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Background: Nonadherence to oral anticoagulants (OACs) is a challenge to stroke risk reduction in patients with nonvalvular atrial fibrillation (NVAF). Data on primary medication nonadherence (PMN) in NVAF are lacking. Objectives: Our aim was to assess the rates and predictors of PMN among NVAF patients who were newly prescribed an OAC. Methods: This was a retrospective database analysis of linked healthcare claims and electronic health record data. Adult NVAF patients with a prescription order for an OAC (apixaban, rivaroxaban, dabigatran, or warfarin) between January 2016 and June 2019 were identified (date of first prescription order = index date). Patients had a 1-year baseline and a 6-month post-index period to assess the rates of PMN, defined as having a prescription order but no paid claim for any OAC on or within 30 days after the index date. Sensitivity analyses explored 60-, 90- and 180-day PMN thresholds. Logistic regression models were used to examine the predictors of PMN. Results: Among 20,393 patients, the overall 30-day PMN rate was 28.4%; PMN rates decreased to 17% with a 180-day threshold. PMN was numerically lowest for warfarin among OACs and numerically lowest for apixaban among direct OACs. A CHA2DS2-VASc score of ≥ 3, commercial insurance, and African American race were associated with higher odds of PMN. Conclusions: More than one-quarter of patients experienced PMN within 30 days of their initial prescription order. This rate decreased over a longer period, suggesting a delay in fills. Understanding the factors associated with PMN is warranted to develop effective interventions for improving OAC treatment rates in NVAF. [ABSTRACT FROM AUTHOR]

Objective: To determine the coalitions and impact of authors, countries, institutions, and journals, evaluate the knowledge base, find the hotspot trends, and identify the emerging topics in lumbar disc herniation (LDH). Method: The articles related to LDH were obtained from the Web of Science Core Collection on August 21, 2021. Two scientometric software (CiteSpace 5.8.R.1 and VOSviewer 1.6.17) were used to perform bibliometric and knowledge-map analysis. Results: From the set parameters, 4642 articles were included in the literature. Although the total number of publications fluctuated between 2001 and 2020, a general trend toward increase was observed. Respectively, the most productive country and institution in the field were the United States and Wooridul Spine Hospital. The most active and cited authors were Lee and Weinstein. Spine was the most impactful and cited journal. Weinstein (JAMA 296:2441–2450, 2006) had the highest number of co-citations and Weinstein(N Engl J Med 358:794-810, 2008) had the highest number of citations. The keyword "low back pain" was ranked first for frequency and total link strength, whereas "risk factor" was ranked first for centrality. Topics including pathogenesis (disc herniation), examination methods (MRI), treatment methods (non-surgical treatment, surgical treatment), surgical options (laminectomy, discectomy), clinical observations (double-blind, efficacy, outcome, learning curve), and evaluation of efficacy (meta-analysis) of LDH have been the focus of leading-edge research in 2001–2020. Conclusion: Using bibliometric methods, this study mapped the knowledge map of LDH research in the past 20 years. The study identifies existing trends to provide a framework for further research. [ABSTRACT FROM AUTHOR]

Objectives: To study transitions between healthcare settings and quantify the cost burdens associated with different combinations of transitions during a 6‐month period before initial Alzheimer's disease (AD) diagnosis so as to investigate how using an episode‐of‐care approach to payment for specific disease states might apply in AD. Design: A retrospective observational cohort study. Setting: United States. Participants: A random sample of 8,995 individuals aged 65 to 100 with a diagnosis of AD (International Classification of Diseases, Ninth Revision, Clinical Modification code 331.0) were identified from the Medicare database between January 1, 2011, and June 30, 2014. This analysis identified individuals with AD diagnosed in inpatient (18%), skilled nursing facility (SNF) (1%), hospice (4%), and home and outpatient (77%) settings and analyzed episodes that began in the index setting (defined as the care setting in which the individual was first diagnosed with AD). Measurements: Study outcomes included number of transitions between settings, primary discharge diagnoses, and total all‐cause healthcare costs during the 6 months after the AD diagnosis. Results: The average numbers of transitions between care settings were 2.8 originating from an inpatient setting, 2.4 from a SNF, 0.3 from a hospice setting and 0.7 from a home or outpatient setting during 6 months post‐AD diagnosis. The overall cost burden during the 6 months after AD diagnosis (including costs incurred at the index setting) was high for individuals diagnosed in a nonambulatory setting (mean $41,468). Individuals diagnosed in an ambulatory setting incurred only $12,597 in costs during the same period. Conclusion: Episodes of care can be defined and studied in individuals with AD. An episode‐of‐care approach to payment could encourage providers to use the continuum of care needed for quality medical management in AD more efficiently. [ABSTRACT FROM AUTHOR]

Introduction: Hypoglycemia and fear of hypoglycemia may contribute to basal insulin discontinuation, poor glycemic control, and increased healthcare burden in patients with type 2 diabetes (T2D). This study aimed to determine the impact of hypoglycemia soon after basal insulin initiation on treatment discontinuation and economic outcomes in patients with T2D.Methods: Hypoglycemic events within 6 months of basal insulin initiation were identified using retrospective cohort data from patients with T2D, at least 18 years of age, initiated on basal insulin therapy in the Clinformatics™ Data Mart for Multiplan claims database from January 1, 2008, through August 31, 2012. Data were adjusted for baseline characteristics. Discontinuation was established for patients with 12-month follow-up data, while discontinuation risk was assessed in the extended analysis (6- to 24-month follow-up) by Cox regression analysis. Healthcare use and costs were determined.Results: Of 55,608 patients, 4.5% experienced hypoglycemia within 6 months of basal insulin initiation. Patients with hypoglycemia were more likely to discontinue basal insulin within 12 months of initiation (79.0% vs. 74.2%; P < 0.001). Data, adjusted for baseline characteristics such as age, any baseline hypoglycemia, and use of oral antidiabetes drugs, showed that patients with hypoglycemia had a greater risk of discontinuation (hazard ratio 1.16; 95% confidence interval 1.03, 1.32; P = 0.0164), were more likely to have a hospitalization (41.0% vs. 24.3%; P < 0.001) or an ED visit (55.8% vs. 35.1%; P < 0.001), and had higher diabetes-related ($13,662 vs. $7506; P < 0.001) and all-cause ($30,719 vs. $19,079; P < 0.001) healthcare costs.Conclusions: US patients with T2D who experienced hypoglycemia within 6 months of basal insulin initiation were more likely to discontinue treatment, accompanied by a greater healthcare burden.Funding: Sanofi US, Inc. [ABSTRACT FROM AUTHOR]

