Total All-cause Costs Research Articles

S900 Real World Treatment (Tx) Patterns and Healthcare Costs Among U.S. Commercially Insured Adults Initiating Biologics for Ulcerative Colitis (UC)

Introduction: UC tx typically begins with conventional agents followed by advanced therapies if conventional agents are inadequate. However, it is unclear if current first-line biologics meet the needs of patients (pts). This study examined real-world tx patterns, clinical outcomes, and healthcare costs among US commercially insured pts with UC who newly initiated biologics. Methods: A retrospective analysis was conducted of MarketScan Commercial Claims data from 1/1/13 to 12/31/18. All pts with UC (18-64 years) who newly initiated biologics (adalimumab [ADA], infliximab [IFX], golimumab [GOL], vedolizumab [VED]) between 1/1/14 and 12/31/16 were identified. Suboptimal tx patterns (nonadherence, discontinuation, switching, dose escalation) and clinical outcomes (UC-related surgeries/hospitalizations, steroid use) were measured over 12 and 24 months following biologic initiation. Clinical outcomes and healthcare costs by suboptimal vs optimal tx pattern were also examined. Results: The final sample included 2,072 pts. Over 90% of pts received TNFi therapy (ADA [54%], IFX [32%], GOL [5%]); 8% used VED. Overall, the rate of suboptimal tx patterns was 69% over 12 months and 80% over 24 months. All subsequent results are over 24 months. Pts initiating IV biologics had lower rates of nonadherence, discontinuation, and switching (49%, 51%, and 14% [VED]; 51%, 54%, and 22% [IFX], respectively) vs pts initiating SC biologics (60%, 59%, and 25% [ADA]; 58%, 57%, and 27% [GOL]). While ADA and GOL switchers were more likely to be TNFi cyclers, VED and IFX switchers were most likely to switch to the other IV biologic. IFX initiators (33%) had the highest rate of dose escalation. There were no differences across biologics in rate/timing of UC-related surgeries/hospitalizations or steroid use. Pts with suboptimal tx patterns had higher rates of UC-related surgeries/hospitalizations (23% vs 6%), prolonged steroid use (6% vs 2%), or any steroid use (60% vs 38%) vs pts with optimal tx patterns. UC-related costs comprised >80% of all-cause costs. Pts with suboptimal tx patterns had higher total UC-related costs vs pts with optimal tx patterns; while UC-related pharmacy costs were lower, UC-related medical costs were higher. Total all-cause costs were highest for TNFi cyclers. Conclusion: Suboptimal tx patterns occur in most pts with UC who initiate biologics. Pts with suboptimal tx patterns had worse clinical outcomes and higher healthcare costs vs pts with optimal tx patterns.

Characteristics, treatment patterns, and economic burden of patients with metastatic cervical cancer receiving systemic anticancer therapy.

51 Background: In 2021, 14,480 patients are estimated to be diagnosed with cervical cancer in the US; 16% of patients are expected to have metastatic disease for whom the 5-year survival rate is 17.6% per SEER estimates. Patients with metastatic cervical cancer (mCC) are treated mainly with systemic therapy. This study aims to describe the clinical characteristics, demographics, treatment patterns, and economic burden of patients with mCC receiving systemic therapy. Methods: Eligible women had been diagnosed with cervical cancer, as evidenced by >2 outpatient or >1 inpatient claim in the Optum Research Database from January 2014 through January 2020. Patients were included if they had metastasis within 6 months before or after cervical cancer diagnosis, with evidence of systemic treatment on or after the latter of a claim date for cervical cancer disease or metastatic disease. The index date was the first-line treatment initiation date. Patients were required to have ≥6 months of pre-index continuous enrollment. The top 3 treatment regimens and median treatment duration by line of therapy were described. All-cause per-patient-per-month (PPPM) costs (2019 US dollars), including plan and patient paid amounts, were reported for full follow-up period from first-line and second-line therapy initiation. Results: The study sample consisted of 778 patients (mean age, 59 years; commercial, 58%; Medicare Advantage, 42%). The mean (median) follow-up period was 14 (9) months. Top baseline comorbidities were diseases of the urinary system (71%) and diseases of the female genital organs (70%), and the median Charlson comorbidity index was 7. In the first line, 80% of patients received platinum-based therapy and 23% received bevacizumab (bev). Of 778 patients, only 294 (38%) received second-line therapy, with 34% receiving bev. Top first-line treatment regimens were carboplatin + paclitaxel (27%), cisplatin (21%), and bev + carboplatin + paclitaxel (10%); the median (95% CI) duration of treatment was 3.4 (3.1-3.7) months. Top second-line treatment regimens were bev + carboplatin + paclitaxel (13%), carboplatin + paclitaxel (11%), and pembrolizumab (6%); the median duration of treatment was 3.8 (3.1-4.2) months. Mean all-cause total PPPM costs were $19,519 from first-line and $22,660 second-line therapy initiation (table). Conclusions: This study indicates that real-world mCC patients have short treatment durations and significant economic burden with first-line and second-line therapy. Novel therapies associated with greater clinical benefits in patients with mCC may provide economic benefit.[Table: see text]

Health Care Costs and Treatment Patterns Associated with Uterine Fibroids and Heavy Menstrual Bleeding: A Claims Analysis

Background:Heavy menstrual bleeding (HMB) is one of the most common distressing complications of uterine fibroids (UF); however, data on the health care costs for treatments in women experiencing HMB associated with UF are lacking. The objective of this study was to compare the direct costs and treatments patterns for women diagnosed with UF+HMB, UF only, and HMB only in the United States.Materials and Methods:The study design was retrospective matched cohort study using claims data. Women, aged 18–51 years, comprising four cohorts (HMB only, UF only, UF+HMB, and controls) were identified in the IBM MarketScan® Commercial Claims and Encounters Database (October 1, 2007‒September 30, 2018) and matched by demographics and Charlson Comorbidity Index score. Baseline characteristics and treatments during the 12 months post-diagnosis were summarized descriptively. Costs (2018 U.S. dollars) during the post-diagnosis year were compared using analysis of variance.Results:Before matching, women with UF+HMB represented 54% of UF cases. Following diagnosis, 32% in the matched UF+HMB cohort had no treatment, 49% underwent surgeries/procedures with (12%) or without (37%) medications, and 18% received medications only. The mean all-cause total costs for UF+HMB ($16,762) exceeded that for UF only by 24% ($13,506) and HMB only by 50% ($11,135), and almost tripled the mean cost for the control cohort ($6,691) (all, p < 0.001). The mean diagnosis-related costs were significantly higher for UF+HMB ($8,741) than for UF only ($4,550) and HMB only ($3,081) (all, p < 0.0001). Surgery/procedure costs comprised 80% of diagnosis-related medical costs for UF+HMB.Conclusions:UF with HMB were associated with significant economic burden, driven primarily by surgical/procedural costs and treatment patterns.

Frequency, severity and costs of flares increase with disease severity in newly diagnosed systemic lupus erythematosus: a real-world cohort study, United States, 2004–2015

ObjectiveTo evaluate frequency, severity and costs of flares in US patients with newly diagnosed SLE.MethodsAdults diagnosed with SLE between January 2005 and December 2014 were identified from US commercial claims...

