Retrospective descriptive analysis of a managed care population with obesity.

OBJECTIVES: To reveal the extent of obesity in a single healthcare system and provide a blueprint for other health systems to perform similar analyses, this study describes characteristics and weight change patterns of patients classified with overweight and obesity at a large integrated delivery network (IDN) in the South-Central United States. METHODS: A descriptive, observational, retrospective study was conducted using electronic medical records and claims data. Patients were ≥18 years old, body mass index (BMI) ≥27 kg/m2, and continuously enrolled in the IDN plan for ≥6 months before and ≥12 months after the index date. Demographics, comorbidities, BMI, and weight were collected. Weight changes were assessed annually, and anti-obesity medications (AOM) use was also captured. RESULTS: A total of 36,430 eligible patients were identified. A subset of 22,712 patients was continuously enrolled for the entire study period (mean age: 57.2) and were primarily white (83.3%) and commercially insured (54.3%). Most patients were categorized as overweight (40.1%) or obesity class I (32.5%) at baseline. At years 1 and 4 post-index, patients who maintained index weight (±3%) was 56.2% and 37.0%, respectively, whereas weight gain (≥3% increase) was 23.7% and 33.3%, respectively. AOM use (1.1%) primarily consisted of phentermine-hydrochloride (n = 114, 0.5%) and orlistat (n = 115, 0.5%). CONCLUSIONS: An increasing proportion of patients gained weight over time, combined with low AOM use, emphasizing the need for weight-loss interventions in this population. Findings from this study provide a foundation for health systems to perform similar analyses.

Associations of weight loss with obesity-related comorbidities in a large integrated health system.

AIMS: To determine the health outcomes associated with weight loss in individuals with obesity, and to better understand the relationship between disease burden (disease burden; ie, prior comorbidities, healthcare utilization) and weight loss in individuals with obesity by analysing electronic health records (EHRs). MATERIALS AND METHODS: We conducted a case-control study using deidentified EHR-derived information from 204 921 patients seen at the Cleveland Clinic between 2000 and 2018. Patients were aged ≥20 years with body mass index ≥30 kg/m2 and had ≥7 weight measurements, over ≥3 years. Thirty outcomes were investigated, including chronic and acute diseases, as well as psychological and metabolic disorders. Weight change was investigated 3, 5 and 10 years prior to an event. RESULTS: Weight loss was associated with reduced incidence of many outcomes (eg, type 2 diabetes, nonalcoholic steatohepatitis/nonalcoholic fatty liver disease, obstructive sleep apnoea, hypertension; P < 0.05). Weight loss >10% was associated with increased incidence of certain outcomes including stroke and substance abuse. However, many outcomes that increased with weight loss were attenuated by disease burden adjustments. CONCLUSIONS: This study provides the most comprehensive real-world evaluation of the health impacts of weight change to date. After comorbidity burden and healthcare utilization adjustments, weight loss was associated with an overall reduction in risk of many adverse outcomes.

A Retrospective Analysis of Therapeutic Inertia in Type 2 Diabetes Management Across a Diverse Population of Health Care Organizations in the USA.

INTRODUCTION: If their target glycated hemoglobin (HbA1c) is not achieved after 3 months, timely treatment intensification is recommended in people with type 2 diabetes to maintain glycemic control and minimize vascular complications. We retrospectively investigated potential therapeutic inertia in the management of type 2 diabetes in multiple health care organizations across the USA. METHODS: Electronic health records were analyzed from 22 American Medical Group Association (AMGA) health care organizations. Bolus insulin-naïve patients with type 2 diabetes and HbA1c ≥ 8.0% (≥ 64 mmol/mol) at baseline were followed for 24 months to identify the frequency and average duration of therapeutic inertia (no new class of glucose-lowering medication prescribed, or not achieving their target HbA1c [< 8.0%; < 64 mmol/mol]). RESULTS: The study cohort comprised almost 28,000 patients. Therapeutic inertia was observed in ≈ 50% of patients after 6 months, and in > 10% after 24 months. Less therapeutic inertia was observed in patients receiving one or no oral antidiabetic drugs (OADs) (36% or 28%, respectively, at 6 months), while more inertia was seen following multiple OADs or basal insulin (54% of those on baseline basal insulin at 6 months). Although an observable action was recorded for 90% of patients, many (44%) had still not achieved their target HbA1c after 24 months. CONCLUSION: The results corroborate the presence of therapeutic inertia in people with type 2 diabetes, suggesting that treatment intensification guidelines are not being followed. Extensive variability in the presence of therapeutic inertia was observed both across and within organizations; investigating this further and sharing best practices across providers might help improve the quality of patient care at organizational and national levels.

