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Prior observational studies suggest rivaroxaban is safe and effective among patients with morbid obesity who suffered a venous thromboembolism (VTE) event, but existing data are more limited in the broader population of VTE patients with obesity. This study assessed VTE recurrence, major bleeding, healthcare resource utilization, and healthcare costs among VTE patients with obesity who received rivaroxaban versus warfarin. VTE patients with obesity who initiated rivaroxaban or warfarin after a first VTE (index date) were identified from the IQVIA PharMetrics® Plus database (01/02/2011–09/30/2019). The follow-up period spanned from the index date until health plan disenrollment, end of data availability, cancer diagnosis/treatment, end of the 12 month post-index period, or (for the analysis of major bleeding) anticoagulant discontinuation or switch. Patient characteristics were balanced using inverse probability of treatment weighting. The weighted rivaroxaban (N = 8666) and warfarin cohorts (N = 5946) were well balanced (mean age = 51 years, females = 52%). Over a 9.6 months mean observation period, rivaroxaban users had a significantly lower risk of VTE recurrence [7.0% vs. 8.2%, HR(95% CI) = 0.85(0.75;0.97)] and a similar risk of major bleeding [4.1% vs. 3.6%, HR(95% CI) = 1.11(0.89;1.37)] relative to warfarin users at 12 months. Relative to warfarin users, rivaroxaban users had significantly fewer all-cause outpatient visits [RR(95% CI) = 0.71(0.70;0.74)]. The higher pharmacy costs incurred by rivaroxaban recipients (cost difference = $1252) were offset by lower medical costs (cost difference = − $2515, all p

Background Real-world evidence suggest that next generation hormonal agents (NHAs) abiraterone and enzalutamide were preferred as first-line (1L) therapies for metastatic castration-resistant prostate cancer (mCRPC) in the United States (US) pre-2020, with chemotherapies, particularly docetaxel, being preferred in subsequent lines (2L+). This real-world study described patient characteristics, treatment patterns, time on treatment (ToT) and overall survival (OS) among patients with mCRPC treated with 2L and 3L docetaxel post-NHAs in the mCRPC setting. Methods Adults with confirmed adenocarcinoma mCRPC diagnosis and ≥1 month of follow-up post-diagnosis were selected from a US electronic health record-derived oncology de-identified database (01/2013–03/2019). Based on the observed line of therapy sequences post-mCRPC diagnosis, patients who received NHA therapy in 1L and docetaxel therapy in 2L were included in the 2L docetaxel cohort, and patients who received NHA therapy in both 1L and 2L and docetaxel therapy in 3L were included in the 3L docetaxel cohort. ToT and OS were evaluated using Kaplan-Meier analysis. Results Among 5,213 patients with mCRPC, 278 and 166 were included in the 2L and the 3L docetaxel cohorts, respectively (median age: 73 years for both cohorts). ADT was the most used class of medication pre-mCRPC (>75%). For the 2L cohort, the most common sequence post-mCRPC was 1L abiraterone → 2L docetaxel (52.5%), while the median ToT and OS post-2L start were 4.1 and 10.5 months, respectively; for the 3L cohort, the most common sequence post-mCRPC was 1L abiraterone → 2L enzalutamide → 3L docetaxel (67.5%), while the median ToT and OS post-3L start were 3.8 and 8.7 months, respectively. Conclusions This real-world study provides novel data on patients treated with docetaxel post-NHAs in a mCRPC setting and highlights the critical unmet need for developing more effective treatment options in this population.

Introduction Approximately 30% of patients with a first acute pericarditis episode experience a recurrence ≤ 18 months; ~ 15% experience multiple recurrences. This study assessed the recurrence and economic burden among patients with multiple recurrences. Methods Adults with idiopathic pericarditis were identified in the OptumHealth Care Solutions, Inc., database (2007–2017). Recurrent pericarditis (RP) was defined as ≥ 2 episodes of care separated by > 28 days; multiple recurrences were defined as ≥ 2 recurrences. Results Among 944 patients with RP, 375 (39.7%) experienced multiple recurrences and were propensity score-matched 1:1 to 375 patients without recurrence. Among patients with multiple recurrences, median disease duration (time from first episode to end of last recurrence, confirmed by a 1.5-year recurrence-free period) was 2.84 years. The multiple recurrences cohort had higher rates of hospitalizations per-patient-per-month (PPPM) than the no recurrence cohort (rate ratio [95% confidence interval (CI)] = 2.22 [1.35–3.65]). Mean total healthcare costs were significantly higher in the multiple recurrences versus no recurrence cohort ($2728 vs. $1568 PPPM, cost ratio [95% CI] = 1.74 [1.29–2.32]), mainly driven by higher hospitalization costs in the multiple recurrences cohort (mean: $1180 vs. $420 PPPM, cost ratio [95% CI] = 2.81 [1.80–4.66]). Mean work loss costs were higher in the multiple recurrences versus no recurrence cohort ($696 vs. $169 PPPM, cost ratio [95% CI] = 4.12 [1.64–9.61]). In patients with multiple recurrences, mean cost of the first episode was $19,189; subsequent recurrences ranged from $2089 to $7366 (second recurrence = $6222). Conclusion In conclusion, among patients with multiple pericarditis recurrences, disease symptoms persisted several years, and healthcare and work loss costs were further compounded in this subset of patients. Supplementary Information The online version contains supplementary material available at 10.1007/s12325-021-01868-7.

Aim: To assess the patterns of genetic testing for homologous recombination repair mutations in patients with metastatic castration-resistant prostate cancer (mCRPC) pre-PARP inhibitors approval. Patients & methods: mCRPC patients were selected in an oncology electronic medical records database. Patterns and predictors of testing for ATM, BRCA1/2, CDK12, PALB2 and FANCA gene alterations were assessed. Results: Of 5213 mCRPC patients, 674 (13%) had a documented genetic test. The number of tested patients increased from 1 in 2013 to 313 in 2018 (out of 3161 and 3010 clinically active patients, respectively). Receiving care in an academic oncology center (versus a community-based center) strongly predicted genetic testing (hazard ratio = 2.41). Conclusion: The use of and access to genetic testing pre-PARP inhibitor approval was suboptimal.