Retrospective Analysis of Disease Severity, Health Care Resource Utilization, and Costs Among Patients Initiating Belimumab for the Treatment of Systemic Lupus Erythematosus

The goal of this study was to evaluate clinical and economic outcomes associated with the initiation of intravenous (IV) belimumab for the treatment of systemic lupus erythematosus (SLE) in clinical practice in the United States. This retrospective study used administrative claims data from the IBM MarketScan Commercial Claims and Encounters Database and the Medicare Supplemental and Coordination of Benefits Database. Data for patients with SLE who initiated (index) IV belimumab were collected for the 12 months before (pre-index) and the 12 months after (post-index) belimumab initiation. Outcomes included SLE disease severity and flares, all-cause health care resource utilization (HCRU) and health care costs, and hospital-based costs and service visits. Post hoc analyses of total hospital-based costs were conducted to further explore drivers of mean post-index costs. Baseline characteristics (N=908) are as follows: female, 93.4%; mean (SD) age, 45.6 (11.9) years; mean Charlson Comorbidity Index score, 0.9 (2.0); and moderate or severe disease, 94.9%. Disease activity (SLE flare episodes) was significantly reduced between the pre-index and post-index periods (severe flares, 16.4% vs 10.1% [P < 0.0001]; moderate flares, 92.1% vs 85.6% [P < 0.0001]; and mild flares, 77.4% vs 71.1%; [P=0.0003]). The proportion of patients receiving oral corticosteroids (OCS) was reduced between the pre-index and post-index periods, especially among patients at higher OCS thresholds (prednisone-equivalent dose: ≥60 mg/d, 7.3% vs 4.2%; >40 mg/d, 14.1% vs 7.9%). From the pre-index to the post-index period, few differences in HCRU were observed, although all-cause physician office visits, outpatient visits, and unique prescriptions filled increased significantly. In the 12-month post-index period, patients had a mean of 12.2 (9.0) encounters (eg, outpatient visit or prescription) associated with IV belimumab. All-cause total, medical, and pharmacy costs increased from the pre-index to the post-index period. Mean all-cause hospital-based costs increased from the pre-index to the post-index period ($7735 [26,603] vs $11,030 [88,086]; P=0.396). However, the 75th, 90th, and 95th percentile costs decreased from the pre-index to the post-index period ($305, $2107, and $3861, respectively). After initiation of IV belimumab, disease activity (number of moderate and severe SLE flares) and use of OCS were significantly reduced. However, HCRU and costs, including hospital-based costs, were generally greater in the post-index period. Further studies will increase understanding of SLE, with the specific goals of incorporating disease activity measures and long-term outcomes in studies of HCRU, costs, and patient outcomes.

Economic Burden in US Patients with Relapsed or Refractory Classical Hodgkin Lymphoma Treated with Brentuximab Vedotin or Chemotherapy after Failure of Autologous Hematopoietic Cell Transplantation

Introduction: Classical Hodgkin lymphoma (cHL) is a lymph node cancer of germinal center B-cell origin. Although most patients diagnosed with cHL are cured with multiagent chemotherapy (ChT), those with advanced-stage disease are more likely to harbor refractory disease or relapse. Brentuximab vedotin (BV) was approved by the FDA in 2011 for patients who have relapsed following autologous hematopoietic cell transplantation (auto-HCT), and for patients ineligible for auto-HCT who have received 2 prior lines of therapy. Real-world data are needed to understand the direct costs of medical care among patients with relapsed or refractory cHL treated with BV or ChT after auto-HCT failure.Methods: US patients with a primary diagnosis of cHL were identified from the Truven MarketScan® databases (Commercial, Medicare, and Medicaid) from August 1, 2011 to June 30, 2016 and followed until last visit. The BV cohort comprised all patients with observed BV use, while the non-BV cohort comprised patients who received ChT after auto-HCT but never received BV. Index therapy was defined as BV-based therapy for the BV cohort and first ChT after auto-HCT failure for the non-BV cohort, and the date of first claim for index therapy was defined as the index date. The BV cohort were further grouped into subcohorts based on any observed receipt of auto-HCT (BV alone vs BV + auto-HCT). Demographics were summarized and descriptively compared between cohorts. The total all-cause costs (inpatient, outpatient, and pharmacy claims) were assessed every 6 months in a 2-year period and also calculated using a standard cost per-patient-per-month (PPPM) metric over the entire follow-up period. All costs were inflated to 2016 US dollars.Results: 795 HL patients met the study eligibility criteria (mean age: 43.0 years; 58% male); 575 (72%) were in the BV cohort and 220 (28%) in the non-BV cohort. Median follow-up time for the BV and non-BV cohorts was 10.9 and 10.6 months, respectively. Patients in these 2 cohorts were similar in terms of sex and prevalence of multiple cancers (Table), although compared to those in the non-BV cohort, patients on BV were younger on average (mean age: 42.9 vs 45.9 years, p=0.0284). Mean PPPM all-cause medical costs were $51,245 for non-BV and $30,387 for BV. The use of BV was associated with higher mean PPPM all-cause pharmacy costs than non-BV ($17,934 vs $7645), but mean PPPM inpatient and outpatient costs were higher for non-BV than for BV ($35,165 vs $8021 and $8436 vs $4431, respectively).Within the BV cohort, 357 (62%) received BV alone and 218 (38%) received BV + auto-HCT. Similarly, there was no significant difference in sex and prevalence of multiple cancers between the 2 groups, although those treated with BV + auto-HCT were younger (mean age: 36.0 vs 47.1 years, p<0.0001) and were more likely to be insured with commercial insurance (72% vs 60%, p<0.0001) than those on BV alone. Mean PPPM total all-cause costs were $28,313 for patients treated with BV alone and $33,782 for patients treated with BV + auto-HCT. While mean PPPM pharmacy costs were similar between BV alone and BV + auto-HCT ($18,412 vs $17,152), mean PPPM inpatient and outpatient costs were both higher for BV + auto-HCT than for BV alone ($5992 vs $11,346 and $3909 vs $5285, respectively).Mean total direct medical costs were calculated at 6, 12, 18, and 24 months from index date for those with available follow-up over the corresponding time period. Costs were consistently higher for non-BV and BV + auto-HCT relative to BV alone. At 24 months, mean total all-cause costs reached $550,000 for non-BV, $497,000 for BV + auto-HCT, and $379,000 for BV alone. Inpatient, outpatient, and pharmacy represent approximately 69%, 16%, and 15% of total all-cause costs for non-BV; 34%, 16%, and 51% for BV + auto-HCT; and 21%, 14%, and 65% for BV alone. These patterns were relatively consistent across all 4 timepoints considered (Table).Conclusions: While drug acquisition costs result in higher pharmacy costs for patients receiving newer agents, lower medical costs (including costs of inpatient and outpatient care for the management of cHL, cHL-related events, and other clinical conditions) may be associated with the use of newer efficacious therapies with potentially lower toxicity; thus, the use of newer agents may lead to overall cost savings.Study support: Bristol-Myers Squibb. [Display omitted] DisclosuresChen:Bristol-Myers Squibb: Employment. Johnston:Bristol Myers Squibb: Consultancy. Szabo:Bristol Myers Squibb: Consultancy. Connors:Bayer Healthcare: Research Funding; Cephalon: Research Funding; Takeda: Research Funding; Seattle Genetics: Research Funding; NanoString Technologies, Amgen, Bayer, BMS, Cephalon, Roche, Genentech, Janssen, Lilly, Merck, Seattle Genetics, Takeda,: Research Funding; Amgen: Research Funding; Bristol-Myers Squibb: Research Funding; NanoString Technologies: Research Funding; F Hoffmann-La Roche: Research Funding; Genentech: Research Funding; Lilly: Research Funding; Merck: Research Funding; Janssen: Research Funding. Yasenchak:Seattle Genetics: Consultancy; Bristol-Myers Squibb: Consultancy.

