title: A pragmatic, randomized, controlled study evaluating the impact of access to smoking cessation pharmacotherapy coverage on the proportion of successful quitters in a Canadian population of smokers motivated to quit (ACCESSATION).
abstract: BACKGROUND
  Many smokers find the cost of smoking cessation medications a barrier. Financial coverage for these medications increases utilization of pharmacotherapies. This study assesses whether financial coverage increases the proportion of successful quitters.
  
  
  METHODS
  A pragmatic, open-label, randomized, controlled trial was conducted in 58 Canadian sites between March 2009 and September 2010. Smokers (≥10 cigarettes/day) without insurance coverage who were motivated to quit within 14 days were randomized (1:1) in a blinded manner to receive either full coverage eligibility for 26 weeks or no coverage. Pharmacotherapies covered were varenicline, bupropion, or nicotine patches/gum. Investigators/subjects were unblinded to study group assignment after randomization and prior to choosing a smoking cessation method(s). All subjects received brief smoking cessation counseling. The primary outcome measure was self-reported 7-day point prevalence of abstinence (PPA) at week 26.
  
  
  RESULTS
  Of the 1380 randomized subjects (coverage, 696; no coverage, 684), 682 (98.0%) and 435 (63.6%), respectively, were dispensed at least one smoking cessation medication dose. The 7-day PPA at week 26 was higher in the full coverage versus no coverage group: 20.8% (n = 145) and 13.9% (n = 95), respectively; odds ratio (OR) = 1.64, 95% confidence interval (CI) 1.23-2.18; p = 0.001. Urine cotinine-confirmed 7-day PPA at week 26 was 15.7% (n = 109) and 10.1% (n = 69), respectively; OR = 1.68, 95% CI 1.21-2.33; p = 0.002. After pharmacotherapy, coverage eligibility was withdrawn from the full coverage group, continuous abstinence between weeks 26 and 52 was 6.6% (n = 46) and 5.6% (n = 38), in the full coverage and no coverage groups, respectively; OR = 1.19, 95% CI 0.76-1.87; p = 0.439.
  
  
  CONCLUSIONS
  In this study, the adoption of a smoking cessation medication coverage drug policy was an effective intervention to improve 26-week quit rates in Canada. The advantages were lost once coverage was discontinued. Further study is required on the duration of coverage to prevent relapse to smoking. (clinicaltrials.gov identifier: NCT00818207; the study was sponsored by Pfizer Inc.).
authors.affiliation: Addictions Division, Centre for Addiction and Mental Health, Toronto, Ontario, Canada. peter.selby@camh.ca.
authors.forename: Peter
authors.initials: P
authors.lastname: Selby
authors.forename: Gerald
authors.initials: G
authors.lastname: Brosky
authors.forename: Paul
authors.initials: P
authors.lastname: Oh
authors.forename: Vincent
authors.initials: V
authors.lastname: Raymond
authors.forename: Carmen
authors.initials: C
authors.lastname: Arteaga
authors.forename: Suzanne
authors.initials: S
authors.lastname: Ranger
mesh_terms: D001552:Benzazepines / Q000191:economics / Q000627:therapeutic use; D016642:Bupropion / Q000191:economics / Q000627:therapeutic use; D002170:Canada; D005260:Female; D006297:Health Services Accessibility / Q000191:economics / Q000706:statistics & numerical data*; D006801:Humans; D007348:Insurance, Health / Q000191:economics / Q000706:statistics & numerical data*; D008297:Male; D008875:Middle Aged; D009042:Motivation; D009538:Nicotine / Q000008:administration & dosage / Q000191:economics; D018722:Nicotinic Agonists / Q000191:economics / Q000627:therapeutic use; D011810:Quinoxalines / Q000191:economics / Q000627:therapeutic use; D012907:Smoking / Q000188:drug therapy / Q000191:economics; D016540:Smoking Cessation / Q000191:economics* / Q000379:methods* / Q000706:statistics & numerical data; D061485:Tobacco Use Cessation Devices / Q000191:economics; D014029:Tobacco Use Disorder / Q000188:drug therapy* / Q000191:economics; D016896:Treatment Outcome; D000068580:Varenicline
chemical_list: D001552:Benzazepines; D018722:Nicotinic Agonists; D011810:Quinoxalines; D016642:Bupropion; D009538:Nicotine; D000068580:Varenicline