People with type 2 diabetes have their glycated hemoglobin (HbA_1c) level measured regularly by their care provider to check their blood sugar levels over the previous 2­3 months and the diabetes control achieved with their current treatment. To keep HbA_1c within an individually recommended range, changes to therapies or doses may be needed, which is known as 'treatment intensification.' Despite guidelines describing this best-practice approach, 'therapeutic inertia' (not intensifying treatment when needed) is common. This therapeutic inertia may be a result of complicated or confusing guidelines, a lack of time or awareness/understanding on the part of the health care provider, or patient-specific barriers such as treatment cost or fear of side effects. Due to therapeutic inertia, patients can have poorly controlled diabetes for a long time, increasing their risk of other diabetes-related health problems or complications. This study describes widespread therapeutic inertia in the management of type 2 diabetes across the USA, suggesting that treatment intensification in patients with poor diabetes control is not taking place when needed. Diabetes-related health complications caused by poorly controlled disease over a period of time can significantly reduce quality of life. Diabetes and its complications also increase costs for the health care system due to the resulting medical costs and diabetes-related reductions in productivity. It is important to encourage early diagnosis of diabetes and appropriate and timely treatment. Investigating the variations in therapeutic inertia seen within and between health care organizations and sharing the lessons learned by the top-performing organizations may help spread best practices and improve the quality of patient care.

Natural Language Processing Improves Detection of Nonsevere Hypoglycemia in Medical Records Versus Coding Alone in Patients With Type 2 Diabetes but Does Not Improve Prediction of Severe Hypoglycemia Events: An Analysis Using the Electronic Medical Record in a Large Health System.

OBJECTIVE: To determine if natural language processing (NLP) improves detection of nonsevere hypoglycemia (NSH) in patients with type 2 diabetes and no NSH documentation by diagnosis codes and to measure if NLP detection improves the prediction of future severe hypoglycemia (SH). RESEARCH DESIGN AND METHODS: From 2005 to 2017, we identified NSH events by diagnosis codes and NLP. We then built an SH prediction model. RESULTS: There were 204,517 patients with type 2 diabetes and no diagnosis codes for NSH. Evidence of NSH was found in 7,035 (3.4%) of patients using NLP. We reviewed 1,200 of the NLP-detected NSH notes and confirmed 93% to have NSH. The SH prediction model (C-statistic 0.806) showed increased risk with NSH (hazard ratio 4.44; P < 0.001). However, the model with NLP did not improve SH prediction compared with diagnosis code-only NSH. CONCLUSIONS: Detection of NSH improved with NLP in patients with type 2 diabetes without improving SH prediction.

Evaluation of the Short-Term Cost-Effectiveness of IDegLira Versus Basal Insulin and Basal-Bolus Therapy in Patients with Type 2 Diabetes Based on Attainment of Clinically Relevant Treatment Targets.

BACKGROUND: Effective glycemic control can reduce the risk of complications and their related costs in patients with type 2 diabetes (T2D). Many patients fail to reach hemoglobin A1c (HbA1c) ≤ 6.5% or < 7.0%, often due to adverse effects of treatment, such as hypoglycemia and weight gain. Glycemic targets should be individualized and consider multiple factors, including the risk of adverse events and the patient's characteristics and comorbid conditions. OBJECTIVE: To compare the odds and annual cost of achieving treatment targets, which incorporate HbA1c targets of < 7.5%, < 8.0%, and ≤ 9.0%, with insulin degludec/liraglutide (IDegLira) versus basal insulin and basal-bolus therapy. METHODS: This is a post hoc analysis of the DUAL V and DUAL VII 26-week trials, which randomized patients with T2D uncontrolled (HbA1c 7%-10%) on insulin glargine 100 units/mL (IGlar U100) and metformin to IDegLira or continued IGlar U100 titration (DUAL V) or IGlar U100 + insulin aspart (DUAL VII), all with metformin. Proportions of patients achieving HbA1c targets (< 7.5%, < 8.0%, and ≤ 9.0%) by the end of trial were assessed via 3 outcomes: alone, without either hypoglycemia or weight gain (double composite outcome), or without a combination of hypoglycemia and weight gain (triple composite outcome). The cost per patient achieving the triple composite outcome at each HbA1c target (< 7.5%, < 8.0%, and ≤ 9.0%) was calculated by dividing the annual cost of treatment by the proportion of patients achieving the target. This short-term (1-year) cost-effectiveness analysis was conducted from the perspective of a U.S. health care payer. RESULTS: More patients achieved HbA1c < 7.5% (P < 0.0001) and < 8.0% (P = 0.0003), and a similar percentage achieved HbA1c ≤ 9.0% with IDegLira versus IGlar U100 (DUAL V). Similar proportions of patients achieved all 3 HbA1c targets with IDegLira compared with basal-bolus therapy (DUAL VII). The odds of achieving double or triple composite outcomes were significantly higher for IDegLira versus IGlar U100 or basal-bolus for all 3 HbA1c targets (P < 0.0001 in each case) in both trials. For each $1 spent on IDegLira, the equivalent annual costs per patient to achieve HbA1c targets of < 7.5%, < 8.0%, or ≤ 9.0% without hypoglycemia and without weight gain were $2.43, $2.10, and $2.05, respectively, for IGlar U100 and $6.33, $5.80, and $6.06, respectively, for basal-bolus therapy. CONCLUSIONS: Based on data from DUAL V and DUAL VII, this analysis showed that a greater or similar proportion of patients with T2D reached HbA1c targets with IDegLira compared with IGlar U100/basal-bolus therapy. Odds of achieving double or triple composite outcomes of HbA1c reduction without hypoglycemia and/or without weight gain were greatest for IDegLira. Short-term cost analyses based on the triple composite outcomes suggest that IDegLira is a cost-effective treatment option in the United States compared with either uptitration of IGlar U100 or basal-bolus therapy. DISCLOSURES: This study was supported by Novo Nordisk A/S. The analysis was based on the DUAL V (NCT01952145) and DUAL VII (NCT02420262) trials, which were funded and conducted by Novo Nordisk. This post hoc analysis was conceived and interpreted by the authors and drafted with medical writing support that was funded by Novo Nordisk. Novo Nordisk also reviewed the manuscript for medical accuracy. Hunt and Malkin are employees of Ossian Health Economics and Communications, which received consulting fees from Novo Nordisk during the conduct of this study and has received consulting fees from Novo Nordisk, unrelated to this study. Mocarski, Ranthe, and Schiffman are employees of Novo Nordisk and Novo Nordisk A/S. Cannon has received speaker fees/honoraria from Abbvie, Amgen, and Janssen; speaker fees from Novo Nordisk; and has stock ownership in Novo Nordisk. Bargiota has received speaker fees/honoraria from AstraZeneca, Eli Lilly, MSD, Novo Nordisk, Sanofi, Boehringer Ingelheim, and Novartis. Billings has received personal fees from Novo Nordisk, Sanofi, and Dexcom, unrelated to this study. Leiter reports grants and personal fees from AstraZeneca, Boehringer Ingelheim, Eli Lilly, Janssen, Merck, Novo Nordisk, Sanofi, Servier, and GSK, unrelated to this study. Doshi has no relevant conflicts of interest to disclose. Parts of this study were presented as a poster at the AMCP Managed Care & Specialty Pharmacy Annual Meeting; April 23-26, 2018; Boston, MA.

