scholarly journals Time to Next Treatment, Healthcare Resource Utilization, and Healthcare Costs Among Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Following First-Line Ibrutinib

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 4016-4016
Author(s):  
Swetha Challagulla ◽  
Bruno Emond ◽  
Raisa R. Volodarsky ◽  
Alex Young ◽  
Ameur Manceur ◽  
...  

Abstract Background: Ibrutinib is an oral once-daily Bruton's tyrosine kinase inhibitor (BTKi) and is the only targeted treatment that has demonstrated significant progression-free survival (PFS) and overall survival (OS) benefit in multiple phase 3 trials for chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). With ibrutinib established as a preferred first-line (1L) treatment option, it is important to better understand the treatment sequence after 1L ibrutinib and the characteristics of patients who are treated with a second-line (2L) therapy. Using a real-world US administrative claims database, this study aimed to compare time to next treatment (TTNT), healthcare resource utilization (HRU), and healthcare costs between different 2L treatment regimens (cohorts) used after ibrutinib. Methods: Adults with CLL/SLL treated with 1L ibrutinib were identified in a US claims database (Optum's de-identified Clinformatics ® Data Mart Database; 02/12/2013-03/31/2020). Those receiving a 2L therapy were considered eligible for the study. Retreatment with ibrutinib, in-class switch to another BTKi, or treatment with anti-CD20 immunotherapy-only were not considered eligible 2L treatment options for this evaluation. The most commonly used treatment regimens were categorized into the following clinically-relevant treatment cohorts: 1) chemoimmunotherapy (CIT) or chemotherapy (CT)-only, and 2) venetoclax (VEN)- or idelalisib (IDELA)-based regimens (monotherapy or combination regimens). Comparisons of TTNT, HRU (inpatient admissions, outpatient visits, emergency room visits, other ancillary services), and per patient per month healthcare costs (inpatient admissions, outpatient visits, emergency room visits, other ancillary services, pharmacy) were evaluated based on the sum of the payer and patient paid amount during 2L treatment. Comparisons were adjusted using multivariate regression including confounders observed in the baseline period and during 1L ibrutinib therapy. For costs and HRU, 95% confidence intervals and p-values were obtained from 499 bootstrap resamples. Results: A total of 132 CLL/SLL patients who received ibrutinib as a 1L treatment and had a subsequent eligible 2L therapy were included; mean age was 74 years old, 64% were male. Eligible patients received 2L CIT/CT-only (63/132, 48%), or VEN/IDELA-based regimens (69/132, 52%). TTNT was significantly longer for 2L VEN/IDELA-based regimens than for CIT/CT (hazard ratio at 12 months: 0.37; P=0.0337) (Figure 1). The number of outpatient visits for antineoplastic drug administration was significantly lower for patients receiving 2L VEN/IDELA-based regimens compared to CIT/CT (rate ratio=0.44; P=0.004). Total mean monthly healthcare cost (includes CLL/SLL and non-CLL/SLL-related medical/pharmacy costs) was $1,754 higher, but not significantly different (P=0.593), for patients receiving VEN/IDELA-based regimens compared with CIT/CT (Figure 2). Total mean monthly medical cost (non-pharmacy) was significantly lower ($-5,202; P=0.036) for patients receiving VEN/IDELA-based regimens compared to CIT/CT (Figure 2). Conclusions: This study demonstrates that VEN/IDELA-based regimens may be a more viable treatment option post-1L ibrutinib use for CLL/SLL patients compared to CIT/CT. When compared to 2L CIT/CT, use of VEN/IDELA-based regimens post-1L ibrutinib use was associated with significantly longer TTNT and lower medical costs, signifying reduced disease burden to the patients and lessened burden to the healthcare system. These findings also suggest that treatment convenience associated with 2L oral targeted regimens may play an important role in improving treatment outcomes. These results support the need for evaluating treatment sequencing strategies in the real-world setting to further improve clinical outcomes and reduce the burden of total cost of care for patients with CLL/SLL. Figure 1 Figure 1. Disclosures Challagulla: Pharmacyclics LLC, an AbbVie Company: Current Employment; AbbVie: Current equity holder in publicly-traded company. Emond: Janssen: Consultancy; Novartis: Consultancy; Pfizer: Consultancy; Pharmacyclics LLC, an AbbVie Company: Consultancy; GlaxoSmithKline: Consultancy. Volodarsky: Pharmacyclics LLC, an AbbVie Company: Current Employment; AbbVie: Current equity holder in publicly-traded company. Young: AbbVie: Current equity holder in publicly-traded company; Pharmacyclics LLC, an AbbVie Company: Current Employment. Manceur: AbbVie: Consultancy; Actelion, part of the Janssen Pharmaceutical Companies of Johnson & Johnson: Consultancy; Bristol-Myers Squibb: Consultancy; Daiichi-Sankyo: Consultancy; Janssen: Consultancy; Novartis: Consultancy; Pharmacyclics LLC, an AbbVie Company: Consultancy. Karve: AbbVie: Current Employment, Current equity holder in publicly-traded company.

