epidemiologiaRESUMO
This retrospective study estimated postinfusion health care resource utilization (HCRU) by site of care among 303 patients with relapsed/refractory large B-cell lymphoma who received third- or later-line treatment with lisocabtagene maraleucel (liso-cel) in the TRANSCEND NHL 001 and OUTREACH trials. Inpatients (n = 256) had higher rates of hospitalization versus outpatients (n = 47; >99% vs 62%), by definition, and higher rates of tocilizumab use for cytokine release syndrome and/or neurological events (22% vs 9%). Rates of intensive care unit admission, corticosteroid use, vasopressor use, hemodialysis, and intubation were generally low and similar between groups. Median (range) total hospital length of stay was 15 (0-88) days (inpatients) and 4 (0-77) days (outpatients). Over 6 months, estimated mean postinfusion cost of care was $89,535 (inpatients) and $36,702 (outpatients). Most costs were incurred in the first month post infusion (inpatients, $50,369 [56%]; outpatients, $19,837 [54%]). Lower overall HCRU was observed with outpatient postinfusion monitoring.