Introduction Therapeutic options for metastatic castration-resistant prostate cancer (mCRPC) patients are continuously advancing. We described mCRPC treatment patterns in the US from 2013 to 2019. Methods Patients with a confirmed mCRPC diagnosis and adenocarcinoma histology were included in the US Flatiron Health Electronic Health Record-derived de-identified database. Treatment patterns [including treatment per lines of therapies (LOTs), LOT sequences, and time on treatment] and overall survival (OS) have been described in mCRPC settings. Results Of 5213 patients (mean age: 72.6 years), 4374 (83.9%) were treated with ≥ 1 LOT post-mCRPC diagnosis (among those with ≥ 1 LOT, 55.3%, 29.5%, 14.7%, and 6.7% had ≥ 2, 3, 4, and 5 LOTs, respectively). In first line (1L), the main treatment class was next-generation hormonal agents (NHA; 62.5% of patients with ≥ 1 LOT), while the shortest and longest time on 1L were observed for chemotherapy (median 2.8 months) and NHA (median 5.1 months), respectively. The most common LOT sequences were NHA → NHA (29.4% of patients with ≥ 2 LOTs) and NHA → NHA → chemotherapy (16.7% of patients with ≥ 3 LOTs). In Kaplan–Meier analyses, the median OS was 19.4, 14.6, and 11.1 months post-1L, 2L, and 3L start, respectively. Patients who moved rapidly through LOTs had an increased risk of death. Conclusions NHA were widely used as 1L therapy in mCRPC patients from 2013 to 2019, but time on 1L NHA treatment was on average

Introduction To evaluate the economic burden and treatment patterns of patients with paroxysmal nocturnal hemoglobinuria (PNH) treated with eculizumab, a C5 inhibitor, who were defined as blood transfusion-dependent (TD) versus blood transfusion-free (TF) in the US population. Methods Patients aged at least 12 years with at least two claims for eculizumab infusion (first claim was the index date) were identified from the IBM® MarketScan® Research Databases (April 1, 2014–September 30, 2019). The overall PNH eculizumab user cohort was stratified into the TD cohort (i.e., at least one claim for blood transfusion within 6 months following any eculizumab infusion, including on the infusion date) or the TF cohort (i.e., all non-TD patients). Treatment patterns, healthcare resource utilization (HRU), and costs were evaluated and compared during follow-up (i.e., index date to end of enrollment or data availability). Results Of 151 patients in the overall cohort (mean age 36.7 years; 55.6% female), 55 were TD (mean age 35.1 years; 67.3% female) and 96 were TF (mean age 37.6 years; 49.0% female). A total of 61% of patients (TD, 66%; TF, 58%) discontinued eculizumab, with TD patients having a shorter median time to discontinuation (TD, 0.5 years; TF, 0.9 years). TD patients had more all-cause hospitalizations than TF patients (p

Background Diffuse large B‐cell lymphoma (DLBCL) represents the most common subtype of non‐Hodgkin lymphoma in the U.S., but current real‐world data are limited. This study was conducted to describe real‐world characteristics, treatment patterns, health care resource utilization (HRU), and health care costs of patients with treated DLBCL in the U.S. Materials and Methods A retrospective study was conducted using the Optum Clinformatics Data Mart database (January 2013 to March 2018). Patients with an International Classification of Diseases, Tenth Revision, Clinical Modification diagnosis for DLBCL after October 2015 and no prior International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis for unspecified DLBCL or primary mediastinal large B‐cell lymphoma were classified as incident; those with such codes were classified as prevalent. An adapted algorithm identified lines of therapy (e.g., first line [1L]). All‐cause HRU and costs were calculated per‐patient‐per‐year (PPPY) among patients with a ≥1L. Results Among 1,877 incident and 651 prevalent patients with ≥1L, median age was 72 years and 46% were female. Among incident patients, 22.6% had at least two lines (2L), whereas 38.4% of prevalent patients had ≥2L. The most frequent 1L therapy was rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R‐CHOP). Incident patients had 1.3 inpatient and 42.0 outpatient (OP) visits PPPY, whereas prevalent patients had 0.8 and 31.3 visits PPPY, respectively. Total costs were $137,156 and $81,669 PPPY for incident and prevalent patients, respectively. OP costs were the main driver of total costs at $88,202 PPPY, which were higher within the first year. Conclusion This study showed that a large portion of patients require additional therapy after 1L treatment to manage DLBCL and highlighted the substantial economic burden of patients with DLBCL, particularly within the first year following diagnosis. Implications for Practice Patients diagnosed with diffuse large B‐cell lymphoma (DLBCL) carry a substantial clinical and economic burden. A large portion of these patients require additional therapy beyond first‐line treatment. There is significant unmet need among patients with DLBCL who require additional therapy beyond first‐line treatment. Patients who do not respond to first‐line therapy and are not eligible for transplants have very high health care resource utilization and costs, especially in the first 12 months following initiation of treatment., This article describes the real‐world demographic and clinical characteristics, as well as current treatment patterns, among patients diagnosed with diffuse large B‐cell lymphoma (DLBCL) and treated in the United States. Health care resource use and associated costs are assessed.

Aim: Evaluate healthcare resource utilization (HRU) and costs associated with rivaroxaban and warfarin among nonvalvular atrial fibrillation (NVAF) patients with obesity and polypharmacy. Materials & methods: IQVIA PharMetrics ® Plus (January 2010–September 2019) data were used to identify NVAF patients with obesity (BMI ≥30 kg/m 2 ) and polypharmacy (≥5 medications) initiated on rivaroxaban or warfarin. Weighted rate ratios and cost differences were evaluated post-treatment initiation. Results: Rivaroxaban was associated with significantly lower rates of HRU, including hospitalization (rate ratio [95% CI]: 0.83 [0.77, 0.92]). Medical costs were reduced in rivaroxaban users (difference [95% CI]: -US$6868 [-US$10,628, -US$2954]), resulting in significantly lower total healthcare costs compared with warfarin users (difference [95% CI]: -US$4433 [-US$8136, -US$582]). Conclusion: Rivaroxaban was associated with lower HRU and costs compared with warfarin among NVAF patients with obesity and polypharmacy in commercially insured US patients.

Objective: Patients with cancer are at high risk for developing primary but also recurrent venous thromboembolism (VTE). This study examined healthcare utilization (HRU) and costs related to VTE re...

Objective: To assess long-term healthcare costs related to ischemic stroke and systemic embolism (stroke/SE) and major bleeding (MB) events in patients with non-valvular atrial fibrillation...

Aim: To evaluate Medicaid spending and healthcare resource utilization (HRU) in treatment-resistant depression (TRD). Materials & methods: TRD beneficiaries were identified from Medicaid claims databases (January 2010–March 2017) and matched 1:1 with major depressive disorder (MDD) beneficiaries without TRD (non-TRD-MDD) and randomly selected patients without MDD (non-MDD). Differences in HRU and per-patient-per-year costs were reported in incidence rate ratios (IRRs) and cost differences (CDs), respectively. Results: TRD beneficiaries had higher HRU than 1:1 matched non-TRD-MDD (e.g., inpatient visits: IRR = 1.41) and non-MDD beneficiaries (N = 14,710 per cohort; e.g., inpatient visits: IRR = 3.42, p Conclusion: TRD is associated with higher HRU and costs versus non-TRD-MDD and non-MDD. TRD poses a significant burden to Medicaid.

