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Chi Nguyen,1 Luke Bamber,2 Vincent J Willey,1 Thomas Evers,2 Thomas P Power,3 Judith J Stephenson1 1HealthCore, Inc., Wilmington, DE, USA; 2Bayer AG, Wuppertal, 42096, Germany; 3AIM Specialty Health, Chicago, IL, USACorrespondence: Chi Nguyen, HealthCore, Inc., 123 Justison Street, Suite 200, Wilmington, DE, USA, Tel +1- 302-230-2000, Fax +1-302-230-2020, Email cnguyen@healthcore.comBackground: Patient-reported health related quality of life (HRQOL) is not routinely assessed in clinical practice. Little is known about health status outcomes reported by patients with heart failure with preserved ejection fraction (HFpEF) in non-clinical trial settings.Purpose: To better understand patient burden of HFpEF in terms of HF-specific functional and symptom status, HRQOL, healthcare resource utilization (HCRU) and costs in a US-based commercial and Medicare Advantage insured population.Patients and methods: We conducted a cross-sectional survey of patients with HFpEF and linked their survey and administrative claims data. Consenting, eligible patients completed a survey that included the 23-item Kansas City Cardiomyopathy Questionnaire (KCCQ-23) and the PROMIS Global Health-10 (GH-10) questionnaire, as well as clinical and demographic questions. HF medication use, HCRU and costs during the 12-month baseline period before the survey were determined from claims data. Generalized linear regression was used to assess the associations between baseline characteristics and the KCCQ-23 overall summary score.Results: Of 598 survey respondents with survey and claims data, 54.7% were female with mean age 74.0 years. The KCCQ-23 overall summary and clinical summary scores were 64.8 and 63.0, respectively, and the GH-10 physical and mental health summary scores were 39.9 and 45.5. Factors related to lower KCCQ-23 overall summary scores were HF treatment and symptom changes during the past 4-weeks before the survey, hospital admission during the past year, low household income, high comorbidity index, and morbid obesity (BMI> 40). Total all-cause healthcare costs were $38,243 during the year prior to the survey, of which 42% were HF-related.Conclusion: Patient-reported outcome measure scores indicated impairment due to HF symptoms and physical limitations in this real-world sample of patients with HFpEF, highlighting a need to assess patient-reported outcomes as well as the clinical and economic outcomes traditionally assessed by clinicians, health systems and payers.Keywords: heart failure with preserved ejection fraction, HFpEF, patient-reported health related quality of life, healthcare resource utilization, healthcare costs

Description of risk of cardiovascular (CV) events associated with diabetes is evolving. This US-based real-world study estimated risk of future CV events and heart failure (HF) from type 2 diabetes (T2DM) only, prior CV events only or T2DM plus prior CV events, versus controls, and evaluated healthcare resource utilization (HCRU) and costs. This retrospective cohort study queried claims and mortality data for 638,301 patients: T2DM only (377,205); prior CV events only (130,964); both T2DM and prior CV events (130,132); and matched (1:1) controls, during 1 January 2012–31 December 2012. Cardiovascular diagnoses/events and death were assessed individually, and as composite endpoint (myocardial infarction [MI], stroke, transient ischemic attack [TIA], peripheral artery disease [PAD]), during follow-up, ending 31 July 2018. Adjusting for age and gender, patients with T2DM only were 1.6, prior CV events only 2.5 and T2DM plus prior CV events 3.8 times likelier to have primary composite CV events relative to controls, p In this large and geographically broad US based cohort, CV risk for T2DM patients was elevated, as was the risk for patients with prior CV events, while patients with T2DM plus prior CV events had the highest risk of future CV events. The substantial clinical and economic burden of CV events and HF in patients with both T2DM and prior CV events suggest a need for an integrated treatment and targeted intervention across both conditions.

Jay Visaria,1 Neeraj N Iyer,2 Amit D Raval,3 Sheldon X Kong,2 Todd Hobbs,2 Jonathan Bouchard,2 David M Kern,4 Vincent J Willey1 1HealthCore, Inc., Wilmington, DE, USA; 2Novo Nordisk, Inc., Plainsboro Township, NJ, USA; 3Merck & Co., Inc, Kenilworth, NJ, USA; 4Janssen Research and Development, Titusville, NJ, USACorrespondence: Jay VisariaHealthCore, Inc., 123 Justison Street, Suite 200, Wilmington, DE 19801, USATel +1 302 230-2117Email jvisaria@healthcore.comObjective: The objective of this study was to estimate the incremental long-term costs associated with T2DM attributable to vascular diseases.Research Design and Methods: This retrospective cohort study identified newly diagnosed (incident) T2DM patients in 2007 (baseline to 01/01/2006) using the HealthCore Integrated Research Database, a repository of nationally representative claims data. Incident T2DM patients were 1:1 exact matched on age, gender and other factors of interest to non-DM patients, and followed until the earlier of 8 follow-up years or death. Patients with documented vascular disease diagnosis were identified during the study period. All-cause and T2DM/vascular disease-related annual healthcare costs were examined for each follow-up year.Results: The study included 13,883 individuals with T2DM and matched non-DM controls. Among individuals with T2DM, 11,792 (85%) had vascular disease versus 9251 (66.6%) non-T2DM between 01/01/2006 and 12/31/2015. Among T2DM patients, mean all-cause annual costs were greater than in non-T2DM patients ($13,806 vs $7,243, baseline, $21,745 vs $8,524, post-index year 1, $12,756-$14,793 vs $8,349-$9,940 years 2– 8, p< 0.001), respectively. A similar trend was observed for T2DM/vascular disease-related costs (p< 0. 001). T2DM/vascular disease-related costs were largest during post-index year 1, accounting for the majority of all-cause cost difference between T2DM patients and matched non-DM controls. Incident T2DM individuals without vascular disease at any time had significantly lower costs compared to non-DM controls (p< 0. 001) between years 2– 8 of follow-up.Conclusion: Vascular disease increased the cost burden for individuals with T2DM. The cost impact of diabetes and vascular disease was highest in the year after diagnosis, and persisted for at least seven additional years, while the cost of T2DM patients without vascular disease trended lower than for matched non-DM patients. These data highlight potential costs that could be offset by earlier and more effective detection and management of T2DM aimed at reducing vascular disease burden.Keywords: type 2 diabetes mellitus, microvascular complications, macrovascular complications, diabetes, healthcare costs, diabetes costs

IntroductionOnce-weekly subcutaneous semaglutide, a glucagon-like peptide-1 analog, is approved in the USA as an adjunct to diet and exercise for adults with inadequately controlled type 2 diabetes (T2D) to improve glycemic control and reduce the risk of major adverse cardiovascular events in people with T2D and established cardiovascular disease. The Semaglutide Unabated Sustainability in Treatment of Type 2 Diabetes (SUSTAIN) phase III clinical trial program demonstrated the efficacy and safety of once-weekly subcutaneous semaglutide; however, determining its effectiveness in a real-world setting could support decision-making by clinicians, payers and policy makers in routine clinical practice.Research design and methodsSEmaglutide PRAgmatic (SEPRA) is an ongoing open-label, randomized, pragmatic clinical trial designed to compare the effects of once-weekly subcutaneous semaglutide versus standard of care in US health-insured adults with T2D and physician-determined inadequate glycemic control. The primary end point is the proportion of participants achieving glycated hemoglobin (HbA1c) ResultsBetween July 2018 and March 2021, 1278 participants were enrolled from 138 study sites across the USA. At baseline, 54% were male with mean±SD age 57.4±11.1 years and body mass index 35.7±8.0 kg/m2. Mean diabetes duration was 7.4±6.0 years and mean HbA1c was 8.5±1.6%. At baseline, concomitant antidiabetes medications included metformin, sulfonylureas, sodium-glucose co-transporter-2 inhibitors, and dipeptidyl peptidase-4 inhibitors. The majority of participants had hypertension and dyslipidemia. The trial design was self-assessed using the PRagmatic Explanatory Continuum Indicator Summary-2 tool by the study steering group and was scored 4–5 in all domains suggesting a highly pragmatic study.ConclusionsSEPRA, a highly pragmatic ongoing study, will provide data on the effects of once-weekly subcutaneous semaglutide in a real-world setting when used during routine management of T2D.Trial registration numberNCT03596450.Trial registration number

Asthma self-management can improve symptom control, but adherence to established self-management behaviors is often poor. With adult asthma uncontrolled in over 60% of U.S. cases, there is a need for scalable, cost-effective tools to improve asthma outcomes. Here we describe a protocol for the Asthma Digital Study, a 24-month, decentralized, pragmatic, open-label, randomized controlled trial investigating the impact of a digital asthma self-management (DASM) program on asthma outcomes in adults. The program leverages consumer-grade devices with a smartphone app to provide "smart nudges," symptom logging, trigger tracking, and other features. Participants are recruited (target N = 900) from throughout the U.S., and randomized to a DASM or control arm (1:1). Co-primary outcomes at one year are a) asthma-associated costs for acute care and b) change from baseline in Asthma Control Test™ scores. Findings may inform decisions around adoption of digital tools for asthma self-management. Trial registration:clinicaltrials.gov identifier: NCT04609644. Registered: Oct 30, 2020.