Divergence in perceptions of diabetes control among patients with type 2 diabetes mellitus treated with basal insulin and health care professionals: results from the US Perceptions of Control (POC-US) study.

Background: Approximately 60% of the patients with type 2 diabetes mellitus (T2DM) on basal insulin have an HbA1c ≥7%. This analysis of the US Perceptions of Control (POC-US) study aimed to understand US patient and health care professional (HCP) views of diabetes "control," which may play a role in whether patients reduce their HbA1c or achieve HbA1c <7%. Methods: A cross-sectional, Web-based survey of 500 US HCPs (primary care physicians, endocrinologists, nurse practitioners/physician assistants) and 618 US adults with T2DM using basal insulin was conducted to assess perceptions, attitudes, and behaviors associated with T2DM management. The survey was developed from previous research examples and qualitative exploratory research and was pretested. Patients self-reported their most recent HbA1c level and confirmed this value with their HCP, if necessary. Results: Patients and HCPs differed on some definitions of "in control." HbA1c value was used most often by both populations, but more frequently by HCPs (91% vs 69%). Patients also often used behavioral criteria (eg, adherence to lifestyle changes and/or treatment regimens), and HCPs often used clinical criteria (eg, hypoglycemia). Most HCPs focused on the last 3 months to define control (67% vs 34% patients; P<0.05), whereas patients more frequently reported focusing on "the current moment" or "the past week." Patients were more likely to agree that controlling their condition is "completely the patients' responsibility" (patients, 67%; HCPs, 34%; P<0.05); HCPs were more likely to agree that they have "a responsibility to actively contribute to the control of their patients' T2DM" (90% vs 60%; P<0.05). Conclusion: US patients with T2DM have differing views from HCPs on key aspects of diabetes control and management and are less likely to consider HbA1c value as a criterion for determining control. Recognizing and addressing these differences may improve patient-HCP communication and may potentially improve patient outcomes.

The Economic Burden of Elevated Blood Glucose Levels in 2017: Diagnosed and Undiagnosed Diabetes, Gestational Diabetes Mellitus, and Prediabetes.

OBJECTIVE: This study was conducted to update national estimates of the economic burden of undiagnosed diabetes, prediabetes, and gestational diabetes mellitus (GDM) in the United States for year 2017 and provide state-level estimates. Combined with published estimates for diagnosed diabetes, these updated statistics provide a detailed picture of the economic costs associated with elevated blood glucose levels. RESEARCH DESIGN AND METHODS: This study estimated medical expenditures exceeding levels occurring in the absence of diabetes or prediabetes and the indirect economic burden associated with reduced labor force participation and productivity. Data sources analyzed included Optum medical claims for ∼5.8 million commercially insured patients continuously enrolled from 2013 to 2015, Medicare Standard Analytical Files containing medical claims for ∼2.8 million Medicare patients in 2014, and the 2014 Nationwide Inpatient Sample containing ∼7.1 million discharge records. Other data sources were the U.S. Census Bureau, Centers for Disease Control and Prevention, and Centers for Medicare & Medicaid Services. RESULTS: The economic burden associated with diagnosed diabetes (all ages), undiagnosed diabetes and prediabetes (adults), and GDM (mothers and newborns) reached nearly $404 billion in 2017, consisting of $327.2 billion for diagnosed diabetes, $31.7 billion for undiagnosed diabetes, $43.4 billion for prediabetes, and nearly $1.6 billion for GDM. Combined, this amounted to an economic burden of $1,240 for each American in 2017. Annual burden per case averaged $13,240 for diagnosed diabetes, $5,800 for GDM, $4,250 for undiagnosed diabetes, and $500 for prediabetes. CONCLUSIONS: Updated statistics underscore the importance of reducing the burden of prediabetes and diabetes through better detection, prevention, and treatment.