Introduction Current evidence indicates that rivaroxaban may be a safe and effective alternative to warfarin among patients with nonvalvular atrial fibrillation (NVAF) and obesity. However, evidence regarding the impact of polypharmacy is limited in this population. The present study evaluated the effectiveness and safety of rivaroxaban versus warfarin among NVAF patients with obesity and polypharmacy in the US. Methods De-identified health insurance claims data from the IQVIA PharMetrics® Plus data (01/2010–09/2019) were used to identify NVAF patients with obesity (BMI ≥ 30 kg/m2) and polypharmacy (≥ 5 medications) initiated on rivaroxaban or warfarin. Inverse probability of treatment weighting (IPTW) was used to adjust for imbalances between groups. Study outcomes were evaluated up to 36 months post-treatment initiation and included the composite of stroke or systemic embolism (stroke/SE) and major bleeding. Subgroup analyses were conducted stratified by polypharmacy category (5–9 or ≥ 10 medications). Outcomes were assessed using Cox proportional hazards regression models with hazard ratios (HR) and 95% confidence intervals (CIs). Results A total of 7000 and 3920 NVAF patients with obesity and polypharmacy were initiated on rivaroxaban and warfarin, respectively. At 36 months of follow-up, rivaroxaban was associated with a 29% lower risk of stroke/SE relative to warfarin (HR 0.71, 95% CI 0.57, 0.90). Major bleeding risk was not significantly different among rivaroxaban- compared to warfarin-treated patients (HR 0.85, 95% CI 0.70, 1.03). Subgroup analyses yielded results that were largely consistent with the overall polypharmacy analysis. Conclusions These results suggest that rivaroxaban is an effective and safe treatment option among NVAF patients with obesity and polypharmacy in a commercially-insured US population. Supplementary Information The online version contains supplementary material available at 10.1007/s12325-021-01746-2.

To assess the real-world healthcare resource utilization (HRU) and costs of patients with non-valvular atrial fibrillation (NVAF) and obesity newly initiated on rivaroxaban or warfarin in the US. This retrospective study used IQVIA PharMetrics Plus data (01/2010–09/2019) to evaluate patients (≥18 years) with NVAF and obesity (body mass index ≥30 kg/m2) initiated on rivaroxaban or warfarin (on or after 01/2013). Inverse probability of treatment weighting (IPTW) was used to adjust for confounding between cohorts. HRU and costs were assessed post-treatment initiation. Weighted cohorts were compared using Poisson regression models and cost differences, with 95% confidence intervals (CIs) and p values generated using non-parametric bootstrap procedures. After IPTW, 10,555 and 5,080 patients were initiated on rivaroxaban and warfarin, respectively (mean age: 59 years). At 12 months follow-up, the rivaroxaban cohort had lower all-cause HRU, including fewer hospitalizations (rate ratio [RR]: 0.80, 95% CI: 0.74, 0.87), emergency room visits (RR: 0.89, 95% CI: 0.83, 0.97), and outpatient visits (RR: 0.72, 95% CI: 0.69, 0.77; all p p Claims data may have contained inaccuracies and obesity was classified based on ICD diagnosis codes given that patient BMI values were not available. Rivaroxaban was associated with reduced HRU and costs compared to warfarin among NVAF patients with obesity in a real-world US setting.

Current evidence indicates that the pharmacokinetic profile of rivaroxaban is not significantly impacted by body weight. However, real-world data are needed to better assess the potential clinical benefits and risks associated with rivaroxaban in non-valvular atrial fibrillation (NVAF) patients with obesity. Thus, our objectives were to assess the real-world effectiveness and safety of rivaroxaban versus warfarin among NVAF patients with obesity in the US nationally representative commercially-insured population. Health insurance claims data from the IQVIA PharMetrics Plus database (January 2010–September 2019) were used to identify NVAF patients with obesity (based on diagnosis codes) initiated on rivaroxaban or warfarin. Inverse probability of treatment weighting (IPTW) was used to adjust for imbalances between groups. Study outcomes of interest were evaluated up to 36 months post-treatment initiation and included the composite of stroke or systemic embolism (stroke/SE) and major bleeding. Outcomes were compared using Cox proportional hazards regression models with hazard ratios (HR) and 95% confidence intervals (CIs). A total of 10,555 patients were initiated on rivaroxaban and 5080 patients on warfarin. Following IPTW, the risk of stroke/SE was 26% lower among patients prescribed rivaroxaban relative to warfarin (HR: 0.74, 95% CI: 0.60, 0.91, p = .004) at 36 months. Rivaroxaban-initiated patients had a risk of major bleeding similar to that of warfarin-initiated patients (HR: 0.85, 95% CI: 0.71, 1.02, p = .085). These results suggest that rivaroxaban is an effective and safe treatment option among NVAF patients with obesity in a commercially-insured US population.

With the advent of ICD-10-CM codes for PMBCL on 10/01/2015, assessment of treatment patterns and healthcare burden among US patients is possible. This study sought to describe the real-world treatment patterns and economic outcomes of patients with PMBCL. Data from the Optum Clinformatics DataMartTM database was used (01/2013-03/2018). Patients with a first PMBCL ICD-10-CM diagnosis (with or without an antecedent ICD-10-CM diagnosis of DLBCL/other lymphoma, which may have been assigned before PMBCL confirmation) after 10/01/2015 (index date) and no ICD-9-CM diagnosis code for unspecified PMBCL/DLBCL were identified as incident patients. Those with PMBCL ICD-10-CM and unspecified ICD-9-CM diagnosis for PMBCL/DLBCL before 10/01/2015 (index date) were identified as prevalent patients. Patients were observed from the index date up to the earliest among death, end of data availability, or end of continuous health plan enrollment. An adapted algorithm was used to identify lines of therapy (LOT). Among 118 incident and 30 prevalent PMBCL patients, 14% and 20% of patients received ≥2 LOTs, respectively. In incident patients, 48% received ≥1 LOT, 14% ≥2, and 4% ≥3 LOTs. Among prevalent patients, 63% received ≥1 LOT and 20% ≥2 LOTs. The most frequently recorded 1L therapy was R-CHOP both among incident and prevalent patients. Mean total healthcare costs for incident and prevalent patients were $149,340 and $92,799 per patient per year, respectively, with higher costs ≤12 months ($187,241 and $167,553). Outpatient costs were the main driver (accounting for 60.5% and 64.6% for incident and prevalent patients, respectively). Potential underuse of ICD-10-CM codes shortly after discontinuation of ICD-9-CM codes in 01/2015; regimens identified for each LOT using the claims-based algorithm may not reflect the regimen administered. The multiple LOTs necessary for a sizeable minority of patients and the high costs of care highlight the significant unmet needs of PMBCL patients.

Introduction: Real-world data describing acute pericarditis (AP) etiology in the US are limited. Data on the characteristics of recurrent pericarditis (RP) patients (pts) are also sparse. To fill this gap, our study assesses longitudinal data from a nationwide privately-insured population. Methods: OptumHealth Reporting and Insights employer claims data (1/2007-3/2017) were used. AP pts were identified and categorized as idiopathic or non-idiopathic etiology based on presence or absence of attributable conditions. Among idiopathic AP pts, a subgroup of RP pts was identified. Recurrence was defined as ≥2 AP events separated by >4 weeks. First recurrence date marked the index date. Pts aged ≥18 years with ≥12 months of continuous enrollment pre-index (baseline) were included. Results: Of 17,168 AP pts, 4,175 (24.3%) had non-idiopathic and 12,993 (75.7%) had idiopathic etiology (Table 1). Application of inclusion criteria left 8,822 idiopathic AP pts, of whom 1,604 (18.2%) had ≥1 recurrence during a mean observation period of 29 months. On average, idiopathic RP pts were aged 50.7 years, 51.6% female, and 42.3% had baseline history of hypertension, 23.8% of coronary artery disease, 11.7% of hypercholesterolemia, and 7.3% of myocardial infarction. Mean (±SD) time from initial AP diagnosis to first recurrence was 8.7 (±12.1) months and mean (±SD) number of recurrences was 1.7 (±1.3) per pt. In idiopathic RP pts with ≥4 years of follow-up after the initial AP diagnosis (N=512), 35.9% had ≥2, 18.2% had ≥3, and 9.8% had ≥4 recurrences within 4 years. Conclusions: The etiologic distribution and proportion of pts with RP are consistent with previous reports. About 36% of RP pts experience ≥2 recurrences after AP diagnosis over 4 years. RP represents a significant clinical burden for affected pts.

