scholarly journals VTE-Related Healthcare Resource Utilization and Costs Associated with Venous Thromboembolism in Cancer Patients Treated with Anticoagulants

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 3524-3524 ◽  
Author(s):  
Michael Streiff ◽  
Dejan Milentijevic ◽  
Keith R. McCrae ◽  
Jonathan Fortier ◽  
François Laliberté ◽  
...  

Abstract Introduction: The standard of care for treatment of cancer-related venous thromboembolism (VTE) is a low molecular heparin (LMWH). In our previous claimsbased analysis, we showed that besides LMWH oral anticoagulants, warafrin and rivaroxaban are widely prescribed in clinical practice (Khorana, 2015). The objective of this study is to compare VTE-related healthcare resource utilization and costs of cancer patients treated with anticoagulant therapies. Methods: Medical and pharmacy claims from the Humana Database between 1/1/2013 and 05/31/2015 were analyzed. Newly diagnosed cancer patients with a first VTE diagnosis occurring after their first cancer diagnosis and with ≥1 dispensing of an anticoagulant agent within 7 days after their VTE diagnosis, were selected. Based on the first anticoagulant agent received, patients were classified into one of the following cohorts: LMWH, warfarin, and rivaroxaban. Inverse probability of treatment weights based on propensity score was used to adjust for differences between treatment cohorts. Baseline characteristics were evaluated during the 6 month period prior to the index VTE. VTE-related resource utilization and costs were identified with a primary or secondary diagnosis of deep vein thrombosis or pulmonary embolism and were evaluated for the entire follow up period, starting from the initiation of the anticoagulant therapy until the earliest either end of enrollment or end of data availability (05/31/2015). Resource utilization components included: number of hospitalizations, hospitalization days, emergency room (ER) visits, and outpatient visits. Comparisons between the different treatment cohorts were performed using rate ratios (RR) and statistical differences between groups as well as 95% confidence intervals [95% CI] were calculated using Poisson regression models. Healthcare costs were evaluated in per-patient-per-year (PPPY) and compared using mean cost difference. Results: A total of 2,428 patients (LMWH: n=660; warfarin; n=1,061; rivaroxaban: n=707) were included. Baseline demographic and clinical characteristics were well balanced across the treatment cohorts including hospitalizations, emergency room (ER) visits, and outpatient visits. Compared to patients treated with LMWH, patients treated with rivaroxaban had significantly fewer VTE-related hospitalizations, hospitalization days, ER visits, and outpatient visits (Figure 1). This resulted in significantly higher VTE-related health care cost difference of $12,000 for LMWH relative to rivaroxaban treatment cohort (Table 1). Patients treated with rivaroxaban had significantly lower VTE-related resource utilization compared to patients treated with warfarin (Figure 1). The total VTE-related costs were however similar between two cohorts (Table 1). The higher drug costs ($1,519) were offset by significantly lower outpatient (-$1,039) and hospitalization costs (-$522) in rivaroxaban relative to warfarin cohort. Conclusion: Healthcare resource use and costs associated with VTE treatment in cancer patients are the highest with LMWH relative to warfarin and rivaroxaban treatments. Healthcare resources use and costs are significantly higher in warfarin relative to rivaroxaban cohort but these resource costs were offset by higher drug costs of rivaroxaban. These results are in line with previous study in cancer patients that found fewer re-hospitalizations related to VTE recurrences in patients treated with rivaroxaban compared to patient treated with LMWH or warfarin (Streiff, 2016). Figure 1 VTE-Related Healthcare Resource Utilization Figure 1. VTE-Related Healthcare Resource Utilization Table VTE-Related Health Care Costs, PPPY Table. VTE-Related Health Care Costs, PPPY Disclosures Streiff: Roche: Research Funding; Portola: Research Funding; Janssen: Consultancy, Research Funding; CSL Behring: Consultancy, Research Funding. Milentijevic:Janssen Scientific Affairs: Employment, Equity Ownership. McCrae:Janssen: Membership on an entity's Board of Directors or advisory committees. Fortier:Janssen Pharmaceuticals: Research Funding. Laliberté:Janssen Scientific Affairs: Research Funding. Lefebvre:Janssen Scientific Affairs: Research Funding. Schein:Johnson & Johnson: Employment, Equity Ownership, Other: Own in excess of $10,000 of J&J stock. Khorana:Sanofi: Consultancy, Honoraria; Leo: Consultancy, Honoraria, Research Funding; Amgen: Consultancy, Honoraria, Research Funding; Bayer: Consultancy, Honoraria; Halozyme: Consultancy, Honoraria; Pfizer: Consultancy, Honoraria; Janssen Scientific Affairs, LLC: Consultancy, Honoraria, Research Funding; Roche: Consultancy, Honoraria.

