Search

The goal of this study was to evaluate clinical and economic outcomes associated with the initiation of intravenous (IV) belimumab for the treatment of systemic lupus erythematosus (SLE) in clinical practice in the United States.This retrospective study used administrative claims data from the IBM MarketScan Commercial Claims and Encounters Database and the Medicare Supplemental and Coordination of Benefits Database. Data for patients with SLE who initiated (index) IV belimumab were collected for the 12 months before (pre-index) and the 12 months after (post-index) belimumab initiation. Outcomes included SLE disease severity and flares, all-cause health care resource utilization (HCRU) and health care costs, and hospital-based costs and service visits. Post hoc analyses of total hospital-based costs were conducted to further explore drivers of mean post-index costs.Baseline characteristics (N = 908) are as follows: female, 93.4%; mean (SD) age, 45.6 (11.9) years; mean Charlson Comorbidity Index score, 0.9 (2.0); and moderate or severe disease, 94.9%. Disease activity (SLE flare episodes) was significantly reduced between the pre-index and post-index periods (severe flares, 16.4% vs 10.1% [P0.0001]; moderate flares, 92.1% vs 85.6% [P0.0001]; and mild flares, 77.4% vs 71.1%; [P = 0.0003]). The proportion of patients receiving oral corticosteroids (OCS) was reduced between the pre-index and post-index periods, especially among patients at higher OCS thresholds (prednisone-equivalent dose: ≥60 mg/d, 7.3% vs 4.2%;40 mg/d, 14.1% vs 7.9%). From the pre-index to the post-index period, few differences in HCRU were observed, although all-cause physician office visits, outpatient visits, and unique prescriptions filled increased significantly. In the 12-month post-index period, patients had a mean of 12.2 (9.0) encounters (eg, outpatient visit or prescription) associated with IV belimumab. All-cause total, medical, and pharmacy costs increased from the pre-index to the post-index period. Mean all-cause hospital-based costs increased from the pre-index to the post-index period ($7735 [26,603] vs $11,030 [88,086]; P = 0.396). However, the 75th, 90th, and 95th percentile costs decreased from the pre-index to the post-index period ($305, $2107, and $3861, respectively).After initiation of IV belimumab, disease activity (number of moderate and severe SLE flares) and use of OCS were significantly reduced. However, HCRU and costs, including hospital-based costs, were generally greater in the post-index period. Further studies will increase understanding of SLE, with the specific goals of incorporating disease activity measures and long-term outcomes in studies of HCRU, costs, and patient outcomes.

Objective:To describe patient characteristics, treatment patterns, and health care costs among patients diagnosed with major headache disorders overall and by type (tension-type headache [TTH], migraine, cluster headache [CH], or >1 primary headache type), and secondarily to evaluate drug treatment patterns among triptan initiators with a major headache diagnosis.Methods:Using US claims data from January 2012 through December 2017, we identified adults with evidence of a major headache disorder: TTH, migraine, or CH; the first diagnosis date was deemed the index date. To evaluate triptan use specifically, patients who initiated triptans were identified; the first triptan claim date was deemed the index date. Patient characteristics, treatment patterns (concomitant treatments, adherence, number of fills), and annual health care costs data were obtained.Results:Of the 418,779 patients diagnosed with major headache disorders, the following 4 cohorts were created: TTH (8%), migraine (87%), CH (1%), and >1 primary headache type (4%). The majority used analgesic (54–73%) and psychotropic (57–81%) drugs, primarily opioids (36–53%). Headache-related costs accounted for one-fifth of all-cause costs. Of the 229,946 patients who initiated triptans, the following 7 study cohorts were analyzed: sumatriptan (68%), rizatriptan (21%), eletriptan (5%), zolmitriptan (3%), naratriptan (2%), frovatriptan (1%), and almotriptan (Conclusion:The primary headache disorder treatment paradigm is complex, with significant variability. Predominant concomitant use of opioids and switching to opioids is of concern, necessitating solutions to minimize opioid use. Switching to non-oral/fast-acting or targeted preventive therapies should be considered.

