title: Impact of roflumilast on exacerbations of COPD, health care utilization, and costs in a predominantly elderly Medicare Advantage population.
abstract: BACKGROUND
  Chronic obstructive pulmonary disease (COPD) exacerbations are associated with declining lung function and health-related quality of life, and increased hospitalization and mortality. Clinical trials often poorly represent the elderly and thus have only partial applicability to their clinical care.
  
  
  OBJECTIVE
  To compare exacerbations, COPD-related health care utilization (HCU), and costs in a predominantly elderly Medicare COPD population initiated on roflumilast versus those not initiated on roflumilast.
  
  
  METHODS
  Deidentified administrative claims data from a large, national payer were utilized. Medicare patients aged 40-89 years with at least one COPD diagnosis from May 1, 2010 to December 31, 2012 were included. Members with at least one roflumilast pharmacy claim (index) were assigned to the roflumilast group and those without were assigned to the non-roflumilast group. Proxy index dates for the non-roflumilast group were randomly assigned for similar distribution of all patients' time at risk. Subjects with at least one pre-index COPD exacerbation had to be continuously enrolled for ≥365 days pre-index and post-index. Unadjusted and adjusted difference-in-difference (DID) analyses contrasted pre-index with post-index changes in exacerbations, HCU, and costs of roflumilast treatment compared with non-roflumilast treatment.
  
  
  RESULTS
  A total of 500 roflumilast and 60,145 non-roflumilast patients were included (mean age 69.7 and 72.3 years, respectively; P<0.0001). Unadjusted DID favored roflumilast for all exacerbations, with greater pre-index to post-index reductions in mean per 30-day COPD-related hospitalizations (-0.0182 versus -0.0013, P=0.009), outpatient visits (-0.2500 versus -0.0606, P<0.0001), and COPD-related inpatient costs (-US$141 versus -US$11, P=0.0346) and outpatient costs (-US$31 versus -US$4, P<0.0001). Multivariate analyses identified significantly improved pre-index to post-index COPD-related total costs (P=0.0005) and total exacerbations (P<0.0001) for the roflumilast group versus non-roflumilast group.
  
  
  CONCLUSIONS
  In a predominantly elderly Medicare COPD population, newly initiated roflumilast patients displayed similar or significantly better unadjusted reductions in all exacerbation-related, COPD-related HCU-related, and COPD-related costs outcomes compared with non-roflumilast patients. These analyses also suggest better adjusted COPD-related costs and total exacerbations for roflumilast-initiated patients.
authors.affiliation: Comprehensive Health Insights, Inc., Humana, Louisville, KY, USA.
authors.forename: Keran
authors.initials: K
authors.lastname: Moll
authors.affiliation: Health Economics and Outcomes Research, Forest Laboratories, LLC, an affiliate of Actavis, Inc., Jersey City, NJ, USA.
authors.forename: Shawn X
authors.initials: SX
authors.lastname: Sun
authors.affiliation: Comprehensive Health Insights, Inc., Humana, Louisville, KY, USA.
authors.forename: Jeffrey J
authors.initials: JJ
authors.lastname: Ellis
authors.affiliation: Comprehensive Health Insights, Inc., Humana, Louisville, KY, USA.
authors.forename: Andrew
authors.initials: A
authors.lastname: Howe
authors.affiliation: Department of Medicine, University of California-Irvine, Orange, CA, USA.
authors.forename: Alpesh
authors.initials: A
authors.lastname: Amin
mesh_terms: D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000553:Ambulatory Care / Q000191:economics; D000631:Aminopyridines / Q000191:economics* / Q000627:therapeutic use*; D001549:Benzamides / Q000191:economics* / Q000627:therapeutic use*; D016009:Chi-Square Distribution; D003362:Cost-Benefit Analysis; D003521:Cyclopropanes / Q000191:economics / Q000627:therapeutic use; D018450:Disease Progression; D016527:Drug Costs; D005260:Female; D006295:Health Resources / Q000191:economics* / Q000706:statistics & numerical data; D017721:Hospital Costs; D006760:Hospitalization / Q000191:economics; D006801:Humans; D016014:Linear Models; D008297:Male; D020398:Medicare Part C / Q000191:economics*; D008875:Middle Aged; D018803:Models, Economic; D015999:Multivariate Analysis; D058988:Phosphodiesterase 4 Inhibitors / Q000191:economics* / Q000627:therapeutic use*; D029424:Pulmonary Disease, Chronic Obstructive / Q000175:diagnosis / Q000188:drug therapy* / Q000191:economics*; D012189:Retrospective Studies; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
chemical_list: D000631:Aminopyridines; D001549:Benzamides; D003521:Cyclopropanes; D058988:Phosphodiesterase 4 Inhibitors; C424423:Roflumilast
keywords: COPD; Medicare; exacerbations; health care utilization; roflumilast
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