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 4734-4734
Author(s):  
Alok A. Khorana ◽  
Keith R. McCrae ◽  
Dejan Milentijevic ◽  
Jonathan Fortier ◽  
François Laliberté ◽  
...  

Abstract Introduction: Patients with cancer are not only at a high risk for developing primary but also recurrent venous thromboembolism (VTE). These events lead to increased burden of cancer management and healthcare costs. It was estimated that all-cause health care costs for cancer patients with VTE were $30,538/patient higher than in those without VTE (Khorana, 2013). To our knowledge, very little information exists on cost of VTE recurrence among cancer patients. The objective of this study was to analyze resource utilization and costs of patients with cancer experiencing a VTE recurrence using a large claims database. Methods: Medical and pharmacy claims from the Humana Database between 1/1/2013 and 05/31/2015 were analyzed. Newly diagnosed cancer patients with a first VTE diagnosis occurring after their first cancer diagnosis and with ≥1 dispensing of an anticoagulant agent within 7 days after their VTE diagnosis, were selected. Baseline characteristics were evaluated during the 6 month period prior to the index VTE. VTE recurrences were defined as hospitalizations with a primary diagnosis of VTE. Patients were classified into two groups: patients who experienced a VTE recurrence and patients who did not. Resource utilization and costs were evaluated for the entire follow up period, starting with the initiation of the anticoagulant therapy until whichever was earlier, end of eligibility or end of data. Healthcare resource utilization evaluated included number of hospitalizations, hospitalization days, emergency room (ER) visits, and outpatient visits. All-cause and VTE-related healthcare resource utilization was evaluated. Comparisons between patients with a VTE recurrence and patients without a VTE recurrence were performed using rate ratios (RR) and statistical differences between groups as well as 95% confidence intervals [95% CI] were calculated using Poisson regression models. All-cause and VTE-related healthcare costs were evaluated in per-patient-per-year (PPPY) and compared using mean cost difference. Results: A total of 2,428 newly diagnosed cancer patients who developed VTE and were treated with anticoagulants were identified. Of these, 413 (17.1%) experienced recurrent VTE during the follow up period. Patients who developed recurrent VTE and those who did not were similar in terms of age, gender, race, and region. No statistically significant differences between groups were observed in Charlson comorbidity index or in selected comorbidities during the 6 month baseline period. However, more patients with recurrent VTE recurrence had their index VTE documented during a hospitalization (61.3% vs. 55.4%, p=0.03). Patients with a VTE recurrence had significantly more ER and outpatient visits at baseline compared to those without recurrence, but no statistically significant difference was observed in baseline total healthcare costs ($29,352 vs. $27,955, p=0.44, respectively). The mean follow-up was similar between groups: 9.6 months for patients experiencing a VTE recurrence and 9.3 months for patients without a VTE recurrence (p=0.4059). Patients with a VTE recurrence had higher all-cause resource utilization rates (RRs; 95% CI) compared to patients without a VTE recurrence (hospitalization [2.37; 2.23 - 2.52], hospitalization days [2.64; 2.57 - 2.72], ER visits [1.62; 1.48 - 1.76], and outpatient visits [1.26; 1.24 - 1.28]). The rates of VTE-related hospitalization and VTE-related hospitalization days were close to $30,000 higher in patients with a VTE recurrence (Figure 1). The all-cause healthcare costs were $84,708 PPPY in patients with a VTE recurrence compared to $44,903 in patients without a VTE recurrence. The difference was mainly explained by lower VTE-related hospitalization costs (Figure 2). Conclusion: This real-world claims analysis showed that cancer patients with recurrent VTE consume significantly more healthcare resources. Total healthcare costs were nearly 2-fold higher in cohort with than in cohort without VTE recurrence. Close to 75% of the total cost difference was associated with VTE recurrence. VTE-related costs were ~4-fold higher in cohort with than in cohort without VTE recurrence. Reducing VTE recurrence in patients with cancer could lead to substantial healthcare cost savings. Figure 1 VTE-Related Healthcare Resource Utilization Figure 1. VTE-Related Healthcare Resource Utilization Figure 2 VTE-Related Healthcare Costs, PPPY Figure 2. VTE-Related Healthcare Costs, PPPY Disclosures Khorana: Pfizer: Consultancy, Honoraria; Bayer: Consultancy, Honoraria; Sanofi: Consultancy, Honoraria; Halozyme: Consultancy, Honoraria; Amgen: Consultancy, Honoraria, Research Funding; Janssen Scientific Affairs, LLC: Consultancy, Honoraria, Research Funding; Leo: Consultancy, Honoraria, Research Funding; Roche: Consultancy, Honoraria. McCrae:Janssen: Membership on an entity's Board of Directors or advisory committees. Milentijevic:Janssen Scientific Affairs: Employment, Equity Ownership. Fortier:Janssen Pharmaceuticals: Research Funding. Laliberté:Janssen Scientific Affairs: Research Funding. Crivera:Janssen Scientific Affairs, LLC, Raritan, New Jersey: Employment, Equity Ownership. Lefebvre:Janssen Scientific Affairs: Research Funding. Schein:Johnson & Johnson: Employment, Equity Ownership, Other: Own in excess of $10,000 of J&J stock.


Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 5826-5826
Author(s):  
Crystal Watson ◽  
Arie Barlev ◽  
Jodie Worrall ◽  
Steve Duff ◽  
Rachel Beckerman

Objectives: CHOP (vincristine, cyclophosphamide, prednisone, doxorubicin) is a treatment option for post-transplant lymphoproliferative disorder (PTLD) following solid organ transplant, an aggressive and potentially fatal disease. The most common and impactful CHOP-related adverse events (AEs) are febrile neutropenia (FN), chemotherapy-induced (CI) peripheral neuropathy (PN), infection, CI-anemia (A), and CI-nausea and vomiting (NV). These CHOP-related AEs have a large humanistic burdensignificant impact to quality of life (QoL) of patients, especially shortly after treatment. The evidence for a positive QoL benefit associated with some AE treatments (e.g., erythropoietin stimulating agents [ESA], granulocyte colony stimulating factors) is inconsistent and many patients likely remain with QoL deficits even after treatment. The impact of these short-term CHOP-related AEs is likely to be accompanied by an increase in healthcare resource utilization and costs. The objective of this study was to explore the economic burden of short-term CHOP-associated AEs in PTLD patients. Since PTLD is a rare disease with limited available data, we expanded our search to include all patients with lymphoproliferative disorders (LPD). Methods: Short-term (within several months after treatment) AEs associated with CHOP with an incidence of >4% in patients with LPDs were determined and sourced from the published literature and cancer websites. A comprehensive literature search was conducted using PubMed and EMBASE to identify economic burden studies published from 2010 to 2018 of the AEs associated with CHOP and its components in the United States (US). Studies incorporating rituximab alongside CHOP (CHOP + R) were also included as this is a valid treatment option for PTLD patients. Economic burden was defined as the management costs and resource utilization associated with treating CHOP-emergent adverse events. The conduct of this comprehensive literature review was guided by the PRISMA protocol wherein the research question (using the PICOS format), search strategy, target short-term AEs, and inclusion and exclusion criteria were pre-specified in detail. Results: Overall, 3,946 non-duplicate citations were screened, 39 studies were included for abstraction and no studies included patients with PTLD. Studies were methodologically heterogenous, with approximately half (56%) based on some form of retrospective analysis or prospective observational study. FN was the AE most commonly encountered, followed by CIA, infection, CI-nausea and vomiting, and CIPN. FN was an important driver of hospitalization (proportion of FN patients with hospitalization was up to 83.2%) and extended length of stay (LOS) was substantial for several AEs (LOS range in days: infection, 8.4-23.6; FN, 7.9-19.7). Mean LOS was longer in FN patients with multiple hospitalizations as well as in FN patients with comorbidities. Rates of transfusion in CI-anemia patients varied dramatically, from 10.8% to 47.4%. Transfusion rates were attenuated by ESA use in LPD patients, although a significant proportion of anemic cancer patients receiving ESAs still required transfusions. Total management costs were highly variable, ranging from nominal for events such as CIPN to over $197,000 in hospitalization costs per infection discharge per patients complicated with clostridium difficile. One recent study showed the inpatient costs attributable to FN were $33,006 per patient per episode. Studies identified CINV as a top reason for unplanned service use, but no studies were identified assessing its economic impact in LPD patients. Outpatient care costs for each AE varied but tended to have a low to moderate economic impact. The costs attributable to several AEs (FN, infection) were highest in the first cycle of chemotherapy. Conclusions: Several common short-term AEs due to CHOP in the LPD population were associated with substantial healthcare resource utilization and costs that were primarily driven by increased hospitalization and length of inpatient stays. Costs for FN and infections associated with CHOP ranged from $33,000 to over $197,000, demonstrating the high economic burden to the US healthcare system. No PTLD-specific studies were found, highlighting the absence of published data addressing the economic burden associated with chemotherapy in PTLD patients and the need for effective and tolerable therapies. Disclosures Watson: Atara Biotherapeutics: Employment, Equity Ownership. Barlev:Atara Biotherapeutics: Employment, Equity Ownership. Worrall:Atara Biotherapeutics, Inc: Consultancy. Duff:Atara Biotherapeutics, Inc: Consultancy. Beckerman:Atara Biotherapeutics, Inc: Consultancy.


Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 3841-3841
Author(s):  
Eric Qiong Wu ◽  
Annie Guerin ◽  
Vamsi Bollu ◽  
Denise Williams ◽  
Amy Guo ◽  
...  

Abstract Abstract 3841 Background: Ph+ CML patients may develop PE, as an adverse event of some tyrosine kinase inhibitors (TKI) drug therapy. PE is characterized by an excessive accumulation of fluid in the fluid-filled space that surrounds the lungs. PE requires medical care, may compromise the course of CML treatment, and have economic consequence beyond the costs of treating PE. Aim: To compare healthcare resource utilization and costs between CML patients treated with a TKI who developed PE and their matched PE-free controls. Methods: MarketScan and Ingenix Impact databases (2001-2009) were combined to identify adult CML patients (ICD-9CM code 205.1×) who received ≥1 prescription of imatinib, dasatinib, or nilotinib before the index date and had continuous enrollment ≥6 months prior to and after the index date. The index date was defined as 30 days before the first PE diagnosis (ICD-9CM code 511.9×) for patients with PE and was randomly selected among all the eligible calendar dates (i.e., following a prescription for a TKI and a diagnosis for CML) for the PE-free controls. Patients were followed for 6 months after the index date. PE and PE-free patients were matched on a 1:1 ratio using propensity score matching. PE-related (i.e., medical claims with a PE diagnosis) resource utilization (inpatient [IP], outpatient [OP], emergency room [ER] and other medical visits) and costs were estimated for PE patients. To estimate the overall incremental impact of PE, all-cause and CML-related (i.e., medical services associated with a diagnosis code of 205.1×) resource utilization and costs were compared between PE and PE-free controls. All costs were reported in 2009 US dollars. Incidence rate ratios (IRR) for healthcare resource utilization were estimated by Poisson regression models. Incremental costs were estimated using generalized linear models or two-part models. Multivariate regression models controlled for age, gender, treatment duration with tyrosine kinase inhibitor, other chemotherapy, bone marrow or stem cell transplant, CML complexity, Charlson comorbidity index, adverse events, and comorbidities. Results: The study included 179 matched pairs. On average, patients were 63.4 and 63.8 years old with 41% and 49% of the population being female for PE-free and PE patients, respectively. During the study period, PE patients were estimated to have an average of 0.62 PE-related IP admissions, 8.43 IP days, 0.06 ER admissions, and 1.76 OP visits. Compared to PE-free patients, PE patients had more than 7 times as many IP days (IRR=7.23; p<.01), almost 3 times as many IP admissions (IRR=2.96; p<0.01), almost twice as many OP visits (IRR=1.98; p<.01) and ER visits (IRR=1.77; p<.01). Especially, PE patients had almost 10 times as many CML-related IP days (IRR=9.91; p<.01), more than 3 times as many CML-related IP admissions (IRR=3.95; p<0.01), twice as many CML-related OP visits (IRR=2.16; p<.01), and almost 6 times as many CML-related ER visits (IRR=5.60; p<.01). On average, PE-related medical costs were estimated at $11,015 per patient, where 84.2% was accounted for by IP costs. Total costs for all-cause related medical services were estimated at $37,566 for PE patients and $14,841 for PE-free patients. After adjusting for confounding factors, the incremental total medical cost of PE patients was $22,299 (p<.01), mostly due to the incremental OP cost ($12,931; p<.01) and IP cost ($8,737; p<.01). Similarly, PE patients incurred higher CML-related medical costs compared to PE-free patients, with a $15,859 (p<.01) incremental cost. Conclusion: Compared to PE-free patients, PE patients have a substantial economic burden with higher PE-related costs, CML-related costs, and total medical cost. Disclosures: Wu: Analysis Group, Inc.: Employment. Guerin:Analysis Group, Inc.: Employment. Bollu:Novartis: Employment, Equity Ownership. Williams:Novartis: Employment, Equity Ownership. Guo:Novartis Pharmaceuticals Corporation: Employment, Equity Ownership. Ponce de Leon Barido:Analysis Group, Inc.: Employment. Yu:Analysis Group, Inc.: Employment.


Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 4873-4873
Author(s):  
Alexander Röth ◽  
Jon Fryzek ◽  
Xiaohui Jiang ◽  
Jaime Morales ◽  
Catherine M. Broome