Objectives Compare healthcare resource utilization ( HCRU) and costs between patients prescribed opioids ( Rx OP) and those who were not ( No Rx OP) during an emergency department ( ED) or inpatient visit. Methods Retrospective cohort analysis was performed ( January 2006 to September 2010). Continuously eligible Rx OP patients in ED/inpatient settings ( January 2007 to September 2009) were included if age was ≥ 12 years by initial prescription date (or random date between first ED/inpatient admission and September 30, 2009 [ NoRx OP patients]). Healthcare resource utilization and costs for 12 months after initial prescription were compared. Univariate descriptive analyses were performed for baseline and outcome variables and compared using appropriate tests. Risk adjustment compared HCRU between Rx OP and No Rx OP cohorts for the postindex period. Results Of 27,599 eligible patients, Rx OP patients ( n = 18,819) were younger, less likely to be male, more likely to reside in southern United States and to have Preferred Provider Organization health plans, and had lower comorbidity index scores, compared with No Rx OP patients ( n = 8,780). Rx OP patients were less likely to have nonpain-related comorbidities and more frequently diagnosed with pain-related comorbidities. Unmatched and propensity-matched Rx OP patients experienced higher HCRU and costs in all subcategories (total, inpatient, outpatient ED, physician, pharmacy, other outpatient settings). Opioid abuse frequency was low in patients with common diagnoses/procedures within 3 months before initial prescription (0.48%). Average time to abuse was < 1 year (201 days). Conclusion Most patients were prescribed opioids initially during ED/inpatient visits and incurred higher HCRU than those not prescribed opioids. Among those with diagnosed opioid abuse after initiating opioids, time to diagnosis was rapid (range: 14 to 260 days) for patients with common diseases and procedures. [ABSTRACT FROM AUTHOR]

Objective Evaluate prevalence and risk-adjusted healthcare costs of diagnosed opioid abuse in the national Veterans Health Administration ( VHA). Costs were compared between patients with and without diagnosed opioid abuse. Design Medical and pharmacy claims analysis of VHA data (10/01/2006 to 09/30/2010) were retrospectively analyzed. Prevalence was calculated as the percent of patients with diagnosed opioid abuse for the entire VHA membership and those with noncancer pain diagnoses, compared between patients prescribed opioids prior to abuse diagnosis and those not prescribed opioids through the VHA system. Healthcare utilization and costs were estimated using matching techniques and generalized linear models to control for clinical and demographic differences between patients with and without diagnosed opioid abuse. Separate comparisons were made (with diagnosed abuse vs. without) for each cohort: patients with/without opioid prescriptions. Results Five-year diagnosed opioid abuse was 1.11%. Among patients prescribed opioids, 5-year abuse prevalence was 3.04%. Pain patients prescribed opioids had the highest abuse rate at 3.26%. Adjusted annual healthcare costs for diagnosed opioid abuse patients were higher than for those without diagnosed abuse, (prescribed opioids overall healthcare costs: $28,882, with diagnosed abuse vs. $13,605 for those without; not prescribed opioids: $25,197 vs. $6350, P-value< 0.0001; opioid-specific healthcare costs for patients prescribed opioids: $8956 vs. $218; patients not prescribed opioids: $8733 vs. $20). Conclusions Diagnosed opioid abuse prevalence is almost 7-fold higher in the veteran's administration population than in commercial health plans and translates to a significant economic burden. Appropriate interventions should be considered to prevent and reduce opioid abuse. [ABSTRACT FROM AUTHOR]

Atlantoaxial spine surgery is a challenge to spinal surgeons because of its proximity to neurovascular structures. This study aimed to identify and analyze the scientific publications in atlantoaxial spine surgery from different countries and institutions. Clarivate Analytics Web of Science was used to search all articles for information on atlantoaxial spine surgery. The annual research, countries, journals, authors, institutions, citation frequency, and journal metrics were extracted. These results from countries and hotspots (keywords in publications) were subjected to co-occurrence analysis using VOSviewer, after which the top 100 most-cited articles were analyzed further. A total of 3161 articles were included. A trend toward an increasing number of publications on atlantoaxial spine surgery in recent years was evident. Among all countries, the United States contributed the most publications. Seth Gordhandas Sundarda Medical College had the highest number of publications among institutions. Among all research categories, fixation and fusion were the most common areas discussed. The screw-rod system described in the most-cited article (cited 823 times) appeared to be the most popular fixation method. With the development of C1 and C2 screw technology, the screw-rod system is becoming increasingly popular. The atlantoaxial spine surgery literature has grown continuously in recent years. The United States is the largest contributor in this field. Fixation and fusion are the most common areas, and fixation-related studies should be closely followed. The screw-rod fixation system is becoming increasingly popular. [ABSTRACT FROM AUTHOR]

Abstract: Objective: Triple-negative breast cancer (TNBC) is a high-grade breast cancer with an aggressive clinical course. We examined the recurrence rate, health care utilization, and cost of early-stage TNBC in the US managed care setting. Study Design: A retrospective study using linked cancer registry, health care claims, and social administration databases. Methods: This retrospective study used the Impact Intelligence Oncology Management cancer registry, linked to 1999-2009 administrative claims, from a national managed care health plan and also Social Security Administration mortality data. Patients with stage I-III TNBC and non-TNBC were followed from diagnosis to recurrence, disenrollment, or end of observation period. Risk-adjusted recurrence rate, health care utilization, and costs during the follow-up period were compared. Results: A total of 1967 women (403 with TNBC) were included; 289 (14.7%) had local/distant recurrence during the follow-up period. Patients with TNBC were younger (53.68 vs. 56.16 years, P < .0001) and more likely to experience recurrence compared with non-TNBC (21.6% vs. 12.9%, P < .0001; adjusted hazard ratio=2.11, P < .0001). In terms of adjusted annual health care utilization and costs, patients with TNBC had significantly higher numbers of hospitalizations (1.20 vs. 0.90, P =.001); hospitalization days (8.80 vs. 4.97, P < .0001); and emergency department (ED) visits (1.45 vs. 0.95, P =.009). They also had significantly higher inpatient costs (all-cause: $9154 vs. $5501; cancer-related: $5632 vs. $2869; P < .0001 for both); and ED costs (all-cause: $303 vs. $182, P =.003; cancer-related: $240 vs. $138, P =.012). Conclusions: This study demonstrates that, compared with non-TNBC, early-stage TNBC is associated with higher rate of recurrence, resulting in increased health care utilization and costs. [Copyright &y& Elsevier]

