Real-world utilization and costs with biosimilar and reference filgrastim in patients with breast cancer receiving myelosuppressive chemotherapy in a community oncology setting from 2015 to 2017.

57 Background: Biosimilars have potential to reduce healthcare costs and increase access in the United States, but lack of uptake has contributed to lost savings. Filgrastim-sndz was the first FDA-approved biosimilar, and much can be learned by evaluating its uptake. In February 2016, the US Oncology Network converted to filgrastim-sndz as its short-acting granulocyte colony-stimulating factor (GCSF) of choice for prevention of febrile neutropenia (FN) following myelosuppressive chemotherapy (MCT). To understand utilization and cost patterns, this study analyzes real-world data of GCSFs within a community oncology network during the initial period of conversion to the first biosimilar available in the US. Methods: This descriptive retrospective observational study used electronic health record data for female breast cancer (BC) patients receiving GCSF and MCT at high risk of FN. Patient cohorts were defined by first receipt of either filgrastim or filgrastim-sndz during the 410 days before and after biosimilar conversion. Healthcare resource utilization (HCRU) and costs for GCSF and complete blood counts (CBC) were collected at GCSF initiation through the earliest of 30 days following end of MCT, loss to follow up, death, or data cutoff. Results: 146 patients were identified: 81 (55.5%) filgrastim and 65 (44.5%) filgrastim-sndz. No directional differences existed in baseline characteristics between the cohorts. Higher proportions of filgrastim-sndz patients received dose-dense MCT (33.8% vs 22.2%). Time trends show an initial spike in HCRU and cost for filgrastim-sndz patients after formulary conversion, which subsequently decreased and converged to that of the filgrastim cohort after 12 months. When aggregated, the overall median total administration counts, per patient per month (PPPM) and dosage, were marginally higher for filgrastim-sndz (5 vs 3; 2.9 vs 1.4; 1920 vs 1440 mcg, respectively). Median PPPM costs were higher for filgrastim-sndz ($803 vs $545). Median CBC utilization and costs were higher for filgrastim-sndz (2.8 vs 2.5; $28 vs $23, respectively). Conclusions: This study provides insight into real-world HCRU and cost patterns after formulary conversion to a biosimilar for BC patients receiving MCT and GCSF. As a descriptive study, causal inferences cannot be made and an underlying effect from index chemotherapy cannot be excluded. Convergence of HCRU and costs after 12 months suggests that overall results may be driven by behavior at initial formulary switch. Since filgrastim-sndz was the first US biosimilar approved, the uptake may be indicative of an experience with biosimilar acceptance in general. Future real-world studies of biosimilars must consider inconsistent utilization and practice trends during the time frame directly following formulary conversion.

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COVID19 Real-World Data for the US and Lessons to Re-Open Business

10.1101/2020.06.02.20120618 ◽

2020 ◽

Author(s):

Pascal J. Goldschmidt-Clermont

Keyword(s):

Enterprise Resource Planning ◽

Real World ◽

Resource Planning ◽

The United States ◽

Lessons Learned ◽

Planning System ◽

Real World Data ◽

World Data ◽

The Us ◽

Contact Tracking

AbstractIn March of 2020, the COVID19 pandemic had expanded to the United States of America (US). Companies designated as “essential” for the US had to maintain productivity in spite of the growing threat created by the SARS-CoV-2 virus. With this report, we present the response of one such company, the Lennar Corporation, a major homebuilder in the US. Within days, Lennar had implemented a morning health check via its enterprise resource planning system, to identify associates (employees) who were sick, or not in their “usual state of health”. With this survey, Lennar was able to ensure that no one sick would show up to work, and instead, would self-quarantine at home. Furthermore, with thorough contact tracking, associates exposed to COVID19 patients (suspected or RT-PCR test-confirmed), were also asked to self-quarantine. This survey, in addition to other safety measures, such as an overhaul of the company with nearly 50% of the company working from home, prolific communication, and many more measures, Lennar was able to function safely for its associates and successfully as an enterprise. The data that we present here are “real world data” collected in the context of working throughout a dreadful pandemic, and the lessons learned could be helpful to other companies that are preparing to return to work.

