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.

Ethnic differences in psychological outcomes among people with diabetes: USA results from the second Diabetes Attitudes, Wishes, and Needs (DAWN2) study.

OBJECTIVE: To assess differences in psychological outcomes as well as risk and protective factors for these outcomes among several USA ethnic groups and identify correlates of these psychological outcomes among adults with diabetes in the second Diabetes Attitudes, Wishes and Needs (DAWN2 * ) study. RESEARCH DESIGN AND METHODS: The core USA DAWN2 sample was supplemented by independent samples of specific ethnic minority groups, yielding a total of 447 White non-Hispanics, 241 African Americans, 194 Hispanics, and 173 Chinese Americans (n = 1055). Multivariate analysis examined ethnic differences in psychological outcomes and risk/protective factors (disease, demographic and socioeconomic factors, health status and healthcare access/utilization, subjective burden of diabetes and social support/burden). Separate analyses were performed on each group to determine whether risk/protective factors differed across ethnic groups. MAIN OUTCOME MEASURES: Psychological outcomes include well-being, quality of life, impact of diabetes on life domains, diabetes distress, and diabetes empowerment. CLINICAL TRIAL REGISTRATION: NCT01507116. RESULTS: Ethnic minorities tended to have better psychological outcomes than White non-Hispanics, although their diabetes distress was higher. Levels of most risk and protective factors differed significantly across ethnic groups; adjustment for these factors reduced ethnic group differences in psychological outcomes. Health status and modifiable diabetes-specific risk/protective factors (healthcare access/utilization, subjective diabetes burden, social support/burden) had strong associations with psychological outcomes, especially diabetes distress and empowerment. Numerous interactions between ethnicity and other correlates of psychological outcomes suggest that ethnic groups are differentially sensitive to various risk/protective factors. Potential limitations are the sample sizes and representativeness. CONCLUSIONS: Ethnic groups differ in their psychological outcomes. The risk/protective factors for psychological outcomes differ across ethnic groups and different ethnic groups are more/less sensitive to their influence. These findings can aid the development of strategies to overcome the most prominent and influential psychosocial barriers to optimal diabetes care within each ethnic group.

Insights on practice variations in the management of lymphoma and leukemia.

Clinical practice guidelines are systematically developed statements designed to assist practitioners in making decisions about appropriate healthcare for specific clinical circumstances. Their successful implementation should improve quality of care by decreasing inappropriate variation and expediting the application of effective advances to everyday practice. Despite wide promulgation, guidelines have had limited effect on changing physician behaviors. This two-part review article highlights variations in the current recommended management of lymphoma (Part I) and leukemia (Part II), with some focus on targeted therapies. Focus on variations that may be amenable to educational programs designed for physicians were also considered in the review. For the purpose of this report, "variation" is defined as any deviation in the treatment or management of a particular hematologic malignancy where practice guidelines exist. Specific studies that demonstrate factors that may cause variations in clinical outcomes of hematologic malignancies and may contribute to variations in practice are featured.