Background: Up to 30% of incident pericarditis patients (pts) recur within 18 months. Recurrences can be debilitating and typically last several weeks despite conventional treatments (Tx). Recurrence burden (likelihood and frequency) is poorly defined. Improved understanding of recurrence burden can inform Tx decisions and the introduction of novel therapies. Method: Adults with idiopathic recurrent pericarditis (RP) were identified in the OptumHealth Reporting and Insights dataset (2007-2017). RP was defined as ≥2 episodes separated by >4 weeks. Disease duration (time from first episode to end of last recurrence, confirmed by a 1.5-year recurrence-free period) was evaluated using Kaplan-Meier analysis. Recurrence frequency and time between recurrences were evaluated among pts with 4+ years of observation. Result: Of the 1,604 RP pts, mean age was 50.7 years and 51.6% were female. Median RP duration was 2.1 and 3.1 years for pts with ≥1 and ≥2 recurrences, respectively ( Figure ). Over 4 years with RP, 15% of pts with ≥1 recurrence and 22% of pts with ≥2 recurrences had more than one episode/year. Mean ± SD time from first episode to first recurrence was 14.5 ± 17.9 months and 10.7 ± 12.1 months between subsequent recurrences. Conclusion: Recurrent pericarditis can span many years. Over half of pts with ≥2 recurrences have RP persisting over 3 years. Subsequent recurrences are more frequent but highly variable, making RP unpredictable. Tx to reduce recurrences could benefit pts with ≥2 recurrences.

The EINSTEIN-Extension trial showed that an extended rivaroxaban treatment significantly reduced the risk for venous thromboembolic (VTE) recurrence. The present study assessed the risk for VTE recurrence and major bleeding associated with extended rivaroxaban treatment in a clinical practice setting among patients with VTE.A retrospective study was conducted using claims data from February 2011 to April 2015. It included adult patients who initiated rivaroxaban therapy within 7 days after their first VTE and who continuously used rivaroxaban for at least 3 months (index date: end of initial 3-month treatment). Categorized into discontinued and continued cohorts, patients were followed up from the index date until the end of continuous treatment (continued cohort) or end of data or reinitiation of oral anticoagulant therapy (discontinued cohort). Using inverse probability of treatment weights controlling for confounders, adjusted Kaplan-Meier rates of recurrent VTE and major bleeding events were compared.The analysis showed that, compared with the discontinued cohort (n = 1,536), the continued cohort (n = 5,933) had a significantly lower VTE recurrence rate after an additional 3 months (0.70% vs 1.70%), 6 months (1.41% vs 2.34%), 9 months (1.82% vs 3.01%), and 12 months (1.97% vs 3.01%) of treatment (all, p0.05). The difference in the cumulative event rates for major bleeding was not statistically significant. Similar results were obtained in an analysis among patients with VTE receiving rivaroxaban for ≥6 months.Our results suggest that, in clinical practice settings, patients with VTE who continued rivaroxaban therapy after the initial 3- or 6-month treatment period had a significantly lower risk for VTE recurrence without a statistically significant increased risk for major bleeding.

INTRODUCTION The C5 inhibitor eculizumab is the current standard of care for the treatment of PNH. However, some pts receiving eculizumab to treat PNH continue to experience ongoing hemolysis and anemia, resulting in red blood cell transfusion dependence, substantial unmet clinical needs, and considerable health economic burden. This study evaluated the treatment patterns of pts with PNH receiving eculizumab and compared HRU among blood transfusion-dependent (TD) pts versus blood transfusion-free (TF) pts in real-world clinical practice in the United States. METHODS Pts aged ≥12 years with ≥2 claims for eculizumab infusion between April 1, 2014, and September 30, 2019, were identified from the IBM® MarketScan® Research Databases. The index date was the first observed claim for eculizumab infusion with ≥3 months of continuous eligibility prior (baseline period). Pts with ≥1 diagnosis of indications other than PNH for eculizumab (ie, atypical hemolytic uremic syndrome, generalized myasthenia gravis, neuromyelitis optica spectrum disorder) during the baseline period or on the index date were excluded to identify pts with PNH. The full cohort of PNH pts treated with eculizumab were then stratified into the TD cohort (≥1 claim for blood transfusion within 6 months following any eculizumab infusion) or TF cohort. Patient demographic and clinical characteristics in the baseline period were compared between TD and TF cohorts using standardized differences (std diff), with >20% indicating substantial differences. Treatment patterns and HRU (all-cause and PNH-related) were evaluated during the observation period (ie, from index date to earliest date between end of continuous healthcare plan enrollment and end of data availability). Time from index date to treatment discontinuation among pts in the full cohort was assessed using Kaplan-Meier analysis. HRU was compared between TD and TF cohorts using incidence rate ratios (IRRs) adjusted for baseline covariates. RESULTS A total of 151 eculizumab users with PNH were identified as the full cohort; 55 (36%) were TD and 96 (64%) were TF. Mean (range) age was 36.7 (12-74) years among all pts (TD: 35.1 years; TF: 37.6 years). Overall, 56% of pts were female, with a higher proportion in the TD vs TF cohort (67% vs 49%; std diff = 38%). More pts in the TD vs TF cohort had blood transfusions (71% vs 18%; std diff = 127%) and use of corticosteroid therapy (46% vs 32%; std diff = 27%) during baseline. Baseline coagulopathy and aplastic anemia were more common in the TD vs TF cohort (coagulopathy: 49% vs 30%; std diff = 39%; aplastic anemia: 64% vs 43%; std diff = 43%). Myelodysplastic syndrome was present in 10% of the full cohort (TD: 13%; TF: 8%; std diff = 14%). During a mean observation period of 19 months for the overall sample (TD: 20 months; TF: 19 months), pts had a median (interquartile range) of 8 (3-30) eculizumab infusions (TD: 5 infusions; TF: 8 infusions) during maintenance phase; 29% of pts (TD: 21%; TF: 33%) had on average 14 days between maintenance eculizumab infusions; 61% of pts (TD: 66%; TF: 58%) discontinued eculizumab treatment (ie, gap of >42 days between 2 infusions) and the median time to treatment discontinuation was 254 days (TD: 180 days; TF: 337 days). Mean (range) number of blood transfusions among TD pts was 8.5 (1-54). During the observation period, pts in the TD cohort had 2.95 times more all-cause hospitalizations and 4.58 times more hospitalization days compared to pts in the TF cohort (all P < 0.05). Similar trends were observed for PNH-related hospitalizations. Results for all-cause and PNH-related HRU are presented in the Table. CONCLUSIONS This study demonstrated a considerable economic burden among pts with PNH treated with eculizumab, particularly among pts dependent on blood transfusions. TD eculizumab users comprised >36% of the overall sample, indicating that disease activity may not be well controlled. These pts had >4 times the number of hospitalization days compared to TF pts, emphasizing the substantial unmet clinical need despite treatment with eculizumab. These findings suggest that the current PNH standard of care may be insufficient for TD pts. Based on time between dosing intervals, >70% of PNH pts in this study were not dosed per label, and two-thirds of pts discontinued eculizumab within an average of a 1.5-year timeframe. New therapies are needed to reduce the considerable burden of pts with PNH. Disclosures Cheng: Apellis: Research Funding. Sarda:Apellis: Current Employment, Current equity holder in publicly-traded company. Mody-Patel:Apellis: Current Employment, Current equity holder in publicly-traded company. Krishnan:Apellis: Current Employment, Current equity holder in publicly-traded company. Yenikomshian:Apellis: Research Funding. Scoble:Apellis: Current Employment, Current equity holder in publicly-traded company. Mahendran:Apellis: Research Funding. Lejeune:Apellis: Research Funding. Yu:Apellis: Research Funding. Duh:Apellis: Research Funding; Takeda Oncology: Research Funding; GlaxoSmithKline: Research Funding; AstraZeneca: Research Funding; Blueprint Medicine: Research Funding; Novartis: Research Funding; Shire: Research Funding; Merck: Research Funding; Pharmacyclics: Research Funding.

