A real-world comparison of cardiovascular, medical and costs outcomes in new users of SGLT2 inhibitors versus GLP-1 agonists.

AIMS: To compare SGLT2 inhibitors and GLP-1 agonists on cardiovascular (CV) outcomes, treatment persistence/discontinuation, healthcare utilization and costs. METHODS: This retrospective cohort study utilized medical and pharmacy claims to identify new SGLT2 inhibitor or GLP-1 agonist users from January 2015 to June 2017. A total of 5,507 patients were included in each treatment group after 1:1 propensity score matching. Cox proportional hazards models were used to compare CV outcomes and treatment discontinuation. Healthcare utilization and costs were compared using Wilcoxon signed rank test. RESULTS: No differences in the primary composite CV outcome or secondary CV outcome were observed. Patients using GLP-1 agonists were more likely to discontinue treatment (hazard ratio 1.15, 95% confidence interval 1.10-1.21) and more likely to have an inpatient hospitalization (14.4% vs. 11.9%, P < 0.001) or emergency department visit (27.4% vs. 23.5%, P < 0.001) compared to patients on SGLT2 inhibitors. The average per-person per-month cost difference was +$179 for total cost (P < 0.001), +$70 for medical cost (P < 0.001) and +$108 for pharmacy cost (P < 0.001) for GLP-1 agonists compared to SGLT2 inhibitors. CONCLUSIONS: Differences in composite CV outcomes were not established. However, other findings that favored SGLT2 inhibitors should be weighed against the known risks associated with this therapeutic class.

Treatment Patterns and Characteristics of Individuals Initiating High-Dose Insulin for Type 2 Diabetes Mellitus.

BACKGROUND: Few studies have examined patient characteristics and treatment patterns of high-dose insulin therapy (> 200 units/day) among patients with type 2 diabetes mellitus (T2DM). OBJECTIVE: To understand patient characteristics, dosing, adherence, and persistence related to high-dose insulin therapy. METHODS: This was a retrospective observational study that used administrative claims from a large national health plan. Patients were identified who had been diagnosed with T2DM and who were aged 18-89 years, enrolled in a commercial or Medicare Advantage Prescription Drug plan, newly initiated on a total daily dose (TDD) > 200 units of insulin between January 2011 and August 2015. Patients were required to be enrolled 6 months before and 12 months after the index date. Patients were categorized to Regimen-100 if treated with U-100 insulin only or Regimen-500 if treated with U-500R with or without U-100. Baseline demographic and clinical characteristics were evaluated. An adjustment factor for the days supply was calculated as the ratio of median time between insulin claims, and median pharmacy reported days supply for each insulin prescription. Adjusted days supply, quantity, and concentration were used to calculate TDD for each quarter after the index date. Adherence was measured as the proportion of days covered (PDC) for each regimen. Persistence was measured in 2 ways: the percentage of patients remaining on index medications in each quarter and the proportion of patients who maintained TDD > 200 units during all 4 quarters of the 12-month post-index period. RESULTS: We identified 2,339 patients newly titrated up to TDD > 200 units on either Regimen-100 (2,062, 88.2%) or Regimen-500 (277, 11.8%). Patients on Regimen-500 were slightly younger with higher prevalence of comorbidities. The mean TDD (SD) for Regimen-100 decreased from 228.6 (36.0) units during the first quarter to 194.2 (181.4) units during the last quarter. The mean TDD (SD) for Regimen-500 increased from 294.2 (102.2) units in the first quarter to 304.8 (281.6) units in last quarter. The average adherence to the high-dose insulin regimen was 68.2% (30.7; median 72.6%) for the Regimen-100 cohort and 75.5% (27.0; median 85.2%) for the Regimen-500 cohort. In the Regimen-100 and Regimen-500 cohorts, 45.3% and 55.2% had a PDC ≥ 80%, respectively. Only 23.0% and 51.6% of patients maintained TDD > 200 units for the Regimen-100 and Regimen-500 cohorts, respectively, throughout the 4 quarters after the index date. CONCLUSIONS: We observed that many patients did not maintain high-dose insulin use over time, especially those on standard U-100 insulin only. This dosing pattern appears to reflect the differences in patient characteristics, insulin needs, and adherence/persistence behavior between those on Regimen-100 and those on Regimen-500. DISCLOSURES: This study was supported by funding from Eli Lilly and Company to Humana as a collaborative research project involving employees of both companies. Chen, Brown, Fan, Taylor, and He are employees of Eli Lilly and Company. Nair and Meah are employees of Humana, which received funding to complete this research. Siadaty was an employee of Humana at the time of this study.