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.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18696-e18696
Author(s):  
Ali McBride ◽  
Shoshana Daniel ◽  
Maurice T. Driessen ◽  
Agota Szende ◽  
Azhar Choudhry ◽  
...  

e18696 Background: Rituximab is a chimeric anti-CD20 monoclonal antibody therapy, used primarily for treating chronic lymphocytic leukemia (CLL) and non-Hodgkin’s lymphoma (NHL). Rituximab-abbs, the first rituximab biosimilar, was approved in the UK in 2017 and was expected to significantly reduce drug acquisition costs, but there is a lack of real-world evidence regarding patient outcomes with rituximab-abbs. This non-interventional study assessed the real-world effectiveness and tolerability of rituximab-abbs and rituximab in treatment-naive patients with CLL or NHL. Methods: Anonymized data on patient characteristics, response to treatment, healthcare resource utilization and costs were abstracted retrospectively via an online physician survey. UK-registered hematologists and oncologists reported on randomly selected patients aged ³18 years from four cohorts with documented CLL or NHL, who had received rituximab-abbs or rituximab as first-line immunotherapy (between January 1, 2018 and June 30, 2019). Patient outcomes data were provided from first treatment to the last date of follow-up available in the medical records. Results: In total, 46 physicians abstracted data from 201 patient charts. Demographic profiles of the cohorts were similar. For both treatments, the overall response rate (ORR) was very high for patients with CLL or NHL (Table) along with rates for six-month progression-free survival (96–98% across cohorts) and one-year survival (98–100% across cohorts). Most patients did not experience a grade ≥3 adverse event during treatment (54–66% across cohorts); the most common grade ≥3 adverse events were neutropenia, fatigue, anemia and infusion reactions. Healthcare resource utilization was similarly high across cohorts, driven by drug costs, diagnostic testing, oncologist office visits, and day case hospital admissions. Mean annual savings of approximately £1,000 per patient were seen with rituximab-abbs, attributable to first-line treatment costs. Conclusions: The originator (rituximab) and biosimilar (rituximab-abbs) products yielded comparable efficacy and tolerability in treating CLL and NHL in routine UK clinical practice, with rituximab-abbs demonstrating cost-savings. These findings should inform decision-makers on the potential for cost reductions where the biosimilar rituximab-abbs is available as a treatment alternative.[Table: see text]


Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 837-837
Author(s):  
Shaum Kabadi ◽  
Lisa Le ◽  
Stacey Dacosta Byfield ◽  
Temitope O Olufade