Comparison of Healthcare Resource Utilization and Costs Related to Infections between Patients Newly Diagnosed with Chronic Myeloid Leukemia Treated with Dasatinib and Nilotinib As First-Line Therapy in the United States

Introduction:In the past decade, targeted inhibition of BCR-ABL1 with tyrosine kinase inhibitor therapies (TKIs) has become the standard-of care for treatment of chronic myeloid leukemia (CML). Second-generation TKIs, including dasatinib and nilotinib, have been shown to be more effective treatment options over imatinib and are approved as first-line therapies for newly diagnosed patients (pts) with Philadelphia chromosome positive CML in chronic phase (CP) and as second-line therapies for pts in CP and accelerated phase resistant to or intolerant to prior therapy. Although TKIs have been demonstrated to prolong overall and progression-free survival, there is evidence that TKIs may be associated with an increased risk of infections. This risk of infections can occur with or without neutropenia and is potentially due to an immunosuppressive effect from off-target activity of the treatment (Reinwald 2016). The real-world healthcare resource utilization (HRU) and costs related to infections have not been well studied, particularly in pts diagnosed with CML treated with second generation TKIs. To address this gap, this study compared HRU and costs of pts receiving dasatinib or nilotinib in first-line therapy for CML, with a focus on infection-related economic outcomes.Methods:Adult pts newly diagnosed with CML who were initiated on dasatinib or nilotinib as first-line therapy on/after October 2010 were identified from 2 large US administrative claims databases (2006-2016). First-line TKI initiation was defined as the index date, the 6-month period before the index date was defined as the baseline period, and pts were observed from index date until the end of first-line TKI therapy (i.e., discontinuation, switch, end of data availability/continuous health plan enrollment). HRU, including inpatient (IP) days, emergency room (ER) visits, and days with outpatient (OP) services, and associated healthcare costs from a payers' perspective (USD 2016) were measured during first-line TKI therapy. All-cause HRU and costs and those related to infections of any type, identified using diagnosis recorded in medical claims, were compared between dasatinib and nilotinib pts using multivariate regression models.Results:A total of 1,156 dasatinib and 677 nilotinib pts met the sample selection criteria. Mean age was 52 years and 54% were male in both cohorts (p>.05). Mean TKI therapy duration was 13.6 months for dasatinib and 15.5 months for nilotinib (p=.014).On average, dasatinib pts had 2.7 all-cause IP days annually, where 1.4 (52%) were related to infections; nilotinib pts had 1.3 all-cause IP days annually, where 0.6 (46%) were related to infections. Dasatinib pts had 90% more all-cause IP days (adjusted IRR=1.9; p=.003) and 2 times more IP days related to infections (adjusted IRR=2.1; p=.020) than nilotinib pts (Figure 1). On average, dasatinib pts had 0.7 all-cause ER visits annually, where 0.2 (29%) were related to infections; nilotinib pts had 0.6 all-cause ER visits annually where 0.1 (16%) were related to infections. Dasatinib pts had 30% more all-cause ER visits (adjusted IRR=1.3; p=.041); 2 times more ER visits related to infections (adjusted IRR=2.1; p<.001) than nilotinib pts (Figure 1). On average, dasatinib pts had 27.5 days with all-cause OP services annually, where 1.6 (6%) were related to infections; nilotinib pts had 26.0 all-cause days with OP services annually where 1.5 (6%) was related to infections (difference not statistically significant).On average, the annual all-cause total cost was $157,767 for dasatinib pts with $37,110 (24%) for medical service costs and $120,657 (76%) for pharmacy costs. Of this total cost, $10,943 (7%) was related to infections. On average, the annual all-cause total cost was $136,290 for nilotinib pts with $24,508 (18%) for medical service costs and $111,782 (82%) for pharmacy costs. Of this total cost, $7,620 (6%) was related to infections. Dasatinib pts incurred higher all-cause total costs by $17,265 per patient per year compared to nilotinib pts (adjusted cost difference; p=.004); where $6,572 (38%) of the difference was related to infections (adjusted cost difference; p=.004; Figure 1). Overall, among pts with infection, the average cost related to infection during first-line TKI therapy was $9,637.Conclusion:Dasatinib was associated with higher HRU and healthcare costs, particularly related to infections, compared to nilotinib. [Display omitted] DisclosuresSeiter:Novartis: Consultancy, Honoraria, Speakers Bureau; Incyte: Consultancy, Honoraria, Speakers Bureau; Celgene: Honoraria, Research Funding, Speakers Bureau. Latremouille-Viau:Analysis Group, Inc.: Employment; Novartis: Other: Analysis Group, Inc. has received consulting fees from Novartis. Guerin:Novartis: Other: I am an employee of Analysis Group, which received consulting fees from Novartis; AbbVie Inc.: Other: I am an employee of Analysis Group, which received consulting fees from AbbVie ; Analysis Group, Inc: Employment. Ndife:Novartis Pharmaceuticals Corporation: Employment. Habucky:Novartis: Employment. Joseph:Novartis Pharmaceuticals Corporation: Employment; Pfizer: Other: stock/stock options; Amgen: Other: stock/stock options; Express Scripts: Other: stock/stock options. Pivneva:Analysis Group, Inc: Employment; Novartis: Other: Analysis Group, Inc. has received consulting fees from Novartis. Gagnon-Sanschagrin:Novartis: Other: Analysis Group, Inc. has received consulting fees from Novartis; Analysis Group, Inc.: Employment. Tang:Novartis: Employment, Equity Ownership.

Use of Extracorporeal Photopheresis (ECP) in the Treatment of Patients with Cutaneous T-Cell Lymphoma (CTCL), 2010-2015