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1358. A Real-World Study of the Burden of Illness and Treatment Patterns Among Patients with Uncomplicated Urogenital Gonorrhea in the United States

Open Forum Infectious Diseases ◽

10.1093/ofid/ofab466.1550 ◽

2021 ◽

Vol 8 (Supplement_1) ◽

pp. S765-S766

Author(s):

Madison T Preib ◽

Fanny S Mitrani-Gold ◽

Ziyu Lan ◽

Xiaoxi Sun ◽

Ashish V Joshi

Keyword(s):

Real World ◽

Healthcare Costs ◽

Linear Models ◽

Burden Of Illness ◽

Unmet Need ◽

The United States ◽

Prescribing Practices ◽

Real World Data ◽

The Us

Abstract Background Gonorrhea (GC) is a major public health threat in the US. The Centers for Disease Control and Prevention (CDC) estimated direct healthcare costs of &271 million in 2018. CDC 2015 guidelines (applicable up to December 18, 2020) recommended cephalosporin plus azithromycin for GC. We used real-world data to assess patterns of inappropriate or suboptimal (IA/SO) or appropriate and optimal (AP&OP) antibiotic (AB) prescription (by CDC 2015 guidelines), and related healthcare costs, in US patients with uncomplicated urogenital GC (uUGG) diagnosed from July 1, 2013–June 30, 2018. Methods A retrospective cohort study of IBM MarketScan data (commercial/Medicare claims) in patients ≥ 12 years old with uUGG. Eligible patients had an AB prescription ±5 days of uUGG diagnosis (index date) and continuous health-plan enrollment with ≥ 6 months’ baseline/≥ 12 months’ follow-up data. Patients with complicated urogenital GC were excluded. Patients were stratified by AB prescription (IA/SO or AP&OP; defined in Table 1) during the first uUGG episode (ie, within 30 days of index). Generalized linear models were used for multivariate analysis. Table 1. Definitions of appropriateness of AB prescriptions Results Of 2847 patients with uUGG (58.5% male), 77.1% had an IA/SO prescription (mostly due to IA AB class [~82.0%] and duration [24.0%]), while only 22.9% had an AP&OP prescription; uUGG episodes were more frequent with IA/SO (n=2386) than AP&OP (n=714) prescriptions during follow-up. Patients with IA/SO prescriptions had higher GC-related total adjusted costs per patient (PP) per index episode (&196) vs those with AP&OP prescriptions (&124, p < 0.0001; Figure). Patients with IA/SO prescriptions also had higher GCrelated total adjusted costs PP during follow-up (&220) vs those with AP&OP prescriptions (&148, p < 0.0001), mostly driven by higher outpatient ambulatory and emergency room (ER) adjusted costs with IA/SO (&148 and &71, respectively) vs AP&OP prescriptions (&129 and &12, respectively, p ≤ 0.0152; Figure). ER visits PP at index and during follow-up were higher with IA/SO vs AP&OP prescriptions (p < 0.0001; Table 2). Figure. GC-related costs per patient with uUGG, stratified by appropriateness of AB prescription* Table 2. GC-related HRU per patient with uUGG, stratified by AB prescription Conclusion Most patients with uUGG were not prescribed treatments in accordance with CDC 2015 guidelines. High IA/SO AB prescriptions and associated healthcare costs suggest an unmet need for improved prescribing practices for uUGG in the US. Disclosures Madison T. Preib, MPH, STATinMED Research (Employee, Former employee of STATinMED Research, which received funding from GlaxoSmithKline plc. to conduct this study) Fanny S. Mitrani-Gold, MPH, GlaxoSmithKline plc. (Employee, Shareholder) Ziyu Lan, MSc, STATinMED Research (Employee, Employee of STATinMED Research, which received funding from GlaxoSmithKline plc. to conduct this study) Xiaoxi Sun, MA, STATinMED Research (Employee, Employee of STATinMED Research, which received funding from GlaxoSmithKline plc. to conduct this study) Ashish V. Joshi, PhD, GlaxoSmithKline plc. (Employee, Shareholder)

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Abstract 307: Real-world Clinical Characteristics and Recurrence Burden of Patients Diagnosed With Recurrent Pericarditis in The United States

Circulation Cardiovascular Quality and Outcomes ◽

10.1161/hcq.13.suppl_1.307 ◽

2020 ◽

Vol 13 (Suppl_1) ◽

Author(s):

David Lin ◽

Christine Majeski ◽

Maral DerSarkissian ◽

Matt Magestro ◽

Cristi Cavanaugh ◽

...