Abstract Background: CLL is one of the most common types of leukemia among adults. Treatment options for CLL have expanded in recent years, but few studies provide contemporary real-world data on treatment patterns, treatment-related adverse events (AEs) and the economic burden associated with these agents. This study aimed to evaluate treatment-related AEs and the healthcare resource utilization (HCRU) and cost associated with the current treatment for chronic lymphocytic leukemia (CLL). Methods: This retrospective study used medical and pharmacy claims from the Optum Research Database, a large national US database, to identify adults (≥ 18 years old) commercially insured and Medicare Advantage (MA) enrollees. The study included patients with CLL (≥ 2 medical claims at least 7 days apart between July 1, 2012, through May 30, 2017), at least 1 claim for systemic CLL-directed therapy and continuous enrollment for 12 months prior to (baseline period) and ≥ 1 month after the first observed CLL-directed therapy (index date). Patients with systemic CLL-directed therapy during the baseline period or undergoing stem cell transplantation during the entire study period were excluded from analysis. Up to 3 line of therapy (LOT) periods were captured based on timing and receipt of systemic CLL-directed therapy. Cohorts based on the most common regimens received, regardless of LOT sequence, were created. Potential treatment-related AEs (prevalent and incident conditions) during regimen cohorts were identified by ICD-9 and ICD-10 diagnosis codes in position 1 or 2 on claims. All-cause and AE-related healthcare resource utilization and costs (per patient per month (PPPM)) were examined. All analyses were descriptive. Results: A total of 3292 patients with CLL met all study criteria; 65% were MA enrollees and 35% were commercially insured. Mean age (standard deviation, [SD]) was 71 years (SD 11) with a baseline Charlson comorbidity index score of 3.5 (SD 1.9). During the study period, 31% of patients had ≥ 2 LOTs and 10% had ≥ 3 LOTs. The most common regimens (excluding rituximab maintenance therapy) observed by LOT were; bendamustine + rituximab (23%) during LOT1, ibrutinib (22%) during LOT2 and ibrutinib (17%) during LOT3. Among the study patients, 4,509 LOT periods (LOT1-LOT3) were observed. Of these periods, 3177 accounted for the 5 most common treatment regimens observed: rituximab (excluding maintenance therapy) (30%); bendamustine + rituximab (28%); ibrutinib (20%); obinutuzumab ± chlorambucil (14%); and cyclophosphamide + fludarabine + rituximab (8%). The most common AEs associated with these treatment regimens are reported in the Table. Conclusions: The most common regimen during LOT1 was bendamustine + rituximab, and was ibrutinib during LOT2 and LOT3.This study provides evidence that occurrence of AEs among patients with CLL receiving systemic anti-cancer therapy in the real-world setting is substantial and associated with significant health care cost. The economic burden associated with increased AEs underscores the need for treatments with fewer AEs. Figure. Figure. Disclosures Kabadi: AstraZeneca: Employment. Le:Optum: Employment; Optum/United Health Group: Equity Ownership. Dacosta Byfield:Optum/United Health Group: Equity Ownership; Optum: Employment. Olufade:AstraZeneca: Employment; AstraZeneca: Equity Ownership.


Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 1923-1923
Author(s):  
Matthew J. Matasar ◽  
Sheila Shapouri ◽  
Jamie T. Ta ◽  
Tu My To ◽  
Mei Wu ◽  
...  