Objectives: To investigate the journey to oral anticoagulant (OAC) access following formulary-related rejection of apixaban (Eliquis) and evaluate characteristics associated with failure to achieve OAC access among patients with atrial fibrillation (AF)., Study Design: Retrospective study using the Optum Market Clarity Data from January 2016 through February 2020., Methods: Patients had at least 1 claim rejection for apixaban due to prior authorization (PA), formulary exclusion (FE), or quantity limit (QL) and at least 1 AF diagnosis on or before the rejected claim. Descriptive statistics summarized transaction journeys by type of formulary restriction. Multivariable regression assessed patient characteristics associated with not receiving an OAC within 60 days after initial rejection., Results: Among 18,434 patients in the analytic sample, QL was the most common reason for rejection (68.7%), followed by PA (21.2%) and FE (10.2%). Most patients received a paid OAC claim within 60 days after rejection (82.2%-85.5% across restriction types). Mean time from rejection to paid claim ranged from 5.2 to 10.7 days among patients with a paid OAC claim and 12.4 to 17.6 days among those with multiple attempts before OAC receipt. Characteristics associated with higher odds of not receiving OAC treatment included being male, beingAfrican American, having Medicaid coverage, possessing a high stroke risk score, exhibiting no evidence of prior apixaban treatment, and being prescribed a low dose of apixaban on the initial rejected claim., Conclusions: Most patients with a claim rejection for apixaban received approval for apixaban within 60 days, suggesting that initial rejection merely created a delay in treatment. Vulnerable populations were at greater risk of not receiving a paid OAC claim.

Introduction: In this real-world study, the incidence of cardiovascular events (CV) including major adverse cardiac events (MACE), arterial occlusive events (AOE), and venous occlusive events (VOE) was evaluated in chronic myeloid leukemia (CML) patients treated with ponatinib or bosutinib in a US commercial database population., Materials and Methods: CML patients aged ≥18 years with use of 1 or 2 prior tyrosine kinase inhibitors prescribed bosutinib or ponatinib were selected from the IBM® MarketScan® Research database. Cox proportional hazard model analyses were conducted to examine any difference in CV event risk., Results: Ponatinib and bosutinib was associated with similar incidence and risk of CV events, including MACEs (HR: 1.02; 95% CI: 0.35, 3.01), AOEs (HR: 0.90; 95% CI: 0.43, 1.85) and VOEs (HR: 0.92; 95% CI: 0.44, 1.94)., Conclusion: Treatment with ponatinib or bosutinib was not associated with significant differences in the incidence of CV events in CML patients., (Copyright © 2021. Published by Elsevier Ltd.)

Introduction: Crohn's disease (CD) is a chronic inflammatory disease of the gastrointestinal tract. This real-world study evaluated persistence, dose titration, health care resource utilization (HCRU) and associated costs, and medication use among CD patients treated with ustekinumab (UST) in several pooled US commercial database populations., Methods: CD patients aged ≥ 18 years with medical or pharmacy claims for UST were selected from pooled data from 3 large, national commercial databases. The first observed medical or pharmacy claim for UST was the index date. Patients were required to have had ≥ 1 medical claim with a CD diagnosis during the 12 months prior to the index date and continuous health plan enrollment for a minimum of 12 months prior to and 12 months after the index date. Comparisons of outcomes during the baseline and follow-up periods were conducted using inferential statistical tests., Results: A total of 214 eligible UST patients were selected. The majority (74.8%) were biologic experienced (mean age: 41 years), and 83.6% remained treatment persistent during the 12-month post-index period. Among discontinuers, 25.7% restarted UST, and 8.6% switched from UST in the 12-month observation period. The mean treatment duration was 329 days. Most patients (77%) used the recommended UST dose, as defined as being within a 20% dose variation from label (90 mg/8 weeks ± 20%), 17.9% experienced dose escalation, and 5.1% experienced dose reduction. Post-index immunomodulator and corticosteroid use reduced by 20% and 28%, respectively, as compared with pre-index use among CD patients using UST. Annual all-cause ER visits and inpatient stays decreased by 20.5% and 30.3%, respectively, with similar downward trends for annual CD-related HCRU., Conclusions: The majority of CD patients prescribed UST were biologic experienced, and persistence was high over the 1-year follow-up. UST treatment initiation was associated with reductions in ER visits, inpatient stays, and steroid and other medication use.

Introduction: This study aimed to characterize chronic hepatitis B (CHB)-infected patients and estimate the association between nucleos(t)ide analogue (NA) persistence and economic outcomes using data from the Veterans Health Administration (VHA) database., Methods: Patients (at least 18 years of age) with two or more claims for CHB and at least one pharmacy claim for NA were identified using VHA data from 1 April 2013 to 31 March 2018. The index date was the first NA prescription fill date during 1 October 2014 to 31 March 2017. Persistence and non-persistence to NA treatment were assessed during the first 2 years post index date. Non-persistence was defined as at least one failure to refill medication within 30 days from the run-out date. Generalized linear models were used to compare health care utilization and costs between persistent and non-persistent patients., Results: Among patients treated with NAs (N = 2368), 1428 (60%) were CHB mono-infected and 748 (32%) were HIV co-infected. Total costs per patient per year (PPPY) were $39,240, $29,957, and $55,220 PPPY for NA-treated, mono-infected, and HIV co-infected patients, respectively. An inception cohort of 564 patients (24%), without a NA prescription in the 6 months pre-index period and at least 2 years of follow-up, was created. Persistence among the inception cohort was 29% for first year and 14% for first 2 years. After adjustment for baseline differences, persistent patients had lower cumulative overall health care costs compared to non-persistent patients, with a net cost saving of $851 (p > 0.05) in the first 2 years., Conclusion: CHB is associated with considerable economic burden. We observed suboptimal persistence to NAs which decreased over time. Short-term savings could be generated for CHB-infected patients when they remain persistent to NAs.