Introduction: Extracorporeal photopheresis (ECP) is an immunotherapeutic procedure approved in the US for the treatment of skin manifestations of cutaneous T-cell lymphoma (CTCL); in Europe, ECP is also used for the treatment of additional conditions such as graft versus host disease (GvHD), organ transplant rejection, and selected autoimmune diseases. Developments in immune system/cell biology and publications of real-world ECP data have advanced the understanding of the effects of ECP as a cell-based immunomodulator. The National Comprehensive Cancer Network (NCCN) CTCL Treatment Guidelines as well as the European Organization for Research and Treatment of Cancer (EORTC) recommend ECP as systemic therapy, which can be used in combination with interferon and/or a retinoid. The objective of this study was to analyze real-world use of ECP in the treatment of patients with CTCL in the US between 2010 and 2015.Methods: A retrospective analysis was conducted using the Truven Health MarketScan® Commercial and Medicare Supplemental claims databases (2010-2015). Patients with CTCL undergoing systemic treatment, with 9 months continuous enrollment (3 months prior to and 6 months after the initiation of systemic treatment), were included. Patient demographics and clinical characteristics by type of systemic therapy (ECP vs non-ECP) were evaluated, as well as most prevalent comorbid conditions. ECP use, frequency, and duration, as well as proportions of patients using ECP as mono- or combination therapy, were described. Propensity score matching and multivariate regression analyses were conducted to compare key outcomes such as length of stay (LOS), hospitalization cost, and total cost associated with use of ECP while controlling for covariates.Results: Of the 2092 patients with CTCL who were receiving systemic treatment (12.6% of the total number of patients with CTCL [N=16,574]), 1106 patients were included who met the continuous enrollment criterion (mean age: 57.4 years; males: 57.1%). The top comorbid conditions were psoriasis (21.8%), organ transplant (12.2%), GvHD (7.5%), and scleroderma (2.5%). Of the 1106 eligible patients, 117 patients (10.6%) received ECP, with an average treatment duration of 13.6 months. ECP was used as monotherapy in 76 patients (65.0%) and combination in 41 patients (35%), mostly with interferon and/or a retinoid. Compared with non-ECP-treated patients (n=989), ECP-treated patients (n=117) had a significantly higher Charlson Comorbidity Index (CCI) score (2.6 vs 2.2, P <0.05), rate of organ transplant (49.6% vs 7.8%, P <0.05) and occurrence of GvHD (41.9% vs 3.4%, P <0.05). Generalized linear models (GLMs) were used to compare key outcomes (all-cause and CTCL-related LOS, hospitalization cost, and total cost) during the follow-up period, based on the pool of ECP-treated patients and propensity score matched non-ECP-treated patients. Results of GLMs indicated that ECP was associated with numerically lower all-cause and CTCL-related total LOS, all-cause hospitalization cost, and all-cause total cost while controlling for covariates.Conclusions: Results from this US claims-based analysis of recent data demonstrated that ECP was used as a systemic treatment in 10.5% of patients with CTCL, with an average duration of 13.6 months. ECP was used twice as often as monotherapy compared with combination uses. CTCL patients treated with ECP appeared to have increased clinical complexity, with higher CCI scores, rates of organ transplant, and occurrence of GvHD. However, patients treated with ECP had lower all-cause LOS as well as numerically reduced hospitalization and total costs. DisclosuresLing:Mallinckrodt Pharmaceuticals: Consultancy. Huang:Mallinckrodt Pharmaceuticals: Employment. Mitri:Mallinckrodt: Employment. Pham:University of California, School of Pharmacy: Employment; Mallinckrodt Pharmaceuticals: Employment. Lovelace:Mallinckrodt Pharmaceuticals: Employment. Knobler:Mallinckrodt Pharmaceuticals: Consultancy. Gao:Mallinckrodt Pharmaceuticals: Consultancy, Employment.

Adverse Events, Resource Use, and Economic Burden in Patients with Mantle Cell Lymphoma in the United States

Introduction : In patients with mantle cell lymphoma (MCL), adverse events (AEs) can impair patient adherence to planned therapeutic regimens. In addition, moderate to severe AEs generally require medical attention and therefore are often associated with increased health care resource use (HRU) and costs. Real-world data on HRU and costs associated with MCL and its treatments are sparse in current literature. The goals of this study were: (1) assess HRU and direct costs of MCL; (2) examine variation in costs across treatment types; and (3) document the economic burden associated with MCL treatment-related AEs.Methods :A retrospective cohort analysis was performed using MarketScan databases that contain employer- and health-plan-sourced administrative claims data, including information on diagnoses, procedures, and associated utilization of health care services for over 60 million privately insured individuals across the US. Cost information in the data include patient copay, coinsurance, charges, and the actual amounts paid by the payers. Patients were included if they were aged ≥18 years, had at least two medical claims on separate dates with a diagnosis code for MCL (ICD-9-CM code 200.4x or ICD-10-CM code C83.1x) during July 2010-June 2015, and were continuously enrolled in medical and drug plans for ≥12 months before the date of first MCL diagnosis (ie, study index date). Patients with evidence of MCL diagnosis or MCL treatment in the 12 months before the study index date were excluded. Mean per-patient monthly HRU and costs were assessed overall and by care setting (eg, inpatient, outpatient, pharmacy). Both all-cause and MCL-related costs were calculated; all cost data, adjusted to 2016 US dollars using the Medical Care component of the US Consumer Price Index, were assessed from the payer's perspective. The incremental HRU and costs associated with AEs were assessed by stratifying these measures according to patients' AE status (AE or no AE) and the number of AEs experienced (0, 1-2, 3-5, ≥6) during follow-up. Additionally, subgroup analyses were conducted to assess the association of AEs with mean HRU and costs among patients receiving specific regimens. All analyses were descriptive in nature.Results :In total, 783 patients with MCL (median age, 65 years [range, 19-99 years]) met the study selection criteria. Mean (standard deviation [SD]) all-cause and MCL-related monthly costs were $8393 ($16,276) and $6730 ($14,779), respectively. Inpatient admission costs ($4817 [$14,267]) and office visit costs ($1493 [$3250]) were the largest drivers of total all-cause costs. Among patients receiving systemic therapies, mean all-cause monthly costs were highest for rituximab/cyclophosphamide/doxorubicin/vincristine (R-CHOP), followed by ibrutinib monotherapy, bendamustine/rituximab (B-R), and rituximab alone (including rituximab maintenance therapy) (Figure 1); prescription drug costs were highest in patients receiving ibrutinib ($14,038 [$21,936]). The median length of stay per all-cause inpatient admission was 3.0 days (range, 2-4) among patients with no AE, which increased to 5.2 days (range, 1-50) among those with six or more AEs, as observed during all available follow-up (Figure 2). A corresponding increase in the length of stay per admission was also observed, with increasing numbers of AEs. The mean (SD) all-cause monthly costs were $4298 ($10,082) among those with no AEs and more than twofold higher ($10,335 [$16,868]) among those with at least six AEs during follow-up (Figure 3).Conclusions :This is the largest series of patients with MCL in which real-world economic burden data have been reported. Our results demonstrate that the economic burden of MCL is substantial, with mean monthly costs varying considerably by treatment regimen and care setting. We found that inpatient admissions and office visits were the largest drivers of total costs for patients treated with R-CHOP, B-R, and rituximab, while prescription drug costs were the largest component of total costs for patients receiving ibrutinib. Patients experiencing more AEs were observed to have higher monthly costs than those experiencing few AEs. [Display omitted] DisclosuresKarve:AstraZeneca: Employment, Other: Stocks. Nagar:RTI Health Solutions: Research Funding. Goyal:RTI Health Solutions: Research Funding. Kaye:RTI Health Solutions: Research Funding. Mato:Regeneron: Research Funding; TG Therapeutics: Membership on an entity's Board of Directors or advisory committees, Research Funding; Portola: Research Funding; Janssen: Consultancy; Pharmacyclics: Research Funding; DTRM: Research Funding; Celgene: Consultancy, Membership on an entity's Board of Directors or advisory committees; Gilead Sciences, Inc.: Membership on an entity's Board of Directors or advisory committees; AbbVie: Consultancy, Research Funding; Acerta: Research Funding; AstraZeneca: Consultancy; Kite: Consultancy.

Burden of illness and costs associated with eosinophilic granulomatosis with polyangiitis: evidence from a managed care database in the United States.