This claims-based retrospective cohort study examined the prevalence and incremental impact of non-alcoholic steatohepatitis among children with type 2 diabetes mellitus in the United States. Although diagnoses of non-alcoholic steatohepatitis were not common among diabetic children, it was associated with significantly higher incremental healthcare cost and risk of hospitalization.

Chronic disease is associated with increased health care resource utilization and costs. Effective development and implementation of health care management and clinical intervention programs require an understanding of health plan member enrollment and disenrollment behavior.To examine the health plan enrollment and disenrollment behavior of commercially insured and Medicare Advantage members with established chronic disease compared with matched members without the disease of interest, using data from a large national health insurer in the United States.This retrospective matched cohort study used administrative claims data from the HealthCore Integrated Research Database from January 1, 2006, to November 30, 2015, to identify adults with chronic disease (type 2 diabetes mellitus [T2DM], cardiovascular disease [CVD], chronic obstructive pulmonary disease [COPD], rheumatoid arthritis [RA], and breast cancer [BC]). Members with no established chronic disease (controls) were directly matched to members with established chronic disease (cases) on demographic characteristics. The earliest date on which members met the criteria for a given disease was defined as the index date. Controls had the same index date as the matched cases. All members had ≥ 12 months of continuous health plan enrollment before the index date. Outcomes included health plan member disenrollment and enrollment duration. Incidence rates per 1,000 member-years for member disenrollment were evaluated along with incidence rate ratios (relative risk) using a Poisson model. Time to disenrollment was analyzed by Cox proportional hazard models and Kaplan-Meier survival curves. Sensitivity analyses were conducted where death was included as a disenrollment event.70,907 health plan members with BC (99.7% female, mean age 60.5 years); 28,883 members with COPD (52.3% female, mean age 66.7); 835,358 members with CVD (50.5% female, mean age 62.7 years); 210,936 members with T2DM (45.2% female, mean age 53.6 years); and 31,954 members with RA (72.0% female, mean age 55.5 years) were matched to controls and met the study criteria. The incidence rates of health plan disenrollment ranged from 155 to 192 members per 1,000 members per year. Compared with controls, members with chronic disease were 30%-40% less likely to disenroll from a health plan (This real-world study demonstrated that members with chronic disease had a significantly lower rate of disenrollment and a longer duration of enrollment compared with matched controls and were continuously enrolled for almost a year longer than members without a diagnosed chronic disease. Understanding health plan enrollment and disenrollment behavior may provide a valuable context for determining the time frame for the effect of health care programs and initiatives.Funding for this study was provided by HealthCore, a wholly owned subsidiary of Anthem. Chung, Deshpande, Zolotarjova, Quimbo, and Willey are employees of HealthCore. Kern and Cochetti are former employees of HealthCore. Quimbo, Cochetti, and Willey are shareholders of Anthem. HealthCore receives funding from multiple pharmaceutical companies to perform various research studies outside of the submitted work. The preliminary results of this study were presented at AMCP Nexus 2015; March 26-29, 2015; Orlando, FL, and the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 2017 Conference; May 20-24, 2017; Boston, MA.

Background: Both primary care physicians (PCPs) and endocrinologists (Endos) commonly prescribe T2D medications. This study presents real-world effectiveness of sema OW by prescriber specialty in a cohort of US commercially insured/Medicare Advantage T2D patients newly initiating a GLP-1 agonist. Methods: Claims and lab result data were used to identify T2D patients who initiated sema OW between 12/1/17 - 6/30/20 (index as first claim). Selected patients had ≥1 A1c result within ≤3 months pre and ≥3 months post-index. Patients with no claim for any GLP-1 agonist in the 12 months pre-index and persistent on sema OW (those with a sema OW prescription with days supply dispensed overlapping/in proximity of date of post-index A1c) were assessed for A1c changes stratified by prescriber specialty (PCPs/Endos) and by pre-index A1c >9%. Results: A1c was significantly reduced vs. pre-index in 1,284 patients prescribed sema OW by a PCP or Endo (both -1.3%; p 9% (both -2.8%; p Conclusion: Similar pre/post reductions in A1c were observed when initiating sema OW in T2D GLP-1 agonist naive patients being treated by PCPs and Endos. Disclosure N. Shivappa: Other Relationship; Self; Novo Nordisk. J. Noone: Employee; Self; Novo Nordisk Inc. C. Swift: Employee; Self; Novo Nordisk Inc. S. Du: None. H. Tan: Other Relationship; Self; HealthCore. Y. M. Paprocki: Employee; Self; Novo Nordisk, Stock/Shareholder; Self; Novo Nordisk. V. Willey: Employee; Self; HealthCore.

Background: With OS’s FDA approval in September 2019, this study sought to provide real-world evidence on its effectiveness in a cohort of early users. Methods: Claims and lab result data were used to identify T2D patients who initiated OS between 09/20/19 - 10/31/20 (first claim date set as index). Selected patients had ≥1 HbA1c result within both ≤3 months pre- and ≥3 months post-index and ≥ 12 months pre-index health plan eligibility. Study groups included: all patients, patients persistent on OS (those with a OS prescription within 1.5 times of days supply dispensed overlapping/in proximity to most recent post-index HbA1c), GLP-1 naive patients, and patients with a pre-index HbA1c >9%. Results: Of the 323 individuals with T2D initiating OS, 42.4% were female with a mean age of 55 years and 77% were GLP-1 naive. Mean HbA1c was significantly reduced in all patients (-0.9%) and subgroups (all p Conclusions: OS initiation was associated with a significant reduction in HbA1c and increase in HbA1c goal attainment in real-world practice in this preliminary cohort. Disclosure N. Shivappa: Other Relationship; Self; Novo Nordisk. C. Swift: Employee; Self; Novo Nordisk Inc. J. Noone: Employee; Self; Novo Nordisk Inc. S. Du: None. M. Radin: Employee; Self; Novo Nordisk Inc. C. Gamble: Employee; Self; Novo Nordisk Inc. H. Tan: Other Relationship; Self; HealthCore. V. Willey: Employee; Self; HealthCore.

Background: This study presents real-world evidence on effectiveness of sema OW in a broad cohort of US commercially insured and Medicare Advantage T2D patients. Methods: Claims and lab result data were used to identify T2D patients who initiated sema OW between 12/1/17 - 6/30/20 (index as first claim). Selected patients had ≥1 A1c result within ≤3 months pre- and ≥3 months post-index. Patients persistent on sema OW (those with a sema OW prescription with days supply dispensed overlapping/in proximity of date of post-index A1c measurement) were assessed for A1c changes and stratified by age ( 9%. Results: 3,010 patients initiated sema OW, 49% were female and 10% were ≥ 65 years of age. A1c was significantly reduced vs. pre-index in all persistent patients (-1.1%) and in each age subgroup ( 9%. Attainment of A1c Conclusion: In this broad, real-world cohort of US T2D patients, initiation of sema OW was associated with significant reduction in A1c and an increase in reaching an A1c Disclosure V. Willey: Employee; Self; HealthCore. N. Shivappa: Other Relationship; Self; Novo Nordisk. J. Noone: Employee; Self; Novo Nordisk Inc. C. Swift: Employee; Self; Novo Nordisk Inc. S. Du: None. Y. M. Paprocki: Employee; Self; Novo Nordisk, Stock/Shareholder; Self; Novo Nordisk. H. Tan: Other Relationship; Self; HealthCore.