Ideglira is Associated With Improved Short-Term Clinical Outcomes and Cost Savings Compared with Insulin Glargine U100 Plus Insulin Aspart in the U.S.

OBJECTIVE: In the DUAL (Dual Action of Liraglutide and Insulin Degludec in Type 2 Diabetes) VII trial, IDegLira (a combination of insulin degludec and liraglutide) was compared with insulin glargine U100 plus insulin aspart. Both treatment approaches achieved similar glycemic control, but there were differences in hypoglycemia, changes in body weight, and injection frequency. The aim of the present analysis was to assess the short-term cost effectiveness of IDegLira versus insulin glargine U100 plus insulin aspart for treatment of patients with type 2 diabetes mellitus not meeting glycemic targets on basal insulin in the U.S. METHODS: A cost-utility model was developed to evaluate the clinical and economic outcomes associated with the 2 treatments over a 1-year time horizon, capturing the impact on quality of life of hypoglycemic events, body mass index, and injection frequency. Costs were captured from a healthcare payer perspective in 2017 U.S. dollars ($). RESULTS: IDegLira was associated with improved quality of life by 0.12 quality-adjusted life years compared with insulin glargine U100 plus insulin aspart. The key drivers of this difference were reduced injection frequency and hypoglycemic events avoided. IDegLira was associated with increased annual drug costs, but this was entirely offset by reduced needle costs and reduced costs of self-monitoring of blood glucose testing. IDegLira was associated with total annual cost savings of $743 per patient. CONCLUSION: IDegLira was found to improve quality-adjusted life expectancy and reduce costs when compared with insulin glargine U100 plus insulin aspart for treatment of patients with type 2 diabetes not achieving glycemic control on basal insulin in the U.S. ABBREVIATIONS: ADA = American Diabetes Association; BMI = body mass index; CI = confidence interval; DUAL = Dual Action of Liraglutide and Insulin Degludec in Type 2 Diabetes; GLP-1 = glucagon-like peptide-1; HbA1c = glycated hemoglobin; ICER = incremental cost-effectiveness ratio; IU = international units; QALY = quality-adjusted life year; SMBG = self-monitoring of blood glucose.

Long-term cost-effectiveness analysis shows that IDegLira is associated with improved outcomes and lower costs compared with insulin glargine U100 plus insulin aspart in the US.

AIMS: The clinical and economic impact of diabetes is growing in the US. Choosing therapies that are both effective and cost-effective is becoming increasingly important. The aim of the present analysis was to assess the long-term cost-effectiveness of IDegLira for treatment of patients with type 2 diabetes mellitus not meeting glycemic targets on basal insulin, vs insulin glargine U100 plus insulin aspart, in the US setting. MATERIALS AND METHODS: Long-term projections of cost-effectiveness outcomes were made using the IQVIA CORE Diabetes Model. Clinical inputs were based on the DUAL VII trial, with costs (accounted from a healthcare payer perspective) and utilities based on published sources. Future costs and clinical benefits were discounted at 3% annually. RESULTS: IDegLira was associated with increased discounted life expectancy by 0.02 years and increased discounted quality-adjusted life expectancy by 0.22 quality-adjusted life years compared with insulin glargine U100 plus insulin aspart. Evaluation of direct medical costs suggested that the mean cost per patient with IDegLira was $3,571 lower than with insulin glargine U100 plus insulin aspart. The cost saving was driven predominantly by the lower acquisition cost of IDegLira compared with insulin glargine U100 plus insulin aspart, with further cost savings identified as a result of avoided treatment of diabetes-related complications. IDegLira was associated with improved clinical outcomes at a reduced cost compared with insulin glargine U100 plus insulin aspart. CONCLUSIONS: Based on clinical trial data, the present analysis suggests that IDegLira is associated with improved clinical outcomes and cost savings compared with treatment with insulin glargine U100 plus insulin aspart for patients with type 2 diabetes not achieving glycemic control on basal insulin in the US. Therefore, IDegLira is likely to be considered dominant (cost saving and more effective) and, consequently, highly cost-effective in the US setting.

Slow Titration and Delayed Intensification of Basal Insulin Among Patients with Type 2 Diabetes.

