Edward S. Kimball

Decreasing incidence of type 2 diabetes mellitus in the United States, 2007–2012: Epidemiologic findings from a large US claims database

AIMS To explore epidemiological trends in type 2 diabetes mellitus (T2D) in the US between 2007 and 2012 using a large US claims database, with a particular focus on demographics, prevalence, newly-diagnosed cases, and comorbidities. METHODS Truven Health MarketScan® Databases were used to identify patients with claims evidence of T2D in the years 2007 and 2012. Newly-diagnosed T2D was characterized by an absence of any T2D claims or related drug claims for 6months preceding the index claim. Demographic and comorbidity characteristics of the prevalent and new-onset T2D groups were compared and analyzed descriptively for trends over time. RESULTS The overall prevalence of T2D remained stable from 2007 (1.24 million cases/15.07 million enrolled; 8.2%) to 2012 (2.04 million cases/24.52 million enrolled; 8.3%), while the percentage of newly-diagnosed cases fell dramatically from 2007 (152,252 cases; 1.1%) to 2012 (147,011 cases; 0.65%). The mean age of patients with prevalent T2D was similar in 2007 (60.6y) and 2012 (60.0y), while the mean age of newly-diagnosed T2D patients decreased by 3years from 2007 (57.7y) to 2012 (54.8y). Hypertension and hyperlipidemia were the most common comorbidities, evident in 50-75% of T2D patients, and increased markedly from 2007 to 2012 in both prevalent and new-onset T2D populations. Cardiovascular disease decreased slightly in prevalent (-0.9%) and new-onset (-2.8%) cases. CONCLUSIONS This large US health claims database analysis suggests stabilization in prevalence and declining incidence of T2D over a recent 5-year period, a downward shift in age at T2D diagnosis, but increases in several comorbidities.

Historical cohort analysis of treatment patterns for patients with type 2 diabetes initiating metformin monotherapy

Abstract Objective: To describe treatment regimen changes of patients with type 2 diabetes mellitus (T2DM) initiating metformin monotherapy, and assess factors associated with those changes 12 months post-initiation. Methods: Retrospective cohort analysis of medical, pharmacy and laboratory claims of 17,527 Medicare Advantage (MAPD) Humana members aged 18–89, who had ≥1 medical claim with primary diagnosis or ≥2 medical claims with secondary diagnosis of T2DM (ICD-9-CM code 250.x0 or 250.x2) who filled an initial prescription for metformin (GPI code 2725) between 1 January 2008 and 30 September 2011. The main outcome measure was change in metformin monotherapy during the 12 months following initiation. Factors associated with treatment changes during follow-up were examined using Cox proportional hazards regression models. Results: Fifty-nine percent of patients (mean age 69.6 years) remained on metformin monotherapy with no changes. Discontinuation was the most common treatment change (33%), followed by addition (5%), and switching (2%) to other antidiabetics. Of patients who discontinued treatment (median time to discontinuation = 90 days), 61% did not reinitiate any diabetic treatment during the follow-up period. Among patients who added or switched to other antidiabetics, sulfonylureas were the most common addition or replacement agent. Predictors of discontinuation were being female, Black or Hispanic, low-income subsidy eligible, having higher initial out-of-pocket metformin costs, or a diagnosis of depression. Discontinuation was less likely during follow-up if patients had higher pre-index pill burdens or records of a pre-index A1C screening test. A higher risk of discontinuation was observed for patients with low baseline A1C. One study limitation was that exact discontinuation dates could not be determined using claims. Conclusions: The findings suggest that gender, race, ethnicity, depression, and low income status were contributory factors to metformin discontinuation. More intensive monitoring and treatment adjustments may be warranted for patients newly initiated on metformin. This could ultimately improve morbidity, mortality, and costs associated with poor glycemic control.

Drug usage patterns and treatment costs in newly-diagnosed type 2 diabetes mellitus cases, 2007 vs 2012: findings from a large US healthcare claims database analysis.

Abstract Objective To explore trends in demographics, comorbidities, anti-diabetic drug usage, and healthcare utilization costs in patients with newly-diagnosed type 2 diabetes mellitus (T2DM) using a large US claims database. Methods For the years 2007 and 2012, Truven Health Marketscan Research Databases were used to identify adults with newly-diagnosed T2DM and continuous 12-month enrollment with prescription benefits. Variables examined included patient demographics, comorbidities, inpatient utilization patterns, healthcare costs (inpatient and outpatient), drug costs, and diabetes drug claim patterns. Results Despite an increase in the overall database population between 2007–2012, the incidence of newly-diagnosed T2DM decreased from 1.1% (2007) to 0.65% (2012). Hyperlipidemia and hypertension were the most common comorbidities and increased in prevalence from 2007 to 2012. In 2007, 48.3% of newly-diagnosed T2DM patients had no claims for diabetes medications, compared with 36.2% of patients in 2012. The use of a single oral anti-diabetic drug (OAD) was the most common diabetes medication-related claim (46.2% of patients in 2007; 56.7% of patients in 2012). Among OAD monotherapy users, metformin was the most commonly used and increased from 2007 (74.7% of OAD monotherapy users) to 2012 (90.8%). Decreases were observed for sulfonylureas (14.1% to 6.2%) and thiazolidinediones (7.3% to 0.6%). Insulin, predominantly basal insulin, was used by 3.9% of patients in 2007 and 5.3% of patients in 2012. Mean total annual healthcare costs increased from

Coverage of insulin delivery devices and basal insulin analogs by US managed care organizations.