Real-world Effectiveness of Liraglutide vs. Sitagliptin Among Older Patients with Type 2 Diabetes Enrolled in a Medicare Advantage Prescription Drug Plan: A Retrospective Observational Study.

INTRODUCTION: Liraglutide and sitagliptin were compared on glycemic control and all-cause healthcare costs over a 1-year period among older adults with type 2 diabetes (65-89 years) enrolled in a national Medicare Advantage Prescription Drug health plan. METHODS: This was a retrospective study in which the index date was the first prescription fill for liraglutide or sitagliptin between 25 January 2010 and 31 December 2014. Post-index treatment persistence and glycosylated hemoglobin (HbA1c) at baseline and 1 year (± 90 days) post-index date were required. Patients were excluded if their record included use of insulin during the baseline period. Inverse probability of treatment weighting using stabilized weights was employed with final covariate adjusted regression modeling to estimate the primary outcome (mean change in HbA1c) and secondary outcomes (achieving glycemic goal and costs), each at 1-year post-index date. RESULTS: Overall, 3056 patients met the selection criteria, of whom 218 filled prescriptions for liraglutide and 2838 for sitagliptin. Adjusted mean change in HbA1c at 1 year post-index was - 0.42 with liraglutide versus - 0.12 with sitagliptin (P = 0.0012). Adjusted odds of achieving the treatment goals of HbA1c < 7% and achieving an HbA1c reduction of ≥ 1% were higher for  those on liraglutide than for those on sitagliptin (1.68, 95% confidence interval [CI] 1.25-2.24 and 1.76, 95% CI 1.31-2.36), respectively. Total healthcare costs in those achieving an HbA1c of < 7% were not significantly different between treatment groups but were higher within the liraglutide group for those achieving an HbA1c < 8%. CONCLUSIONS: When compared to sitagliptin, liraglutide was associated with greater achievement of an HbA1c < 7% over a 1-year period in an older population. This finding was not associated with a statistically significant increase in all-cause total healthcare costs, although costs were slightly higher in the liraglutide group than in the sitagliptin group.

A Retrospective Database Study Comparing Diabetes-Related Medication Adherence and Health Outcomes for Mail-Order Versus Community Pharmacy.

BACKGROUND: Adherence to oral antihyperglycemic agents (AHAs) is important for managing blood glucose levels and avoiding hospitalizations or diabetes complications. Previous studies have found that use of mail-order pharmacy dispensing channels results in greater adherence than use of community pharmacies, but the link between use of mail-order pharmacies and improved clinical outcomes has not been established. OBJECTIVE: To compare the effect of mail-order and community pharmacy use on adherence to oral AHAs, hemoglobin A1c (A1c) level, and glycemic control, as well as emergency department (ED) and inpatient hospital use. METHODS: This retrospective cohort study of administrative claims data from January 1, 2008, to December 31, 2016, included patients with Medicare Advantage Prescription Drug plan coverage with ≥ 2 claims for the same oral AHA and a diagnosis of type 2 diabetes mellitus (T2DM). Patients were indexed to the start of the most advanced oral AHA identified to begin study observations at the start of a new treatment and assigned to mail-order or community pharmacy cohorts based on which channel dispensed ≥ 80% of their oral AHA claims; all others were excluded. Mail-order and community pharmacy patients were 1:1 propensity score matched. Matched cohorts were compared on proportion of days covered (PDC), adherence (PDC ≥ 0.8), A1c level, glycemic control, and ED and inpatient use for measurement periods of 12, 24, 36, and 48 months post-index. RESULTS: 19,307 mail-order and 19,307 community pharmacy users were matched. PDC was higher for mail-order pharmacy users at 12 months (0.93 vs. 0.82, P < 0.001) and sustainable through 48 months (0.87 vs. 0.77, P < 0.001). Adherence was also greater for mail-order pharmacy patients through 12 months (86% vs. 68%, P < 0.001) and sustainable through 48 months (78% vs. 62%, P < 0.001). Glycemic control as A1c < 7% was not significantly different, but control as A1c < 8% was greater for mail-order pharmacy users at 12 months (91% vs. 89%, P = 0.006) and was greater through 36 months (93% vs. 89%, P = 0.043). Effects on A1c level were not evident. Mail-order pharmacy users were less likely to have an ED visit within 12 months (26% vs. 28%, P < 0.0001), and the difference was observed through 36 months (50% vs. 54%, P < 0.0001). Similarly, fewer mail-order pharmacy users had an inpatient hospitalization within 12 months (17% vs. 19%, P < 0.0001), and the difference was observed through 48 months (43% vs. 47%, P = 0.009). CONCLUSIONS: The results of the study demonstrate a benefit to patients who use mail-order pharmacies for chronic medications to treat T2DM. The study identified greater glycemic control, lower ED use, and lower hospitalization among individuals using mail-order pharmacies. These positive outcomes were evident in the near term and sustained over time. DISCLOSURES: This study received no outside funding but was sponsored by Humana through regular employment activities by Schwab, Racsa, and Worley, who are employed by Humana Healthcare Research (formerly Comprehensive Health Insights). This study found benefits related to using mail-order versus community pharmacies for dispensing antihyperglycemic agents in the treatment of type 2 diabetes. Humana owns mail-order pharmacies under the Humana Pharmacy subsidiary. Mourer and Meah are paid employees of Humana Pharmacy Solutions. Rascati is employed by the University of Texas College of Pharmacy at Austin.