Background: Large population-based studies of risk factor for lung metastases at the presentation with primary osseous neoplasms are lacking and necessary. We aim to examine potential risk factors of lung metastases at presentation with primary osseous neoplasms using Surveillance, Epidemiology, and End Results (SEER) database tool., Methods: We collected patients diagnosed with primary osseous neoplasms between 2010 and 2015 from the SEER database. Patients were divided into two groups: patients with lung metastases or patients without lung metastases. Patient characteristics such as age, sex, race, tumor size, histologic types, histologic grade, and lung metastasis were collected. Univariate and multivariate logistic regression analyses were applied to determine which characteristics were risk factors for lung metastasis at diagnosis., Results: A total of 4459 patients were collected, and 507 patients had lung metastases at presentation. Data on age, race, gender, primary site, grade, tumor size, and histology types were enrolled into the multivariate logistic analysis. Higher grade (OR = 5.197, 95% CI 3.328 to 8.117), histology type (Ewing sarcoma: OR = 1.432, 95% CI 1.020 to 2.009; osteosarcoma: OR = 1.597, 95% CI, 1.073 to 2.377), and larger tumor size (≥ 5 cm: OR = 3.528, 95% CI 2.370 to 5.251) were associated with an increased risk of lung metastasis at presentation., Conclusion: Histology types (osteosarcoma and Ewing sarcoma) were related to a higher risk of lung metastases in primary osseous neoplasms patients. Patients with osteosarcoma and lager tumors or higher tumor grade were associated with higher possibility of lung metastases. Patients with Ewing sarcoma and larger tumors have more tendency of lung metastases. These patients are supposed to receive chest CT scans at the presentation with primary osseous neoplasms.

Aims: Systemic lupus erythematosus (SLE) is a multifaceted autoimmune disease involving multiple organs systems and places a significant economic burden on SLE patients. There is a literature gap regarding the standard of care and economic burden in SLE patients, their families, and society. This study assessed medication use patterns among SLE patients and generated the annual and total economic burden associated with the illness. Materials and methods: Adult patients with ≥2 medical claims on different dates for SLE diagnoses were identified from 01 January 2013 to 31 December 2015 using two large administrative claims databases representative of the commercially insured US population. Patient demographics and clinical characteristics during 1-year pre-SLE diagnosis were assessed. Outcomes including the proportion of patients who used SLE medications and annual costs were assessed 1-year post-SLE diagnosis. Total costs related to SLE were extrapolated to the US population to estimate the economic burden based on SLE prevalence. Results: A total of 30,086 SLE patients were identified. The most common baseline comorbidities were hypertension and infections. Corticosteroids and hydroxychloroquine were the most common SLE medications. Biologics utilization was minimal. SLE patients had, on average, 26.0 physician visits, 23.7 prescription claims, 1.7 inpatient admissions, and 2.0 hospital days per patient 1-year post-SLE diagnosis. Annual all-cause median costs among all SLE patients were $8712 per patient per year. Total costs ranged between $1.4-1.6 and $2.8-3.2 billion per year, depending on prevalence estimates. Conclusions: Our findings indicate a nominal use of biologics (∼2%) among SLE patients; despite belimumab being one of the few approved treatments for SLE in the USA. These data reveal an unmet need for availability of advanced SLE therapy, and future studies are warranted concerning the underlying causes. SLE is also associated with a substantial economic burden of ≤3.2 billion per year. These findings may assist in future planning and resource allocation.