Background: This study presents real-world effectiveness of sema OW in a cohort of US commercially insured/Medicare Advantage T2D patients newly initiating a GLP-1 agonist. Methods: Claims and lab result data were used to identify T2D patients who initiated sema OW between 12/1/17 - 6/30/20 (index as first claim). Selected patients had ≥1 A1c result within ≤3 months pre- and ≥3 months post-index. Patients with no claim for any GLP-1 agonist in the 12 months prior to index and persistent on sema OW (those with a sema OW prescription with days supply dispensed overlapping/in proximity of date of post-index A1c) were assessed for A1c changes and stratified by age ( 9%. Results: Of 1,842 patients newly initiating sema OW, 49% were female and 8% were ≥ 65 years of age. The pre/post change in A1c was significant in all patients (-1.3%) and in each age subgroup ( 9%, regardless of age. Attainment of A1c Conclusion: nitiation of sema OW in T2D patients naive to GLP-1 agonists and persistent on sema OW was associated with a significant reduction in A1c and an increase in target attainment of A1c Disclosure N. Shivappa: Other Relationship; Self; Novo Nordisk. C. Swift: Employee; Self; Novo Nordisk Inc. J. Noone: Employee; Self; Novo Nordisk Inc. S. Du: None. Y. M. Paprocki: Employee; Self; Novo Nordisk, Stock/Shareholder; Self; Novo Nordisk. H. Tan: Other Relationship; Self; HealthCore. V. Willey: Employee; Self; HealthCore.

Antidiabetic medication (med) treatment patterns often differ based on a variety of patient and prescriber factors. Understanding these patterns may provide insight on optimizing therapy, especially when considering initiation of a new therapy. This study presents real-world evidence on T2D treatment patterns associated with sema OW initiation within a large cohort of T2D patients. Methods: Claims and lab result data were used to identify T2D patients from a US commercially insured/Medicare Advantage population who initiated sema OW between 12/1/17 - 6/30/20 (index as 1st claim). Selected patients had continuous health plan enrollment for ≥ 2 years pre-index and post-index through at least 90 days after the last available A1c value. Antidiabetic meds prescribed before, at the time and after initiation of sema OW were evaluated overall and for those with an A1c >9%. Results: A total of 3,081 T2D patients were identified, of which 865 patients had A1c >9%. Sema OW was initiated down the treatment pathway, with ~60% on ≥2 and ~30% on 3+ T2D meds at sema OW initiation. Sema OW was an add-on therapy to most T2D med classes overall, although when initiated onto more complex therapy regimens it was more likely to be a therapy switch (T2D monotherapy = 24% switched to sema OW, dual therapy = 46%, triple therapy = 64%, 4+ T2D medications = 70%). Following post-index A1c measurement, 35% of patients overall and 29% with a baseline A1c >9% decreased the number of their T2D meds. Conclusion: Sema OW appeared to be initiated as add-on therapy, except for those on more complex regimens. Approximately 1/3 of patients decreased their overall T2D med use after evaluation of A1c following sema OW initiation. Further research is warranted to assess impact of initiating sema OW earlier in the T2D treatment pathway, especially in patients with cardiovascular and chronic kidney disease. Disclosure V. Willey: Employee; Self; HealthCore. N. Shivappa: Other Relationship; Self; Novo Nordisk. C. Swift: Employee; Self; Novo Nordisk Inc. J. Noone: Employee; Self; Novo Nordisk Inc. S. Du: None. Y. M. Paprocki: Employee; Self; Novo Nordisk, Stock/Shareholder; Self; Novo Nordisk. H. Tan: Other Relationship; Self; HealthCore.

BACKGROUND: The Global Initiative for Chronic Obstructive Lung Disease (GOLD) report for the management of chronic obstructive pulmonary disease (COPD) focuses on reducing existing symptoms, decreasing the risk of future exacerbations, and improving health status by recommending specific drug therapy based on exacerbation risk and symptoms. However, disparities exist between evidence-based recommendations and clinical practice. Research that quantifies the real-world effect of COPD regimen alignment with the GOLD recommendations on clinical and economic outcomes is needed. OBJECTIVE: To compare COPD-related health care resource utilization (HRU) and costs, as well as exacerbation rates, among patients with COPD on maintenance therapy based on 2017 GOLD treatment recommendation compliance status per GOLD ABCD risk group classification in a U.S. commercially insured/Medicare Advantage population. METHODS: This retrospective cohort study utilized administrative claims data in the HealthCore Integrated Research Database. The COPD population was identified using a previously validated claims-based predictive model. Among this population, patients with ≥ 1 claim for a COPD maintenance medication (earliest maintenance fill-date = index date) between January 1, 2014, and March 31, 2017, were identified. Patients were required to be aged ≥ 40 years, have ≥ 12 months of pre-index and ≥ 30 days of post-index health plan enrollment, with no diagnosis for asthma, cystic fibrosis, and/or lung cancer at any time from January 1, 2013, to March 31, 2018. Patients were categorized into exacerbation risk/symptomatology groups according to the 2017 GOLD ABCD assessment recommendations and were then classified into treatment-compliance status based on their maintenance therapy. Multivariable analyses were conducted to examine post-index COPD-related HRU, costs, and exacerbations by compliance status. RESULTS: The primary analytical study sample included 38,382 patients in the GOLD A/B group and 6,525 in the GOLD C/D group. Patients were further categorized into GOLD A (n = 19,345), B (n = 19,037), C (n = 1,865), and D (n = 4,670). GOLD-compliant regimens were observed in 32.9% of patients in the GOLD A/B group and in 58.9% of patients in the GOLD C/D group. Inhaled corticosteroid-containing regimens were the most commonly observed noncompliant regimen. Patients on compliant regimens had significantly fewer COPD-related inpatient and emergency department visits and therefore had significantly lower COPD-related medical costs in both the GOLD A/B and C/D cohorts. Similar results were observed for individual GOLD cohorts B, C, and D. These savings were offset by increased pharmacy expenditures. Being on GOLD guideline-compliant regimens significantly reduced the risk of exacerbation by 8% (hazard ratio [HR] = 0.92; P < 0.0001) in the GOLD A/B cohort and by 12% (HR = 0.88; P = 0.0005) in the GOLD C/D cohort, and was also associated with a significantly reduced exacerbation rate in the GOLD A/B (rate ratio [RR] = 0.93; P < 0.0001) and GOLD C/D (RR = 0.93; P = 0.0129) groups. CONCLUSIONS: This study suggests a continuing trend of high prevalence of suboptimal prescriber compliance to GOLD treatment recommendations. Treatment regimens compliant with GOLD recommendations were associated with improvement in exacerbations, reduced COPD-related HRU, and COPD-related medical cost offsets. DISCLOSURES: This study was funded by Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI). BIPI was given the opportunity to review the manuscript for medical and scientific accuracy as well as intellectual property considerations. Palli and Shaikh are employees of BIPI. Willey is an employee of HealthCore, which was contracted by BIPI to conduct this study. Zhou was an employee of HealthCore at the time of study execution. Data were presented in part during an AMCP webinar (recording not made public) held in lieu of the Spring 2020 AMCP conference, which was canceled due to the COVID-19 pandemic.