Adherence, Persistence, and Health Care Costs for Patients Receiving Dipeptidyl Peptidase-4 Inhibitors.

BACKGROUND: The dipeptidyl peptidase-4 (DPP-4) inhibitors are among the newer, yet more established, classes of diabetes medications. OBJECTIVE: To compare adherence, persistence, and health care costs among patients taking DPP-4 inhibitors. METHODS: Claims were extracted from Humana Medicare Advantage Prescription Drug (MAPD) or commercial plans for patients aged > 18 years with ≥ 1 prescription filled for a DPP-4 inhibitor between July 1, 2011, and March 31, 2013. The first prescription claim for a DPP-4 inhibitor established the index date and index medication; 12-month pre-index and post-index data were analyzed. The Diabetes Complications Severity Index (DCSI) was used to assess a level of baseline diabetes-related comorbidities. Adherence (proportion of days covered [PDC] ≥ 80%) and persistence (< 31-day gap) measures were compared before and after, adjusting for DCSI, pre-index insulin, age, and gender. Post-index costs (in 2013 U.S. dollars) were compared using general linear modeling (GLM) to adjust for pre-index costs, DCSI, pre-index insulin, age, and gender. RESULTS: Based on study criteria, 22,860 patients with MAPD coverage (17,292 sitagliptin, 4,282 saxagliptin, and 1,286 linagliptin) and 3,229 patients with commercial coverage (2,368 sitagliptin, 643 saxagliptin, and 218 linagliptin) were included. For MAPD patients, the mean age was 70-72 years, and females represented 50%-52% of patients. For commercial patients, mean age was 55-56 years, and females represented 44% of patients. Clinical indicators for patients on linagliptin showed a higher comorbidity level than sitagliptin or saxagliptin cohorts (MAPD DCSI 3.0 vs 2.4 and 2.2, P < 0.001; commercial DCSI 1.2 vs. 0.9 and 0.9, P < 0.001); a higher use of pre-index insulin (MAPD 22% vs. 15% and 14%, P < 0.001; commercial 18% vs. 11% and 10%, P = 0.003); and higher mean pre-index costs (MAPD $14,448 vs. $11,818 and $10,399, P < 0.001; commercial $13,868 vs. $9,357 and $8,223, P = 0.016). For the MAPD cohort, the unadjusted PDC was lower for linagliptin patients (67%) compared with saxagliptin (72%) or sitagliptin (72%) patients (P < 0.001). Significant differences were still seen when adjusted for covariates. Linagliptin patients were more likely to be nonpersistent (73%) than those on saxagliptin (65%) or sitagliptin (67%; P < 0.01 for adjusted and unadjusted comparisons). For the commercial population, there were no significant differences in mean PDC between the 3 groups (linagliptin 70%, saxagliptin 72%, and sitagliptin 74%; P = 0.096). Dichotomized comparisons of nonpersistence were significantly different (linagliptin 65%, saxagliptin 62%, and sitagliptin 57%; P = 0.010), although upon adjustment using a Cox proportional hazard model, no significant differences were found. When controlling for other factors, post-index adjusted health care costs were similar between the medication cohorts (MAPD: sitagliptin = $13,913, saxagliptin = $13,651, and linagliptin = $13,859; commercial: sitagliptin = $11,677, saxagliptin = $12,059, and linagliptin = $11,163; all P > 0.25). CONCLUSIONS: For MAPD and commercial populations, baseline patient demographics were similar between the 3 DPP-4 inhibitor groups, but the linagliptin group may have had more complex patients (higher pre-index costs, higher DCSI, and more use of insulin). For the MAPD population, patients on linagliptin were less adherent and persistent than patients taking sitagliptin or saxagliptin for all unadjusted and adjusted comparisons. For the commercial population, which was notably smaller, these differences were in the same direction, but not all were statistically significant. When controlling for baseline factors, 12-month post-index direct medical health care costs were similar between index DPP-4 inhibitors. DISCLOSURES: No external funding was provided for this research. The project was done as part of internal work by Humana employees. Rascati received no compensation. None of the authors have any financial disclosures or conflicts of interests to report. Worley and Everhart are employees of Comprehensive Health Insights, a subsidiary of Humana, and Meah is an employee of Humana. Discussion of the adherence and persistence data was presented as a poster at the Academy of Managed Care Pharmacy Nexus Conference, October 2015. Cost data were presented as a poster at the International Society for Pharmacoeconomics and Outcomes Research 18th Annual European Congress, November 2015. Study concept and design were contributed by Rascati, Worley, and Meah, along with Everhart. Rascati took the lead in data collection, assisted by Meah, and data interpretation was performed by all the authors. The manuscript was written primarily by Rascati, along with Worley, Everhart, and Meah, and revised by Rascati, Everhart, and Worley, with assistance from Meah.