OBJECTIVE To compare obesity-related costs of employees of the healthcare industry versus other major US industries. METHODS Employees with obesity versus without were identified using the Optum Health Reporting and Insights employer claims database (January, 2010 to March, 2017). Employees working in healthcare with obesity were compared with employees of other industries with obesity for absenteeism/disability and direct cost differences. Multivariate models estimated the association between industries and high costs compared with the healthcare industry. RESULTS Obesity-related absenteeism/disability and direct costs were higher in several US industries compared with the healthcare industry (adjusted cost differences of $-1220 to $5630). Employees of the government/education/religious services industry (GERS) with obesity (BMI of 30 or greater) had significantly higher odds of direct costs at the 80th percentile and above (odds ratio vs healthcare industry = 2.20; P

The aim of the study was to assess treatment patterns, healthcare resource utilization, and healthcare costs among patients with neuroendocrine tumors (NETs) receiving long-acting octreotide versus lanreotide, overall and in patients with carcinoid syndrome (CS).A provider-based claims database was used to identify NET patients who first initiated long-acting octreotide or lanreotide (index date) from January 2015 to November 2017. Propensity-score matching 1:1 was used. Patients with CS were identified from the previously mentioned matched cohorts. Time-to-treatment discontinuation (TTD) was estimated using Kaplan-Meier analyses. Per-patient-per-month rates of healthcare resource utilization were compared using rate ratios from multivariable Poisson regression models. Multivariable linear regression models were used to compare mean monthly cost differences.The median TTD was similar between the 2 matched cohorts (N = 543 each; long-acting octreotide = 19.2 months, lanreotide = 17.5 months, P = 0.58). Significantly fewer NET-related outpatient visits (rate ratio = 0.95, P = 0.005) and significantly lower total healthcare costs (mean monthly cost difference: all-cause = US -$3701, NET-related = US -$3752, Ps0.001) were observed in the long-acting octreotide cohort than lanreotide. Similar results were found in CS patients.Patients on first-line long-acting octreotide and lanreotide had similar TTD. Long-acting octreotide was associated with significantly lower total healthcare costs than lanreotide.

OBJECTIVE To evaluate obesity-related costs and body mass index (BMI) as a cost predictor among privately insured employees by industry. METHODS Individuals with/without obesity were identified using the Optum Health Reporting and Insights employer claims database (January, 2010 to March, 2017). Direct/indirect costs were reported per-patient-per-year (PPPY). Multivariate models were used to estimate the association between obesity and high costs (more than or equal to 80th percentile) by industry. RESULTS Overall (N = 86,221), direct and absenteeism/disability cost differences between class I obesity (BMI 30.0 to 34.9) and reference were $1,775 and $617 PPPY, respectively (P

Author(s): Greenberg, Barry; Peterson, Eric D; Berger, Jeffrey S; Laliberte, Francois; Zhao, Qi; Germain, Guillaume; Lejeune, Dominique; Wu, Jennifer W; Lefebvre, Patrick; Fonarow, Gregg C | Abstract: BackgroundReal-world data on the clinical outcomes of heart failure (HF) across the spectrum of ejection fraction (EF) and the prognostic value of B-type natriuretic peptide (BNP) have not been well examined.HypothesisThe real-world association between the clinical outcomes of HF and EF or BNP levels may differ across different EF or BNP values.MethodsThe Optum Integrated Claims-Clinical data (07/2009-09/2016) was used to identify adult patients with ≥1 HF diagnosis during hospitalization or emergency room visit. Three EF cohorts were formed: reduced (rEF; EF l 40%), mid-range (mrEF; EF 40%-49%), and preserved EF (pEF; EF ≥ 50%). Stratifications by BNP levels were performed using median BNP as cutoff between high vs low BNP (H-BNP vs L-BNP).ResultsIn total, 7005 HF patients with EF measurements (2456 patients with both HF and BNP measurements) were identified. rEF patients had higher risk of stroke (hazard ratio [HR] = 1.57, P = 0.010) and acute myocardial infarction (AMI) (HR = 2.42, P l 0.001) compared to pEF patients. H-BNP was associated with a significantly higher risk of mortality (P l 0.001). rEF patients with H-BNP had a significantly higher risk of stroke than those with L-BNP.ConclusionsPatients with rEF had a significantly higher rate of stroke and AMI vs pEF patients, as did patients with H-BNP vs L-BNP. The present study is the first to show the real-world association of EF and BNP (alone and in combination) with clinical outcomes, further supporting the recommendation to use these markers in clinical practice. These results may help to guide future recommendations and improve the clinical management of HF.

Combination regimens of antiepileptic drugs (AEDs) with various mechanisms of action (MOA) are commonly used in patients with refractory epilepsy. However, outcomes related to combination AEDs with novel MOA, such as perampanel (PER), are not well described. This study compared healthcare resource utilization (HRU) among recipients of PER-based combinations versus recipients of other non-PER-based combinations.This retrospective study used claims data from the Symphony Health's IDV® (Integrated Dataverse) database (August 2012 to July 2018). Patients were aged ≥12 years with epilepsy or non-febrile convulsions, were treated with AED combinations, and had ≥12 and ≥6 months pre- and post-index date, respectively (date of initiation of the second AED in the combination). AEDs were categorized based on MOA: selective non-competitive antagonist of AMPA receptors (i.e., PER), sodium channel blocker (SC), synaptic vesicle protein 2A binding (SV2), and gamma-aminobutyric acid analog (G). Patients were then classified into MOA-based cohorts: PER + SC, PER + SV2, PER + G, SC + SC, SC + SV2, SC + G, SV2 + G, and G + G. HRU outcomes were evaluated during follow-up and compared between PER-based cohorts and non-PER-based cohorts.On average, patients in the PER + SC (N = 3,592), PER + SV2 (N = 2,200), and PER + G (N = 1,313) cohorts were younger and had a lower Quan-Charlson comorbidity index than those in non-PER-based cohorts. PER + SC and PER + SV2 users had significantly fewer all-cause hospitalizations than non-PER-based users (adjusted RR range: 0.66-0.89, all P 0.05), while PER + G recipients had fewer all-cause hospitalizations than recipients of SV2 + G and G + G (adjusted RR range: 0.92-0.94). Similar trends were observed for epilepsy-related hospitalizations. Across all comparisons, PER-based combinations were associated with significantly lower rates of all-cause clinic/office/outpatient visits relative to non-PER-based combinations (adjusted RR range: 0.69-0.86, all P 0.05).Results showed that patients treated with PER-based combinations had fewer all-cause and epilepsy-related hospitalizations, and fewer all-cause clinic/office/outpatient visits compared with patients treated with most other non-PER-based combinations.

