Characteristics Relating to Adherence and Persistence to Basal Insulin Regimens Among Elderly Insulin-Naïve Patients with Type 2 Diabetes: Pre-Filled Pens versus Vials/Syringes.

INTRODUCTION: Previous studies have found higher rates of adherence in patients with type 2 diabetes mellitus (T2DM) using insulin pens compared to vial and syringe administration; however, little evidence is available to support this observation in elderly patients. METHODS: This was a retrospective claims database analysis of a predominantly elderly Medicare Advantage with Prescription Drug (MAPD) insurance population consisting of 3172 insulin-naïve patients with T2DM who initiated basal insulin using pre-filled pens or vial and syringe ('vial'). The index date was defined by the first pharmacy claim for basal insulin. Adherence, measured as proportion of days covered (PDC) and medication possession ratio (MPR), and persistence were evaluated in a 12-month follow-up period using an adjusted days' supply. Multivariate regression analyses and a Cox proportional hazards model were used to identify characteristics associated with adherence and non-persistence, respectively, and compare findings between the pen and vial groups. RESULTS: The pen cohort was slightly younger than the vial cohort (69.4 vs. 70.1 years, respectively; P = 0.0338). Similar proportions of male patients (53.3% vs. 56.8%; P = 0.0529) occurred in both cohorts, and lower Deyo-Charlson Comorbidity Index (4.4 vs. 5.0; P < 0.0001) was found for the pen cohort. Adjusted mean PDC was significantly higher in the pen cohort than the vial cohort (0.67 vs. 0.50; P < 0.001), as was mean MPR (0.75 vs. 0.57; P < 0.0001). Adjusted odds for adherence (PDC ≥ 80%) showed a positive association with use of an insulin pen (odds ratio = 2.19, 95% CI: 1.86-2.59). The adjusted risk of non-persistence (discontinuation) was significantly lower (58%) in the pen cohort relative to the vial cohort (hazard ratio = 0.42, 95% CI: 0.38-0.45). Key limitations include assumptions related to accuracy and comprehensiveness of claims data, and specifically days' supply data used to measure insulin adherence. CONCLUSION: These findings suggest that pen devices improved insulin therapy adherence in a primarily elderly MAPD population with T2DM. FUNDING: Novo Nordisk Pharmaceuticals, Inc.

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

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.

Relationship of diabetes complications severity to healthcare utilization and costs among Medicare Advantage beneficiaries.

OBJECTIVES: This study evaluated the usefulness of the Diabetes Complications Severity Index (DCSI) in assessing healthcare resource utilization (HRU) and costs among Medicare Advantage plan members diagnosed with type 2 diabetes mellitus (T2DM). STUDY DESIGN: A retrospective cohort study of medical and pharmacy claims of 333,576 Medicare members aged 18 to 89 years with ≥1 medical claim with primary diagnosis or ≥2 medical claims with secondary diagnosis, of T2DM (International Classification of Diseases, Ninth Revision, Clinical Modification code 250.x0 or 250.x2) during the period of January 1, 2010, to December 31, 2011. METHODS: DCSI was assessed concurrently with HRU and healthcare costs (total, medical, and pharmacy). The cohort was subdivided into 6 DCSI groups: DCSI = 0 (no complications) through DCSI = 5+ (≥5). Associations of complication severity with HRU and costs of care were summarized using regression models. RESULTS: A 1-point increase in DCSI was associated with a $2744 increase in total costs (a $2480 increase in medical costs plus a $264 increase in pharmacy costs). Increasing DCSI was associated with greater use of inpatient and emergency department (ED) services. Among the higher complications subgroups, there were greater representations of older patients, men, and cases of depressive disorders and hypoglycemia. CONCLUSIONS: DCSI is useful for identifying Medicare plan members with T2DM who should be targeted for clinical programs. HRU and costs increased with DCSI severity. Increases in high-cost HRU, driven by inpatient and ED visits, suggest that preventing or delaying utilization of these services are essential to driving down costs in the T2DM population. Furthermore, high rates of depression and hypoglycemia warrant early screening and necessary treatment to improve patient outcomes.