Purpose: Chronic obstructive pulmonary disease (COPD) is a common condition responsible for substantial morbidity, mortality, and costs in the United States. The economic burden of COPD is driven primarily by hospitalizations, with 1 in 5 hospitalized patients experiencing a 30-day readmission. Bronchodilators, delivered via handheld inhalers or nebulizers, are the mainstay of therapy for COPD. However, differences in outcomes between short- and long-acting therapies are unclear. We examined real-world differences in 30-day readmission and exacerbation rates between Medicare beneficiaries with COPD treated with a nebulized long-acting beta 2 -agonist (arformoterol tartrate [ARF]) and beneficiaries treated with a nebulized short-acting beta 2 -agonist (SABA) for maintenance therapy after hospital discharge., Methods: Truven MarketScan Hospital Drug Database and Medicare files were probabilistically matched between 2009 and 2013 to identify beneficiaries who were aged ≥65 years and discharged from a hospital with a primary COPD diagnosis or a secondary COPD diagnosis and a primary diagnosis for another respiratory condition. Matching was performed by using COPD hospitalization date (±7 days) and source, length of stay (±1 day), discharge date and destination, and hospital region. After applying additional inclusion/exclusion criteria, 2 cohorts were created: nebulized ARF users (n = 953) and nebulized SABA users (n = 6939). Logistic regression analyses were used to examine 30-day readmission (all-cause and COPD related) and exacerbation rates. Odds ratios (ORs), 95% CIs, and P values were computed., Findings: On average, nebulized SABA users had more comorbidities than nebulized ARF users, including diabetes, atrial fibrillation, renal disease, musculoskeletal disease, myocardial infarction, and cognitive impairment (all, P < 0.0001). However, nebulized ARF users had a higher average COPD severity score than nebulized SABA users (49.5 v. 38.0; P < 0.001). COPD therapies at baseline were similar in both cohorts and included systemic corticosteroids (≥65%), short-acting bronchodilators (≥33%), and inhaled corticosteroids + long-acting beta 2 -agonists (30%). After adjusting for sociodemographic and hospital characteristics, concomitant medications, and case-mix, nebulized ARF users had 27% lower odds of an all-cause readmission (OR, 0.73; 95% CI, 0.59-0.92; P = 0.008) and 23% lower odds of a COPD-related readmission (OR, 0.77; 95% CI, 0.60-0.98; P = 0.032) at 30 days compared with users of a nebulized SABA. No difference was found in 30-day exacerbation rates between the cohorts., Implications: Nebulized ARF users had lower 30-day readmission rates, greater COPD severity, and fewer comorbidities than nebulized SABA users. In this population, maintenance treatment with ARF reduced costly COPD outcomes., (Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: This study aimed to evaluate sickle-cell disease (SCD) treatment patterns and economic burden among patients prescribed hydroxyurea (HU) in the US, through claims data., Methods: SCD patients with pharmacy claims for HU were selected from the Medicaid Analytic Extracts (MAX) from January 1, 2009 - December 31, 2013. The first HU prescription during the identification period was defined as the index date and patients were required to have had continuous medical and pharmacy benefits for ≥6 months baseline and 12 months follow-up periods. Patient demographics, clinical characteristics, treatment patterns, health care utilization, and costs were examined, and variables were analyzed descriptively., Results: A total of 3999 SCD patients prescribed HU were included; the mean age was 19.24 years, most patients were African American (73.3%), and the mean Charlson comorbidity index (CCI) score was 0.6. Asthma (20.3%), acute chest syndrome (15.6%), and infectious and parasitic diseases (20%) were the most prevalent comorbidities. During the 12-month follow-up period, 58.9% (N = 2357) of patients discontinued HU medication. The mean medication possession ratio (MPR) was 0.52, and 22.3% of patients had MPR ≥80%. The average length of stay (LOS) for SCD-related hospitalization was 13.35 days; 64% of patients had ≥1 SCD-related hospitalization. The mean annual total SCD-related costs per patient were $27,779, mostly inpatient costs ($20,128)., Conclusions: Overall, the study showed the patients had significant unmet needs manifest as poor medication adherence, high treatment discontinuation rates, and high economic burden.

Background: Membranous nephropathy (MN) is a common cause of nephrotic syndrome in nondiabetic adults. Approximately one third of patients with MN progress to end-stage renal disease (ESRD), while others may be successfully treated to remission. Patients with MN represent a high-risk population for whom management strategies can alter and improve outcomes. Currently, there is little real-world evidence regarding the burden of MN on health plans., Objectives: To (a) characterize clinical and economic outcomes during a 1-year time frame among a prevalent cohort of patients with MN and (b) compare the 5% of patients incurring the highest cost with the remaining 95%., Methods: A retrospective analysis of commercially insured patients was conducted using MarketScan administrative health care claims data from January 1, 2012, to December 31, 2015. Patients were aged ≥ 18 years, enrolled In a fee-for-service plan, and had ≥ 2 medical claims for an MN diagnosis (ICD-9-CM codes 581.1, 582.1, and 583.1). Diagnoses indicating clear secondary causes were excluded wherever possible. Demographics were determined as of the first diagnosis date; clinical characteristics (e.g., MN-specific therapy, complications, and procedures), health care resource utilization (HCRU; inpatient, outpatient including other outpatient and emergency department [ED], and prescriptions), and costs were evaluated for 1 year following MN diagnosis. Total costs and cost distribution (2017 U.S. dollars) were examined using plan-paid and patient-paid amounts. The 95th percentile was used to categorize and compare the subcohorts: high-cost cohort (HCC) patients (top 5%) and non-high-cost cohort (NHCC) patients (the remaining 95%). Descriptive analyses, chi-square tests, and Wilcoxon rank-sum tests were conducted., Results: 2,689 patients were identified (60.0% male, mean age = 46.4 years). Severity and advanced disease were observed In a higher proportion of HCC patients (n = 134) versus NHC patients (n = 2,555) via adverse health outcomes, procedures, and immunosuppressant use. HCC patients used significantly more resources on average than NHCC patients (additional use): 1.7 inpatient, 1.2 ED, and 4.8 outpatient office visits; 15 prescriptions; and 64.8 other outpatient visits (i.e., outpatient, hospital, and ESRD facilities). Total MN-related cost and mean (SD) cost per patient were $123.2 million and $45,814 ($101,353); HCC patients accounted for 43.7% of total costs for a mean cost per patient of $401,608 versus NHCC patients at 56.3% and mean cost per patient of $27,154. The greatest costs for both groups were related to outpatient visits (HCC = 46.7%; NHCC = 52.8%), inpatient visits (HCC = 27.7%; NHCC = 28.6%), and prescriptions (HCC = 25.7%; NHCC = 18.6%)., Conclusions: Patients with MN are significantly burdened with high disease severity and adverse health outcomes, resulting In substantial HCRU and costs. Health plan cost drivers for MN (HCC and NHCC patients) occurred primarily In the outpatient setting, followed by the inpatient setting and prescriptions. Modifiable aspects preceding progression to advanced renal disease and worse outcomes should be explored to Identify effective interventions and improve resource allocation earlier In the disease pathway, before ESRD., Disclosures: This study was funded by Mallinckrodt Pharmaceuticals. Kirkemo, Pavlova-Wolf, and Bartels-Peculis are employees and stockholders of Mallinckrodt Pharmaceuticals. Nazareth was an employee of Mallinckrodt Pharmaceuticals at the time of this study. Kariburyo, Xie, and Vaidya are employees of STATinMED Research, a paid consultant to Mallinckrodt Pharmaceuticals. Sim received an investigator-initiated research grant from Mallinkcrodt Pharmaceuticals. A portion of the study results were previously presented at the American Society of Nephrology (ASN) Kidney Week 2017; November 2, 2017; New Orleans, LA.