Abstract Background: Follicular lymphoma (FL) is indolent and typically incurable, and patients (pts) often receive multiple lines of therapy (LOTs) throughout their lifetime (Batlevi et al. Blood Cancer J 2020). Options at relapse following first- or second-line anti-CD20 monoclonal antibody (MoAb)-containing regimens remain limited, although approved third- and later-line therapies (3L+) have become available. Few studies have estimated the real-world economic burden of pts with relapsed/refractory (R/R) FL requiring 3L+ treatment. The aim of this study was to examine real-world healthcare resource utilization (HRU) and costs among pts receiving FL therapies in the 3L+ setting. Methods: This retrospective cohort study used administrative claims data from the IQVIA PharMetrics ® Plus, a US commercial claims database. Adult pts who had ≥1 inpatient claim or ≥2 outpatient claims with an FL diagnosis from January 1, 2011 to September 30, 2020 were included. The final 3L+ population was identified by combining two groups: (1) pts newly initiating FL treatment (defined as systemic anti-cancer therapies listed in the National Comprehensive Cancer Network [NCCN] guidelines) between January 1, 2012 and September 30, 2017 and receiving any subsequent 3L FL treatment during the study period; and (2) pts who received a NCCN-recommended 3L+ FL phosphatidylinositol-3-kinase inhibitor (PI3Ki) between January 1, 2012 and March 30, 2020. Group 1 captured pts who received 3L FL therapies by a proxy algorithm for LOT (Optum 2018) based on NCCN guideline-listed therapies, and group 2 captured pts who received newer available PI3Kis, which are only approved in pts who have received ≥2 previous systemic FL therapies. The index date was the 3L treatment initiation date or the initial PI3Ki claim date. All pts had ≥12 months of pre- and ≥6 months of post-index continuous enrollment in medical and pharmacy benefits. Pts with other primary cancers or evidence of histological transformation during the pre-index period, or clinical trial participation during the study period were excluded. All-cause HRU and all-cause and FL-related (i.e. claim with a FL diagnosis in any position) costs (2020 USD) were annualized during the 3L+ treatment period (defined as the period from index 3L+ treatment until the end of the LOT) to mitigate the effects of different follow-up times. Results: Overall, 100 pts who initiated 3L+ FL treatment were included. Of these, 51% of pts were male, and the mean (standard deviation [SD]) age at index and Charlson Comorbidity Index (non-cancer) at baseline were 62 (10.1) years and 0.9 (1.5), respectively. Mean follow-up time was ~2.3 years, and the mean duration of index 3L+ FL treatment was 273 days. Overall, 44 pts (44%) received subsequent treatment. The most common therapy classes received for index 3L+ FL treatment were oral PI3Kis (n=45, 45%), anti-CD20 MoAb monotherapy (n=19, 19%), and chemoimmunotherapy (CIT; n=18, 18%). A summary of all-cause annualized HRU in pts receiving index 3L+ FL treatment is provided by visit type (Table). For all 3L+-treated pts, mean (SD) all-cause annualized total healthcare costs in the 3L+ treatment period were $193,207 ($148,702), and 83% of total healthcare costs were FL-related costs ($159,815 [$138,477]; Figure). Of the most common 3L+ FL therapy classes, CIT had the highest FL-related mean annualized costs ($214,631 [$120,799]), followed by oral PI3Kis ($131,208 [$86,712]), and anti-CD20 MoAb monotherapy ($105,061 [$73,445]). Conclusions: The economic burden of pts with R/R FL requiring 3L+ FL treatment is substantial, with FL-related costs comprising the majority of total healthcare costs. More than 40% of the pts in this analysis needed subsequent treatment, further compounding the challenges faced by this high-risk population. This analysis provides an initial benchmark for ongoing and future evaluations of the economic value of currently available and emerging therapies for multiple relapsed FL, though future studies with larger sample sizes and longer follow-up are warranted. Figure 1 Figure 1. Disclosures Matasar: Pharmacyclics: Honoraria, Research Funding; Memorial Sloan Kettering Cancer Center: Current Employment; Merck Sharp & Dohme: Current holder of individual stocks in a privately-held company; Genentech, Inc.: Consultancy, Honoraria, Research Funding; Merck: Consultancy; GlaxoSmithKline: Honoraria, Research Funding; F. Hoffmann-La Roche Ltd: Consultancy, Honoraria, Research Funding; Juno Therapeutics: Consultancy; Janssen: Honoraria, Research Funding; Bayer: Consultancy, Honoraria, Research Funding; Teva: Consultancy; Takeda: Consultancy, Honoraria; Seattle Genetics: Consultancy, Honoraria, Research Funding; IGM Biosciences: Research Funding; Daiichi Sankyo: Consultancy; Rocket Medical: Consultancy, Research Funding; ImmunoVaccine Technologies: Consultancy, Honoraria, Research Funding; TG Therapeutics: Consultancy, Honoraria. Shapouri: F. Hoffmann-La Roche Ltd: Current equity holder in publicly-traded company; Genentech, Inc.: Current Employment. Ta: Genentech, Inc.: Current Employment. To: F. Hoffmann-La Roche Ltd: Current equity holder in publicly-traded company, Divested equity in a private or publicly-traded company in the past 24 months; Genentech, Inc.: Current Employment. Wu: Genentech, Inc.: Current Employment; F. Hoffmann-La Roche Ltd: Current equity holder in publicly-traded company. Wang: Genentech, Inc.: Current Employment; F. Hoffmann-La Roche Ltd: Current equity holder in publicly-traded company; Aurinia Pharmaceuticals Inc.: Current equity holder in publicly-traded company; Novavax, Inc.: Current equity holder in publicly-traded company; Oragenics, Inc.: Current equity holder in publicly-traded company; The SPHERE Institute: Ended employment in the past 24 months; TG Therapeutics, Inc.: Current equity holder in publicly-traded company.