BACKGROUND: Clinical inertia in type 2 diabetes mellitus (T2DM) refers to the failure of clinicians to intensify therapy when indicated. Many T2DM patients remain suboptimally controlled after initiating basal insulin. OBJECTIVE: To examine the prevalence of patients treated with basal insulin but in poor glycemic control (hemoglobin A1c [A1c] ≥ 7%) after initiation and subsequent treatment intensification patterns and glycemic outcomes in a real-world setting. METHODS: Adults diagnosed with T2DM newly initiating a basal insulin analog (insulin glargine or detemir) from January 2010 to September 2014 were identified in the QuintilesIMS Real-World Data Adjudicated Claims linked to the QuintilesIMS Real-World Data Electronic Medical Records. Patients were previously naive to insulin and glucagon-like peptide-1 receptor agonists (GLP-1 RAs), were persistent on therapy for ≥ 6 months, and had ≥ 12 months of continuous health plan enrollment after initiation. First treatment intensification (increase in basal insulin dose [of ≥ 10%], addition of bolus insulin, GLP-1 RA, or a new oral antidiabetic drug [OAD]) was assessed among patients in poor glycemic control at 6 months after initiation over the available (minimum ≥ 12-month) follow-up. Subsequent glycemic outcomes and treatment intensification were assessed. Kaplan-Meier (KM) analysis evaluated time-to-treatment intensification and time to A1c goal. RESULTS: Of 427 eligible patients with A1c available at 6 months, 59.3% were male; mean age was 53.9 years; mean follow-up was 29.4 months; and mean dose of the initiated prescription was 29.6 insulin units (U) (median 24U). Six months after initiating basal insulin, 81.0% of patients (n = 346) remained in poor glycemic control, and mean basal insulin dose was 31.0U (median 25U). Most (88.4%; n = 306) of these uncontrolled patients subsequently intensified treatment over the available follow-up. Using KM analysis, these patients intensified treatment in a median of 58 days (range: 17.5 days [GLP-1 RA addition] to 52 days [increase in basal insulin dose]) from the first elevated A1c measurement taken after 6 months, and 72.5% (GLP-1 RA addition) to 91.1% (OAD addition) of patients continued to remain in poor glycemic control at 12 months after intensification. Most patients (66.8%; n = 231/346) first intensified treatment by increasing their basal insulin dose, and mean dose increased to 61.7U (median 38U) at intensification. Six months following basal insulin increase, almost all patients remained on basal insulin therapy and among those with available A1c, 92.1% (140 of 152) were in poor glycemic control. In the subsequent 12 months, only a third (34%) of uncontrolled patients added another antihyperglycemic agent. CONCLUSIONS: The vast majority of patients remained uncontrolled in the 6 months following basal insulin initiation. Basal insulin up-titration was slow and insufficient in the 6 months after initiation, indicating treatment inertia. Subsequently, most patients failed to achieve glycemic targets despite intensification with basal insulin. This finding suggests a substantial unmet need for effective treatment intensification among T2DM patients treated with basal insulin who remain uncontrolled. Improved provider education and guidelines on appropriate intensification are warranted. DISCLOSURES: This study was funded by Novo Nordisk. Mocarski, Guerrero, Langer, and Thorsted are employees and shareholders of Novo Nordisk. Yeaw, Divino, and DeKoven are employed by QuintilesIMS, which received remuneration from Novo Nordisk for work on this study. Study concept and design were contributed by Mocarski, DeKoven, Langer, and Thorsted. Yeaw took the lead in data collection, along with Divino and DeKoven. Data interpretation was performed by Yeaw, Divino, DeKoven, and Guerrero. The manuscript was written by Mocarski and Divino and revised by Guerrero, Langer, and Thorsted, along with Yeaw and DeKoven. Some of the data from this study were presented via poster at the AMCP Annual Meeting in March 2017 and at the 53rd EASD Annual Meeting in September 2017.

Use of International Classification of Diseases, Ninth Revision Codes for Obesity: Trends in the United States from an Electronic Health Record-Derived Database.

Obesity is a potentially modifiable risk factor for many diseases, and a better understanding of its impact on health care utilization, costs, and medical outcomes is needed. The ability to accurately evaluate obesity outcomes depends on a correct identification of the population with obesity. The primary objective of this study was to determine the prevalence and accuracy of International Classification of Diseases, Ninth Revision (ICD-9) coding for overweight and obesity within a US primary care electronic health record (EHR) database compared against actual body mass index (BMI) values from recorded clinical patient data; characteristics of patients with obesity who did or did not receive ICD-9 codes for overweight/obesity also were evaluated. The study sample included 5,512,285 patients in the database with any BMI value recorded between January 1, 2014, and June 30, 2014. Based on BMI, 74.6% of patients were categorized as being overweight or obese, but only 15.1% of patients had relevant ICD-9 codes. ICD-9 coding prevalence increased with increasing BMI category. Among patients with obesity (BMI ≥30 kg/m2), those coded for obesity were younger, more often female, and had a greater comorbidity burden than those not coded; hypertension, dyslipidemia, type 2 diabetes mellitus, and gastroesophageal reflux disease were the most common comorbidities. KEY FINDINGS: US outpatients with overweight or obesity are not being reliably coded, making ICD-9 codes undependable sources for determining obesity prevalence and outcomes. BMI data available within EHR databases offer a more accurate and objective means of classifying overweight/obese status.

Primary care physicians' utilization of type 2 diabetes screening guidelines and referrals to behavioral interventions: a survey-linked retrospective study.

OBJECTIVE: To assess primary care physicians' (PCPs) knowledge of type 2 diabetes screening guidelines (American Diabetes Association (ADA) and 2008 US Preventive Services Task Force (USPSTF)), the alignment between their self-reported adherence and actual practice, and how often PCPs recommended diabetes prevention and self-management education programs (DPP/DSME). RESEARCH DESIGN AND METHODS: An online survey of PCPs to understand knowledge and adherence toward use of USPSTF/ADA guidelines and recommendation of DPP/DSME. Patient data from electronic medical records (EMRs) for each PCP were used to identify rates of screening in eligible patients as per guidelines and the two sources were compared to assess concordance. RESULTS: Of 305 surveyed physicians, 38% reported use of both guidelines (33% use ADA only, 25% USPSTF only). Approximately one-third of physicians who reported use of USPSTF/ADA guidelines had non-concordant EMR data. Similarly, while most PCPs reported they are 'very likely' to screen patients with risk factors listed in guidelines, for each criterion at least one-fourth (24%) of PCPs survey responses were non-concordant with EMRs. PCPs reported they provide referral to DPP and DSME on average to 45% and 67% of their newly diagnosed patients with pre-diabetes and diabetes, respectively. CONCLUSION: Findings show disconnect between PCPs' perceptions of adherence to screening guidelines and actual practice, and highlight limited referrals to DPP/DSME programs. More research is needed to understand barriers to guideline consistent screening and uptake of DPP/DSME, particularly in light of recent policy changes such as the linking USPSTF criteria to reimbursement and expected Medicare DPP reimbursement in 2018.