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.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 analysis period for each subject comprised a 1-year pre-index date and 1-year post-index date. Primary outcome measure was total COPD-related costs per-patient per-year (PPPY) during the follow-up period. Secondary outcome measures included COPD-related exacerbations and the components of COPD-related costs.Overall, 24,040 subjects were identified; the analysis sample consisted of 19,090 subjects (9,545 per cohort) with no significant differences between cohorts. Mean COPD-related total costs PPPY were numerically lower among the FSC cohort; however, the difference was not statistically significant ($2,224 [±4,108] vs $2,352 [±3,721], p = .057). There was no difference between cohorts for COPD-related medical costs (p = .894). COPD-related pharmacy costs were significantly, yet modestly, lower in the FSC cohort compared with the TIO cohort ($1,160 [±1,106] vs 1,275 [±1,110], p .001). There were no statistically significant differences in the rate or number of exacerbations between the matched cohorts.While propensity scoring achieved balance in baseline characteristics, some residual confounding unobserved in the database may be present.Few clinical and economic differences between subjects initiating maintenance therapy with FSC or TIO were observed.

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 analysis period for each subject comprised a 1-year pre-index date and 1-year post-index date. Primary outcome measure was total COPD-related costs per-patient per-year (PPPY) during the follow-up period. Secondary outcome measures included COPD-related exacerbations and the components of COPD-related costs. Results: Overall, 24,040 subjects were identified; the analysis sample consisted of 19,090 subjects (9,545 per cohort) with no significant differences between cohorts. Mean COPD-related total costs PPPY were numerically lower among the FSC cohort; however, the difference was not statistically significant ($2,224 [±4,108] vs $2,352 [±3,721], p = .057). There was no difference between cohorts for COPD-related medical costs (p = .894). COPD-related pharmacy costs were significantly, yet modestly, lower in the FSC cohort compared with the TIO cohort ($1,160 [±1,106] vs 1,275 [±1,110], p Limitations: While propensity scoring achieved balance in baseline characteristics, some residual confounding unobserved in the database may be present. Conclusions: Few clinical and economic differences between subjects initiating maintenance therapy with FSC or TIO were observed.

Purpose To assess the diagnostic costs leading up to a lung cancer diagnosis in patients with abnormal computed tomography (CT) scans. Patients and Methods A retrospective cohort study using the 5% Medicare claims data (January 1, 2009, to December 31, 2011) was conducted. Patients aged 65 to 74 years with an abnormal chest CT scan were identified. Index was defined as the date of the abnormal chest CT scan. Outcomes assessed over a 12-month follow-up after index included lung cancer diagnosis rate and the use and associated costs of follow-up diagnostic tests up to diagnosis of lung cancer. Results Of 8979 patients identified with an abnormal chest CT scan (mean age, 69.3 ± 2.9 years), 13.9% were diagnosed with lung cancer over 12 months. Chest x-rays were the most common diagnostic test. Of the 19% who underwent a biopsy, 43.6% were not diagnosed with lung cancer during follow-up. The average total diagnostic assessment cost per patient was higher for those with versus without lung cancer ($7567 vs. $3558). Among patients not diagnosed with lung cancer, the median diagnostic cost per patient for those with versus without biopsy was ∼ 28 times higher. Adverse events significantly increased the average cost per biopsy (approximately 4-fold). Conclusion Total lung cancer diagnostic cost was $38.3M in the defined study sample, of which 43.1% was accounted for by biopsied patients without a lung cancer diagnosis. Additional risk stratification is required to decrease unnecessary biopsy referrals and costs. Further, adverse events significantly increased costs.

The objective of this study was to assess the inpatient care burden among individuals with autism using the 2007 Health Care Utilization Project Nationwide Inpatient Sample [HCUP-NIS]). There were ~26,000 hospitalizations among individuals with autism in 2007, with an overall rate of 65.6/100,000 admissions. Rates of hospitalizations were the highest among individuals with autism aged 10–20 years, males, having household income >$63,000, and with private insurance, respectively. In terms of hospital characteristics, rates were the highest in hospitals in large urban areas, located in the Northeast region, and with teaching status, respectively. Individuals with autism had significantly higher LOS (6.5 vs. 4.2; p