Abstract Introduction: Cold agglutinin disease (CAD) is a rare form of autoimmune hemolytic anemia in which circulating immunoglobulin M autoantibodies bind to the "I" antigen on red blood cells (RBCs), preferentially at lower temperatures (Berentsen et al. Hematol Oncol Clin North Am, 2015). This results in both agglutination of RBCs and complement-mediated hemolysis. "Cold" typically refers to the immune biology (thermal amplitude) of the antibody and not to clinical features of the disease. Although exposure to cold temperatures may precipitate both the circulatory symptoms of CAD and hemolysis (Berentsen. Br J Haematol, 2018), seasonal variation of CAD manifestations is poorly understood (Lyckholm et al. N Engl J Med, 1996; Berentsen et al. Hematology, 2007). There are no clinical trials to support the efficacy of nonpharmacologic management of CAD by cold avoidance or relocation to warm regions (Berentsen. Br J Haematol, 2018; Swiecicki et al. Blood, 2013). Given the lack of data on clinical and laboratory effects of seasonality on the manifestations of CAD, we compared hemoglobin (Hgb) as well as markers of hemolysis and healthcare resource utilization (HRU) for patients with CAD between seasons. Methods: Patients were identified from the Optum-Humedica database, containing de-identified information on medications, laboratory results, diagnoses, procedures, and clinical notes for more than 14 million people annually from all 50 states. Individuals with "cold agglutinin disease" in their clinical notes on at least 3 separate dates were considered patients with CAD. If "cold agglutinin disease" was documented on just 1 or 2 dates, patients were included only after an independent review and agreement by 2 hematologists. The laboratory parameters related to hemolysis, median minimum Hgb, median maximum bilirubin, and median maximum lactate dehydrogenase (LDH), were evaluated, as well as inpatient days, outpatient visits, emergency room visits, and transfusion days. Multivariate regression models were built to explore variation by season comparing the values in fall, winter, and spring to the values in the summer. Data were adjusted for age at baseline, gender, race, region, year, and Charlson Comorbidity Index prior to baseline and accounted for clustering of correlated observations. Results: A total of 808 patients with CAD were identified from the Optum-Humedica database for analysis from 2009 to 2016. Most patients were ≥65 years of age (66%), female (63%), white (84%), and from the Midwest (43%). The median minimum Hgb value for winter as compared with summer was decreased by 0.54 g/dL (P<0.001). The median maximum bilirubin and LDH increased by 0.12 mg/dL (P=0.005) and 42.1 U/L (P<0.001) in winter versus summer, respectively. There were no differences in inpatient days, outpatient visits, emergency room visits, or transfusion days between winter and summer (Table). No significant seasonal disease pattern in HRU was noted in these patients. Conclusions: Patients with CAD in this cohort had evidence of persistent hemolysis independent of the season. Disease manifestations as evaluated by HRU measures were fairly consistent all year long. The variations in median Hgb, bilirubin, and LDH between winter and summer were not associated with differences in clinical outcomes, as there were no significant changes in HRU or transfusion days. These data suggest that perceptions of CAD as a seasonal disorder may not be accurate and recommendations such as moving to regions with warmer climates likely provide no meaningful clinical benefit. The lack of seasonal variability in this cohort suggests that treatment considerations for patients with CAD should be season-independent. Disclosures Röth: Pfizer: Consultancy, Honoraria, Research Funding; Alexion Pharmaceuticals, Inc.: Consultancy, Honoraria, Research Funding; Novartis: Consultancy, Honoraria, Research Funding; Roche: Consultancy, Honoraria, Research Funding; Bioverativ: Consultancy, Honoraria; Amgen: Research Funding. Fryzek:Sanofi: Research Funding. Jiang:Epidstat: Employment. Morales:Bioverativ: Employment. Broome:Bioverativ: Honoraria, Research Funding; Alexion: Honoraria.


Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 5790-5790
Author(s):  
Chao-Hsiun Tang ◽  
Wesley Furnback ◽  
Bruce C.M. Wang ◽  
Jackson Tang ◽  
Vicky Wei-Hsuen Huang ◽  
...  