Objective: The standard of care for cancer-related venous thromboembolism (VTE) has been low molecular weight heparin (LMWH), but oral anticoagulants are also widely prescribed. This study compared VTE-related healthcare resource utilization and costs of cancer patients treated with anticoagulants. Methods: Claims data from Humana Database (January 1, 2013–May 31, 2015) were analyzed. Based on the first anticoagulant received, patients were classified into LMWH, warfarin, or rivaroxaban cohorts. Characteristics were evaluated during the 6 months pre-index date (i.e. the first VTE); VTE-related resource utilization and costs were evaluated during follow-up. Cohorts were compared using rate ratios, and p-values and 95% confidence intervals were calculated. Healthcare costs were evaluated per-patient-per-year (PPPY) and compared using mean cost differences. Results: A total of 2,428 patients (LMWH: n = 660; warfarin: n = 1,061; rivaroxaban: n = 707) were included. Compared to patients treated with LMWH, patients treated with rivaroxaban had significantly fewer VTE-related hospitalizations, hospitalization days, and emergency room and outpatient visits, resulting in an increase of $12,000 VTE-related healthcare costs PPPY with LMWH vs rivaroxaban. Patients treated with rivaroxaban had significantly lower VTE-related resource utilization compared to patients treated with warfarin; however, VTE-related costs were similar between cohorts. The higher drug costs ($1,519) were offset by significantly lower outpatient (−$1,039) and hospitalization costs (−$522) in rivaroxaban relative to the warfarin cohort. Conclusions: Healthcare resource use and costs associated with VTE treatment in cancer patients are highest with LMWH relative to warfarin and rivaroxaban.

BACKGROUND: Using data from the Reduced-Dose Rivaroxaban in the Long-Term Prevention of Recurrent Symptomatic Venous Thromboembolism (EINSTEIN-CHOICE) trial, this study assessed cost impact of continued anticoagulation therapy with rivaroxaban vs aspirin.METHODS: Total health-care costs (2016 USD) associated with rivaroxaban and aspirin were calculated as the sum of clinical event costs and drug costs from a US managed care perspective. Clinical event costs were calculated by multiplying event rate by cost of care. One-year Kaplan-Meier clinical event rates for recurrent pulmonary embolism, recurrent DVT, all-cause mortality, and bleeding were obtained from EINSTEIN-CHOICE. Cost of care was determined by literature review. Drug costs were the product of drug price (wholesale acquisition cost) and treatment duration. A one-way sensitivity analysis was conducted.RESULTS: Rivaroxaban users had lower per patient per month (PPPM) clinical event costs compared with aspirin users ($123, $243, and $381 for rivaroxaban 10 mg, rivaroxaban 20 mg, and aspirin, respectively). However, vs aspirin, PPPM total health-care costs were $24 higher for patients treated with rivaroxaban 10 mg ($143 higher for rivaroxaban 20 mg) due to higher cost of rivaroxaban. With a 15% discount for rivaroxaban 10 mg, the lower cost of clinical events for the rivaroxaban-treated patients more than fully offset the higher drug costs, and yielded a $19 lower total health-care cost.CONCLUSIONS: Continued therapy with rivaroxaban 10 and 20 mg vs aspirin was associated with lower clinical event costs but higher total health-care costs; with a 15% drug discount rivaroxaban 10 mg had lower total health-care costs than aspirin.

Introduction: Systemic corticosteroids (SCS) are effective anti-inflammatory therapies for patients with severe or persistent asthma. Use of SCS reduces blood eosinophil counts; the magnitu...

The EINSTEIN-Extension trial (EINSTEIN-EXT) found that continued treatment with rivaroxaban for an additional 6 or 12 months (vs placebo) after 6-12 months of initial anticoagulation significantly reduced the risk of recurrent venous thromboembolism (VTE) with a small non-significant increased risk of major bleeding (none fatal or in critical site). This study aimed to compare total healthcare cost between rivaroxaban and placebo, based on the EINSTEIN-EXT event rates.Total healthcare cost was calculated as the sum of treatment and clinical event costs from a US managed care perspective. Treatment duration and event rates were obtained from the EINSTEIN-EXT study. Adjustment on treatment duration was made by assuming a 10% non-adherence rate. Drug costs were based on wholesale acquisition costs. Cost estimates for clinical events (i.e. recurrent deep vein thrombosis [DVT], recurrent pulmonary embolism, major bleeding, clinically relevant non-major bleeding) were determined from the literature. Results were examined over a ±20% range of each cost component and over 95% confidence intervals (CIs) of event rate differences in deterministic (one-way) and probabilistic sensitivity analyses (PSA).Total healthcare cost was $1,454 lower for rivaroxaban-treated (vs placebo-treated) patients in the base-case, with a lower clinical event cost fully offsetting drug cost. The cost savings of recurrent DVT alone (-$3,102) was greater than drug cost ($2,723). Total healthcare cost remained lower for rivaroxaban in the majority (73%) of PSA (cost difference [95% CI] = -$1,454 [-$2,396, $1,231]).This study was conducted over the 1-year observation period of the EINSTEIN-EXT trial, which limited "real-world" applicability and examination of long-term economic impact. Assumptions on drug and clinical event costs were US-based and, thus, not applicable to other healthcare systems.Total healthcare costs were estimated to be lower for patients continuing rivaroxaban therapy compared to those receiving placebo in VTE patients who had completed 6-12 months of VTE treatment.