BACKGROUND: Data on the clinical and economic burden of eosinophilic granulomatosis with polyangiitis (EGPA) are limited. OBJECTIVE: To assess the real-world clinical and economic outcomes of patients diagnosed with EGPA vs patients with asthma (present in > 90% of EGPA cases) receiving treatment in the United States. METHODS: This retrospective cohort study (HO-17-17742) used administrative claims data (July 1, 2007-May 31, 2017) from the Optum Research Database. Eligible patients were aged at least 18 years at index (first date that patients met the EGPA or asthma cohort definition), with a minimum of 6 months of continuous health plan coverage before the index (baseline) period and 12 months following and including the index date (follow-up period). Patients with EGPA were identified either via published algorithms using claim code combinations for conditions and medications (before October 1, 2015) or via a claim with the EGPA ICD-10-CM code (M30.1, after October 1, 2015). Patients with asthma were identified based on ICD-9-CM and ICD-10-CM diagnosis codes and at least 3 pharmacy asthmarelated medication claims within a year of diagnosis. Outcomes included all-cause health care costs (primary), all-cause health care resource utilization (HCRU), systemic corticosteroid (SCS) use, and EGPA relapses requiring hospitalization and EGPA-related (based on EGPA-related HCRU) relapses during the follow-up period (all secondary). EGPA and asthma cohorts were matched (1:3) via propensity score matching based on demographic, insurance, and index timing covariates. RESULTS: 8,904 patients were included in the matched EGPA (n = 2,226) and asthma (n = 6,678) cohorts (mean [SD] age: 59.7 [14.2] vs 59.6 [14.7] years; Quan-Charlson Comorbidity Index scores: 1.8 [1.7] vs 0.8 [1.4]). During follow-up, mean (SD) all-cause costs ($49,593 [$88,161] vs $21,122 [$40,110]; P < 0.001), all-cause HCRU (P < 0.001), and the proportion of patients with 1 or more SCS claims (72.3% vs 66.9%; P < 0.001) were significantly greater in the EGPA vs asthma cohorts, respectively. Mean daily SCS dose (43.6-45.5 mg/day) was similar between cohorts; patients with EGPA had significantly (P < 0.001) longer periods taking SCS doses at least 4 mg/day (mean [SD]: 64.9 [95.6] vs 14.6 [39.3] days) and at least 7 mg/day (52.8 [82.0] vs 12.1 [30.6] days). 35.2% (n = 784/2,226) and 44.1% (n = 981/2,226) of patients with EGPA experienced a minimum of 1 EGPA relapse requiring hospitalization, and at least 1 EGPA-related relapse, respectively. Mean (SD) total all-cause costs were greater than 3-fold higher in patients with vs without a relapse requiring hospitalization ($92,825 [$128,562] vs $26,087 [$38,082]; P < 0.001) and for patients with vs without an EGPA-related relapse ($78,081 [$120,775] vs $27,145 [$35,584]; P < 0.001). CONCLUSIONS: Patients with EGPA have more comorbidities, greater health care costs and HCRU, and use SCS more frequently than patients with asthma. Additionally, more than one third of patients with EGPA experienced disease relapses over 12 months. These results highlight the high disease burden in patients with EGPA and the need for improved treatment options. DISCLOSURES This study was funded by GlaxoSmithKline (GSK ID: HO-17-17742). Bell is an employee of GSK and holds stock/share options in GSK. Blauer-Peterson is an employee of Optum, which was funded by GSK to conduct the study. Mao was an employee of Optum at the time the study was conducted. The authors report no other potential conflicts of interest. These data have previously been presented as a poster at the American College of Rheumatology/Association of Rheumatology Health Professionals Annual Meeting, Chicago, IL, October 19-24, 2018.

Real-World Claims Analyses of Comorbidity Burden, Treatment Pattern, Healthcare Resource Utilization, and Costs in Pediatric Psoriasis.

There are limited real-world data on treatment patterns, comorbidities, and healthcare burden in pediatric patients with psoriasis. We examined patient demographics, comorbidity burden, treatment patterns, and healthcare use and costs in pediatric psoriasis. A retrospective, real-world, exploratory study was conducted using US claims databases. Pediatric patients aged < 18years with newly diagnosed psoriasis (index date) were selected from IBM® MarketScan® databases (2016-2018). Patients were enrolled continuously for ≥ 12months pre- and post-index date. Pre-index demographics, comorbidity, treatment drug classes prescribed, and post-index healthcare resource utilization and costs were studied. Study measures are reported for total population and by severity (categorized as mild and moderate-to-severe psoriasis). Variables were compared using t-test (continuous) or chi-square and Fisher's exact test (categorical). Overall, 4754 pediatric patients with psoriasis (58.3% females) met the selection criteria and were included in the study. Mean and standard deviation (SD) age was 12.6 (3.7) years on index date, with 13.4% patients having moderate-to-severe psoriasis. The mean (SD) Deyo-Charlson Comorbidity Index was 0.14 (0.40); anxiety (6.6%), depression (4.1%), and obesity (3.9%) were the most prevalent comorbidities observed. Topical treatments were prescribed to most patients as first-line treatment of mild (79.1%) and moderate-to-severe (52.0%) psoriasis. Other first-line therapies prescribed in moderate-to-severe cases included non-biologic systemics (21.0%), phototherapy (15.0%), and biologics (9.2%). Healthcare use and costs increased with psoriasis severity during the post-index period. Mean annual total all-cause costs per patient were higher for patients with moderate-to-severe psoriasis compared with mild psoriasis ($27,541 vs. $5,034; P < 0.001). Psychiatric, metabolic, and inflammatory disorders were observed comorbidities in pediatric patients with psoriasis. For moderate-to-severe psoriasis, topicals, phototherapy, and biologics were a common first-, second-, and third-line treatment sequence. Higher unadjusted healthcare costs by severity were driven by outpatient prescription costs.

Real-world treatment sequencing and healthcare costs among CLL/SLL patients treated with venetoclax

Objective This study aimed to describe treatment sequencing and healthcare costs among chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) patients treated with venetoclax in a US managed care population. Methods CLL/SLL patients initiating venetoclax between 04/11/2016 and 06/30/2019 were selected from Optum’s de-identified Clinformatics Data Mart Database. Costs per-patient-per-month were described during the first 60 days of venetoclax-based treatment (initiation phase) and subsequent post-initiation phase. Based on venetoclax prescribing information, clinical event-related costs were identified through claims for tumor lysis syndrome (TLS) diagnosis, monitoring, prophylaxis, immunoglobulin treatment, neutropenia, thrombocytopenia, infection, renal impairment, hypertension, or cardiac arrhythmia. Statistical testing was not conducted due to small sample size. Results Twenty-five, 30, and 66 patients initiated venetoclax as their first observed regimen (1L), second observed regimen (2L), and third or later observed regimen (3L+), respectively. Most 2L (56.7%) and 3L+ (74.2%) venetoclax recipients previously received ibrutinib. Mean monthly all-cause costs during the initiation phase were $26,429 (1L cohort), $19,580 (2L cohort), and $23,918 (3L + cohort). Among the 2L cohort, mean monthly all-cause [clinical event-related] (including TLS) costs during initiation and post-initiation phases of venetoclax treatment were $15,506 [$6368] (initiation phase) and $14,318 [$5273] (post-initiation phase; median duration: 3.7 months) for patients receiving 1L ibrutinib, and $24,908 [$12,198] (initiation phase) and $16,905 [$7066] (post-initiation phase; median duration: 3.0 months) for patients not receiving 1L ibrutinib. Conclusions In this descriptive study, highest mean costs were observed during venetoclax initiation phase. Venetoclax patients previously receiving ibrutinib had lower mean total all-cause and clinical event-related (including TLS) costs during their venetoclax line of therapy than those previously receiving non-ibrutinib therapy.