Introduction: Previous studies have examined the total healthcare resource utilization (HCRU) of patients with beta-thalassemia in relation to the general population. However, limited studies have examined the impact of red blood cell transfusion (RBCT) burden on broad aspects of HCRU beyond transfusion costs among patients with beta-thalassemia. Methods: Patients with beta-thalassemia in Taiwan's National Health Insurance Research Database (NHIRD) in 2016 were identified (International Classification of Diseases, Tenth Revision, Clinical Modification [ICD-10-CM] of D56.1). The index date was the first medical claim in the database after 2001. Identified patients were followed from the index date until the end of the study period (December 31, 2016). During the follow-up period, RBCT units and HCRU (all-cause and thalassemia-related) were measured. Thalassemia-related HCRU was defined as any HCRU claim accompanied by a thalassemia or beta-thalassemia diagnosis code. To control for the different lengths of follow-up between patients, both RBCT units and HCRU were reported as the average per 12 weeks over the entire follow-up period. Patients were categorized into 4 cohorts based on the average number of RBCT units received per 12 weeks during follow-up: 0 RBCT units; > 0 to < 6 RBCT units; ≥ 6 to < 12 RBCT units; or ≥ 12 RBCT units. HCRU outcomes of interest were hospital admissions, hospitalized days, outpatient visits, and emergency room (ER) visits. Descriptive statistics were computed to describe HCRU observed in each cohort. Results: A total of 2,984 patients with beta-thalassemia were included in the analysis, with a mean follow-up of 6.87 years. Mean age at index was 37.8 (standard deviation 23.7) years, and 1,903 (63.8%) patients were female. A total of 1,616 (54.2%) patients did not receive RBCT units during the follow-up period. Of the remaining 1,368 patients, 1,112 (81.3%) received > 0 to < 6 RBCT units, 112 (8.2%) received ≥ 6 to < 12 RBCT units, and 144 (10.5%) received ≥ 12 RBCT units per 12 weeks during follow-up. Mean all-cause and thalassemia-related HCRU was higher for transfused patients than for non-transfused patients across all HCRU categories. Thalassemia-related hospital admissions, hospitalized days, and outpatient days all increased as the transfusion burden increased. Patients in the cohort with the highest average transfusion burden (≥ 12 RBCT units per 12 weeks) had numerically greater mean thalassemia-related hospital admissions (0.5; standard error [SE] = 0.04), hospitalized days (2.5; SE = 0.21), and outpatient visits (4.9; SE = 0.41) than the other cohorts (Figure). Conclusions: Patients with beta-thalassemia and higher average transfusion burden during the follow-up period had additional HCRU compared with patients who required fewer RBCT units. These data may support physician and payer understanding of the downstream economic impact of RBCT burden in beta-thalassemia. Disclosures Tang: GSK: Consultancy; Roche: Research Funding; Pfizer: Research Funding; Janssen: Research Funding; Amgen: Research Funding. Furnback:Sanofi: Consultancy; Regeneron: Consultancy; Celgene Corporation: Consultancy; Abbott: Consultancy; Astellas: Consultancy; Pfizer: Consultancy; Eli Lilly: Consultancy; Janssen: Consultancy; Johnson & Johnson: Consultancy; Gilead: Consultancy; Novocure: Consultancy; Progentec Diagnostics: Consultancy; Becton Dickinson: Consultancy; AstraZeneca: Consultancy; Bristol-Myers Squibb: Consultancy. Wang:Gilead Sciences: Consultancy, Equity Ownership; Celgene Corporation: Consultancy, Equity Ownership; Regeneron Pharmaceuticals: Consultancy, Equity Ownership; Novocure: Consultancy; Pfizer: Consultancy; Eli Lilly: Consultancy; Johnson & Johnson: Consultancy; Astellas: Consultancy; Amgen, Vertex Pharma, Illumina, Biogen, Alexion Pharma, Incyte, Biomarin Pharma, Seattle Genetics, Sarepta Therapeutics, Array Biopharma, Ionis Pharma, Sage Therapeutics, Mylan NV, Neurocrine Biosciences, Bio Techne Corp, Jazz Pharma, Alnylam Pharma, Blue: Equity Ownership. Tang:Asclepius Analytics: Employment. Huang:Celgene Corporation: Employment. Tang:Celgene Corporation: Employment, Equity Ownership. Musallam:Celgene Corporation: Consultancy.


Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 3545-3545 ◽  
Author(s):  
M. Lia Palomba ◽  
Jacob Garcia ◽  
Lei Wang ◽  
Christine Dehner ◽  
Karen C. Chung ◽  
...  