Background: Patients with non-valvular atrial fibrillation (NVAF) use oral anticoagulants (OACs) to decrease their risk of stroke; however, taking OACs may also increase their risk of bleeding. Objective: To assess long-term healthcare costs related to ischemic stroke/systemic embolism (SE) and major bleeding events in patients with NVAF treated with non-vitamin K antagonist oral anticoagulants (NOACs). Methods: Clinformatics™ Data Mart database from 1/2009-12/2016 was analyzed. Patients aged ≥18 with ≥1 ischemic stroke or SE hospitalization claim (index date) were matched 1:1 to patients without a stroke based on propensity scores. Patients with a major bleeding event identified using a validated algorithm (Cunningham et al., 2011) were similarly matched to patients without major bleeding. A randomly selected index date was imputed for patients without an event. All patients had a dispensing of a NOAC agent overlapping with the index date, had ≥12 months of eligibility pre-index date and ≥1 NVAF diagnosis. Healthcare costs were calculated from index date until the earliest date of death, switch to warfarin, end of insurance coverage or end of data availability. Mean costs were evaluated at 1, 2, 3 and 4 years using Lin’s method (Kaplan-Meier product-limit estimator, accounting for death) and compared using non-parametric bootstrap procedures. Results: The additional cost of care for patients with vs. without ischemic stroke/SE were $48,822, $50,418, $56,721 and $59,354 at 1, 2, 3 and 4 years, respectively ( Table ; p Conclusions: Patients experiencing an ischemic stroke/SE or major bleeding event incur higher healthcare costs than those patients that do not, and the all-cause costs associated with ischemic stroke/SE appeared higher than major bleeding.

SummaryObjective The purpose of this study was to evaluate changes in health care resource utilization following the initiation of perampanel for the treatment of epilepsy in the United States. Methods Health care claims from Symphony Health's Integrated Dataverse database between December 2012 and November 2015 were analyzed. Patients newly initiated on perampanel, having ≥1 epilepsy (International Classification of Diseases, Ninth Revision, Clinical Modification [ICD-9-CM] code 345.xx, ICD-10-CM code G40.xxx) or nonfebrile convulsion (ICD-9-CM code 780.39, ICD-10-CM code R56.9) diagnosis, and having ≥6 months of baseline and observation periods were included. Patients

Background: The EINSTEIN-extension trial (EINSTEIN-EXT) found that continued treatment with rivaroxaban for an additional 6 or 12 months (versus placebo) after the initial 6-12 months of anticoagulation significantly reduced the risk of recurrent venous thromboembolism (VTE) with a small increased risk of major bleeding (none was fatal or in a critical site). This study aimed to assess the cost impact of rivaroxaban vs. placebo based on EINSTEIN-EXT recurrent VTE and bleed rates. Methods: Total costs were calculated as the sum of drug and clinical event costs, and compared between cohorts from a US managed care perspective. Treatment duration and event rates were obtained from EINSTEIN-EXT. Drug costs were based on wholesale acquisition costs. Cost estimates for clinical events (i.e., recurrent VTE, major bleeding, clinically relevant nonmajor bleeding, and mortality) were determined based on a targeted literature review. Results were examined over a ± 20% range of each cost component in a one-way sensitivity analysis approach. Results: Total cost per person was $1,161 lower for rivaroxaban (vs. placebo) in the base case, with lower cost of clinical events fully offsetting drug costs (Figure 1). The difference in recurrent DVT alone (-$3,102) was greater than drug cost ($3,025). Total cost of rivaroxaban remained lower than placebo in sensitivity analyses. Conclusions: Rivaroxaban is associated with lower total costs compared to placebo in VTE patients who had completed 6 to 12 months of VTE treatment.

Background: Around a third of patients with diffuse large B-cell lymphoma (DLBCL) either relapse following first-line (1L) chemoimmunotherapy (CIT) or are refractory to 1L CIT. Among patients with relapsed or refractory (R/R) disease eligible for second-line (2L) therapy, fewer than half survive beyond 5 years. Refractory DLBCL entails a poorer prognosis than relapsed DLBCL; however, literature on healthcare resource use (HRU) for these two populations is sparse. This study sought to describe HRU and healthcare costs in U.S. patients with relapsed and refractory DLBCL. Methods: A retrospective claims analysis was conducted using the Optum® ClinformaticsTM DataMartTM database (01/2013-03/2018). Adult patients with ≥1 hospitalizations or ≥2 outpatient (OP) visits with an ICD-10-CM diagnosis code for DLBCL after 10/01/2015 were included. Patients were defined as (1) incident if they had no prior ICD-9-CM diagnosis code for unspecified DLBCL or primary mediastinal large B-cell lymphoma (PMBCL), or as (2) prevalent if they had a prior ICD-9-CM code for unspecified DLBCL or PMBCL. For incident cases, the index date was defined as the date of the first ICD-10 code for DLBCL or other lymphoma (after 10/01/2015); for prevalent cases, the index date was the date of the first unspecified ICD-9 code for DLBCL or PMBCL. Patients with an ICD-10 code for PMBCL at any time, or an ICD-9/ICD-10 code for Hodgkin lymphoma, multiple myeloma, and other selected lymphomas during the 12 months before the index date were excluded. Patients with DLBCL were classified as relapsed if they initiated 2L ≥90 days after the last dose of the 1L therapy and as refractory if they initiated 2L Results: A total of 139 and 68 incident DLBCL patients were identified as relapsed and refractory, respectively, with median (interquartile range [IQR]) age of 74 (68-81) and 72 (67-78), and mean Quan-Charlson comorbidity index score of 3.1 in both cohorts. The mean (SD) number of baseline all-cause hospitalizations was 0.35 (0.67) for relapsed and 0.40 (0.98) for refractory patients. Mean total baseline healthcare costs were $21,195 for relapse and $29,754 for refractory patients. R/R patients with prevalent DLBCL (153 relapsed; 21 refractory) had similar baseline characteristics. In incident DLBCL patients, those with relapsed and refractory DLBCL were observed for 495 and 346 days, respectively. On average, 1.7 and 2.4 hospitalizations PPPY occurred in relapsed and refractory patients, respectively. The table shows the breakdown of HRU by type of visits. Although hospitalizations were qualitatively higher in refractory patient, mean ± SD total healthcare costs were in similar range (relapsed= $164,631 ± 115,503; refractory= $159,729 ± 102,442). Corresponding OP costs (relapsed= $99,748 ± 85,350; refractory= $86,505 ± 59,081) were mainly driven by DLBCL anti-cancer therapy costs and were qualitatively higher among relapse compared to refractory patients ($41,768 ± 46,135 and $29,454 ± 32,242, respectively). In prevalent DLBCL, evaluation periods of relapsed and refractory patients lasted 964 and 786 days, respectively. Patients with relapsed DLBCL had 1.1 hospitalizations PPPY, and those with refractory DLBCL had 1.9 hospitalizations PPPY. Corresponding mean ± SD total healthcare costs were $112,653 ± 79,617 and $95,465 ± 50,167 PPPY, respectively. More pronounced results (i.e., higher rates of hospitalizations and corresponding healthcare costs for refractory compared to relapse patients) were observed in a sensitivity analysis when HRU and costs were assessed up to 6 months post-index date, which suggests that refractory patients are more likely to be hospitalized early on. Conclusions: In this U.S. real-world study, patients with R/R DLBCL incurred substantial HRU and costs, thereby imposing a considerable burden on the healthcare system. There was a trend towards higher hospitalizations for refractory patients, suggesting a worse prognosis; however total healthcare costs were similar, offset by higher anti-cancer therapy costs among relapsed patients. Disclosures Yang: Merck & Co.: Employment. Laliberté:Janssen Scientific Affairs, LLC: Research Funding; Merck & Co., Inc.: Research Funding. Germain:Janssen Scientific Affairs, LLC: Research Funding; Merck & Co., Inc.: Research Funding. Raut:Merck & Co., Inc.: Employment. Duh:Analysis Group, Inc., a consulting firm that has received research funding from Shire, a Takeda company, to conduct this study: Employment; Shire: Research Funding; Merck: Research Funding. Sen:Merck & Co., Inc.: Employment. Lejeune:Merck & Co., Inc.: Research Funding. Desai:Merck & Co., Inc.: Employment. Armand:Merck & Co.: Employment, Membership on an entity's Board of Directors or advisory committees, Other: Travel fees, gifts, and others, Research Funding; Pfizer Inc: Research Funding; Otsuka: Research Funding; Bristol Myers Squibb Pharmaceuticals: Employment, Membership on an entity's Board of Directors or advisory committees, Other: Travel fees, gifts, and others, Research Funding; Roche: Research Funding; Dana-Farber Cancer Institute: Employment; Sigma-Tau: Research Funding; Affimed: Research Funding; Serventa: Research Funding; Infinity Pharmaceuticals: Employment, Membership on an entity's Board of Directors or advisory committees.