Lactate clearance (Δ24Lac) was reported to be inversely associated with mortality in critically ill patients. The aim of our study was to assess the value of Δ24Lac for the prognosis of critically ill patients with cirrhosis and acute-on-chronic liver failure (ACLF). We analysed 954 cirrhotic patients with hyperlactatemia admitted to intensive care units (ICUs) in the United States and eastern China. The patients were followed up for at least 1 year. In the unadjusted model, we observed a 15% decrease in hospital mortality with each 10% increase in Δ24Lac. In the fully adjusted model, the relationship between the risk of death and Δ24Lac remained statistically significant (hospital mortality: odds ratio [OR] 0.84, 95% confidence interval [CI]: 0.78- 0.90, p < 0.001; 90-day mortality: hazard ratio [HR] 0.94, 95%CI 0.92- 0.97, p < 0.001; for Δ24Lac per 10% increase). Similar results were found in patients with ACLF. We developed a Δ24Lac-adjusted score (LiFe-Δ24Lac), which performed significantly better in the area under the receiver operating characteristic curves (AUROCs) than the original LiFe score for predicting mortality. Lactate clearance is an independent predictor of death, and the LiFe-Δ24Lac score is a practical tool for stratifying the risk of death.

While health care costs can be considerable in individuals with diffuse large B-cell lymphoma (DLBCL), the degree to which health care expenditures vary following first-line treatment for non-relapsed versus relapsed DLBCL is unknown. Using 100% Medicare claims, we identified beneficiaries with DLBCL treated with first-line therapy between 1 January 2010 and 30 June 2014. We then compared health care expenditures of patients who received a second-line immunochemotherapy (relapse cohort) to those who did not begin a second-line therapy during follow-up (non-relapse cohort). After propensity score matching, the relapsed cohort incurred significantly higher health care costs ($6998 vs $3314 per month; p < .001), driven by inpatient ($2548 vs $1943 per month; p < .001) and outpatient office visit costs ($3581 vs $753 per month; p < .001). Our analysis confirms older adults with relapsed DLBCL incur higher medical costs and suggests improved first-line treatment would not only reduce the likelihood of relapse, but also contain health care costs.

Introduction: Long-acting injectable (LAI) antipsychotic use may reduce healthcare resource utilization compared with oral antipsychotic use by improving adherence and reducing dosing frequency. Our goal was to examine treatment patterns, healthcare utilization, and costs among recently diagnosed schizophrenia patients receiving oral versus LAI antipsychotics., Methods: The MarketScan Multi-state Medicaid database was used to identify schizophrenia patients aged ≥ 18 years who received an LAI or oral antipsychotic between January 1, 2011 and December 31, 2014. Primary outcomes included treatment patterns such as adherence (measured as proportion of days covered-PDC), persistence, discontinuation, switching, and healthcare resource utilization and costs. Propensity score matching (PSM) was used to control for differences in baseline characteristics between the cohorts. Outcomes were assessed over a 12-month post-index period and compared between treatment cohorts., Results: After PSM, 2302 patients were included in each of the LAI and oral antipsychotics cohorts. There were no differences in PDC or therapy switching between the two cohorts. Compared with the oral cohort, patients receiving LAIs had lower discontinuation rates (46.1 vs. 61.6%, p < 0.001), fewer inpatient admissions (0.5 vs. 0.9, p < 0.001), hospital days (3.9 vs. 6.5, p < 0.001), and ER visits (2.4 vs. 2.9, p = 0.007), and a higher number of prescription fills (29.5 vs. 25.3, p < 0.001). Patients prescribed LAIs had lower monthly inpatient ($US4007 vs. 8769, p < 0.001) and ER visits costs ($682 vs. 891, p < 0.001) but higher monthly medication costs ($10,713 vs. $655, p < 0.001) compared with the oral cohort over the 12-month post-index period. Overall, both cohorts had similar total medical costs (LAI vs. oral: $24,988 vs. 23,887, p = 0.354) during the follow-up period., Conclusion: Patients receiving LAIs were more likely to remain on medication compared with the oral group, which may account for reduced inpatient admissions. Hospitalization cost reductions offset the higher costs of LAI medications, resulting in no increase in total healthcare costs relative to oral antipsychotic use., Funding: Alkermes Inc.

Objectives: The objectives were to compare the long-term outcomes, including hysterectomy, chronic pelvic pain (CPP) and abnormal uterine bleeding (AUB), in women post hysteroscopic sterilization (HS) and laparoscopic tubal ligation (TL) in the Medicaid population., Study Design: This was a retrospective observational cohort analysis using data from the US Medicaid Analytic Extracts Encounters database. Women aged 18 to 49years with at least one claim for HS (n=3929) or TL (n=10,875) between July 1, 2009, through December 31, 2010, were included. Main outcome measures were hysterectomy, CPP or AUB in the 24months poststerilization. Propensity score matching was used to control for patient demographics and baseline characteristics. Logistic regression analysis investigated the variables associated with a 24-month rate of each outcome in the HS versus laparoscopic TL cohorts., Results: Postmatching analyses were performed at 6, 12 and 24months post index procedure. At 24months, hysterectomy was more common in the laparoscopic TL than the HS group (3.5% vs. 2.1%; p=.0023), as was diagnosis of CPP (26.8% vs. 23.5%; p=.0050). No significant differences in AUB diagnoses were observed. Logistic regression identified HS as being associated with lower risk of hysterectomy (odds ratio [OR] 0.77 [95% confidence interval {CI} 0.60-0.97]; p=.0274) and lower risk of CPP diagnosis (OR 0.91 [95% CI 0.83-0.99]; p=.0336) at 24months poststerilization., Conclusion: In Medicaid patients, HS is associated with a significantly lower risk of hysterectomy or CPP diagnosis 24months poststerilization versus laparoscopic TL. Incidence of AUB poststerilization is not significantly different. While some differences in outcomes were statistically significant, the effect sizes were small, and the conclusion is one of equivalence and not clinical superiority., Implications Statement: This propensity score matching analysis confirms that pelvic pain and AUB are common in women before and after sterilization regardless of whether the procedure is performed hysteroscopically or laparoscopically. Moreover, HS is associated with a significantly lower risk of hysterectomy or a CPP diagnosis in the 24months poststerilization when compared to TL., (Copyright © 2018 Elsevier Inc. All rights reserved.)