Comparative Effectiveness of Rapid-Acting Insulins in Adults with Diabetes.

BACKGROUND: Although there are a variety of insulin products and new delivery modalities available, the absence of direct clinical and economic comparisons can make treatment planning and formulary decision making difficult. Direct comparisons between insulin aspart and insulin lispro from a large heterogeneous population are not available. OBJECTIVE: To assess differences in clinical outcomes, medication adherence, utilization, and total health care costs between aspart and lispro and vial versus pen modalities for administering these short-acting insulin analogs. METHODS: This retrospective cohort study used administrative claims data from the Humana Research Database to identify people with type 1 or type 2 diabetes and Medicare or commercial insurance (with medical and pharmacy benefits) who newly initiated rapid-acting insulin between January 1, 2008, and December 31, 2013, and were continuously enrolled during the 12-month baseline and 12-month follow-up periods. Generalized linear models were used to assess differences in costs and utilization. Logistic regression models measured the likelihood of having a hypoglycemic event, worsening diabetes complications, or a change in glycated hemoglobin (A1c). RESULTS: 8,189 patients included in the study were grouped by rapid-acting insulin product (aspart, n = 5,364, and lispro, n = 2,566) and modality (vial, n = 6,135, and pen, n = 2,054). There were no significant differences in the percentage of patients with a hypoglycemic event, new or worsening diabetes complications, or change in A1c, and there were no significant differences in adjusted total health care, medical and pharmacy costs, or emergency department visits between any of the product or modality comparisons. There was a significant difference in mean annual inpatient stays between lispro and aspart (adjusted mean = 2.24, 95% CI = 0.73-6.69, and adjusted mean = 2.65, 95% CI = 0.86-7.86, respectively; P < 0.001) and pen and vial cohorts (adjusted mean = 1.74, 95% CI = 0.56-4.99, and adjusted mean = 3.05, 95% CI = 1.01-9.08, respectively; P < 0.001). Adherence was similar for the lispro and aspart cohorts. Adherence was higher in the pen cohort (as measured by medication possession ratio ≥80%) compared with the vial cohort (adjusted odds ratio = 1.29, 95% CI = 1.12-1.50). CONCLUSIONS: This study provides a comprehensive assessment of outcomes and costs between 2 commonly used rapid-acting insulin products. Overall, there was little differentiation between products, although adherence improved significantly with pen devices. These findings may simplify decisions related to formulary options and choice of therapy. DISCLOSURES: No outside funding supported this study. Racsa and Ellis are employees of Comprehensive Health Insights, a subsidiary of Humana, and Saverno was employed with Comprehensive Health Insights at the time of this study. Meah is an employee of, and owns stock in, Humana. The authors have no financial disclosures or potential conflicts of interest to report. All authors contributed equally to study concept and design, data interpretation, and manuscript preparation. Racsa collected the data.