e19050 Background: PMBCL is a rare mature B-cell neoplasm (2-4% of non-Hodgkin lymphomas) for which there is only limited data on treatment patterns in clinical practice. In October 2015, PMBCL was differentiated from diffuse large B-cell lymphoma (DLBCL) with the advent of ICD-10-CM PMBCL-specific codes. This study aims to describe real-world treatment patterns among pts diagnosed with PMBCL in the US. Methods: A retrospective database analysis was conducted using the Optum Clinformatics DataMart database (01/2013-03/2018). Pts with a first PMBCL ICD-10-CM diagnosis (with or without an antecedent ICD-10-CM diagnosis of DLBCL/other lymphoma, which may have been assigned before PMBCL confirmation) after October 1st, 2015 (index date) and no ICD-9-CM diagnosis code for unspecified PMBCL/DLBCL, were identified as incident pts. Those with PMBCL ICD-10-CM and unspecified ICD-9-CM diagnosis for PMBCL/DLBCL before October 2015 (index date) were identified as prevalent pts. PMBCL diagnoses on ≥2 medical visits and ≥12 months of continuous enrollment pre-index date were required. An adapted algorithm developed from previously published studies was used to identify lines of therapy (LOT). Duration of therapy spanned from LOT initiation up to discontinuation of all agents in the LOT, a switch to another LOT, or the addition of a new agent. Results: Among 148 PMBCL pts (118 incident; 30 prevalent), median (interquartile range) age was 66 (42-77) years. In incident pts, 48.3% were treated with ≥1 LOT (mean ± standard deviation [SD] duration of therapy: 86.0 ± 69.8 days) and 14.4% were treated with ≥2 LOT. The most frequently used first-line (1L) therapy (54.4% of pts) was R-CHOP (rituximab, cyclophosphamide, doxorubicin and vincristine). In prevalent pts, 63.3% were treated with ≥1 LOT (mean ± SD duration of therapy: 88.3 ± 44.6 days) and 20.0% were treated with ≥2 LOT. The most frequently used 1L therapy was R-CHOP (68.4%). Conclusions: This study demonstrated that a large portion of pts require additional therapy after 1L treatment to manage PMBCL, underscoring the significant unmet need in this population.

105 Background: There has been limited research assessing differences between somatostatin analogues (SSAs) as treatments for NET. This study aims to assess treatment pattern, persistence, HRUs and costs among patients (pts) with NET receiving long-acting octreotide versus lanreotide. Methods: Retrospective claims data from Symphony Health Solutions were analyzed for NET pts who initiated octreotide or lanreotide (index date) between 01/2015–11/2017 for ≥ 90 days. Pts with continuous clinical activity (≥ 180 pre and ≥ 90 days post index date) and without prior non-surgical NET treatment were included. A 1:1 propensity score matched sample was used to compare the two SSA groups with respect to treatment persistence (time to treatment discontinuation [TTD] using Kaplan-Meier) and to all cause and NET related HRUs and costs (provider charges for medical services and insurance payments for prescription drugs) using rate ratio (RR) and mean cost difference (CD) with 95% confidence interval (CI). Results: Among 2,043 NET pts identified, a balanced matched cohort of octreotide and lanreotide pts (N = 543 each) was achieved. In both cohorts, mean age was 65 years and baseline Charlson Comorbidity Index was 5.7. Approximately 80% of matched pts initiated monotherapy; others used SSAs in combination with chemo-, targeted or liver-directed therapy as first line therapy. Median TTD was directionally longer but did not reach statistical significance among octreotide vs lanreotide (19.2 vs 17.5 months, p = 0.6). Numerically lower hospitalization rates were observed among octreotide pts (RR [CI]: all cause = 0.87 [0.73, 1.05]; NET related = 0.85 [0.63, 1.15]). Statistically significantly fewer NET related outpatient visits (1.05 vs 1.10 per pts per month [PPPM]; RR [CI]: 0.95 [0.92, 0.99]) and lower total mean costs PPPM were observed for octreotide than lanreotide (CD [CI]: all cause = -$3,701 [-$5,205, -$2,355]; NET related = -$3,752 [-$4,948, -$2,455]). Conclusions: This study shows similar treatment patterns and persistence between SSA cohorts. Octreotide appeared to be associated with less HRU and total costs compared with lanreotide.

Essentials Clinical trials demonstrated the gain of extended anticoagulation among patients with VTE. In a real-world setting, we evaluated outcomes of extended rivaroxaban use for unprovoked VTE. Extended rivaroxaban treatment lowered the risk of recurrent VTE among unprovoked VTE patients. Extended rivaroxaban treatment was not associated with increased risk of major bleeding. Background Randomized trial data demonstrate the gain of extended duration anticoagulation in patients with venous thromboembolic events (VTE); however, real-world data are limited. Objectives Assess the risk of recurrent VTE and major bleeding in a real-world setting of patients who experienced unprovoked VTE and received extended treatment with rivaroxaban. Methods US claims databases (February 2011–April 2015) were used in this retrospective study. The study population included adult patients initiated on rivaroxaban within 7 days after their first unprovoked VTE (ie, deep vein thrombosis, pulmonary embolism) and received ≥3 months continuous rivaroxaban treatment (index date: end of 3-month treatment). Patients who were treated beyond 3 months formed the continued cohort and the remainder formed the discontinued cohort (ie, discontinued at 3 months). Adjusted Kaplan-Meier rates for recurrent VTE and major bleeding events were compared between cohorts with confounders being controlled through a propensity score weighting approach. Results Patients in the continued cohort (N = 3763) had significantly lower rates of recurrent VTE than those who discontinued (N = 1051): 0.57% vs 1.19% (P = .042), 1.07% vs 2.10% (P = .017), and 1.45% vs 2.60% (P = .023) at 3, 6, and 12 months, respectively. No significant differences in the rate of major bleeding were observed between cohorts. A sensitivity analysis among unprovoked VTE patients receiving rivaroxaban for ≥6 months showed similar results. Conclusions Continued rivaroxaban treatment beyond an initial 3- or 6-month treatment period significantly lowered the risk of recurrent VTE without a significant increase of major bleeding, compared to treatment discontinued at 3 or 6 months.