Antidiabetic treatment patterns in a medicare advantage population in the United States.

BACKGROUND: Published guidelines for treatment of type 2 diabetes mellitus (T2DM) agree on initial pharmacotherapy. However, few specific recommendations on second-line agents are provided. OBJECTIVE: The objective of this study was to describe antidiabetic treatment patterns in Medicare Advantage patients with T2DM within 6 months of measurement of the glycosylated hemoglobin (HbA1c) level. RESEARCH DESIGN: This retrospective cross-sectional study utilized medical, pharmacy, and laboratory claims from a large Medicare Advantage with Prescription Drug (MAPD) coverage payer. MAPD members between 65 and 89 years old identified as having T2DM between 2009 and 2011 were eligible for inclusion. A 12-month baseline period before the first HbA1c value (index date) was evaluated for demographic and clinical differences. Antidiabetic therapy was evaluated for 6 months post-index. The study population was stratified into three cohorts based on index HbA1c value: controlled (<8%, 64 mmoL/mol), uncontrolled (≥ 8%, 64 mmoL/mol and <10%, 86 mmoL/mol), and severely uncontrolled (≥ 10%, 86 mmoL/mol). RESULTS: Despite elevated HbA1c values (≥ 8%, 64 mmoL/mol), 7-8% of patients did not receive antidiabetic therapy during the post-index period. Metformin and sulfonylureas were the oral antidiabetics (OADs) most frequently used as monotherapy. The majority of patients on combination therapy were on two or more OADs and higher injectable use was observed in the severely uncontrolled cohort. Metformin was included in >60% of the combination regimens with metformin + sulfonylurea being the most common. CONCLUSION: This study suggests suboptimal treatment of those not in glycemic control (HbA1c ≥ 8%, 64 mmoL/mol). Many patients classified as severely uncontrolled based on HbA1c received only monotherapy. Opportunities exist for treatment modification within this population to achieve tighter glycemic control.

Racial/ethnic and gender differences in severity of diabetes-related complications, health care resource use, and costs in a Medicare population.

This retrospective cohort study evaluated associations of race/ethnicity and gender with outcomes of diabetes complications severity, health care resource utilization (HRU), and costs among Medicare Advantage health plan members with type 2 diabetes (T2DM). Medical and pharmacy claims were evaluated for 333,576 members continuously enrolled from January 1, 2010, to December 31, 2011, aged 18-89 years, with ≥1 primary diagnosis medical claim, or ≥2 claims with a secondary diagnosis of T2DM (International Classification of Diseases, Ninth Revision, Clinical Modification code 250.x0 or 250.x2). Complications severity assessment by Diabetes Complications Severity Index ranged from 0 (no complications) to 5+. Mean (SD) all-cause medical, pharmacy, and total costs were reported alongside all-cause HRU by place of service (outpatient, inpatient, emergency room [ER]) and number of visits. Multivariate regression showed being Hispanic, black, or male was associated with higher prevalence of more severe complications. This racial/ethnic disparity was more pronounced among females, among whom odds of having more severe complications were higher for Hispanic and black as compared to white females [(Hispanic vs. white odds ratio [OR], 1.40; 95% confidence interval [CI], 1.32-1.48), and (black vs. white OR, 1.22; 95% CI, 1.19-1.25)]. Regardless of gender, blacks had more ER visits than whites. White females incurred the highest total health care costs (mean annual costs: $13,086; 95% CI, $12,935-$13,240, vs. Hispanic females: $10,732; 95% CI, $10,406-$11,067). These effects held regardless of other demographic and clinical attributes. These findings suggest racial/ethnic and gender differences exist in certain T2DM clinical and economic outcomes.