The effects of patient out-of-pocket costs on insulin use among people with type 1 and type 2 diabetes with Medicare Advantage insurance-2014-2018.

OBJECTIVE: To identify the association between insulin out-of-pocket costs (OOPC) and adherence to insulin in Medicare Advantage (MA) patients. DATA SOURCES AND STUDY SETTING: The study is based on Optum Labs Data Warehouse, a longitudinal, real-world data asset with de-identified administrative claims and electronic health record data. STUDY DESIGN: Using descriptive and multivariable logistic regression analyses, we identified the likelihood of patients with diabetes having ≥60 consecutive days between an expected insulin fill date and the actual fill date (refill lapse) by OOPC, categorized by $0, >$0-$20 (reference), >$20-$35, >$35-$50, and > $50 per 30-day supply. DATA COLLECTION/EXTRACTION METHODS: The study included MA enrollees with type 1 or type 2 diabetes and prescription claims for insulin between 2014 and 2018. PRINCIPAL FINDINGS: Those with average insulin OOPC per 30-day supply >$35 or $0 were more likely to have an insulin refill lapse versus OOPC of >$0 to $20, with odds ratios ranging 1.18 (95% CI 1.13-1.22) to 1.74 (95% CI 1.66-1.83) depending on OOPC group and diabetes type. CONCLUSIONS: Capping average insulin OOPC at $35 per 30-day supply may help avoid cost-related insulin non-adherence in MA patients; efforts to address non-cost barriers to medication adherence remain important.

The effects of patient out-of-pocket costs for insulin on medication adherence and health care utilization in patients with commercial insurance; 2007-2018.

BACKGROUND: High out-of-pocket costs (OOPCs) for insulin can lead to cost-related nonadherence and poor outcomes, prompting payers to limit insulin OOPCs. However, data are scarce on whether insulin OOPCs at policy-relevant levels is associated with improved adherence and outcomes. OBJECTIVE: To identify associations between insulin OOPCs and insulin adherence, noninsulin antihyperglycemic (AHG) medication adherence, and diabetes-related emergency department (ED) visits and hospitalizations. METHODS: This retrospective cohort study was conducted using OptumLabs Data Warehouse, a longitudinal, real-world data asset with deidentified administrative claims and electronic health record data. Individuals with type 1 diabetes (T1D) or type 2 diabetes (T2D), insulin use on January 1 of a study year (index date: 2007-2018), continuous commercial health plan eligibility 12 months pre-index and post-index date, and at least 1 insulin claim during the 12-month follow-up period were included. Average insulin OOPCs per 30-day supply in the follow-up period was identified and categorized ($0, > $0-$20 [referent group], > $20-$35, > $35-$50, and > $50). The proportion of patients with a gap in insulin supply of 60 or more continuous days, AHG nonadherence per modified proportion of days covered less than 0.80, and a diabetes-related ED visit or hospitalization were identified and compared by insulin OOPC category vs more than $0 to $20 using pairwise chi-square tests and multivariable logistic regression. RESULTS: The study included 21,085 individuals with T1D and 72,512 with T2D. Patients with average OOPCs more than $50 were more likely to have a gap in insulin supply vs those with OOPCs more than $0 to $20, with an odds ratio (OR) of 1.14 (95% CI =1.05-1.24) and 1.38 (95% CI = 1.32-1.45) for T1D and T2D, respectively. Those with T2D and OOPCs more than $35 were also more likely to have a 60-day gap in insulin supply (OR 1.17; 95% CI = 1.11-1.23). Odds of having a diabetes-related hospitalization or ED visit did not increase with higher OOPCs; rather, associations tended to be inverse. Nonadherence to AHG medications in the T2D cohort was higher with insulin OOPCs more than $20 vs those more than $0-$20 (P < 0.05 for all). CONCLUSIONS: Individuals with T2D were more likely to have a 60-day gap in insulin supply when the OOPC was more than $35 per 30-day supply and with the OOPC more than $50 in those with T1D. These findings suggest that health plans can facilitate adherence to insulin therapy and possibly to noninsulin AHG medications by protecting patients with diabetes from experiencing high insulin OOPC. A study with a longer follow-up period is warranted to fully assess ED and hospitalization outcomes. DISCLOSURES: This study was funded by the Robert Wood Johnson Foundation, Health Data for Action Research Program. The study sponsor played no role in the design or conduct of this study. The views expressed here do not necessarily reflect the views of the Foundation.

Niacin and fibrate use among patients with high triglycerides and low high-density lipoprotein cholesterol.

BACKGROUND: National guidelines recommend treating low HDL and/or high triglycerides (TG) with adjunctive therapy that supplements statin monotherapy in patients with multiple cardiovascular disease (CVD) risk factors. Niacin and fibrates have been shown in clinical trials to be effective as adjunctive therapy for these lipid abnormalities. OBJECTIVE: To evaluate the pharmacologic treatment of low HDL and high TG in real-world practice by assessing a large managed-care population with CVD risk factors enrolled in a commercial health plan. RESEARCH DESIGN AND METHODS: Complete lipid panel results (LDL, HDL, TG) obtained between 1/1/2006 and 12/31/2006 (index lab) were available for all participants. Subjects were observed 180 days pre-index to determine which CVD risk factors were present (male aged 45+, female 55+, coronary heart disease, hypertension, diabetes mellitus). Patients whose LDL was at goal but who had low HDL and high TG were assessed for lipid treatment status by evaluating outpatient pharmacy claims 6 months pre- and post-index. RESULTS: Treatment with any lipid therapy increased for all risk groups, and by total risk factors, from pre-index to post-index. Use of fibrates and niacin, alone or in combination with a statin, also increased for all risk groups, and by total risk factors as well, but was below expectations based on guideline recommendations. For example, among patients with 4 risk factors, <20% of patients with low HDL/high TG received niacin and/or a fibrate post-index date. CONCLUSIONS: Our results indicate that in actual clinical practice, niacin and fibrates are underutilized in the treatment of low HDL and high TG. The findings of this study must be considered within the limitations of database analysis as claims data are collected for the purpose of payment and not research.

Dyslipidemia treatment of patients with diabetes mellitus in a US managed care plan: a retrospective database analysis.

BACKGROUND: To evaluate real-world pharmacologic treatment of mixed dyslipidemia in patients with diabetes mellitus (DM). METHODS: All commercial health plan members in a large US managed care database with complete lipid panel results (HDL-C, LDL-C, TG) between 1/1/2006 and 12/31/2006 were identified (N = 529,236). DM patients (N = 53,679) with mixed dyslipidemia were defined as having any 2 suboptimal lipid parameters (N = 28,728). Lipid treatment status 6 months pre- and post-index date was determined using pharmacy claims for any lipid therapy. RESULTS: Post-index, 41.1% of DM patients with 2 abnormal lipid parameters and 45.1% with 3 abnormal lipid parameters did not receive lipid-modifying treatment. Post-index treatment rates were 57.4%, 63.6%, and 66.4% for patients with LDL-C, HDL-C, and TG in the most severe quartiles, respectively. Statin monotherapy was the primary lipid-modifying regimen prescribed (54.8% and 47.8% of patients with any 2 and all 3 lipids not at goal, respectively). Less than 30% of treated patients received combination therapy. CONCLUSION: Over 40% of DM patients with mixed dyslipidemia received no lipid-modifying therapy during the follow-up period. Those who were treated were primarily prescribed statin monotherapy. This study suggests that DM patients are not being treated to ADA-suggested targets.