BACKGROUND: Although the significant burden of heart failure (HF) is well recognized, the relative contributions of systolic HF versus diastolic HF are less defined. OBJECTIVE: To explore the differential burden between patients with systolic and diastolic HF in terms of treatment patterns, healthcare resource utilization (HCRU), costs, and mortality risk. METHODS: This retrospective cohort study used administrative claims data from a large US commercial health insurer integrated with mortality data. Patients newly diagnosed with HF between January 1, 2010, and June 30, 2016, were identified and grouped according to systolic HF or diastolic HF diagnosis and were followed up to 4 years after diagnosis. Treatment patterns, HCRU, costs, and mortality were compared between the 2 groups of patients. RESULTS: Overall, 46,885 patients with systolic HF and 21,854 with diastolic HF were identified and included in the study. Patients with systolic HF had less HCRU than those with diastolic HF during the first year after HF diagnosis, including hospital admissions (70.2% vs 82.4%, respectively; P

Purpose Patients managing type 2 diabetes mellitus (T2DM) often require combination therapy to meet their blood glucose control targets. With limited real-world evidence focused on the use of glucagon-like peptide 1 receptor agonist (GLP-1RA) therapies, the objective of this study was to describe the association between semaglutide once weekly (OW) initiation and changes in hemoglobin A1c (A1c) levels. Methods This retrospective, descriptive cohort study used the HealthCore Integrated Research Environment (HIRE) to examine commercially insured and Medicare Advantage patients who had T2DM while taking semaglutide OW from December 1, 2017, to April 30, 2019. The first semaglutide OW prescription fill was defined as the study index date. Changes in mean A1c levels and A1c target attainment were evaluated among an intention-to-treat (ITT) population (overall group). Furthermore, a persistent population (PP) analysis on the same outcomes was performed that was limited to ITT patients who were observed to continue to use semaglutide OW at the time of the postindex A1c measurement. In addition, these outcomes were explored in patients stratified based on prior use of GLP-1RA therapy (experienced vs naive) and baseline A1c values >9% (75 mmol/mol). Findings A total of 1888 patients were identified in the overall ITT group. The mean change in the overall ITT group between preindex and postindex A1c values was −0.9% percentage points (−9.8 mmol/mol) (mean preindex A1c, 8.2% [66.1 mmol/mol]) and −1.1 percentage points (−12.0 mmol/mol) (mean preindex A1c, 8.2% [66.1 mmol/mol]) in the PP subgroup (all P 9% (75 mmol/mol), percentage point changes in A1c were −2.2 (−24.0 mmol/mol) and −2.4 (−26.2 mmol/mol) (all P Implications Semaglutide OW is associated with clinically and statistically significant A1C reduction and increases in reaching A1 targets using real-world data, even in GLP-1RA–experienced patients, despite more frequent use of insulin or sodium glucose transport protein 2 inhibitors in this group. Target A1c attainment significantly increased overall and within all subgroups and strata, with approximately half of all patients attaining an A1c value

Background: This study presents real-world evidence on effectiveness of sema OW in a large cohort of T2D patients. Methods: Claims and lab result data were used to identify T2D patients who initiated sema OW between 2/1/18 - 4/30/19 (index as first claim). Patients selected had ≥1 A1c result within ≤3 months pre- and ≥3 months post-index. All patients and a group of patients persistent on sema OW (those with a sema OW prescription with days supply dispensed overlapping/in proximity of date of post-index A1c measurement) were assessed for A1c changes and were split into 4 subgroups: GLP-1 naïve, GLP-1 experienced and either group with pre-index A1c >9%. Results: Of 1,888 patients initiating sema OW, 57.8% were GLP-1 naïve. A1c was significantly reduced in all patients (-0.9%) and subgroups (p Conclusion: Initiation of sema OW was associated with significant reduction in A1c and an increase in reaching A1c Disclosure J. Visaria: None. C. Uzoigwe: Employee; Self; Novo Nordisk Inc. C. Swift: Employee; Self; Novo Nordisk Inc. Stock/Shareholder; Self; Novo Nordisk Inc. Y.M. Paprocki: Employee; Self; Novo Nordisk Inc. Stock/Shareholder; Self; Novo Nordisk A/S. V. Willey: Employee; Self; HealthCore. Funding Novo Nordisk

Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality and is associated with substantial economic burden. There is a lack of data regarding COPD outcomes and costs in a real-world setting, particularly by Global Initiative for Chronic Obstructive Lung Disease (GOLD) severity.To (a) characterize a commercially insured U.S. population with COPD and (b) assess prevalence of exacerbations, health care resource utilization (HCRU), costs, and treatment patterns in a cohort of patients with confirmed COPD, overall and stratified by GOLD stage.This retrospective observational cohort study used administrative claims data from the HealthCore Integrated Research Database to identify patients with ≥ 1 inpatient, emergency room (ER), or office visit claim for COPD between January 1, 2012, and November 30, 2013, and continuous enrollment for 1 year before and 2 years after the first COPD diagnosis date. Patients with a spirometry claim within 12 months were eligible for medical record abstraction to confirm COPD diagnosis (forced expiratory volume in 1 second [FEV53,484 patients newly diagnosed with COPD were identified who met initial inclusion criteria: 14,293 (27%) had a qualifying spirometry claim, and 1,505 had confirmed COPD (GOLD 1, 333 [22%]; GOLD 2, 823 [55%]; GOLD 3, 317 [21%]; GOLD 4, 32 [2%]). Patients with greater disease severity had higher rates of moderate/severe COPD exacerbations (GOLD 1 and 2, 40.4 and 48.9 per 100 person-years, respectively; GOLD 3 and 4, 83.6 and 89.1 per 100 person-years, respectively). All-cause and COPD-related inpatient admissions, COPD-related office visits, and COPD-related ER visits were more prevalent with more severe GOLD classification. Mean annual COPD-related medical costs increased with GOLD classification ($5,945 for GOLD 1 patients, $18,070 for GOLD 4). COPD maintenance medication was filled by 42%, 56%, 73%, and 75% of patients in GOLD 1-4 (57% overall), respectively; combination corticosteroid/long-acting beta2-agonist inhalers were the most commonly used medication, regardless of GOLD classification. Patients with more severe disease had greater adherence (range 44%-68% of days covered for GOLD 1-4) and persistence (range 107-209 days for GOLD 1-4).Trends toward increases in exacerbations, HCRU, and costs were observed as airflow limitation worsened. Adherence and persistence with COPD maintenance therapy was suboptimal even with severe disease.This study was supported by Boehringer Ingelheim Pharmaceuticals (Ridgefield, CT), which was given the opportunity to review the manuscript for medical and scientific accuracy, as well as intellectual property considerations. Willey and Singer are employees of HealthCore (parent company Anthem), which received funding from Boehringer Ingelheim to complete this study. Wallace and Shinde were employed by HealthCore at the time of this study. Wallace and Singer report stock ownership in Anthem. Napier is an employee of Anthem. Kaila, Bayer, and Shaikh are employees of Boehringer Ingelheim Pharmaceuticsls. Portions of this research were presented at the following conferences: (a) A. Wallace, S. Kaila, V. Zubek, A. Shaikh, M. Shinde, V. Willey, M. Napier, and J. Singer, Healthcare resource utilization, costs, and exacerbation rates in patients with COPD stratified by GOLD airflow limitation classification in a US commercially insured population, presented at AMCP Nexus 2017; October 16-19, 2017; Dallas, TX; and (b) A.E. Wallace, V. Zubek, S. Kaila, A. Shaikh, M. Shinde, V. Willey, M.B. Napier, and J.R. Singer, Real-world treatment patterns among newly diagnosed COPD patients according to GOLD airflow limitation severity classification in a U.S. commercially insured/Medicare Advantage population, presented at CHEST 2017 Annual Meeting; October 28-November 1, 2017; Toronto, Ontario, Canada.

