Real-World Analysis of Clinical and Demographic Characteristics, Treatment Patterns, and Outcomes in Predominantly Older Patients with HR+/HER2- Metastatic Breast Cancer Receiving Abemaciclib in Routine Clinical Practice.

Introduction: Hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) is the most frequently diagnosed metastatic breast cancer (mBC) subtype. Combinations of endocrine therapy (ET) with cyclin-dependent kinase 4/6 inhibitors (CDK4 & 6is) improve outcomes compared with ET alone. The efficacy and safety of abemaciclib among patients with HR+/HER2- mBC has been demonstrated in the MONARCH clinical trials; however, there is a paucity of real-world evidence, particularly in older patients.

Management of hepatocellular carcinoma from diagnosis in routine clinical practice.

Aim: To assess real-world management of patients diagnosed with hepatocellular carcinoma (HCC) within an integrated delivery network.

Materials & Methods: A retrospective cohort analysis of adults newly diagnosed with HCC from January 2014 to March 2019. Overall survival and treatment journey were assessed over the entire available follow-up period per patient.

Prostate-specific antigen response and clinical progression-free survival in Black and White men with chemotherapy-naïve metastatic castration-resistant prostate cancer treated with enzalutamide in a real-world setting.

Background: In the United States, Black men have a higher incidence of prostate cancer (PC)-related mortality than men of other races. Several real-world studies in advanced PC suggest, however, that Black men respond better to novel hormonal therapies than White men. Data on treatment responses to enzalutamide by race are limited.

Within-trial economic analysis of resource use from COMET-ICE: A phase 3 clinical trial evaluating sotrovimab for the treatment of patients with COVID-19 at high risk of progression.

Final results for the primary endpoint of the COVID-19 Monoclonal antibody Efficacy Trial-Intent to Care Early (COMET-ICE) randomized controlled trial (NCT04545060) showed a 79% ( < 0.001) adjusted relative risk reduction in longer-than-24-hour hospitalization or death due to any cause in high-risk patients with COVID-19 receiving sotrovimab compared with placebo at Day 29. Given the substantial costs associated with COVID-19 hospitalizations, there is a need to quantify the economic impact of clinical trial outcomes to inform decisionmaking.

Health Care Resource Utilization and Costs for Metastatic Breast Cancer Patients Newly Treated with Human Epidermal Growth Factor Receptor 2 (HER2)-Targeted Agents.

Introduction: HER2-positive metastatic breast cancer (mBC) is an incurable disease associated with years of chronic therapy and excess cost. HER2-targeted therapies have shown survival benefit for early-stage and mBC; however, the economic impact of these therapies has not been fully assessed. We evaluated health care resource use (HCRU) and costs of mBC patients treated with HER2-targeted therapy.

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

Purpose: 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.

Methods: 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.

Within-trial economic analysis of flare data from the BLISS-SC trial of subcutaneous belimumab in systemic lupus erythematosus.

Objective: The management of systemic lupus erythematosus (SLE) flares can incur substantial healthcare costs. In the phase III BLISS-SC trial, subcutaneous (SC) belimumab 200 mg plus standard therapy was associated with significant reductions in time to severe flare, and risk of flares, versus placebo plus standard therapy, in adults with active SLE. We evaluated whether the reduction in SLE flares with belimumab SC plus standard therapy translated to lower healthcare costs.

COPD exacerbation costs in the IMPACT study: a within-trial analysis.

Objectives: Exacerbations account for the greatest proportion of costs associated with chronic obstructive pulmonary disease (COPD). Here we aimed to evaluate, from the US payer perspective, the costs associated with moderate and severe COPD exacerbation events for patients treated with fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) compared with FF/VI or UMEC/VI.

Study Design: This post hoc, within-trial economic analysis used data derived from the InforMing the PAthway of COPD Treatment (IMPACT) study (NCT02164513).

Cost analysis of COPD exacerbations and cardiovascular events in SUMMIT.

Objectives: The Study to Understand Mortality and Morbidity in COPD (SUMMIT) trial compared the efficacy of once-daily fluticasone furoate/vilanterol (FF/VI) with placebo, FF monotherapy, and VI monotherapy on mortality in patients with moderate chronic obstructive pulmonary disease (COPD) and a history/increased risk of cardiovascular (CV) disease. We conducted a post hoc economic analysis using data from SUMMIT to evaluate the economic benefits of treating these patients with COPD and CV risk.

Study Design: Patients (aged 40-80 years, with ≥10 pack-years' smoking history and a risk of CV events) were randomized (1:1:1:1) to receive placebo, FF 100 mcg, VI 25 mcg, or FF/VI 100 mcg/25 mcg.

Real-world treatment patterns and outcomes of patients with small cell lung cancer progressing after 2 lines of therapy.

Objectives: To evaluate treatment patterns, physician-assessed overall response rate (ORR), progression-free survival (PFS), and overall survival (OS) among third-line (3L)-plus small cell lung cancer (SCLC) patients.

Materials And Methods: Retrospective analysis of a United States (US)-based community oncology electronic medical record (EMR) database was conducted. Target sample included SCLC patients ≥18 years of age whose disease progressed after at least 2 prior treatments.

COPD affects worker productivity and health care costs.

Purpose: This study aimed to measure the true burden of COPD by calculating incremental direct and indirect costs. Direct medical resource use, productivity metrics, and COPD-specific resource use and costs were also evaluated.