This study examines the relationship between glycated haemoglobin (A1C) levels and treatment persistence with, or time to discontinuation of, basal insulin in patients with type 2 diabetes (T2D) newly initiating insulin. Claims data were extracted from the Optum Clinformatics database from January 2010 to June 2015. Adult patients with T2D initiating insulin glargine 100 U/mL (Gla-100) or insulin detemir (DET) with ≥1 A1C measurement during 12-month baseline and 18-month follow-up periods were included. Patients with a refill gap of >90 days were considered non-persistent; otherwise, patients were considered persistent with insulin. The main outcome was A1C, measured closest to the end of each quarter during the follow-up period. A total of 3993 of 109 934 patients met the inclusion criteria (43.0% persistent; 57.0% non-persistent). Persistent patients were older (54.7 vs 52.7 years; P < .001), were more likely to be male (59.4% vs 54.4%; P = .002), and had significantly lower mean unadjusted A1C values at 18 months (8.26% vs 8.60%; P < .001) and quarterly. Only 43.0% of adults initiating basal insulin persisted with treatment for 18 months, with earlier discontinuation associated with higher A1C., (© 2017 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.)

Objective: Develop a risk index to estimate the likelihood of life-threatening respiratory depression or overdose among medical users of prescription opioids., Subjects, Design, and Methods: A case-control analysis of administrative health care data from the Veterans' Health Administration identified 1,877,841 patients with a pharmacy record for an opioid prescription between October 1, 2010 and September 30, 2012. Overdose or serious opioid-induced respiratory depression (OSORD) occurred in 817. Ten controls were selected per case (n = 8,170). Items for an OSORD risk index (RIOSORD) were selected through logistic regression modeling, with point values assigned to each predictor. Modeling of risk index scores produced predicted probabilities of OSORD; risk classes were defined by the predicted probability distribution., Results: Fifteen variables most highly associated with OSORD were retained as items, including mental health disorders and pharmacotherapy; impaired drug metabolism or excretion; pulmonary disorders; specific opioid characteristics; and recent hospital visits. The average predicted probability of experiencing OSORD ranged from 3% in the lowest risk decile to 94% in the highest, with excellent agreement between predicted and observed incidence across risk classes. The model's C-statistic was 0.88 and Hosmer-Lemeshow goodness-of-fit statistic 10.8 (P > 0.05)., Conclusion: RIOSORD performed well in identifying medical users of prescription opioids within the Veterans' Health Administration at elevated risk of overdose or life-threatening respiratory depression, those most likely to benefit from preventive interventions. This novel, clinically practical, risk index is intended to provide clinical decision support for safer pain management. It should be assessed, and refined as necessary, in a more generalizable population, and prospectively evaluated., (© 2015 The Authors Pain Medicine published by Wiley Periodicals, Inc. on behalf of American Academy of Pain Medicine.)

Objective: This study aimed to compare real world healthcare costs and resource utilization between patients with schizophrenia treated with paliperidone palmitate long-acting injection (PP) and oral atypical antipsychotics (OAT)., Methods: Patients (18-64 years) were selected from the Veterans Health Administration dataset (1 July 2007-31 May 2012). Patients with 2+ claims for PP or 2+ claims for the same OAT comprised the two study cohorts with the first prescription date designated as the index date. Participation in the VA healthcare system for 24 months pre- and 12 months post-index, schizophrenia diagnosis (International Classification of Disease 9th Revision Clinical Modification [ICD-9-CM] code 295.1x-6x, 295.8x-9x) and ≥1 claim for an antipsychotic medication during the baseline period were required. Propensity scores and Mahalanobis metric distances with calipers were used to create two matched cohorts. All-cause healthcare utilization and costs for the 12-month follow-up period were compared between matched cohorts., Results: The matching process produced two cohorts of 335 patients with similar baseline characteristics. During the 12-month follow-up period, patients in the PP cohort had lower mean inpatient costs (18,560 vs $31,505, p = 0.002), lower frequency of hospitalization (34% vs 53%, p < 0.001) and fewer average inpatient days (13.24 vs 24.18, p = 0.002) vs matched OAT patients. While mean pharmacy costs were higher for the PP cohort ($10,063 vs $4167, p < 0.001), mean total healthcare costs were not significantly different ($45,529 vs $52,569, p = 0.128)., Conclusion: VA patients, diagnosed with schizophrenia and treated with PP, had lower inpatient costs and admission rates compared to a matched cohort of OAT patients. Total healthcare costs were not significantly different.

Objective: Prescription opioid use and deaths related to serious toxicity, including overdose, have increased dramatically in the United States since 1999. However, factors associated with serious opioid-related respiratory or central nervous system (CNS) depression or overdose in medical users are not well characterized. The objective of this study was to examine the factors associated with serious toxicity in medical users of prescription opioids., Design: Retrospective, nested, case-control analysis of Veterans Health Administration (VHA) medical, pharmacy, and health care resource utilization administrative data., Subjects: Patients dispensed an opioid by VHA between October 1, 2010 and September 30, 2012 (N=8,987)., Methods: Cases (N=817) experienced life-threatening opioid-related respiratory/CNS depression or overdose. Ten controls were randomly assigned to each case (N=8,170). Logistic regression was used to examine associations with the outcome., Results: The strongest associations were maximum prescribed daily morphine equivalent dose (MED)≥ 100 mg (odds ratio [OR]=4.1, 95% confidence interval [CI], 2.6-6.5), history of opioid dependence (OR=3.9, 95% CI, 2.6-5.8), and hospitalization during the 6 months before the serious toxicity or overdose event (OR=2.9, 95% CI, 2.3-3.6). Liver disease, extended-release or long-acting opioids, and daily MED of 20 mg or more were also significantly associated., Conclusions: Substantial risk for serious opioid-related toxicity and overdose exists at even relatively low maximum prescribed daily MED, especially in patients already vulnerable due to underlying demographic factors, comorbid conditions, and concomitant use of CNS depressant medications or substances. Screening patients for risk, providing education, and coprescribing naloxone for those at elevated risk may be effective at reducing serious opioid-related respiratory/CNS depression and overdose in medical users of prescription opioids., (Wiley Periodicals, Inc.)