Omalizumab is indicated for the management of chronic idiopathic urticaria (CIU) in patients aged 12 years or older with persistent hives that are not adequately controlled by H1 antihistamines. While its safety and efficacy in CIU patients have been evaluated in multiple clinical trials, real-world use of omalizaumab in CIU has not been well characterized.To assess demographics, clinical characteristics, and treatment patterns of CIU patients who initiated omalizumab to better understand the usage of this agent in CIU management in the real world.This retrospective cohort study used medical and pharmacy claims data in the United States from the HealthCore Integrated Database to identify patients with CIU newly treated with omalizumab (≥ 4 omalizumab claims within 6 months of the initial claim) between March 21, 2014, and October 31, 2015 (study intake period). The index date was defined as the date of the first claim for omalizumab during the study intake period. Demographic and clinical characteristics were described for patients treated with omalizumab, as were treatment patterns associated with omalizumab and concomitant medications associated with CIU treatment. Descriptive and inferential statistics were reported. The Kaplan-Meier method was used to examine omalizumab treatment patterns.This study included 298 omalizumab-treated patients (mean [SD] age of 43.5 [13.64] years; 70.8% female); approximately 84% were seen by an allergist/immunologist. All patients had ≥ 12 months of continuous enrolment and a subset of 138 patients had ≥ 18 months of follow-up. For patients with ≥ 12 months of post-index follow-up, 12.1% (n = 36), 28.5% (n = 85), and 32.9% (n = 98) discontinued omalizumab within the 6-month, 12-month, and the entire post-index periods (mean 530 days), respectively; the mean number of days patients were continuously treated with omalizumab was 443.1 (95% CI = 425.0-461.3); the probabilities of continuous treatment (95% CI) were 0.879 (0.836-0.911), 0.711 (0.656-0.759), and 0.647 (0.585-0.703) for the 6-, 12-, and 18-month post-index periods, respectively. For the 98 patients who discontinued omalizumab during the entire post-index period, 28.6% restarted omalizumab after the first discontinuation within the post-index period (mean time from first discontinuation to first restart=329 days). Use of medications such as oral corticosteroids, montelukast, cyclosporine, and prescription H1 and H2 antihistamines decreased during the 1- to 6-month and 7- to 12-month post-index periods compared with those within the 6-month pre-index period.In this cohort of CIU patients who were newly prescribed omalizumab, the majority were treated by allergists/immunologists as expected, and approximately 60% of patients continued on therapy beyond 18 months. Concomitant medication use decreased after omalizumab initiation. These data on the real-world use of omalizumab for CIU may help to better inform decision-making processes for health care payers by quantifying omalizumab and concomitant medication treatment patterns over a longer time frame relative to previous studies. DISCLOSURES This study was sponsored by Novartis Pharmaceuticals, which provided funding support for the conduct of the study. Kavati, Ortiz, and Paknis are employees of Novartis Pharmaceuticals. Ke, Wertz, Huang, Wang, Willey, and Stephenson are employees of HealthCore, an independent research organization that received funding from Novartis Pharmaceuticals for the conduct of this study. Beck is an employee of the University of Rochester Medical Center, who was under contract with Novartis Pharmaceuticals to provide consulting services to this study, and reports grants from Genentech, outside the currently submitted work. Bernstein is affiliated with Bernstein Clinical Research Center, which was under contract with Novartis Pharmaceuticals to provide consulting services to this study, and reports receiving grants and personal fees from Novartis Pharmaceuticals, grants and personal fees from Genentech outside of the submitted work, and is an author on the Joint Task Force for Practice Parameters for Urticaria and the GALEN international guidelines for urticaria under preparation. Study concept and design were primarily contributed by Kavati, Ortiz, and Paknis, with assistance from the other authors. Huang, Wang, and Ke took the lead in data collection, with assistance from Wertz, Willey, and Stephenson. Data interpretation was performed by Ke, Wertz, and Willey, assisted by the other authors. The manuscript was written by Stephenson, Ke, and Wang, along with Willey, Wertz, and Huang, and revised by Bernstein and Beck, with assistance from the other authors. Selected study data were presented in a poster at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 22nd Annual International Meeting on May 20-24, 2017, in Boston, Massachusetts. A poster based on this dataset was presented at the 2017 American College of Allergy, AsthmaImmunology (ACAAI) Annual Scientific Meeting on October 26-30, 2017, in Boston, Massachusetts.

To examine treatment patterns, treatment response, and demographic and clinical characteristics of patients with chronic idiopathic urticaria (CIU) newly initiated on omalizumab therapy in real-world practice in the US.This retrospective observational cohort study used US claims data from the HealthCore Integrated Research Database (HIRDThis study consisted of 88 patients with a mean (SD) age of 43.4 (± 13.46) years, 68.2% were female, and 36 patients had ≥18 months post-index eligibility. Among 69 patients with documented index dose, 75.4% received omalizumab 300 mg and 69.6% remained on index dose throughout follow-up. For 52 patients with documented index dosing frequency, 96.2% had every 4-week dosing frequency. Among 86 patients with omalizumab documentation, 83.7% reported CIU improvement after omalizumab initiation and 24.4% discontinued omalizumab. For all patients, the proportion using oral corticosteroids (OCS) decreased pre- to post-index (52.3% vs 39.8%). Similar results were observed for patients with ≥18 months post-index eligibility.In this real-world analysis, the majority of patients remained on omalizumab for ≥12 months, and had a positive response. OCS use decreased following omalizumab initiation.

Background: With semaglutide’s FDA approval in Dec 2017, this study sought to provide real-world evidence on its effectiveness in a cohort of early users. Methods: Claims and lab result data from a broad national U.S. CI and MA population were used to identify T2DM patients who initiated semaglutide between 12/1/17 - 6/30/18 (first claim date set as index). Of these, patients who had ≥12-month pre-index health plan eligibility as well as ≥1 HbA1c result within both ≤3 months pre- and ≥3 months post-index were selected. Changes in HbA1c were assessed in all patients, GLP-1 naïve patients and GLP-1 naïve patients with a pre-index HbA1c >9%. Results:Of 107 individuals with T2DM initiating semaglutide, 48.6% were female with median age of 52 years. HbA1c was significantly reduced in all patients (-1.3%), GLP-1 naïve patients (-2.0%) and HbA1c >9% GLP-1 naïve patients (-2.9%) (all p9% GLP-1 naïve) (all p Conclusions: Semaglutide initiation was associated with a significant reduction in HbA1c and increase in HbA1c goal attainment in real-world practice in this preliminary T2DM cohort. Ongoing research will include a broader group of semaglutide users as well as allow for longer post-initiation follow-up to fully assess its effect. Disclosure J. Visaria: Employee; Self; HealthCore. T. Dang-Tan: Employee; Self; Novo Nordisk Inc. P.V. Petraro: Employee; Self; Novo Nordisk Inc. B.K. Nepal: None. V. Willey: Employee; Self; HealthCore. Funding Novo Nordisk

Showing up to appointments and adherence to treatment recommendations correlated with glycemic goal attainment for patients.

Diabetes is associated with substantial clinical and economic burdens on patients and on the US healthcare system. Treatment options for patients with type 1 or type 2 diabetes have increased significantly, from only 3 drug classes in 1995 to more than 12 distinct classes today. Although several of the newer treatments are reported to have improved efficacy and safety profiles, they are often substantially more costly than older medications. Consequently, as drug options increase, the cost of diabetes management continues to grow.To estimate the annual real-world costs of type 1 and 2 diabetes, as well as diabetes prevalence, treatment patterns, care quality, and resource utilization during 8 years.In this cross-sectional study, we examined 8 annual cohorts of patients with type 1 or type 2 diabetes, on a biennial basis, using claims data from the HealthCore Integrated Research Database between 2006 and 2014. Patients were matched with controls by age, sex, residency, and health plan type. We assessed the prevalence of diabetes, treatment patterns, care quality measures, and all-cause and diabetes-related healthcare costs using 2 methods. Method 1 calculated the annual costs as the difference in all-cause costs between patients with diabetes and matched controls. Method 2 calculated the costs for healthcare encounters based on specific codes for a diabetes diagnosis or for antidiabetes medications.Between 346,486 and 410,234 patients with type 2 diabetes and between 21,176 and 26,228 patients with type 1 diabetes were included in each study year cohort. Between 2007 and 2014, the prevalence of type 2 diabetes increased from 4.9% to 6.3%. The costs associated with using Method 1 were almost double the cost estimates in Method 2 during most of the study period. For patients with type 1 diabetes, the associated costs were twice greater with Method 1 than with Method 2. Projections to the entire US population in 2014 indicated a total of 19.3 million individuals with diabetes and associated direct costs of $314.8 billion that year.Cost estimates can guide the prioritization of healthcare expenditures. The results of this study showed that costs attributable to diabetes differed by approximately 2-fold, depending on the estimation method. The management of the escalating expenses for diabetes management in the United States requires judicious selection of the methods for estimating costs.