Patients And Methods: This was a retrospective, observational, matched cohort study using administrative claims data from the Truven Health MarketScan Commercial Claims and Encounters and the Health and Productivity Management databases (2007-2010).

Long-term opioid users with chronic noncancer pain: Assessment of opioid abuse risk and relationship with healthcare resource use.

Objective: Identify opioid abuse risk factors among chronic noncancer pain (CNCP) patients receiving long-term opioid therapy and assess healthcare resource use (HRU) among patients at elevated abuse risk.

Design: Data were obtained from an integrated administrative claims database. Classification and Regression Tree (CART) analysis identified risk factors potentially predictive of opioid abuse, which were used to classify the overall population into cohorts defined by levels of abuse risk.

Clinical and economic outcomes associated with the use of fluticasone propionate 250 mcg and salmeterol 50 mcg combination versus tiotropium bromide 18 mcg as initial maintenance treatment for chronic obstructive pulmonary disease in managed care.

Aims: To examine the clinical and economic outcomes associated with the use of long-acting bronchodilators for initial maintenance treatment of chronic obstructive pulmonary disease (COPD) by analyzing health insurance claims data in the US.

Methods: A retrospective, observational, matched cohort study used health insurance claims data (January 2008 to June 2013) to assess COPD-related outcomes for subjects aged ≥40 years. Subjects were assigned to a study cohort according to the first observed prescription fill for a long-acting bronchodilator (fluticasone propionate 250 mcg/salmeterol 50 mcg [FSC] or tiotropium bromide 18 mcg [TIO]).

The cost of cardiovascular-disease-related death in patients with type 2 diabetes mellitus.

Objectives: To assess the magnitude of difference in all-cause healthcare resource utilization (HCRU) and costs between patients with type 2 diabetes mellitus (T2DM) who died from a cardiovascular disease (CVD)-related cause in the year preceding death vs. those who did not die during this same period.

Methods: A large US administrative claims database was used to identify patients with T2DM who died of a CVD-related cause from July 2012 to April 2015.

Incremental burden of type 2 diabetes in patients experiencing cardiovascular hospitalizations.

Objective: To evaluate the incremental economic burden of type 2 diabetes in patients experiencing cardiovascular (CV) hospitalizations.

Research Design And Methods: Adults with ≥1 CV hospitalization were identified using a US-based healthcare claims database from 1 July 2011 to 30 June 2014. Outcomes for patients surviving the index hospitalization were compared between patients with vs.

Confirming the timing of phase-based costing in oncology studies: a case example in advanced melanoma.

Aims: The utilization of healthcare services and costs among patients with cancer is often estimated by the phase of care: initial, interim, or terminal. Although their durations are often set arbitrarily, we sought to establish data-driven phases of care using joinpoint regression in an advanced melanoma population as a case example.

Methods: A retrospective claims database study was conducted to assess the costs of advanced melanoma from distant metastasis diagnosis to death during January 2010-September 2014.

Elevated Cardiovascular Disease Risk in Patients With Chronic Myelogenous Leukemia Seen in Community-based Oncology Practices in the United States.

Introduction: Current National Comprehensive Cancer Network guidelines recommend that comorbidities, including cardiovascular disease (CVD), be considered when selecting tyrosine kinase inhibitors for the treatment of chronic myelogenous leukemia (CML). We report here the prevalence of CVD and its risk factors in patients with CML treated by community-based United States (US) oncologists.

Patients And Methods: Adult patients with a confirmed diagnosis of CML and ≥ 1 encounter after the first date of CML diagnosis in an electronic medical record database between January 1, 2005 and October 31, 2014 were enrolled.

Burden of Alcohol Abuse or Dependence Among Long-Term Opioid Users with Chronic Noncancer Pain.

Background: Substance abuse disorders among chronic noncancer pain (CNCP) patients add to the clinical challenges and economic burden of caring for such patients. Despite potential risks, some CNCP patients with a history of alcohol abuse or dependence (AAD) and pain that is refractory to nonopioid treatment options may still need opioids for pain management. However, there is a lack of data on adverse outcomes in long-term opioid users with CNCP and a history of substance abuse or AAD disorders.

First-Line Treatment with Bevacizumab and Platinum Doublet Combination in Non-Squamous Non-Small Cell Lung Cancer: A Retrospective Cohort Study in US Oncology Community Practices.

Background: Real-world evidence is lacking on the impact of bevacizumab added to carboplatin/paclitaxel (Bev + CP) therapy versus CP alone for patients with non-squamous non-small cell lung cancer (NS-NSCLC), particularly in those excluded from clinical trials.

Methods: This is a retrospective electronic medical record analysis of patients who received first-line therapy with Bev + CP or CP between 1 October 2006 and 30 June 2013. We identified four subsets: elderly patients (≥65 years), patients with brain/central nervous system (CNS) metastases, patients with Eastern Cooperative Oncology Group performance status (ECOG PS) ≥2, and patients receiving anticoagulation.

Prompt initiation of maintenance treatment following a COPD exacerbation: outcomes in a large insured population.

Background: The aim of this study was to extend previous findings and determine the value of prompt initiation of maintenance treatment (MT) following COPD exacerbations requiring hospitalization or an emergency department (ED) visit.

Patients And Methods: Administrative claims data (collected between January 1, 2009 and June 30, 2012) from an employer-sponsored commercially insured population were retrospectively used to identify patients with a COPD exacerbation resulting in hospitalization or an ED visit. Patients initiating approved MT for COPD within 30 days of discharge/diagnosis (prompt) were compared with those initiating MT within 31-180 days (delayed).