title: Impact of Out-of-Pocket Pharmacy Costs on Branded Medication Adherence Among Patients with Type 2 Diabetes.
abstract: BACKGROUND
  Medication adherence is pivotal for the successful treatment of diabetes. However, medication adherence remains a major concern, as nonadherence is associated with poor health outcomes. Studies have indicated that increasing patients' share of medication costs significantly reduces adherence. Little is known about a potential out-of-pocket (OOP) cost threshold where substantial reduction in adherence may occur.
  
  
  OBJECTIVE
  To examine the impact of diabetes OOP pharmacy costs on antihyperglycemic medication adherence and identify the potential threshold at which significant reduction in adherence may occur among patients with type 2 diabetes mellitus (T2DM).
  
  
  METHODS
  This was an observational, retrospective cohort study using longitudinal U.S. pharmacy and medical claims data from the IMS Health Medical Claims (Dx) database. Patients with T2DM who initiated therapy with a branded antihyperglycemic medication during the index period (January 1, 2011, to December 31, 2011) and had 3 years of follow-up data were included. The primary outcome was adherence to antihyperglycemic medications, measured as the number of days covered. Propensity scores were calculated using baseline sociodemographic and clinical characteristics to control for potential confounding factors. Four strata were created based on mean propensity scores. Across each stratum, patients were assigned to 5 diabetes OOP pharmacy (including generics) cost levels: $0-$10, $11-$40, $41-$50, $51-$75, and > $75. Multivariate regression models were used to estimate association of diabetes OOP pharmacy costs and adherence for each stratum. Sensitivity analyses were conducted to assess the impact of total OOP pharmacy costs and index drug category OOP costs on adherence.
  
  
  RESULTS
  A total of 15,416 patients were assessed. Across each stratum in the diabetes OOP pharmacy cost analysis group, mean patient age ranged from 52.3 to 56.1 years, mean number of antihyperglycemic medication classes ranged from 1.5 to 3.2, and mean household income ranged from $60,763 to $79,373. Most patients used a commercial plan (55%-85%). The propensity-stratified multivariate regression model revealed an overall negative relationship between diabetes OOP pharmacy costs and adherence across several OOP cost levels. Diabetes OOP pharmacy cost level $51-$75 appeared as the threshold at which adherence reduced significantly (77-78 fewer days of coverage over 3 years of follow-up; P < 0.05) when compared with the lowest OOP costs ($0-$10) across all strata. Adherence reduced further (99-145 fewer days of coverage; P < 0.0001) for the higher diabetes OOP pharmacy cost levels (> $75) when compared with the lowest OOP cost levels. Sensitivity analyses with total OOP pharmacy costs and index drug category OOP costs revealed negative association with adherence across all strata.
  
  
  CONCLUSIONS
  Diabetes OOP pharmacy cost was negatively associated with patient adherence, and a potential OOP cost threshold ($51-$75) was identified at which adherence reduced significantly. The study findings may be beneficial in informing the design of health care plans to achieve optimal adherence and improve disease management in patients with T2DM.
  
  
  BACKGROUND
  This study was funded by Eli Lilly and Company. Eli Lilly and Company was involved in the study design; collection, analysis, and interpretation of data; preparation of the manuscript; and decision to submit for publication. Fu is an employee of Eli Lilly and Company. Taylor and Kwan are employees of Lilly USA. Fu and Kwan hold stock or stock options in Eli Lilly and Company. Bibeau was an employee of Eli Lilly and Company at the time of this study and initial submission of this manuscript. Bibeau is currently employed by Janssen Scientific Affairs. The abstract for this study was presented at the AMCP Managed Care & Specialty Pharmacy Annual Meeting 2016; April 19-22, 2016; San Francisco, California. Bibeau and Fu contributed to the study design and collected the data. All authors contributed equally to data interpretation and manuscript preparation and revision.
authors: 1 Eli Lilly and Company, Indianapolis, Indiana.
authors: Wendy S
authors: WS
authors: Bibeau
authors: 1 Eli Lilly and Company, Indianapolis, Indiana.
authors: Haoda
authors: H
authors: Fu
authors: 2 Lilly USA, Indianapolis, Indiana.
authors: April D
authors: AD
authors: Taylor
authors: 2 Lilly USA, Indianapolis, Indiana.
authors: Anita Y M
authors: AY
authors: Kwan
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015331:Cohort Studies; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy / Q000191:economics*; D005252:Fees, Pharmaceutical / Q000639:trends; D005260:Female; D005500:Follow-Up Studies; D005102:Health Expenditures / Q000639:trends; D006801:Humans; D007004:Hypoglycemic Agents / Q000191:economics* / Q000627:therapeutic use; D007345:Insurance Claim Review / Q000191:economics / Q000639:trends; D008137:Longitudinal Studies; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D010604:Pharmacy / Q000639:trends; D012189:Retrospective Studies; D055815:Young Adult
chemical_list: D007004:Hypoglycemic Agents