Evaluation of the Short-Term Cost-Effectiveness of IDegLira Versus Continued Up-Titration of Insulin Glargine U100 in Patients with Type 2 Diabetes in the USA.

INTRODUCTION: Effective glycemic control can reduce the risk of complications and their related costs in type 2 diabetes mellitus (T2DM). However, many patients fail to reach glycemic targets, often because of adverse effects of treatment (including hypoglycemia or weight gain). The present analysis evaluated the short-term cost-effectiveness of IDegLira versus continued up-titration of insulin glargine U100 in patients with T2DM failing to achieve glycemic control on basal insulin in the US setting. METHODS: The cost per patient achieving treatment target (cost of control) was assessed for various single and composite endpoints for the entire trial population and in patients with baseline glycated hemoglobin (HbA1c) >8.0% and HbA1c >9.0%. The proportions of patients achieving treatment targets were analyzed using data obtained in the DUAL V study. Costs were accounted based on published wholesale acquisition costs. RESULTS: When assessing the full trial population, IDegLira was associated with lower annual cost of control than continued up-titration of insulin glargine U100 for patients achieving HbA1c ≤6.5% without confirmed hypoglycemia (by $10,608), HbA1c ≤6.5% without weight gain (by $29,215), and HbA1c ≤6.5% without confirmed hypoglycemia and weight gain (by $57,351). A similar pattern was observed when multifactorial treatment targets were based on achieving a glycemic target of 7.0%. When only HbA1c was considered, IDegLira was associated with a lower cost per patient achieving HbA1c ≤6.5% (by $3306) but cost of control was equivalent for a target of HbA1c <7.0%. In patients with baseline HbA1c >8.0% and HbA1c >9.0%, IDegLira was associated with a lower cost of control for all treatment targets. CONCLUSION: The significantly greater clinical efficacy in terms of bringing patients to treatment targets identified in the DUAL V study results in lower cost of control values for IDegLira versus continued up-titration of insulin glargine U100 in the USA. This suggests IDegLira is a cost-effective treatment option in the USA. FUNDING: Novo Nordisk A/S and Novo Nordisk Inc.

IDegLira Versus Insulin Glargine U100: A Long-term Cost-effectiveness Analysis in the US Setting.

INTRODUCTION: Treatment with IDegLira has the potential to improve glycemic control in patients with type 2 diabetes mellitus (T2DM) without the weight gain and with a lower risk of hypoglycemia than with other therapies. The aim of the present analysis was to evaluate the long-term cost-effectiveness of IDegLira versus insulin glargine U100 with re-education and up-titration of the dose for treatment of patients with T2DM failing to achieve glycemic control on basal insulin in the US setting. METHODS: Data were obtained from the DUAL V randomized controlled trial in which adults with T2DM failing to achieve glycemic targets with insulin glargine U100 were randomly allocated to receive either IDegLira or insulin glargine U100. Long-term projections of clinical outcomes and direct costs were made using the IMS CORE Diabetes Model. Costs were accounted from a healthcare payer perspective. Future costs and clinical benefits were discounted at 3% annually. RESULTS: IDegLira was associated with improved discounted life expectancy (13.99 [standard deviation 0.19] versus 13.82 [standard deviation 0.20] years) and quality-adjusted life expectancy (9.14 [standard deviation 0.12] versus 8.87 [standard deviation 0.13] quality-adjusted life years [QALYs]) compared to insulin glargine U100. IDegLira was associated with increased direct costs of $16,970, yielding an incremental cost-effectiveness ratio (ICER) of $63,678 per QALY gained versus insulin glargine U100. Sensitivity analyses identified that the key driver of cost-effectiveness was the greater reduction in glycated hemoglobin with IDegLira compared with insulin glargine U100. CONCLUSIONS: Based on head-to-head clinical trial data, the present analysis suggests that IDegLira is likely to improve long-term clinical outcomes for patients with T2DM not achieving glycemic control on basal insulin compared to re-education and up-titration of the dose of insulin glargine U100, with these improvements coming at an increased cost from a healthcare payer perspective. An ICER within the range described as high care value was calculated, suggesting IDegLira is a cost-effective treatment option in the US. FUNDING: Novo Nordisk A/S and Novo Nordisk Inc.

Benefits of Early Roflumilast Treatment After Hospital or Emergency Department Discharge for a COPD Exacerbation.