PRO18 A Systematic Literature Review of the Economic Burden and Cost Drivers in Pulmonary Arterial Hypertension

The aim of this study was to identify cost drivers in Pulmonary Arterial Hypertension (PAH) in the US through a systematic literature review of economic and humanistic burden. A systematic literature review was conducted adhering to methodology published by the Cochrane Collaboration and the National Institute for Health and Clinical Excellence (NICE) in the UK. Population, Intervention & Comparators, Outcomes and Study Design (PICOS) criteria were used to identify resource utilization and economic burden studies in PAH published from credible databases (EMBASE, MEDLINE, MEDLINE In-Process) over the last 10 years. A total of 170 publications were extracted with most publications from the US. Total all-cause costs per patient per month (PPPM) in the US (all costs reported in 2019 $USD) were found to range from $2,494 to $11,037, driven primarily by medical costs. Medical costs accounted for a larger portion of total costs than pharmacy costs within both all-cause ($2,113 to $7,625 PPPM) and PAH-related ($293 to $5,086 PPPM) health care costs; among all-cause medical cost components, inpatient admission costs ($1,115 to $2,146 PPPM) contributed the highest costs, followed by outpatient costs ($954 to $1,944 PPPM). Although total costs increased after initiation of PAH therapies, increased pharmacy costs were partially offset by reduced medical costs ($1,506 to $57,409 decreased annual medical costs from baseline). Management of PAH carries a considerable economic burden with the major cost drivers consisting of primarily medical costs. All-cause costs vary widely in current literature, which may be due to heterogeneity in study population and cost components.

EC3 Economic Burden of Cardiovascular Events in Patients with Chronic Lymphocytic Leukemia Treated with Novel Agents

Novel agent treatments (NATs) have improved survival in chronic lymphocytic leukemia (CLL), but can be associated with increased cardiovascular (CV) events. This analysis examined real-world healthcare costs associated with CV events in CLL patients treated with NATs. Using US-commercial administrative claims data (IBM MarketScan), we compared unadjusted healthcare costs among CLL patients taking NATs with and without a CV event during treatment (CV vs. noCV). Inclusion criteria were adult CLL patients, evidence of NATs (acalabrutinib, duvelisib, ibrutinib, idelalisib, venetoclax) between November 2013-November 2019 (index date=earliest fill date), continuous enrollment for 6-months pre-index (baseline), and no evidence of NATs or trial participation during baseline. Annual all-cause and CV-related healthcare costs (adjusted to 2019 US dollars) were measured in a fixed 12-month follow-up period while per-patient-per-month (PPPM) costs were compared in variable-length pre/post-CV event periods. Of 1,886 CLL patients with NATs, 27.7% experienced a CV event during treatment, occurring a mean(SD) 103.0(93.9) days following NAT initiation. Almost half (47.1%) of CV patients had a CV event pre-index, the majority of which were hypertension. CV patients were older (71.7 vs. 65.8, p<0.001) and had a higher baseline NCI score (1.2 vs. 0.8, p<0.001) than noCV patients. Annual all-cause total healthcare costs were higher in the CV vs. noCV cohort ($203,349 vs. $165,144, p<0.001). Higher annual medical costs ($82,949 vs. $45,293, p<0.001) compensated for numerically lower NAT costs in CV vs. noCV cohort ($110,925 vs. $115,026, p=0.262). Pre-CV event, outpatient pharmacy PPPM costs contributed most to total healthcare costs; post-CV event, PPPM medical costs contributed more: outpatient pharmacy 74.8% vs. 38.8%, hospitalization 7.6% vs. 38.8%, and outpatient services 17.7% vs. 22.4%. In CLL patients with a CV event, higher medical costs compensate for decreased novel agent costs, suggesting increased medical management in addition to NAT discontinuation.

PMU8 The Economic Burden of Thromboembolic Events Among Patients with Immune-Mediated Diseases

Little is known about the economic burden of thromboembolic events [TE] among patients with immune-mediated diseases [IMD]. This study aimed to estimate the healthcare costs associated with TE among patients with IMD. Using the IBM MarketScan Commercial and Medicare-Supplemental Claims databases (2014-2018), adult patients with IMD were classified into two cohorts. Patients with TE (deep vein thrombosis, pulmonary embolism, myocardial infarction, ischemic stroke) were matched 1:1: on IMD type, age, sex, and year of IMD to patients without TE. The index date was the date of the first TE following the first IMD diagnosis for patients with TE and was calculated based on time from first IMD diagnosis to index date of the matched patient with TE for patients without TE. The baseline period was the 6-month period prior to index, and the study periods were the 30-day and 1-year periods following index. Outcomes included all-cause and TE-related healthcare costs during the study periods. Unadjusted comparisons were conducted using Wilcoxon signed-rank tests, and adjusted results were estimated using generalized estimating equations, adjusting for baseline demographics and clinical characteristics. There were 9,681 matched pairs (mean age 61.1 years, 63.7% female) included in the study. Patients with TE had higher proportions of comorbidities than patients without TE (i.e., Charlson comorbidity index [1.5 v 0.9], p<0.0001). Adjusted all-cause total healthcare costs in the 30-day and 1-year study periods were higher among patients with TE compared to patients without TE (cost differences: 30-day: $17,574; 1-year: $36,459; both p<0.0001), and were driven by inpatient costs. TE-related costs were $15,955 and $20,239 in the 30-day and 1-year study periods, respectively. Among patients with IMD, TE are associated with a substantial economic burden within the 30-day and 1-year periods following a TE. Risk reduction of TE has both clinical and economic benefits.

PIN15 Real-World Healthcare Costs of Patients Receiving Dolutegravir/Lamivudine and Other Single Tablet Regimens for the Treatment of HIV-1 in the US

Dolutegravir/lamivudine (DTG/3TC) is a two-drug regimen FDA-approved in 2019 and currently, the lowest priced single-tablet regimen (STR) based on wholesale acquisition costs. This study evaluates healthcare costs of DTG/3TC users compared to current standard of care three- or four-drug STRs. This retrospective study used IQVIA PharMetrics® Plus claims (1/1/2015–3/31/2020) from US adult patients with a diagnosis of HIV, ≥1 dispensing of DTG/3TC, ABC/DTG/3TC, BIC/FTC/TAF, EVG/COBI/FTC/TAF, or DRV/COBI/FTC/TAF on or after 04/08/2019 (approval of DTG/3TC for HIV; index date=first dispensing), and ≥6 months of continuous eligibility pre-index. All-cause and HIV-related healthcare costs were reported per-patient-per-month (PPPM) to account for varying lengths of follow-up. Adjusted cost ratios (aCR) were estimated using multivariate models adjusting for differences in baseline characteristics between cohorts. Analyses were further stratified by treatment-naïve and treatment-experienced. A total of 22,061 patients met study criteria (590 DTG/3TC, 4,355 ABC/DTG/3TC, 9,068 BIC/FTC/TAF, 7,081 EVG/COBI/FTC/TAF, and 967 DRV/COBI/FTC/TAF). Mean age was similar across all cohorts (45.6–46.3 years) and mean follow-up period ranged 4.4–9.5 months. Mean all-cause total healthcare costs PPPM were significantly lower for DTG/3TC users compared to users of BIC/FTC/TAF ($3,368 vs. $3,783; aCR:0.77), EVG/COBI/FTC/TAF ($3,368 vs $3,456; aCR:0.70), and DRV/COBI/FTC/TAF ($3,368 vs. $4,029; aCR:0.78; all p<0.001), and similar to users of ABC/DTG/3TC ($3,368 vs. $3,322; aCR:0.97; p = 0.689). Across all comparisons, cost differences were primarily driven by significantly lower pharmacy costs (BIC/FTC/TAF: $2,595 vs. $3,116, aCR:0.76; EVG/COBI/FTC/TAF: $2,595 vs. $2,965, aCR:0.75; DRV/COBI/FTC/TAF: $2,595 vs. $3,558, aCR:0.69; ABC/DTG/3TC: $2,595 vs. $2,760, aCR:0.83; all p < 0.001). Similar trends were observed among the subgroups of treatment-naïve and treatment-experienced patients. Patients treated with DTG/3TC had substantially lower (22–30%) healthcare costs compared to current standard of care STRs, although similar costs to ABC/DTG/3TC, highlighting the economic benefits of its use with sustained management of HIV infection.