Abstract Background: Relapsed/refractory (R/R) DLBCL is associated with high healthcare resource utilization (HRU) and cost (Danese 2017). Patients with R/R DLBCL have poor outcome with median OS <10 months (Van den Neste 2015). As transformative therapies are being developed for these patients, resource utilization may become an issue. Liso-cel is an investigational defined composition, CD19-directed 4-1BB CAR T cell product administered at a precise dose of CD8 and CD4 CAR T cells in a multicenter, seamless design Phase 1 pivotal trial of (R/R) DLBCL (TRANSCEND NHL 001; NCT02631044). In a recent analysis with 6 months follow-up, liso-cel treatment demonstrated a best overall response rate of 75% (55% CR) with low rates of severe cytokine release syndrome (1%) and neurologic events (13%) (Abramson 2018). The objective of this analysis is to characterize HRU, including site of care, associated with liso-cel in an interim analysis of the TRANSCEND pivotal trial. Methods: Eligible patients with R/R DLBCL, PMBCL, FL grade 3B, or MCL (≥18 years who received ≥2 lines of therapy) and adequate organ function (no minimum ALC requirement for apheresis) received lymphodepletion (LD) with fludarabine and cyclophosphamide, followed by a single flat-dose infusion of liso-cel at one of two dose levels (DL1, 5 × 107 cells; DL2, 1 × 108 cells). Clinical site of care for liso-cel infusion was not protocol-defined. HRU was collected at all sites. Results: 94 patients (91 patients in the efficacy database and 3 patients from the safety database that were not in the electronic clinical as of data cut) were included in the preliminary site of care analysis. 86 patients received liso-cel in the inpatient setting and 8 patients in the outpatient setting. Mean (SD) number of hospital days was 15.6 (9.6) and 9.3 (11.9) among patients receiving inpatient and outpatient liso-cel infusion, respectively, reflecting a 40% lower duration in mean hospital days. The median time to hospitalization following outpatient infusion was 5 days (range: 4-22). No patients infused in the outpatient setting required subsequent ICU care or received corticosteroids, and only one received tocilizumab for cytokine release syndrome (CRS). Of all treated patients in the efficacy database (n=91), 12% (11/91) of patients required ICU care for management of toxicity, including 10% (9/91) for CRS or neurotoxicity and 3% (3/91) for management of acute respiratory events. Rates of hemofiltration and ventilation for patients in this cohort were 2% (2/91) and 7% (6/91), respectively. Outcomes based on site of administration will be presented (based on longer follow-up). Conclusions: CAR T cell therapy represents an additional treatment option for patients with R/R DLBCL. Liso-cel has been infused in both the inpatient and outpatient setting. Outpatient infusion was associated with 40% lower mean hospital days compared with