A Historical Retrospective Analysis of the Impact of Diabetes Quality Measure Attainment on Outcomes in Medicare Advantage Members.

The objective of this study was to assess achievement of 4 diabetes mellitus (DM)-related quality measures (QMs) and examine the relationship between QM attainment, concurrent health care costs, and DM complications over 1 year by conducting a retrospective analysis of claims data for Medicare Advantage Prescription Drug plan members with DM. Claims and member-level quality data were used to assess QM achievement, concurrent health care costs, and presence of new or worsening DM complications during the QM year. Multivariable regression models were used to examine the relationship between QM achievement and outcome measures controlling for potentially confounding baseline characteristics. QM attainment rates ranged from 54.2% for DM Treatment measure to 83.4% for Cholesterol Screening measure. Odds of new or worsening complications were greater for members who did not meet the Blood Sugar Controlled performance goal (odds ratio [OR]: 1.12, P < 0.001), DM Treatment goal (OR: 1.40, P < 0.001), or Cholesterol Screening goal (OR: 1.32, P < 0.001). Failure to attain the DM Medication Adherence goal was associated with lower odds of new or worsening complications (OR: 0.94, P < 0.001). In the regression models, all-cause health care costs were greater for members who achieved the Blood Sugar Controlled quality goal (P < 0.001), but lower for members who attained DM Treatment (P < 0.001) and low-density lipoprotein Cholesterol Screening goals (P < 0.001). There was no statistically significant relationship between attaining the DM Medication Adherence measure and all-cause costs. Achievement rates for individual QMs varied across the study population and relationships between QM attainment, health care costs, and DM complications during the QM measurement year were mixed.

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.

Type 2 Diabetes Mellitus Patients' Healthcare Costs Related to Inpatient Hospitalizations: A Retrospective Administrative Claims Database Study.

INTRODUCTION: Diabetes-related healthcare costs are increasing in the United States, with inpatient hospitalization the largest component of medical expenditures. The aims of this study were to characterize hospitalized type 2 diabetes mellitus (T2DM) patients, understand the relationship between hospitalization and healthcare costs, and explore treatment modification after inpatient hospitalization. METHODS: A retrospective cohort analysis of Humana Medicare Advantage and commercial members with T2DM was conducted. T2DM members were identified and assigned to three groups: (1) inpatient hospitalization (IPH) without a 30-day readmit (IPH group); (2) IPH with a 30-day readmission (IPH readmission group); and, (3) matched non-IPH group. Demographics, clinical characteristics, comorbidities and healthcare costs were measured based on enrollment data and claims. Descriptive statistics were used and the relationship between IPH and costs was assessed using generalized linear models. RESULTS: A total of 15,555 IPH patients, 1757 IPH readmission patients, and 17,312 matched non-IPH patients were included in the study. The IPH readmission group had the highest adjusted mean all-cause total costs ($76,806), followed by the IPH group ($42,011), and the non-IPH group ($9624). A similar trend was observed for adjusted all-cause mean medical and pharmacy costs. DM-related total healthcare costs were highest for the IPH readmission group ($13,714), followed by the IPH group ($7477), and non-IPH group ($1620). While overall therapy modification (discontinuation, addition, switch) was low, T2DM patients with an IPH (with or without a readmission) had greater rates of therapy modification relative to the non-IPH patients. CONCLUSION: Adjusted all-cause and DM-related total costs were greatest for IPH readmission patients. Rates of treatment modification within 10 days of discharge after IPH were generally low. Identifying T2DM patients at high risk of readmission and employing methods to decrease that risk during the index hospitalization could have a significant impact on health system costs. FUNDING: Novo Nordisk.

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.