To compare outcomes between patients with type 2 diabetes mellitus (T2DM) using fixed-dose combination (FDC) and loose-dose combination (LDC) products.This retrospective cohort study used MarketScan Commercial and Medicare Supplemental data from January 1, 2009-December 31, 2013. The identified population included patients with T2DM and ≥1 additional oral anti-diabetic prescription (of the same regimen [FDC/LDC] as the index prescription) within 12 months following the fill date. Persistence (no ≥30-day gap) and adherence (medication possession ratio [MPR] ≥0.8) were assessed as primary end-points; secondary end-points included hypoglycemia, healthcare resource utilization, and costs.Of 23,361 patients identified, 12,590 (53.9%) were on FDC therapy and 10,771 (46.1%) were on LDC therapy. FDC patients had a significantly lower rate of non-persistence (67.9% vs. 73.4%, p 0.0001) and a significantly higher rate of adherence to therapy (57.0% vs. 50.7%, p 0.0001) when compared to LDC patients. Average time to non-persistence was significantly longer among FDC vs. LDC patients (207.1 vs. 186.3 days, p 0.0001). After adjusting for baseline characteristics, the odds of non-persistence were 21% lower with FDC vs. LDC therapy (OR = 0.79, 95% CI = 0.74-0.85, p 0.0001), with a 28% higher odds of adherence (OR = 1.28, 95% CI = 1.20-1.36, p 0.0001). Differences in most secondary outcomes significantly favored FDC therapy, including total predicted monthly all-cause costs ($1008 vs. $1053; p = 0.006) and T2DM-related costs ($142 vs. $155; p 0.001).Cohort classification was based on prescription claims data. The lack of clinical data limits assessment of potential influencers of FDC vs. LDC decisions, residual confounding was possible, and diabetes-related medical costs only captured claims with a primary diagnosis for diabetes. The results may not be generalizable to populations such as Medicaid.Management of T2DM using FDC therapies provides a compliance benefit relative to LDC therapies that may translate to reductions in healthcare utilization and costs.

Background: Novel oral anticoagulants (NOACs) are recommended for stroke risk reduction in non-valvular atrial fibrillation (NVAF) patients withCHADS 2 ≥2. Efficacy and safety of the different NOACs are well documented in the clinical trial setting, however, real-world evidence of the effectiveness and safety of these agents is limited. This study provides an early assessment of all-cause hospitalizations and economic outcomes among NVAF patients initiated on different NOAC treatments in the real-world. Methods: A retrospective cohort study of patients diagnosed with AF (ICD-9-CM 427.31 and 427.32) who were naïve to anticoagulant therapy and initiated on a NOAC (dabigatran, rivaroxaban and apixaban) was conducted using PharMetrics Plus data from 01/ 2012 through 03/2014. The first NOAC prescription date served as the index date. Patients were required to be ≥18 years old and have no evidence of valvular disease, CHADS 2 score ≥ 1, and ≥ 1 month of follow-up. Follow-up ended upon the earliest of the following: treatment discontinuation, switch to a different NOAC, end of continuous enrollment, 1 year after the index date, or end of study. A Cox proportional hazards model were used to model the likelihood and timing of all-cause hospitalizations while a generalized linear model (GLM) was used for costs. Results: There were 9,150 patients included in the study. The majority of patients were prescribed rivaroxaban (61.5%), followed by dabigatran 1,374 (23.5%), and apixaban (15.0%). Males were 71.4% of the sample and mean age was 63.4 years, with the apixaban patients being slightly older (P=0.0170). Mean CHADS 2 score was 1.8. Mean HAS-BLED score was 2.0, and was slightly higher for patients on apixaban and rivaroxaban (P=0.0025). After adjusting for baseline characteristics, treatment with dabigatran (HR 1.37, 95% CI 1.10-1.69) and rivaroxaban (HR 1.57, 95% CI 1.30-1.90) was associated with increased rate of all-cause hospitalization relative to apixaban. Mean monthly all-cause costs were lower for patients on apixaban compared to those on dabigatran ($3,581 vs $4,236; P Conclusions: This early assessment shows that among anticoagulant naïve NVAF patients, treatment with apixaban was associated with a lower rate of all-cause hospitalization, as well as lower overall costs compared to other NOACs. Further evaluation is needed to provide additional detail on potential drivers of utilization differences.