Keyword(s):

Real World ◽

The United States ◽

Recurrent Pericarditis ◽

Real World Data ◽

Acute Pericarditis ◽

The Us ◽

History Of ◽

Artery Disease ◽

First Recurrence

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.

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Bone Targeting Agent Treatment Patterns Among Patients with Multiple Myeloma Treated at Oncology Clinics Across the United States: Observations from Real-World Data

Blood ◽

10.1182/blood.v128.22.2364.2364 ◽

2016 ◽

Vol 128 (22) ◽

pp. 2364-2364

Author(s):

Christopher Kim ◽

Rohini K. Hernandez ◽

Paul C Cheng ◽

Jeremy Smith ◽

Lori Cyprien ◽

...

Keyword(s):

Zoledronic Acid ◽

Real World ◽

The United States ◽

Treatment Patterns ◽

First Year ◽

Real World Data ◽

Employment Equity ◽

The Us ◽

Equity Ownership

Abstract Introduction: Multiple myeloma (MM) is a hematologic malignancy with 30,330 estimated new cases in the US in 2016. The International Myeloma Working Group recommended that intravenous (IV) bisphosphonates be initiated in all patients with active MM administered at 3 to 4-week intervals. However, there are limited data to date on the real-world use of bone target agents (BTA; zoledronic acid and pamidronate disodium) in MM. The primary goal of this study is to describe current real-world BTA treatment patterns. Methods: A database of electronic medical records from >1 million patients treated at approximately 220 cancer centers across the United States, OSCER (Oncology Services Comprehensive Electronic Records, generated by Flatiron Health), was used to identify individuals 18 years or older diagnosed with MM (ICD-9 203.00; ICD-10 C90.00) with at least 1 clinic visit within 1 month of diagnosis date between January 1, 2009 and March 31, 2016. Timing of BTA administrations, frequency, schedule, and changes/discontinuation were calculated, renal function, and BTA treatment relative to anti-MM therapy regimens was also determined. Results: During the study period, 11,099 patients were diagnosed with MM; most were male (55%), white (59%), and 65 and older at diagnosis (66%). Through the end of the follow-up period (median follow-up: 687 days), 64% of patients received ≥1 administration of a BTA (% consistent across study period) and zoledronic acid was the predominant BTA (93% of patients received ≥1 administration). The mean time from MM diagnosis until first BTA was 105.7 days (median: 29, IQR: 11-78). In more recent years, the time to BTA initiation decreased. Initial BTA treatment occurred in first year after MM diagnosis in 58.7% of patients. By calendar year of diagnosis, the percentage of patients that ever received BTA treatment had decreased over time (2009-2010: 72.3%; 2011-2012: 68.0%; 2013-2014: 63.6%). Most BTA administrations were dosed on a Q4W schedule (77%), particularly in the first year of MM diagnosis (84%). A total of 2,350 patients (33.2%) either discontinued or changed BTA dosing scheduling through the end of follow-up. Approximately 54% of patients that received a first line anti-MM therapy received BTA concomitantly; in second line, concomitant BTA was 59%, and in third line, 55%. Conclusions: Real-world data from oncology practices across the US indicate that approximately two-thirds of MM patients received BTA treatment, and the treatment rate did not increase in more recent years. Additionally, few patients continued BTA beyond 2 years. Among BTA treated patients, BTA initiation occurred at approximately 3.5 months after diagnosis, and the majority of administrations followed a Q4W schedule with zoledronic acid. Further work will explore reasons for non-treatment and treatment discontinuation with particular attention given to potential contraindications such as renal impairment, and the added burden of IV therapy in MM. Disclosures Kim: Amgen Inc.: Employment, Equity Ownership. Hernandez:Amgen: Employment, Equity Ownership. Cheng:Amgen: Employment, Equity Ownership. Smith:Amgen: Consultancy. Cyprien:Amgen: Consultancy. Liede:Amgen: Employment, Equity Ownership.

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