BACKGROUND: Chronic lower respiratory disease, which includes chronic obstructive pulmonary disease (COPD), is the third leading cause of death in the United States. Roflumilast is an oral, once-daily, selective phosphodiesterase-4 inhibitor approved for reducing the risk for COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. OBJECTIVES: To evaluate the effects of roflumilast treatment timing on COPD exacerbation rates (primary objective) and on resource utilization and healthcare costs (secondary objective) after hospital or emergency department discharge associated with a COPD exacerbation. METHODS: In this retrospective cohort study, claims data from March 2011 to March 2013 were extracted from Truven Health MarketScan combined commercial healthcare claims and Medicare supplemental claims databases and were analyzed to compare the exacerbation rates and the healthcare resource utilization and costs between the early roflumilast treatment (treatment initiation ≤30 days after hospital or emergency department discharge) and the delayed roflumilast treatment (treatment initiation 31-180 days after discharge) cohorts. Multivariate logistic regression and generalized linear models with log-link function and gamma distribution were adjusted for age, sex, insurance plan type, COPD disease complexity, and comorbidities. RESULTS: A total of 995 patients (N = 280 early roflumilast treatment, N = 715 delayed roflumilast treatment) were included. Compared with the delayed roflumilast treatment group, patients in the early roflumilast treatment group were 39% less likely to have an exacerbation after hospital discharge (P = .004). The patients receiving early roflumilast treatment also had 42% (P = .003) and 37% (P = .005) lower risks for COPD-related and all-cause rehospitalizations, respectively, than patients in the delayed roflumilast treatment group. Significantly fewer patients receiving early roflumilast treatment had moderate (P = .013) or severe (P = .002) exacerbations. Early roflumilast treatment also was associated with reduced annualized COPD-related (P = .012) and all-cause (P = .009) rehospitalizations, outpatient visits per patient (P <.001 for COPD-related and all-cause), and procedures or therapies (COPD-related, P = .016; all-cause, P = .009). The early treatment group had fewer COPD-related emergency department visits per patient than the delayed roflumilast treatment group (P = .035), and the total mean annualized COPD-related and all-cause costs were reduced by $7273 (P = .014) and $14,111 (P = .002), respectively. Multivariate analyses showed that early treatment was associated with lower COPD-related and all-cause annualized health services costs per patient annually (P <.001 for both). CONCLUSION: In this real-world study, the patients with COPD who initiated roflumilast treatment ≤30 days after a hospital or emergency department discharge for a COPD-related exacerbation experienced fewer subsequent exacerbations and rehospitalizations, reduced healthcare utilizations, and lower healthcare costs than the patients who delayed their roflumilast treatment.

Evaluation of the psychometric properties of the Nighttime Symptoms of COPD Instrument.

BACKGROUND: Nighttime symptoms can negatively impact the quality of life of patients with chronic obstructive pulmonary disease (COPD). The Nighttime Symptoms of COPD Instrument (NiSCI) was designed to measure the occurrence and severity of nighttime symptoms in patients with COPD, the impact of symptoms on nighttime awakenings, and rescue medication use. The objective of this study was to explore item reduction, inform scoring recommendations, and evaluate the psychometric properties of the NiSCI. METHODS: COPD patients participating in a Phase III clinical trial completed the NiSCI daily. Item analyses were conducted using weekly mean and single day scores. Descriptive statistics (including percentage of respondents at floor/ceiling and inter-item correlations), factor analyses, and Rasch model analyses were conducted to examine item performance and scoring. Test-retest reliability was assessed for the final instrument using the intraclass correlation coefficient (ICC). Correlations with assessments conducted during study visits were used to evaluate convergent and known-groups validity. RESULTS: Data from 1,663 COPD patients aged 40-93 years were analyzed. Item analyses supported the generation of four scores. A one-factor structure was confirmed with factor analysis and Rasch analysis for the symptom severity score. Test-retest reliability was confirmed for the six-item symptom severity (ICC, 0.85), number of nighttime awakenings (ICC, 0.82), and rescue medication (ICC, 0.68) scores. Convergent validity was supported by significant correlations between the NiSCI, St George's Respiratory Questionnaire, and Exacerbations of Chronic Obstructive Pulmonary Disease Tool-Respiratory Symptoms scores. CONCLUSION: The results suggest that the NiSCI can be used to determine the severity of nighttime COPD symptoms, the number of nighttime awakenings due to COPD symptoms, and the nighttime use of rescue medication. The NiSCI is a reliable and valid instrument to evaluate these concepts in COPD patients in clinical trials and clinical practice. Scoring recommendations and steps for further research are discussed.

Impact and factors associated with nighttime and early morning symptoms among patients with chronic obstructive pulmonary disease.

Patients with chronic obstructive pulmonary disease (COPD) exhibit poor sleep quality and consider morning as the worst time of day for their symptoms. While work has been done to characterize nighttime (NT) and early morning (EM) symptoms in various populations, the impact and factors associated with NT/EM symptoms among patients with COPD in the United States is not well understood. Commercially insured patients aged ≥40 years with one or more medical claim for COPD and one or more pharmacy claim for COPD maintenance medication were identified from the HealthCore Integrated Research Database between September 1, 2010 and August 31, 2011. Consenting respondents were asked whether they had COPD symptoms on at least three nights or at least three mornings during the past week. Respondents were then either assigned to one of three symptom groups to complete the survey or excluded if their predefined group quota limit had been met. Survey completers completed the survey with questions about COPD symptoms and other commonly used patient-reported outcome measures. Respondents with NT/EM symptoms were asked about the frequency, severity, and impact of the symptoms on sleep, morning activities, and anxiety levels. Among respondents with symptoms, 73.1% of respondents with NT symptoms (N=376) and 83% of respondents with EM symptoms (N=506) experienced at least three distinct types of symptoms over the past week, with cough being the most frequently reported symptom. Approximately half of respondents with NT or EM symptoms perceived their symptoms as moderate to very severe, with a majority reporting their symptoms affected their NT sleep and morning activities, and more than half felt anxious due to their symptoms. Multinomial logistic regression showed COPD patients with both or either NT/EM symptoms were associated with poorer health status compared to those without. Improved disease management may reduce NT/EM symptoms and improve health status in patients with COPD.