13,744 in 2007 to

Treatment patterns and clinical characteristics of patients with type 2 diabetes mellitus according to body mass index: findings from an electronic medical records database

15,175 in 2012, driven largely by outpatient services, although costs in all individual categories of healthcare services (inpatient and outpatient) increased. Conversely, total drug costs per patient were lower in 2012 compared with 2007. Conclusions Despite a drop in the rate of newly-diagnosed T2DM from 2007 to 2012 in the US, increased total medical costs and comorbidities per individual patient suggest that the clinical and economic trends for T2DM are not declining.

Longitudinal Changes in Medical Services and Related Costs in a Single Cohort of Patients Newly Diagnosed With Type 2 Diabetes, 2006 to 2012.

Abstract Objective: The perception in the US is that insulin formulations prescribed for type 1 and type 2 diabetes and delivered via insulin pens are more costly to patients than the same or similar products provided in vials, and that basal insulin analogs offered either in pens or vials are likewise more costly to patients than human insulin formulations. This study compares levels of coverage and copays by private and Medicare Part D plans for insulin pens and vials containing basal insulin analogs and for NPH formulations in vials. Methods: A commercially available formulary database (Access Point, Pinsonault Associates; updated quarterly) was analyzed as of January 2010 for private insurance plans and as of March 2010 for Medicare Part D plans. Analyses were performed for Tier-level coverage and copays per prescription for basal insulin analogs in pens and vials, and NPH in vials. Results: Basal insulin analogs in pens were covered by >91% of private and Part D plans. NPH coverage was reported by >92% of private plans and 69–95% of Part D plans, depending on brand. Irrespective of delivery mode, copays in the majority of private plans for basal insulin analogs and NPH were in the >

Trends in comorbidity burden and treatment patterns in type 2 diabetes: Longitudinal data from a US cohort from 2006 to 2014

10–35 range. Copays were higher in Part D plans, with the majority of plans and subscribers in a >

Effects of Age on Glycemic Control in Patients With Type 2 Diabetes Treated with Insulin Detemir: A Post-Hoc Analysis of the PREDICTIVE™ 303 Study

35–50 range. Prior authorization was required by <10% of insurance plans for insulin analog pen prescriptions, and <3% of plans for insulin analog or NPH prescriptions in vials. Limitations: This analysis was descriptive, copay stratification was not based on a statistical model but on copay ranges typically used by the plans, and there were no direct correlations performed on the numbers of subscribers per plan vs copay or Tier level. Conclusion: These results counter the widely held perception that insurance coverage is less extensive for insulin pens vs vials. Medicare Part D plans often had higher copay requirements than private plans for the same product at the same copay Tier.

BODY MASS INDEX IN TYPE 2 DIABETES

Objective This study evaluated relationships between glycaemic control, body mass index (BMI), comorbidities and pharmacological treatment in patients with type 2 diabetes mellitus (T2D). Research design and methods This was a retrospective, cross-sectional analysis of Quintiles electronic medical records research data (study period 1 October 2013–30 September 2014). Eligibility included age ≥18 years, T2D diagnosis, and at least one available BMI measurement. Results The study included 626 386 patients (mean age, 63.8 year; 51.3% female; 78.5% white; 62.6%, BMI ≥30 kg/m2). A1c data were available for 414 266 patients. The proportion of patients with good glycaemic control (A1c ≤6.5) decreased as BMI category increased, ranging from 40.1% of patients with BMI <30% to 30.1% of patients with BMI ≥40. The proportions of patients with poor glycaemic control (A1c >8% and A1c ≥9%) increased with increasing BMI category. Oral antidiabetic drugs (OAD) were the most frequently used (54.4% of patients with A1c values). Among patients using insulin-based therapy, 50% had an A1c ≥8% and 29% had an A1c ≥9% regardless of concomitant OAD or glucagon-like peptide 1 receptor agonist use. Among patients using three or more OADs, 34.3% and 16.1% had A1c values ≥8% and ≥9%, respectively. There was no common trend observed for changes in the proportion of patients with T2D-related comorbidities according to BMI category. The most notable trend was a 7.6% net increase in the percentage of patients with hypertension from BMI <30 to BMI ≥40. Conclusions This large dataset provides evidence that roughly one out of four patients with T2D is not well controlled, and the prevalence of poor glycaemic control increases as BMI increases.

Comparison of Insulin And Non-Insulin Treatment Modification Within 90 Days of An Hba1c Greater Than or Equal To 9% On Diabetes Progression Rates In A Medicare Advantage Cohort Over 4 Years

PURPOSE Documenting diabetes treatment patterns and associated costs over time is an important step in gauging the medical and economic impact of current treatment guidelines in a real-world setting. This study was designed to assess changes in medication treatment patterns, health care costs, and comorbidities over a 6-year period after a new diagnosis of type 2 diabetes mellitus (T2DM). This analysis is the first of its kind to observe, over time, a single US cohort of patients newly diagnosed with T2DM. METHODS This study was a longitudinal assessment of changes in medical services and comorbidities for a single cohort (N = 35,017) of adults newly diagnosed with T2DM in 2006 using claims data from Truven Health Analytics MarketScan(®) databases. Prevalence of diabetes-related comorbidities and utilization/costs of inpatient/outpatient services and medications were analyzed annually for the index (diagnosis) year (Y1) through year 6 (Y6) postindex. Costs were adjusted to 2012 dollars. FINDINGS From Y1 to Y6, increased prevalence was noted for several T2DM-associated comorbidities: cerebrovascular disease (13%-21%), peripheral vascular disease (3%-10%), nephropathy (3%-13%), and retinopathy (4%-14%). All-cause costs of inpatient and outpatient services and medications were analyzed for the index year (Y1) through Y6 postindex (adjusted to 2012 dollars). Total health care utilization costs (services plus drugs) increased by 33.3% from Y1 (