Background: Diabetes accounts for almost 15% of all direct healthcare expenditures. Managed care organizations try to reduce costs and improve patient outcomes. Increasing patient persistence with antidiabetes treatment could help achieve these goals., Subjects and Methods: A retrospective study was conducted using the Optum Research Database (Optum, Eden Prairie, MN) to analyze clinical and economic outcomes associated with initiation of insulin glargine via a disposable pen (GLA-P) or vial and syringe (GLA-V) among adult, insulin-naive patients with type 2 diabetes mellitus (T2DM). Propensity-matched patient cohorts were assessed for persistence with insulin therapy, glycated hemoglobin (A1C), hypoglycemic events (based on diagnosis codes), and healthcare costs (total paid amount of adjudicated claims) after follow-up at 1 year., Results: In 1,308 matched patients, persistence was significantly higher (P=0.011) and longer (P=0.001) with GLA-P. Follow-up A1C values were significantly lower (P=0.038), and decreases in A1C from baseline significantly larger (P=0.043), in GLA-P than in GLA-V. Significantly fewer hypoglycemic events (P=0.042) were experienced, and a lower rate of diabetes-related inpatient admissions (P=0.008) was reported in GLA-P than GLA-V. Despite higher study drug costs with GLA-P than GLA-V, all-cause and diabetes-related healthcare costs were similar., Conclusions: In insulin-naive patients with T2DM, initiation of insulin glargine using the disposable pen rather than the vial and syringe is associated with higher persistence, better A1C control, and lower rates of hypoglycemia. The higher study drug costs associated with pen use do not increase total all-cause or diabetes-related healthcare costs. This may help treatment selection for patients with T2DM in a managed care setting.

Introduction: Type-2 diabetes mellitus (T2DM) is a progressive disease, and many patients eventually require insulin therapy. This study examined real-world outcomes of switching basal insulin analogs among patients with T2DM., Methods: Using two large United States administrative claims databases (IMPACT(®) and Humana(®)), this longitudinal retrospective study examined two cohorts of adult patients with T2DM. Previously on insulin glargine, Cohort 1 either continued insulin glargine (GLA-C) or switched to insulin detemir (DET-S), while Cohort 2 was previously on insulin detemir, and either continued insulin detemir (DET-C) or switched to insulin glargine (GLA-S). One-year follow-up treatment persistence and adherence, glycated hemoglobin (HbA1c), hypoglycemia events, healthcare utilization and costs were assessed. Selection bias was minimized by propensity score matching between treatment groups within each cohort., Results: A total of 5,921 patients (mean age 60 years, female 50.0%, HbA1c 8.6%) were included in the analysis (Cohort 1: IMPACT(®): n = 536 DET-S matched to n = 2,668 GLA-C; Humana(®): n = 256 DET-S matched to n = 1,262 GLA-C; Cohort 2: n = 419 GLA-S matched to n = 780 DET-C), with similar baseline characteristics between treatment groups in each cohort. During 1-year follow-up, in Cohort 1, DET-S patients, when compared with GLA-C patients, had lower treatment persistence/adherence with 33-40% restarting insulin glargine, higher rapid-acting insulin use, worse HbA1c outcomes, significantly higher diabetes drug costs, and similar hypoglycemia rates, health care utilization and total costs. However, in Cohort 2 overall opposite outcomes were observed and only 19.8% GLA-S patients restarted insulin detemir., Conclusions: This study showed contrasting clinical and economic outcomes when patients with T2DM switched basal insulin analogs, with worse outcomes observed for patients switching from insulin glargine to insulin detemir and improved outcomes when switching from insulin detemir to insulin glargine. Further investigation into the therapeutic interchangeability of insulin glargine and insulin detemir in the real-world setting is needed.

Background: Patients with uncontrolled type 2 diabetes mellitus (T2DM), despite therapy with 2 oral antidiabetic drugs (OADs), may add a third OAD or a glucagon-like peptide-1 receptor agonist (GLP-1) or initiate insulin therapy. The transition to insulin has been shown to be delayed in current practice, potentially through clinical inertia--the failure of health care providers to initiate or advance therapy when indicated. Patients and physicians may be resistant to insulin therapy because of beliefs about side effects and limitations to patients' lifestyle, while patients may consider that starting injectable therapy signifies a considerable worsening of their disease and may feel they have "failed" to manage it effectively., Objective: To describe current treatment patterns and outcomes among adult patients with T2DM in the United States who were treated with 2 OADs and added a third antidiabetic drug., Methods: This retrospective study followed patients with T2DM who added a third OAD (the "3OAD" cohort), insulin ("+Insulin"), or a GLP-1 ("+GLP-1") between July 2000 and March 2009. Patients were followed for up to 2 years. Baseline characteristics and follow-up outcomes--including blood glucose level (HbA1c), hypoglycemia, and health care costs--were examined. Treatment persistence was assessed to determine how long patients continued with their prescribed medications without discontinuing or switching., Results: A total of 51,771 patients adding a third agent to their 2OAD regimen were included in this study. Most patients added a third OAD (n = 41,052) over insulin (n = 6,904) or GLP-1 (n = 3,815). At baseline, +Insulin patients were older, with higher comorbidity burden and higher HbA1c. During follow-up, 3OAD patients were more likely to be persistent with their treatment than +Insulin or +GLP-1 patients, but +Insulin patients had the greatest HbA1c reduction from baseline, while continuing with insulin treatment was associated with higher HbA1c reduction. Among 3OAD patients, most of those who switched a third agent initiated insulin, and those who switched early during the follow-up period had greater HbA1c reduction than those who continued with the 3OAD treatment regimen. Average annual health care costs declined in +Insulin patients but increased among 3OAD and +GLP-1 patients. Treatment persistence and HbA1c reduction in +GLP-1 patients were low., Conclusions: This study found that in current practice, physicians seem to be reluctant to prescribe injectable agents for patients with uncontrolled T2DM despite combination OAD therapy. Despite higher treatment persistence among patients adding a third OAD, this persistence did not translate into better glycemic control and may not necessarily be a long-term cost-saving solution. These data indicate a need for more evidence-based and patient-centered treatment decisions for patients unable to achieve and maintain glycemic targets on multiple OADs.