e18314 Background: There is limited real-world information on the utilization of TPO-RAs, eltrombopag (ELT) and romiplostim (ROM), for the treatment of ITP. Methods: The study employed a retrospective, longitudinal cohort design using integrated healthcare claims data from July 2008-June 2015. Adults diagnosed with ITP initiating TPO-RA therapy from Jan 2009-July 2014 were included. Patients not continuously enrolled in benefits for 6-months prior and 12-months post the index date (first TPO-RA claim date) were excluded. Index TPO-RA discontinuation rates, concomitant therapy, restarts, subsequent therapy, and treatment free periods were assessed. Results: Of the 1,067 patients included, 26.5% (283) received ELT and 73.4% (784) ROM. Age (58.8 vs 59.3; P= 0.705) and gender (males: 45.9% vs 46.6%; P= 0.858) were similar between cohorts. Among ELT and ROM patients 35.7% and 27.6% continued therapy (no gap of ≥30 days) for ≥1 year ( P= 0.010). The average duration of continuous therapy (up to gap ≥30 days) was 131 and 108 days, respectively ( P= 0.001). During continuous course of index TPO-RA treatment 52.7% ELT and 47.2% ROM patients received concomitant ITP-related treatment ( P= 0.115). Following discontinuation, 42.9% of ELT patients restarted ELT, 22.0% did not initiate any subsequent ITP treatments, and 35.2% started a new ITP treatment. Among patients who discontinued ROM, 38.4% restarted, 26.9% did not receive any subsequent therapy, and 34.7% initiated a new treatment. Treatment free periods (≥30 days with no ITP treatment) were experienced by 52.7% of ELT patients and 61.6% ROM patients ( P= 0.009). Mean duration of treatment free period was 109 and 137 days ( P< 0.001), respectively. Conclusions: ITP patients receiving ELT had a longer duration of treatment and shorter treatment free periods compared to patients receiving ROM. Further research is needed to compare clinical outcomes (e.g., platelet counts, bleeding symptoms and remissions) among ITP patients receiving ELT and ROM, in the real-world setting.

Anna D Coutinho,1 Tasneem Lokhandwala,1 Robert L Boggs,2 Anand A Dalal,2 Pamela B Landsman-Blumberg,1 Julie Priest,2 David A Stempel3 1Real World Evidence, Xcenda LLC, Palm Harbor, FL, 2US Health Outcomes, GlaxoSmithKline, Research Triangle Park, NC, 3US Medical Affairs, GlaxoSmithKline, Research Triangle Park, NC, USA 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 30days of discharge/diagnosis (prompt) were compared with those initiating MT within 31–180days (delayed). COPD-related total, medical, and prescription drug costs during a 1-year follow-up period were evaluated using semilog ordinary least square regressions, controlling for baseline characteristics plus COPD-related costs from the previous year. The odds and number of subsequent COPD-related exacerbations during the follow-up were compared between the prompt and delayed cohorts using logistic regression and zero-inflated negative binomial models, respectively. Results: A total of 6,521 patients with a COPD-related hospitalization or an ED visit were included, of whom 4,555 received prompt MT and 1,966 received delayed MT. Adjusted COPD-related total and medical costs were significantly lower for the prompt MT than the delayed MT cohorts (US$3,931 vs US$4,857 and US$2,327 vs US$3,087, respectively; both P

Background— The Intracardiac Echocardiography Guided Cardioversion Helps Interventional Procedures study evaluated the concordance of intracardiac echocardiography (ICE) with transesophageal echocardiography (TEE) in patients with atrial fibrillation (AF). Methods and Results— Patients with AF undergoing right heart catheterization underwent left atrium (LA) and interatrial septal (IAS) imaging by TEE and ICE. A blinded comparison of the 2 modalities was performed at a core laboratory. Ninety-five patients aged 58±12 years completed the study. The LA was profiled in all patients with both techniques, and concordance for image quality was 96%. LA appendage (LAA) imaging was achieved in 85% with ICE and 96% with TEE. There was no difference in the presence of spontaneous echo contrast between ICE and TEE during LA imaging, but there was a trend toward a greater incidence in the LAA with TEE ( P =0.109). Intracardiac thrombus was uncommonly seen (TEE, 6.9%; ICE, 5.2%). The concordance for the presence or absence of thrombus was 97% in the LA and 92% in the LAA, but the latter was detected more frequently with TEE. IAS imaging was achieved in 91% with ICE and in 97% with TEE ( P =0.177). Concordance for patent foramen ovale and atrial septal aneurysms was 100% and 96%, respectively. A negative ICE examination was associated with absence of dense echo contrast or thrombus on TEE in 86%. Conclusions— This study provides validation for the use of ICE for LA and IAS imaging. ICE imaging was less sensitive compared to TEE for LAA thrombus identification. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00281073.