Retrospective real-world comparison of clinical and economic burden between first-generation and second-generation tyrosine kinase inhibitors (TKIs) in chronic myeloid leukemia (CML).

e19030 Background: TKIs are the standard of care for the treatment of chronic phase CML under National Comprehensive Cancer Network (NCCN) guidelines. Imatinib is recommended as a first-generation TKI (1GTKI), and bosutinib, dasatinib, nilotinib, and ponatinib are recommended as second-generation TKIs (2GTKIs). TKIs are associated with high healthcare resource utilization (HRU) and costs, although literature is limited comparing 1GTKI and 2GTKIs in a U.S. population. Methods: Using the Veteran’s Health Administration (VHA) database between April 1, 2013 and March 31, 2018, the study included patients aged ≥18 years with ≥1 medical claim for CML and ≥1 prescription claim for a TKI on or after the initial CML diagnosis date during the identification period (October 1, 2014 to September 30, 2017); the first TKI prescription claim was defined as the index date. Inverse probability of treatment weighting (IPTW) minimized potential confounding; included variables were age, race, Quan-Charlson Comorbidity Index (CCI) score, and CHA2DS2-VASc Score. Medication possession ratio (MPR) assessed adherence to index TKI; optimal adherence was defined as MPR ≥80%. Results: 944 patients were included: 78.9% on 1GTKI and 21.1% on 2GTKI. Mean age was 62.21 years (SD:18.8); 77.2% were white. At baselinetients on 1GTKI had a higher comorbidity burden than 2GTKIs: COPD (19.7% vs. 8%; p &lt; 0.01), anemia (17.7% vs. 11.1%; p = 0.02), GI symptoms (28.5% vs. 18.6%; p &lt; 0.01), cardiac dysrhythmias (15.6% vs. 7.5%; p &lt; 0.01), coronary artery disease (26.3% vs. 13.6%; p &lt; 0.01), hypertension (55.7% vs. 43.2%; p &lt; 0.01) and CHA2DS2-VASc Score (2.2 vs 1.6; p &lt; 0.01). Optimal adherence was higher with 1GTKI (69.6% vs. 62.2%; p = 0.04), although this was not statistically significant when mean MPR was compared. During follow-up, no difference between 1GTKI and 2GTKIs patients occurred with cardiac-related risk factors or CHA2DS2-VASc Score. Compared to 1GTKI, 2GTKIs had lower medical (inpatient and outpatient) costs ($3,162 vs. $3,906; p = 0.04) but higher all-cause pharmacy cost ($7,214 vs. $3,895; p &lt; 0.01) due to imatinib becoming a generic drug during the study period. CML-related ($2,260 vs. $1,640, p &lt; 0.01) and cardiac-related medical costs ($1,365 vs. $665, p &lt; 0.01) were significantly higher in 1GTKI vs. 2GTKIs patients. Conclusions: Adherence to TKI therapy was suboptimal for both 1GTKI and 2GTKIs. 2GTKIs incurred lower medical cost in comparison to 1GTKI. Differences in total all-cause cost was primarily driven by pharmacy cost of TKIs. These results show that, beyond the cost of the TKI, using a 2GTKIs in the first-line can lead to cost offsets when compared to imatinib.

Healthcare utilization and costs associated with first-line treatment with obinutuzumab- and rituximab-based regimens for follicular lymphoma.

e19536 Background: Current real-world data on healthcare utilization (HCU) and costs of common first-line (1L) follicular lymphoma (FL) regimens, including obinutuzumab (G), remain limited. The aim of this study was to examine real-world HCU and costs for the most common National Comprehensive Cancer Network (NCCN)-recommended 1L FL treatments. Methods: This was a retrospective cohort study using administrative claims data from the IQVIA PharMetrics Plus and IBM MarketScan Commercial and Medicare Supplemental databases. We identified patients (pts) ≥18 years, who had ≥1 inpatient claim or ≥2 outpatient claims, with a diagnosis of FL from February 1, 2015 to March 31, 2020, and had received 1L FL treatment (per NCCN guidelines) between February 1, 2016 and September 30, 2019. The first claim for FL treatment was the index 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, FL treatment, or stem cell transplant during the pre-index period, and clinical trial participation or end-stage renal disease during the study period were excluded. All-cause HCU and costs (2020 USD) per pt during the 6-month post-index period were reported for the five most common 1L FL regimens (only complete NCCN regimens were considered). Results: Overall, 1991 pts met the eligibility criteria, and 53% were male. The mean (standard deviation [SD]) age and Charlson Comorbidity Index at index were 58 (10.4) years, and 1.7 (1.0), respectively. The most common 1L regimens were rituximab-bendamustine (R-benda; n=818 [41.1%]), R-monotherapy (R-mono; n=592 [29.7%]), R-CHOP (n=461 [23.2%]), G-benda (n=86 [4.3%]), and R-CVP (n=34 [1.7%]). The proportion of pts who had ≥1 hospitalization or an emergency room visit was highest with R-CHOP (26.7% and 33.6%, respectively) and lowest with R-mono (11.3% and 18.1%, respectively). Mean (SD) all-cause total healthcare costs were highest with R-benda and G-benda, followed by R-CHOP, R-CVP, and R-mono (Table). Mean (SD) all-cause medical and FL treatment costs (drug and administration) were highest for R-benda ($174,407 [$110,520]; $135,520 [$96,492]) and lowest for R-mono ($87,368 [$83,910]; $54,271 [$40,433]). Conclusions: This real-world study provides an update on HCU and costs among pts initiating current NCCN-recommended 1L treatment for FL. Unadjusted 6-month total healthcare costs were highest with R-benda, followed by G-benda, while the lowest costs were seen with R-CVP and R-mono. Future studies with adjustment for pt characteristics are needed to compare HCU and costs between FL regimens.[Table: see text]

Healthcare utilization and costs associated with cancer-related diarrhea.