Objectives With the approval of new non-vitamin K antagonist oral anticoagulants for stroke prevention in non-valvular atrial fibrillation (NVAF), it is anticipated that their introduction may change NVAF treatment patterns; however, there is limited supporting real-world evidence. This study investigated guideline-recommended oral anticoagulation (OAC) treatment and persistence in newly diagnosed patients with NVAF to understand demographic and clinical characteristics. Design Retrospective observational administrative claims study in the USA. Setting Patients with NVAF with ≥1 pharmacy claim for OAC (warfarin, dabigatran, rivaroxaban or apixaban) and no atrial fibrillation diagnosis within 12 months prior to the first claim were identified in the HealthCore Integrated Research Database between 1 November 2010 and 30 November 2013. Participants 45 092 patients with NVAF were included. Outcomes The proportion of OAC-treated patients was stratified by CHADS2 score. Treatment persistence was measured from OAC initiation to discontinuation, end of eligibility or end of study period (30 November 2014), whichever occurred first. Results Almost half of the patients (41.1%) received an OAC. The proportion treated differed slightly in baseline stroke risk (CHADS23: 40.3%: p

The objective of this study was to examine patient characteristics, treatment patterns, and exacerbations among patients with asthma newly treated with omalizumab.Data for this study were obtained from administrative claims and medical records. The index date was the date of the first claim for omalizumab. All patients had ≥12 months of continuous health plan eligibility before and after the index date. Demographic and clinical characteristics were obtained 12 months before the index date. Treatment patterns of asthma medications, including omalizumab, and asthma exacerbations were evaluated in the preindex and postindex periods.The study included 1564 patients. Asthma-related medication use decreased from the preindex to the postindex periods (oral corticosteroids, 83.3%-66.4%, P0.001; inhaled corticosteroids [ICSs], 33.1%-26.8%, P0.001; long-acting βIn this real-world analysis, patients newly initiating omalizumab therapy for allergic asthma used fewer concomitant asthma medications, while experiencing significant reductions in asthma exacerbations, especially hospitalization- and emergency department-specific exacerbations, from pre- to post-omalizumab treatment initiation periods.

David M Kern,1 John J Barron,1 Bingcao Wu,1 Alex Ganetsky,2 Vincent J Willey,1 Ralph A Quimbo,1 Michael J Fisch,3 Joseph Singer,1 Ann Nguyen,4 Ronac Mamtani5 1Health Economics and Outcomes Research, HealthCore, Inc, Wilmington, DE, 2Department of Pharmacy, Hospital of the University of Pennsylvania, Philadelphia, PA, 3Medical Oncology, AIM Specialty Health, Chicago, IL, 4Oncology Solutions, Anthem, Inc, Indianapolis, IN, 5Division of Hematology/Oncology, Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, USA Background: Data from a Cancer Care Quality Program are directly integrated with administrative claims data to provide a level of clinical detail not available in claims-based studies, and referred to as the HealthCore Integrated Research Environment (HIRE)-Oncology data. This study evaluated the validity of the HIRE-Oncology data compared with medical records of breast, lung, and colorectal cancer patients.Methods: Data elements included cancer type, stage, histology (lung only), and biomarkers. A sample of 300 breast, 200 lung, and 200 colorectal cancer patients within the HIRE-Oncology data were identified for medical record review. Statistical measures of validity (agreement, positive predictive value [PPV], negative predictive value [NPV], sensitivity, specificity) were used to compare clinical information between data sources, with medical record data considered the gold standard. Results: All 300 breast cancer records reviewed were confirmed breast cancer, while 197 lung and 197 colorectal records were confirmed (PPV =0.99 for each). The agreement of disease stage was 85% for breast, 90% for lung, and 94% for colorectal cancer. The agreement of lung cancer histology (small cell vs non-small cell) was 97%. Agreement of progesterone receptor, estrogen receptor, and human epidermal growth factor receptor 2 status biomarkers in breast cancer was 92%, 97%, and 92%, respectively; epidermal growth factor receptor and anaplastic lymphoma kinase agreement in lung was 97% and 92%, respectively; and agreement of KRAS status in colorectal cancer was 95%. Measures of PPV, NPV, sensitivity, and specificity showed similarly strong evidence of validity.Conclusion: Good agreement between the HIRE-Oncology data and medical records supports the validity of these data for research. Keywords: validation, administrative claims, breast cancer, lung cancer, colorectal cancer, oncology&nbsp

Objectives Little is known about the contribution of telephone-based prescribing on overall antibiotic utilization. The objective of this study was to determine the extent and characteristics of telephone-based antibiotic prescribing in teaching and non-teaching primary care practices. Methods This retrospective cohort study included all patients (n = 114 610) cared for by teaching and non-teaching internal medicine, pediatrics, family practice, and obstetrics/gynecology practices (n = 19) affiliated with a large US healthcare system during 2006–2010 and using a common electronic medical record. Rates and types of antibiotics prescribed by teaching and non-teaching practices via telephone contact and office visit were compared among the overall cohort. All telephone-related prescriptions during 2008 underwent chart review to determine indications for antibiotic prescribing. Results Overall, 28.9 antibiotic prescriptions were issued per 100 patient-years, with 63 418 total antibiotic prescriptions and 7876 (12.4%) generated after telephone contact. Telephone-based prescribing increased steadily from 2.2 to 4.2 per 100 patient-years during the study period. Both telephone-based and office-based antibiotic prescribing were higher in non-teaching practices. Of 1790 antibiotics prescribed by telephone during 2008, the majority were for urinary tract infection (28.3%), sinusitis (20.1%), and unspecified upper respiratory infection (URI, 15.0%). Conclusions Overall, one in every eight antibiotics was prescribed via telephone encounter. These data highlight the need to include the impact of this practice in analysis of outcomes associated with outpatient antibiotic prescribing and to incorporate telephonic prescribing into guidelines facilitating appropriate antibiotic use. Copyright © 2014 John Wiley & Sons, Ltd.

Background The occurrence of low rates of rhabdomyolysis among patients receiving lipid-lowering drugs (LLDs) in randomized clinical trials may be elucidated with population-based studies. Objective To determine the risk of hospitalized rhabdomyolysis associated with LLD therapy. Methods This observational study used claims data from 9 million members of five United States health plans to identify patients (≥18 years) who received >2 statin and nonstatin LLDs during July 2000 to December 2004. Inpatient International Classification of Diseases , Ninth Revision, Clinical Modification, codes for rhabdomyolysis (791.3, 728.89, and 728.88) were observed during the follow-up period; cases were confirmed with patients' medical records. Rhabdomyolysis events were reported per 10,000 person-years of LLD exposure; multivariate analysis was conducted. Results The study cohort (N = 473,343) received 490,988 and 11,624 person-years of LLD, and combination therapy, respectively. Medical charts were obtained for 104 of 144 eligible patients with rhabdomyolysis claims; 42 cases were confirmed. With atorvastatin as reference, rhabdomyolysis rates (95% confidence interval) were greatest for cerivastatin, 8.4 (2.3-21.7); no difference among available statins was observed. Rates for other LLD monotherapies were: niacin, 2.1 (0.3−7.7), ezetimibe, 2.1 (0.3−7.8), fenofibrate, 0 (0−1.7), and gemfibrozil, 2.0 (0.5−5.2). Multivariate analysis showed only cerivastatin with a significantly greater risk of rhabdomyolysis (odds ratio 4.74, 95% confidence interval 1.1-21.2, P = .041) versus atorvastatin among the statins. Combination therapies had increased rhabdomyolysis risk (OR 7.1, 1.6-31.6, P = .010) versus LLDs alone. Conclusion The risk of habdomyolysis among hospitalized patients receiving statins was low; no difference among the available statins was evident. Further data are needed to establish the risk profile but current findings already offer guidance to physicians.