The effects of atrial pacing mode on atrial and ventricular function in patients with atrial fibrillation (AF) and bradycardia have not been evaluated. We evaluated atrial and ventricular function during randomization to support pacing (SP), high right atrial pacing (HRA), and dual site right atrial pacing (DAP).Seventy-nine patients (66 +/- 12 yr, 46 male) with standard pacing indications and symptomatic AF were randomized to each of three pacing modes (DAP, HRA, SP) for 6 months in a crossover design. Echocardiographic studies were performed at enrollment and the end of each mode. Paired comparisons of atrial and ventricular function parameters were performed between each pacing mode and baseline.HRA pacing in DDDR mode resulted in increased left ventricular (LV) end systolic volume (78 +/- 42 vs. 60 +/- 31 ml, p = 0.001) and reduced LV ejection fraction (44 +/- 14 vs. 50 +/- 11%, p = 0.007) compared to baseline. These parameters did not change during DAP. DAP resulted in increased peak A wave velocity (75 +/- 19 vs. 63 +/- 23 cm/s, p = 0.003) and atrial filling fraction compared to baseline (0.47 +/- 0.15 vs. 0.38 +/- 0.13, p = 0.005). Atrial and ventricular function were similar between control and SP.DAP, but not HRA or SP, improved left atrial (LA) function in patients with AF and bradycardia. HRA pacing in DDDR mode resulted in LA dilatation and deterioration of LV function which was not observed with DAP.

Objectives Animal studies and clinical trials have examined the potential benefits of statins in asthma management with contradictory results. The objective of this study was to determine if asthma patients on concurrent statins are less likely to have asthma-related hospitalisations. Design A retrospective cohort study using Mississippi Medicaid data for 2002–2004. Participants Asthma patients ≥18 years were identified using the ICD9 code 493.xx from 1 July 2002 through 31 December 2003. The index date for an exposed subject was any date within the identification period, 180 days prior to which the subject had at least one inhaled corticosteroid prescription and at least an 80% adherence rate to statins. Asthma patients on inhaled corticosteroids, but not on statins, were selected as the unexposed population. The two groups were matched and followed for 1 year beginning the index date. Main outcomes measures Patient outcomes in terms of hospitalisations and ER visits were compared using conditional logistic regression. Results After matching, there were 479 exposed subjects and 958 corresponding unexposed subjects. The odds of asthma-related hospitalisation and/or emergency room (ER) visits for asthma patients on concurrent statins were almost half the odds for patients not on statins (OR=0.55; 95% CI (0.37 to 0.84); p=0.0059). Similarly, the odds of asthma-related ER visits were significantly lower for patients on statins (OR=0.48; 95% CI (0.28 to 0.82); p=0.0069). Conclusion The findings suggest beneficial effects of statins in asthma management. Further prospective investigations are required to provide more conclusive evidence., Article summary Article focus Statins have been shown to have promising therapeutic potential in mediating anti-inflammatory processes in animal model studies as well as clinical trials of rheumatoid arthritis, autoimmune encephalomyelitis, inflammatory colitis and psoriasis. Along the same line of reasoning, recently there has been some discussion regarding the use of statins in asthma management in addition to inhaled corticosteroid therapy. The purpose of this study was to investigate the beneficial effects of statins on asthma outcomes using the Mississippi Medicaid claims database. Key messages The findings suggest that statins may be beneficial in asthma management. The study accounts for several additional potential confounders not previously explored in the other observational studies. Strengths and limitations of this study The study uses a propensity score-matched cohort study design, which in itself should take into account potential confounding effects. The study was conducted using Medicaid claims data, and therefore, there is a possibility of misclassification due to coding errors during claims processing.