infusions administered in the inpatient setting. As enrollment is ongoing, updated data will be reported. Disclosures Palomba: Celgene: Consultancy; Pharmacyclics: Consultancy. Garcia:Juno Therapeutics, a fully owned subsidiary of Celgene: Employment, Equity Ownership. Wang:Juno Therapeutics, a fully owned subsidiary of Celgene: Employment, Equity Ownership. Dehner:Juno Therapeutics, a fully owned subsidiary of Celgene: Employment, Equity Ownership. Chung:Juno Therapeutics, a fully owned subsidiary of Celgene: Employment. Maloney:Janssen Scientific Affairs: Honoraria; GlaxoSmithKline: Research Funding; Seattle Genetics: Honoraria; Juno Therapeutics: Research Funding; Roche/Genentech: Honoraria.


10.36469/9791 ◽  
2018 ◽  
Vol 6 (1) ◽  
pp. 96-112 ◽  
Author(s):  
Sue Perera ◽  
Shibing Yang ◽  
Marni Stott-Miller ◽  
Joanne Brady

Background: This retrospective cohort study aimed to describe and quantify healthcare resource utilization and costs for patients with ulcerative colitis (UC) and Crohn’s disease (CD) following initiation of biologic therapy. Methods: Resource utilization and costs were analyzed at baseline and 1- and 2-years after initiating a biologic. Data were extracted from a US administrative health insurance claims database for adults ≥18 years. Eligible patients were continuously enrolled in a health plan with medical and pharmacy benefits for ≥12 months prior to, and 12 months (primary analysis) or 24 months (secondary analysis) after index date (biologic initiation). Results: In total, 4864 and 2692 patients with UC, and 8910 and 5227 patients with CD were identified in the 1- and 2-year follow-up cohorts, respectively. Of 1-year follow-up cohort patients, 45% received the same biologic initiated at index for ≥1 year. Infliximab and adalimumab were the most commonly initiated biologics in patients with UC or CD. The highest proportion of patients who continued with the same biologic after 1-and 2-years had initiated therapy with infliximab for both indications (although at the 1-year follow-up for CD, the highest proportion continued to use natalizumab, but this was a small sample [n=15]). Generally, the proportion of patients having inpatient admissions and emergency department (ED) visits decreased after receiving the same biologic for 1 year compared with baseline, although the proportion having outpatient visits did not change. Mean per patient all-cause costs for inpatient hospitalizations, ED visits and outpatient visits decreased for patients with UC or CD who received the same biologic for 1 year, while mean pharmacy costs per patient increased. Conclusions; This descriptive analysis shows that although biologics effectively reduced inpatient and ED resource utilization and corresponding costs in patients with UC and CD, total management costs increased, driven by increased pharmacy costs.


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