Summary Background: The burden of cardiovascular (CV) disease remains high despite substantial improvements in low-density lipoprotein cholesterol (LDL-C) goal achievement rates. Methods and Results: Two cohorts of mixed dyslipidaemia patients were identified from the HealthCore Integrated Research Database. Patients with no baseline lipids [LDL-C, triglycerides (TG), high-density lipoprotein cholesterol (HDL-C)] at optimal values (n = 27,094) and patients at LDL-C goal but with at least one other lipid not at optimal value at baseline (n = 83,067) were followed for approximately 2 years. The primary outcome was the association between achievement of optimal lipid values (OLV) and occurrence of ischaemic heart disease, cerebrovascular disease or peripheral arterial disease. Achievement of OLV during follow up occurred in 6.8% of patients with no baseline lipids at optimal values and in 17.9% of patients at LDL-C goal with at least one other lipid not at optimal value at baseline. After adjustment, significant reductions in CV events were associated with achievement of OLV across the entire lipid panel in patients who had no optimal baseline lipid values (hazard ratio, 0.407; 95% confidence interval, 0.303–0.546) or when patients were at LDL-C goals at baseline (hazard ratio, 0.764; 95% confidence interval, 0.703–0.831). Conclusions: In conclusion, challenges to effective treatment of mixed dyslipidaemia remain, as evidenced by a minority of patients achieving optimal lipid levels. There appears to be an association with incremental lowering of CV event rates beyond LDL-C goal attainment when compared with achieving OLV across the entire lipid panel for LDL-C, TG and HDL-C.

PURPOSE: Because second generation antipsychotics (SGA) might affect the risk of suicide, systematic assessment of suicide risk associated with SGA in the postmarketing setting is important and of interest to regulatory authorities. To fulfill a postmarketing request, our objective was to determine suicide event (attempted or completed) incidence in patients with schizophrenia or bipolar disorder, prescribed aripiprazole. METHODS: Using administrative data from three US sources, we assessed study endpoints of suicide attempts and death by suicide in patients aged ≥18 enrolled continuously for ≥3 months in their health plans before receiving their first ever antipsychotic (November 2002-December 2005). RESULTS: Among 20 489 antipsychotic users (8985 patient-years), unadjusted suicide event rates (per 1000 patient-years) were: 20.69 (aripiprazole); 23.99 (olanzapine); 32.33 (quetiapine); 19.69 (risperidone); 48.52 (ziprasidone). Compared with current users of other SGA combined, aripiprazole users did not have an increased risk of suicide events (crude hazard ratio (HR) = 0.79, 95%CI: 0.48-1.30; adjusted HR = 0.69, 95%CI: 0.42-1.14-(controlling for study site, age, sex, index prescription year, antipsychotic use history, other pharmacotherapy exposure, comorbidity presence, schizophrenia/bipolar disorder, suicide attempts, number inpatient/outpatient encounters). CONCLUSIONS: In this large, multi-site study, compared with other SGA combined, aripiprazole is not associated with an increased risk of suicide events in an inception cohort of patients with ICD-9/ICD-10 codes indicative of schizophrenia or bipolar disorder. Copyright © 2010 John Wiley & Sons, Ltd. Language: en

Background— This study directly compares risk of acute myocardial infarction (AMI), acute heart failure (AHF), or all-cause death among pioglitazone- and rosiglitazone-treated patients in a managed-care population. Methods and Results— Patients ≥18 years of age, newly initiated on rosiglitazone or pioglitazone between January 1, 2001, and December 12, 2005, were included. The date of the first pharmacy claim for rosiglitazone or pioglitazone was defined as index date. Patients were excluded if they had P =0.666) when patients were followed from index date until end of study period, termination of enrollment status, or diagnosis of AMI/AHF/death. Conclusions— In this retrospective cohort study directly comparing rosiglitazone and pioglitazone with a propensity score–matched population that includes mortality data, no significant differences were found in the risk of AMI, AHF or death.

ACADEMIC EMERGENCY MEDICINE 2010; 17:824–833 © 2010 by the Society for Academic Emergency Medicine Abstract Objectives: The objective was to evaluate the use of a payer-based electronic health record (P-EHR), which is a clinical summary of a patient’s medical and pharmacy claims history, in an emergency department (ED) on length of stay (LOS) and plan payments. Methods: A large urban ED partnered with the dominant health plan in the region and implemented P-EHR technology in September 2005 for widespread use for health plan members presenting to the ED. A retrospective observational study design was used to evaluate this previously implemented P-EHR. Health plan and electronic hospital data were used to identify 2,288 ED encounters. Encounters with P-EHR use (n = 779) were identified between September 1, 2005, and February 17, 2006; encounters from the same health plan (n = 1,509) between November 1, 2004, and March 31, 2005, were compared. Outcomes were ED LOS and plan payment for the ED encounter. Analyses evaluated the effect of using the P-EHR in the ED setting on study outcomes using multivariate regressions and the nonparametric bootstrap. Results: After covariate adjustment, among visits resulting in discharge (ED-only), P-EHR visits were 19 minutes shorter (95% confidence interval [CI] = 5 to 33 minutes) than non-P-EHR visits. Among visits resulting in hospitalization, the P-EHR was associated with an average 77-minute shorter ED LOS (95% CI = 28 to 126 minutes), compared to non–P-EHR visits. The P-EHR was associated with an average of $1,560 (95% CI = $43 to $2,910) lower total plan expenditures for hospitalized visits. No significant difference in total payments was observed among discharged visits. Conclusions: In the study ED, the P-EHR was associated with a significant reduction in ED LOS overall and was associated with lower plan payments for visits that resulted in hospitalization.

Summary Background: The introduction of a generic formulation of simvastatin has created the potential to provide significant low-density lipoprotein cholesterol (LDL-C) reduction in a highly cost-effective manner. Methods: This retrospective cohort analysis utilised electronic medical record data from a United States, community-based, independent physician family medicine practice. Patients switched from other statins or statin combinations to simvastatin by the family medicine physicians during routine patient care from January 2002 to October 2008 were identified. Equivalent statin dosing, lipid panel changes and National Cholesterol Education Program – Adult Treatment Panel III (NCEP) LDL-C goal attainment rates were compared preswitch and postswitch. The potential economic impact of simvastatin switching was also evaluated. Results: A total of 78 patients were identified, and in 76.9% of the switches, an equipotent dose of simvastatin was prescribed. All lipid fractions showed small, non-significant increases, with LDL-C having a 2.2 mg/dl (0.06 mmol/l) increase after switching (p = 0.476). NCEP LDL-C goal attainment rates were 79.5% and 78.2% before and after switching, respectively (p = 1.00). Modelled annual cost savings associated with switching were estimated at $671.99 per patient. Conclusions: These results demonstrate that an independent family medicine physician practice can successfully perform statin therapeutic substitution during routine patient care. Equivalent clinical outcomes with regards to changes in lipid fractions and NCEP LDL-C goal attainment were observed in conjunction with the potential for reduced costs for patients.

The availability of generic simvastatin has changed the relative cost structure within the statin marketplace and has been associated with third-party payer changes to formularies and statin utilization policies. The current study examines simvastatin therapy modification patterns and associated low-density lipoprotein cholesterol (LDL-C) goal attainment rates.This retrospective, observational study utilized administrative claims linked to laboratory result data from a national health plan. Patients newly initiated on generic simvastatin from January 2007 to March 2008 were identified. National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) risk categories and goal LDL-C targets were assigned. Simvastatin dose titrations and switches to other statins were described, as were changes in LDL-C values and NCEP ATP III goal attainment rates both before and after therapy modifications.Of the 1654 patients newly initiated on simvastatin, 84% had no simvastatin therapy modification in the1-year follow-up period. For patients with no therapy modification, 54.4% did not achieve their LDL-C NCEP ATP III goal at their first lipid panel and goal attainment was strongly associated with the level of cardiovascular risk (goal attainment rate = 75.1%, 51.7%, and 28.6% for low-, moderate- and high-risk categories, respectively). Of patients not achieving NCEP ATP III LDL-C goals (n = 885), 85.4% had no therapy modification. Goal was achieved after therapy modification in 36% (dose titration) and 42% (switchers); high-risk patients goal attainment rates were 23% and 38%, respectively.LIMITATIONS of the study include the observational design, use of an administrative claims database to assess cardiovascular risk, relatively short follow-up time (slightly more than 1 year) and the lack of assessment of adherence to therapy.This study found that the majority of patients initiated on generic simvastatin stayed on their initial starting dose regardless of NCEP ATP III goal attainment status. The findings of low rates of therapy modification irrespective of baseline CV risk and associated low rates of goal attainment, especially in high risk patients treated with simvastatin, indicate an opportunity to encourage clinical decision making based on the needs of the individual patient.