e18623 Background: Diarrhea is a common toxicity of cancer treatments, including radiotherapy, chemotherapy, and/or targeted therapies. Cancer-related diarrhea (CRD) leads to increased healthcare utilization and cost. This study evaluated the all-cause and CRD-specific healthcare utilization and cost of patients with CRD compared to a matched non-CRD cohort. Methods: We conducted a longitudinal observational study among adult patients ( &gt; 18 years) with CRD using diagnosis codes or pharmacy claims compared to matched non-CRD patients using claims data from the IQVIA PharMetrics Plus database (October 2015 to March 2020). The index date was the date of the first cancer claim, and we re-indexed patients based on their CRD claim. Each patient had a 6-month pre-index period and a minimum 3-month post-index period. Patients were also required to have ≥12 months of continuous enrollment following the CRD index date. We directly matched patients 1:1 from the CRD cohort to the non-CRD cohort to adjust for selection bias and baseline differences. Our aim was to compare all-cause healthcare costs over a fixed 12-month post-index period, converting all costs to 2020 USD using the Consumer Price Index's medical component. We analyzed healthcare utilization for CRD-treated, CRD-inadequately treated, and CRD-untreated sub-cohorts (per Buono et al., J Econ 2017). Secondary endpoints included healthcare cost (proportion of patients, per-patient mean and median) and healthcare utilization (prescription fills and visits to the emergency department [ED], physician office, lab/pathology and outpatient ancillary services). We built one generalized estimating equation model with log link and gamma distribution adjusted for type of cancer, therapy and Charlson Comorbidity Index (CCI) to estimate the difference in total healthcare cost between CRD and non-CRD cohorts. Results: We evaluated a total of 104,135 matched pairs of CRD and non-CRD adult patients with solid or hematologic cancer receiving either targeted or chemotherapy, with 12-month continuous enrollment. Patients with CRD incurred significantly higher mean ($104,880 vs $39,664, p &lt; 0.0001) and median ($59,969 vs $8,914, p &lt; 0.0001) all-cause healthcare cost compared to patients without CRD over the 12-month post-index period. Inadequately treated CRD patients had the mean highest cost ($129,531) vs adequately CRD-treated ($107,050) or untreated CRD patients ($56,350) (all p &lt; 0.0001). Mean pharmacy cost for CRD and non-CRD patients were ($35,190 vs $15,883); visits to the ED ($1,107 vs $431), physician office ($3,457 vs $2,058), lab/pathology ($4,074 vs $1,404), and outpatient ancillary services ($15,805 vs $4,940) (all p-values &lt; 0.0001). Conclusions: Our findings show that patients with CRD had nearly 2.9 times higher all-cause total cost than patients without CRD after adjusting for covariates. Prevention of CRD may result in a significant reduction in cancer-treatment cost.

POS0283 TREATMENT PATTERNS AND CLINICAL CHARACTERISTICS OF PATIENTS WITH OSTEOARTHRITIS OF THE HIP AND/OR KNEE TREATED WITH TRADITIONAL NSAIDS VS COX-2S: A REAL-WORLD STUDY OF COMMERCIALLY-INSURED PATIENTS

Background:The 2019 American College of Rheumatology (ACR) guidelines strongly recommend oral nonsteroidal anti-inflammatory drugs (NSAIDs) for management of hip and knee osteoarthritis (OA) and strongly recommend topical NSAIDs for knee OA. There are, however, important safety considerations with NSAIDs in terms of increased rates of gastrointestinal, cardiovascular, and renal events. Given these risks, it is important to understand the characteristics and drug utilization of the patients who start treatment on these different treatments (i.e., traditional NSAIDs [tNSAIDs] and cyclooxygenase-2 inhibitors [COX-2s]).Objectives:The goal of this research was to describe and compare baseline characteristics of commercially-insured patients diagnosed with OA of the hip and/or knee who started treatment on different types of NSAIDs (i.e., oral tNSAIDs, topical tNSAIDs, and COX-2s).Methods:The Optum Healthcare Solutions, Inc. claims database (1/2012-3/2017) was used to identify patients ≥18 years old, with ≥2 diagnoses of hip and/or knee OA, and ≥90 days supply of oral tNSAIDs, topical tNSAIDs, or COX-2s during the one-year follow up period. The index date was defined as the first prescription after the first OA diagnosis. Patients were assigned to cohorts based on the type of NSAID prescribed on index date. Patients were required to be continuously-enrolled six months before (baseline period) and 36 months after (follow-up period) the index date. Demographic and clinical characteristics including age, sex, comorbidities, and healthcare resource use (HRU) were summarized during baseline. Drug utilization characteristics including days supply and number of prescriptions for the different NSAIDs types were summarized during follow-up period.Results:Data for 23,796 patients were analyzed: 18,100 patients received oral tNSAIDs, 4,825 received COX-2s, and 871 topical tNSAIDs. Patients who initiated treatment on oral tNSAIDs were the youngest (mean age of 60.6 vs. 64.6 for COX-2s and 65.0 for topical tNSAIDs) and topical tNSAIDs had the highest proportion of female patients (71% vs. 62% for oral tNSAIDs and 63% for COX-2s). The topical tNSAIDs cohort had the highest presence of chronic kidney disease (2.6% vs. 1.0% and 1.5% for oral tNSAIDs and COX-2s, respectively) and congestive heart failure (2.5% vs. 0.8% and 1.7% for oral tNSAIDs and COX-2s, respectively) at baseline. In terms of HRU during baseline, topical tNSAIDs had the most patients with emergency department visits (20.8% vs. 16.7% in both COX-2s and oral tNSAIDs), and COX-2 had the most patients with inpatient visits (18.1% vs. 15.4% for topical tNSAIDs and 11.8% for oral tNSAIDs). Oral tNSAIDs had the lowest total all-cause cost ($6,504), and the topical tNSAIDs cohort had the highest costs ($8,455), but fairly comparable with COX-2s ($8,289). During follow-up, oral tNSAIDs patients stayed mostly on oral tNSAIDs as less than 15% of oral tNSAIDs patients later had a prescription for COX-2s or topical tNSAIDs. 37% of COX-2 patients and 56% of topical tNSAIDs patients later took oral tNSAIDs. Topical tNSAIDs patients had an average of 184.4 days of supply for topical tNSAIDs yet also extensively used oral NSAIDs during follow-up (average days of supply for oral tNSAIDs was 315.5 days and for COX-2s was 383.5 days).Conclusion:This study suggests that patients with more complex comorbidity profiles, including higher rates of adverse effects, often start pharmacological treatment with topical tNSAIDs. However, patients who start treatment with topical tNSAIDs switch to other types of NSAIDs; oral tNSAIDs were the most frequently prescribed treatment across the cohorts. Thus, despite the safety concerns with oral tNSAIDs and COX-2s, patients are still placed on these treatments to manage their OA pain. There is a need for new innovative treatments as there is currently a lack of other options.Disclosure of Interests:Stuart Silverman Consultant of: Stuart Silverman is a paid consultant to Pfizer and Eli Lilly and Company in connection with this study, Patricia Schepman Shareholder of: Patricia Schepman is an employee of Pfizer with stock and/or stock options, Employee of: Pfizer, James B Rice Consultant of: Brad Rice is an employee of Analysis Group, who were paid consultants to Pfizer and Eli Lilly and Company for this study, Craig Beck Shareholder of: Craig Beck is an employee of Pfizer with stock and/or stock options, Employee of: Pfizer, Alan White Consultant of: Alan White is an employee of Analysis Group, who were paid consultants to Pfizer and Eli Lilly and Company for this study, Sheena Thakkar Shareholder of: Sheena Thakkar is an employee of Pfizer with stock and/or stock options, Employee of: Pfizer, Michaela Johnson Consultant of: Michaela Johnson is an employee of Analysis Group, who were paid consultants to Pfizer and Eli Lilly and Company for this study, Rebecca Robinson Shareholder of: Rebecca Robinson is an employee and minor stockholder of Eli Lilly and Company, Employee of: Eli Lilly and Company, Birol Emir Shareholder of: Birol Emir is an employee of Pfizer with stock and/or stock options, Employee of: Pfizer