title: Migraine-related healthcare resource use and costs for subjects prescribed fixed-dose combination sumatriptan/naproxen sodium vs. single-entity oral triptans in a managed care population in the USA.
abstract: BACKGROUND
  Randomized clinical trials have demonstrated that the efficacy of a fixed-dose single-tablet combination containing sumatriptan and naproxen sodium (S/NS) was greater than either of its individual components. Simplifying drug regimens (e.g., via a fixed-dose combination) has been shown to improve "real-world" outcomes by reducing pill burden and treatment regimen complexity, improving adherence, and reducing healthcare resource use and associated costs; however, no studies assessing such outcomes have been conducted to date for the acute treatment of migraine.
  
  
  OBJECTIVE
  To assess migraine-related healthcare resource use and associated costs for subjects prescribed S/NS vs. subjects prescribed single-entity oral triptans (SOTs) within a managed care population in the USA.
  
  
  METHODS
  In this retrospective analysis of administrative claims data from July 1, 2008 to December 31, 2009 (IMS LifeLink), subjects meeting the following criteria were selected: one or more pharmacy claim(s) for either S/NS or SOT (index date), aged 18-64 years; at least one migraine diagnosis, and continuous enrollment in the 6 months prior to and post the index date. The study population was subsequently stratified for two analyses: triptan-naïve (triptan naïve in the 6-month period prior to the index date) and triptan-switch (triptan user in the 6-month period prior to the index date and switching to another triptan). Subjects prescribed S/NS were propensity-score matched with subjects prescribed SOT (triptan-naïve analysis: 1:3; triptan-switch analysis: 1:1) to assess differences in healthcare resource use and associated costs (2009 US$) between the S/NS and SOT groups.
  
  
  RESULTS
  Results from the triptan-naïve and triptan-switch analyses suggest that subjects prescribed S/NS are likely to have similar healthcare resource use patterns as those either newly initiated on an SOT or switching SOTs, as measured by migraine medication use, migraine-related healthcare resource use, and all-cause healthcare resource use. One exception was the observed increased use of opioids in the SOT group compared with the S/NS group (change in mean number of tablets pre-index vs. post-index, S/NS vs. SOT; triptan-naïve analysis: 8.6 vs.18.3, p = 0.045; triptan-switch analysis: -8.2 vs. 17.7; p = 0.120). Total costs from the triptan-naïve analysis indicated that the S/NS group had lower migraine-related (US$744 vs. US$820; p = 0.067) and all-cause healthcare costs (US$4,391 vs. US$4,870; p = 0.040) when compared with the SOT group, driven by savings in medical costs (migraine-related: US$252 vs. US$380; p = 0.001; all-cause: US$3,023 vs. US$3,599; p = 0.014). However, no significant differences were observed for total costs from the triptan-switch analysis (migraine-related healthcare costs, S/NS vs. SOT: US$1,159 vs. US$1,117; p = 0.929; all-cause healthcare costs: US$5,128 vs. US$4,788; p = 0.381).
  
  
  CONCLUSIONS
  Study results suggest similar healthcare resource use patterns and associated costs when comparing S/NS and SOT across a triptan-naïve and triptan-experienced population. While the current study focuses on direct medical costs, future studies should extend beyond such a perspective to explore functional status, productivity, and health-related quality of life and satisfaction, attributes not captured in administrative claims data, but nonetheless important treatment goals.
authors.affiliation: GlaxoSmithKline, Research Triangle Park, Durham, NC, USA.
authors.forename: M Chris
authors.initials: MC
authors.lastname: Runken
authors.forename: Bridgett
authors.initials: B
authors.lastname: Goodwin
authors.forename: Manan
authors.initials: M
authors.lastname: Shah
authors.forename: Michael
authors.initials: M
authors.lastname: Eaddy
authors.forename: Anna
authors.initials: A
authors.lastname: D'Souza
authors.forename: Brian
authors.initials: B
authors.lastname: Bowers
authors.forename: Christopher F
authors.initials: CF
authors.lastname: Bell
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D004338:Drug Combinations; D005260:Female; D017048:Health Care Costs / Q000706:statistics & numerical data; D006801:Humans; D008297:Male; D008329:Managed Care Programs / Q000191:economics; D008875:Middle Aged; D008881:Migraine Disorders / Q000188:drug therapy* / Q000191:economics; D009288:Naproxen / Q000008:administration & dosage* / Q000191:economics*; D012189:Retrospective Studies; D018170:Sumatriptan / Q000008:administration & dosage* / Q000191:economics*; D014363:Tryptamines / Q000008:administration & dosage* / Q000191:economics*; D055815:Young Adult
chemical_list: D004338:Drug Combinations; D014363:Tryptamines; D009288:Naproxen; D018170:Sumatriptan