This study examined the incidence of and healthcare costs attributable to genital warts within a large US commercially insured, geographically dispersed population.Using a retrospective cohort study design, this longitudinal analysis assessed administrative claims of integrated medical and pharmacy encounters from five Blue Cross Blue Shield health plans. Genital warts cases were identified using a methodology previously described by Insinga et al.Age- and gender-specific incidence of genital warts per 1000 person-years in 2004, and duration-of-episode attributable direct medical costs (2004 US dollars) and healthcare resource utilization of cases diagnosed in 2002. Overall outcome measures were age- and gender-adjusted to the 2004 US civilian population.Genital warts incidence in 2004 was 1.2/1000 females and 1.1/1000 males. Incidence was highest among females aged 20-24 (4.6/1000) and males aged 25-29 (2.7/1000). Projected overall incidence was over 340,000 cases in 2004. Mean duration-of-episode per incident case in 2002 was 95.4 days (males 116.3 days; females 69.7 days). Mean ambulatory visits per episode were 1.5 for females and 1.9 for males, with1 drug prescription/episode. Mean costs were $647/episode ($745 males; $528 females). The 2004 estimated economic burden was $760 per 1000 individuals in the general population with the total exceeding $220 million.Only those genital warts cases that sought evaluation or for which the treating provider was covered by the health plan were captured in the study.Genital warts represent a significant health and cost burden in the US. Adoption of novel healthcare technologies such as vaccines along with traditional interventions such as physician education of signs and symptoms, condom use and abstinence or limiting number of sexual partners may significantly help reduce the burden of genital warts.

To compare the baseline characteristics, episodes of care, and cost of erythropoiesis-stimulating agents among cancer patients in a US managed-care population.Retrospective analysis of administrative claims data. Episodes of care for patients with cancer receiving erythropoiesis-stimulating agents between January 1, 2004 and January 17, 2006 included all claims for erythropoiesis-stimulating agents withor = 42 days' gap between claims, plus the duration of therapeutic benefit based on median days between consecutive doses.Main outcome measures were average weekly dose of erythropoiesis-stimulating agents and costs of therapy.A total of 15,007 eligible episodes of care (darbepoetin alfa, 7769 episodes [5587 patients]; epoetin alfa 7238 episodes [5157 patients]) were identified. Fewer claims were observed per episode of care for darbepoetin alfa than for epoetin alfa (mean [SD] 3.7 [4.1] vs. 5.3 [6.4]). The median time between consecutive claims was 15 days (darbepoetin alfa) and 8 days (epoetin alfa). The mean (SD) weekly doses were 105 (56) microg (darbepoetin alfa) and 34,242 (28173) U (epoetin alfa), a dose-comparison ratio of 326 : 1. Dose-comparison ratios were sensitive to assumptions about duration of clinical benefit. The mean (95% CI) weekly costs were significantly lower for darbepoetin alfa ($560 [553-567]) than for epoetin alfa ($645 [630-659], p0.0001) when duration of clinical benefit was considered.Significant differences characterize patterns of use of erythropoiesis-stimulating agents. Duration of therapeutic benefit is an important variable in comparing darbepoetin alfa with epoetin alfa; incorporation of this variable in analyses of costs of therapy may have notable effects on calculated treatment costs. Limitations of the study include the potential for database errors or omissions, lack of detailed disease data, and lack of adjustment for differences in the ages and comorbidities of patients.

BACKGROUND: Patients with bipolar disorder typically present to physicians in the depressed rather than the manic or hypomanic phase of illness. Because the depressive episodes in bipolar disorder may be indistinguish- able from those in major depressive disorder (MDD), misdiagnosis may occur. OBJECTIVES: To estimate from administrative claims data and a telephone survey the prevalence of potential misdiagnosis of bipolar disorder among patients with MDD and the humanistic (health-related quality of life (HRQOL) and disability) effects associated with misdiagnosis in a managed care setting. METHODS: Administrative claims data were used to identify patients with medical claims for MDD from a database of 9 million members of commer- cial health plans from 3 U.S. regions. The inclusion criteria were as follows: (a) adults aged 18 years or older; (b) at least 2 medical claims, including RESULTS: Of 1,360 adult patients aged 18 years or older with a diagnosis of MDD but without a medical claim for diagnosis of bipolar disorder, 94 (6.9%) screened positive for bipolar disorder on the MDQ. More patients with a positive screen for bipolar disorder reported lifetime histories of obsessive compulsive disorder (24.5% vs. 8.2%, P < 0.001), psychotic disorders or hallucinations (9.6% vs. 2.4%, P < 0.001), suicidal ideation (61.7% vs. 29.4%, P < 0.001), and drug abuse (34.0% vs. 11.1%, P < 0.001) than did patients with a negative screen for bipolar disorder. In the subgroup of patients who completed the SF-12 and SDS, patients with a positive screen for bipolar disorder (n = 33) had lower scores (i.e., greater impairment) on the social functioning, role emotional, and overall mental component summary scales of the SF-12 than did patients with a negative screen for bipolar disorder (n = 79, P < 0.001), but did not significantly differ on the physical component summary scale. Patients with a positive screen for bipolar disorder on the MDQ were more likely than patients who screened MDQ-negative to report severe depression-related impairment (scores of 7 and higher on the SDS scale) with work life (54.5% vs. 24.1%, respectively, P = 0.002), social life (66.7% vs. 39.2%, P = 0.008), and family life (66.7% vs. 34.2%, P = 0.002) on the SDS. CONCLUSIONS: In this study of patients carrying medical claims for a diagnosis of MDD in their administrative claims data, approximately 7% screened positive for bipolar disorder on a validated self-report assessment instrument. Patients with MDD who screened positive for bipolar disorder reported poorer HRQOL and disability scores than did patients with MDD who screened MDQ-negative. These findings may encourage interventions for appropriate screening, diagnosis, and management of potentially misdiagnosed bipolar disorder patients. J Manag Care Pharm. 2008;14(7):632-642

Current prevention guidelines support efforts to achieve optimal high-density lipoprotein (HDL-C) and triglyceride (TG) values, in addition to low-density lipoprotein (LDL-C) in order to reduce cardiovascular (CV) events. The study objective was to evaluate the risk of CV events in patients attaining versus not attaining combined (LDL-C, HDL-C, and TG) optimal lipid values.This retrospective cohort analysis was conducted using a 1.1 million member managed care database. Eligible patients had a full lipid panel between 10/1/99 and 9/30/00, were naive to lipid therapy, and had health plan eligibility 12 months pre- and post-index (baseline) lipid laboratory value. Optimal lipid values (LDL-C, HDL-C, and TG) were established using the National Cholesterol Education Program Adult Treatment Panel (NCEP ATP III) guidelines, and patients were placed into one of four groups: none, one, two, or three lipid components non-optimal at baseline. The presence of cardiovascular risk, disease, and events were determined by selected International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9 CM) and Current Procedural Terminology (CPT codes). The definition of a CV event included: diagnosis of ischemic heart disease, peripheral arterial disease, stroke/TIA, or revascularization procedure. Odds ratios (OR) for a CV event associated with attainment of each optimal lipid fraction were determined by multivariate logistic regression. The study cohort included 30,348 patients, with a mean follow-up of 27 +/- 8 months. Mean age was 66 +/- 12 years; 16,549 (54%) were male; and 17,289 (57%) patients had coronary heart disease (CHD) or CHD risk equivalent. There were 5955 CV events that occurred in 4059 (13%) study patients. The presence of a single non-optimal lipid value slightly increased CV event risk [OR: 1.06; 95% CI: 0.95-1.18], whereas two or all three non-optimal lipid values significantly increased the risk of a CV event [OR: 1.22; 95% CI: 1.08-1.37; and 1.45; 95% CI: 1.24-1.68, respectively].As with all large observational databases there are potential limitations including: patient selection bias (e.g., more interventions in patients with greater illness, lack of mortality data, and frequency of lipid monitoring), unknown confounding variables, and potential coding errors.Not attaining optimal combined lipid values, independently and significantly, increased the risk of CV events in this large at-risk population with approximately 68,283 patient years of follow-up. The combination of non-attainment of optimal LDL-C with non-attainment of optimal HDL-C or TG values, or both, increased the adjusted risk of CV events by 22-45%. Thus, therapeutic strategies should focus on assessment and management of multiple lipid abnormalities, and not on single lipid risk factor modification.