Economic evaluation of aclidinium bromide in the management of moderate to severe COPD: an analysis over 5 years.

PURPOSE: Aclidinium bromide is a long-acting muscarinic antagonistic used in maintenance treatment of chronic obstructive pulmonary disease (COPD). A model-based health economic study evaluated the cost-effectiveness of aclidinium 400 µg bid as an alternative to tiotropium 18 µg od for this indication in the US. PATIENTS AND METHODS: PATIENT CHARACTERISTICS IN THIS MODEL REFLECT THOSE IN THE ACLIDINIUM CLINICAL STUDIES: age >40 years, stable moderate-to-severe COPD, current or ex-smokers (>10 pack-years), post-salbutamol forced expiratory volume in 1 second (FEV1) ≥30% and <80% of predicted normal value, and FEV1/forced vital capacity <70%. The model consists of five main health states indicating severity of COPD and the level of utility, resource use, and costs. Treatment efficacy over 5 years was modeled using FEV1% predicted; a network meta-analysis comparing aclidinium and tiotropium was used to estimate disease progression during the first 24 weeks, and results from the UPLIFT trial were used for time points after 24 weeks. Quality of life was assessed using utility scores in US patients from the UPLIFT trial. Cost-effectiveness was assessed as the incremental cost per quality-adjusted life year (QALY) gained. RESULTS: Over 5 years, QALYs were 3.50 for aclidinium versus 3.49 for tiotropium; life years accumulated were 4.52 for both. In this economic model, aclidinium versus tiotropium showed marginally fewer exacerbations (3.364 versus 3.390, respectively) and mean total health care costs (US$126,274 versus US$128,591, respectively). In all scenario analyses performed (discount factors of 0% and 6% for benefits and costs; time horizon of 1 year; mapping St George's Respiratory Questionnaire to European Quality of Life-5 Dimensions; excluding pharmacy costs, COPD-related cost only; cost of exacerbations; including ACCORD II trial in the network meta-analysis), aclidinium was associated with lower costs and marginally greater QALYs versus tiotropium. CONCLUSION: Aclidinium is potentially cost-effective compared with tiotropium for maintenance treatment of moderate-to-severe COPD.

Comparative efficacy of aclidinium versus glycopyrronium and tiotropium, as maintenance treatment of moderate to severe COPD patients: a systematic review and network meta-analysis.

BACKGROUND: Aclidinium bromide is a new long-acting muscarinic antagonist (LAMA) indicated for maintenance bronchodilator treatment of chronic obstructive pulmonary disease (COPD). The efficacy of aclidinium was compared with tiotropium and glycopyrronium, using a network meta-analysis (NMA) of randomized controlled trials (RCTs) in moderate-to-severe COPD patients. METHODS: A systematic review was performed to identify RCTs evaluating aclidinium 400 µg twice daily (BID), glycopyrronium 50 µg once daily (OD), tiotropium 18 µg OD, or tiotropium 5 µg OD in adults with moderate-to-severe COPD. The outcomes of interest were: trough forced expiratory volume in 1 second (FEV1); St George's Respiratory Questionnaire (SGRQ) total score and proportion of patients achieving ≥4 unit change; Transition Dyspnea Index (TDI) focal score and proportion of patients achieving ≥1 point change. The results were synthesized by means of a Bayesian NMA. RESULTS: Twenty-one studies (22,542 patients) were included: aclidinium 400 µg BID (three studies); tiotropium 5 µg OD (three studies); tiotropium 18 µg OD (13 studies); and glycopyrronium 50 µg OD (two studies). Regarding trough FEV1 at 24 weeks, aclidinium demonstrated comparable efficacy to tiotropium 5 µg (difference in change from baseline [CFB]), (0.02 L [95% credible interval CrI -0.05, 0.09]); tiotropium 18 µg (0.02 L [95% CrI -0.05, 0.08]); and glycopyrronium (0.00 L [95% CrI -0.07, 0.07]). Aclidinium resulted in higher improvement in SGRQ score at 24 weeks, compared to tiotropium 5 µg (difference in CFB, -2.44 [95% CrI -4.82, -0.05]); and comparable results to tiotropium 18 µg (-1.80 [95% CrI -4.52, 0.14]) and glycopyrronium (-1.52 [95% CrI -4.08, 1.03]). Improvements in TDI score were comparable for all treatments. CONCLUSION: Maintenance treatment with aclidinium 400 µg BID is expected to produce similar improvements in lung function, health-related quality of life, and dyspnea compared to tiotropium 5 µg OD; tiotropium 18 µg OD; and glycopyrronium 50 µg OD.