2021 ◽  
Vol 104 (12) ◽  
pp. 1953-1958

Objective: Health care costs (HCCs) are a significant concern in developing countries. The authors investigated the healthcare resource utilization (HCRU) and HCCs for patients with COVID-19 based on disease severity and infection site. Materials and Methods: The authors reviewed data from the electronic medical records of COVID-19 patients admitted to the present study hospital between January 2020 and April 2020. The authors used comorbidities and patient characteristics as covariates. Analyses were conducted using simple linear regression and generalized linear regression models with a log-link and gamma distribution. Results: Two hundred two patients had confirmed SARS-CoV-2 infection. Total costs per patient were 6,626 USD (756 to 45,586). Personal protection equipment costs were the most significant cost for COVID-19 patients with a mean of 3,778 USD. The mean treatment cost per patient was 326 USD. Patients with severe symptoms and lower respiratory tract infection (LRI) had a higher cost and resource utilization value before and after adjusting for covariates. Conclusion: COVID-19 patients with severe symptoms and LRI had higher HCRU. Length of stay, severity of symptoms, and LRI were associated with higher cost of treatment. Keywords: SARS-CoV-2; COVID-19; Healthcare resource utilization; Healthcare costs; Thailand


10.36469/9889 ◽  
2014 ◽  
Vol 2 (1) ◽  
pp. 63-74
Author(s):  
Christopher M. Blanchette ◽  
Şerban R. Iorga ◽  
Aylin Altan ◽  
Jerry G. Seare ◽  
Ying Fan ◽  
...  

Background: Autosomal dominant polycystic kidney disease (ADPKD), a hereditary nephropathy, eventually leads to end-stage renal disease (ESRD), typically by mid-life. Objectives: The objective of this study was to assess real-world healthcare resource utilization and cost among commercially insured (COM) and Medicare Advantage (MAPD) ADPKD patients in addition to the cost profile by chronic kidney disease (CKD) stage. Methods: Patients diagnosed with ADPKD (two or more claims) with ≥30 days of continuous medical and pharmacy benefits and no evidence of autosomal recessive polycystic kidney disease were selected (Optum Research Database and Impact National Benchmarking Database: 1/1/06–8/31/12). Plan and patient paid healthcare costs and resource utilization per patient per month (PPPM) were described in total and by insurance type. CKD stage was established based on serum creatinine laboratory values or dialysis-related codes. Adjusted, CKD stage-specific costs were predicted for 4 years using regression models. Results: Of the 36,253,096 patients in the databases (1/1/06-8/31/12), 5,051 had evidence of ADPKD. Following exclusion criteria, 4,356 COM and 468 MAPD ADPKD patients remained. Total healthcare resource utilization and costs were high, and costs increased substantially from CKD stage 1–5. PPPM healthcare costs were 37% for ADPKD management and 52% for dialysis services. Predicted 4-year healthcare costs by CKD stage were $40,164 (stage 1), $33,397 (stage 2), $42,686 (stage 3), $148,402 (stage 4), and $207,548 (stage 5). Conclusions: Healthcare resource utilization and costs associated with ADPKD were substantial, irrespective of payer type, and primarily driven by CKD stage. Of the total healthcare costs, 88% were ADPKD- and dialysis-related. Most impactful was the spike in predicted cost when patients progressed from CKD stage 3 to stage 4 (by 348%) after multivariate adjustment. These stage 4–associated costs are primarily due to ultimate progression into stage 5 and ESRD within the 4-year time frame.


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