title: Cost effectiveness of leukotriene receptor antagonists versus long-acting beta-2 agonists as add-on therapy to inhaled corticosteroids for asthma: a pragmatic trial.
abstract: BACKGROUND
  Information is lacking on the relative effectiveness and cost effectiveness--in a real-life primary-care setting--of leukotriene receptor antagonists (LTRAs) and long-acting beta2 adrenergic receptor agonists (beta2 agonists) as add-on therapy for patients whose asthma symptoms are not controlled on low-dose inhaled corticosteroids (ICS).
  
  
  OBJECTIVE
  To estimate the cost effectiveness of LTRAs compared with long-acting beta2 agonists as add-on therapy for patients whose asthma symptoms are not controlled on low-dose ICS.
  
  
  METHODS
  An economic evaluation was conducted alongside a 2-year, pragmatic, randomized controlled trial set in 53 primary-care practices in the UK. Patients aged 12-80 years with asthma insufficiently controlled with ICS (n = 361) were randomly assigned to add-on LTRAs (n = 176) or long-acting beta2 agonists (n = 185). The main outcome measures were the incremental cost per point improvement in the Mini Asthma Quality of Life Questionnaire (MiniAQLQ), per point improvement in the Asthma Control Questionnaire (ACQ) and per QALY gained from perspectives of the UK NHS and society.
  
  
  RESULTS
  Over 2 years, the societal cost per patient receiving LTRAs was pounds sterling 1157 versus pounds sterling 952 for long-acting beta2 agonists, a (significant, adjusted) increase of pounds sterling 214 (95% CI 2, 411) [year 2005 values]. Patients receiving LTRAs experienced a non-significant incremental gain of 0.009 QALYs (95% CI -0.077, 0.103). The incremental cost per QALY gained from the societal (NHS) perspective was pounds sterling 22,589 (pounds sterling 11,919). Uncertainty around this point estimate suggested that, given a maximum willingness to pay of pounds sterling 30,000 per QALY gained, the probability that LTRAs are a cost-effective alternative to long-acting beta2 agonists as add-on therapy was approximately 52% from both societal and NHS perspectives.
  
  
  CONCLUSIONS
  On balance, these results marginally favour the repositioning of LTRAs as a cost-effective alternative to long-acting beta2 agonists as add-on therapy to ICS for asthma. However, there is much uncertainty surrounding the incremental cost effectiveness because of similarity of clinical benefit and broad confidence intervals for differences in healthcare costs.
  
  
  BACKGROUND
  UK National Research Register N0547145240; Controlled Clinical Trials ISRCTN99132811.
authors.affiliation: Faculty of Health, University of East Anglia, Norwich, UK. ed.wilson@uea.ac.uk
authors.forename: Edward C F
authors.initials: EC
authors.lastname: Wilson
authors.forename: David
authors.initials: D
authors.lastname: Price
authors.forename: Stanley D
authors.initials: SD
authors.lastname: Musgrave
authors.forename: Erika J
authors.initials: EJ
authors.lastname: Sims
authors.forename: Lee
authors.initials: L
authors.lastname: Shepstone
authors.forename: Jamie
authors.initials: J
authors.lastname: Murdoch
authors.forename: H Miranda
authors.initials: HM
authors.lastname: Mugford
authors.forename: Annie
authors.initials: A
authors.lastname: Blyth
authors.forename: Elizabeth F
authors.initials: EF
authors.lastname: Juniper
authors.forename: Jon G
authors.initials: JG
authors.lastname: Ayres
authors.forename: Stephanie
authors.initials: S
authors.lastname: Wolfe
authors.forename: Daryl
authors.initials: D
authors.lastname: Freeman
authors.forename: Richard F T
authors.initials: RF
authors.lastname: Gilbert
authors.forename: Elizabeth V
authors.initials: EV
authors.lastname: Hillyer
authors.forename: Ian
authors.initials: I
authors.lastname: Harvey
mesh_terms: D000280:Administration, Inhalation; D000293:Adolescent; D000305:Adrenal Cortex Hormones / Q000008:administration & dosage / Q000191:economics / Q000627:therapeutic use*; D058666:Adrenergic beta-2 Receptor Agonists; D000318:Adrenergic beta-Agonists / Q000008:administration & dosage / Q000191:economics* / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001249:Asthma / Q000188:drug therapy*; D002648:Child; D003362:Cost-Benefit Analysis; D003692:Delayed-Action Preparations; D004359:Drug Therapy, Combination; D006801:Humans; D020024:Leukotriene Antagonists / Q000008:administration & dosage / Q000191:economics* / Q000627:therapeutic use; D008875:Middle Aged; D019057:Quality-Adjusted Life Years; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D006113:United Kingdom; D055815:Young Adult
chemical_list: D000305:Adrenal Cortex Hormones; D058666:Adrenergic beta-2 Receptor Agonists; D000318:Adrenergic beta-Agonists; D003692:Delayed-Action Preparations; D020024:Leukotriene Antagonists
references.citation: Respir Med. 2005 Jan;99(1):11-9
references.pmid: 15672843
references.citation: Allergy. 2004 May;59(5):469-78
references.pmid: 15080825
references.citation: Health Technol Assess. 2011 May;15(21):1-132
references.pmid: 21554855
references.citation: Thorax. 2007 Mar;62(3):219-23
references.pmid: 17105779
references.citation: Pharmacoeconomics. 2004;22(12):815-25
references.pmid: 15294013
references.citation: Respir Med. 2005 May;99(5):553-8
references.pmid: 15823451
references.citation: Eur Respir J. 2002 Aug;20(2):260-7
references.pmid: 12212953
references.citation: Eur Respir J. 1999 Jul;14(1):32-8
references.pmid: 10489826
references.citation: J Allergy Clin Immunol. 2002 Mar;109(3):433-9
references.pmid: 11897987
references.citation: BMC Pulm Med. 2006 Nov 30;6 Suppl 1:S6
references.pmid: 17140424
references.citation: Eur Respir J. 1996 Apr;9(4):636-42
references.pmid: 8726924
references.citation: Health Policy. 1990 Dec;16(3):199-208
references.pmid: 10109801
references.citation: Health Econ. 2001 Dec;10(8):779-87
references.pmid: 11747057
references.citation: Curr Opin Pulm Med. 2006 Jan;12(1):12-7
references.pmid: 16357573
references.citation: J Allergy Clin Immunol. 2004 Jul;114(1):40-7
references.pmid: 15241342
references.citation: Lancet. 2003 Oct 18;362(9392):1314-9
references.pmid: 14575979
references.citation: Health Policy. 1996 Jul;37(1):53-72
references.pmid: 10158943
references.citation: J Allergy Clin Immunol. 2001 Jan;107(1):3-8
references.pmid: 11149982
references.citation: J Allergy Clin Immunol. 2003 Nov;112(5 Suppl):S107-11
references.pmid: 14586395
references.citation: J Health Econ. 1999 Jun;18(3):341-64
references.pmid: 10537899
references.citation: Am J Respir Crit Care Med. 2006 Feb 15;173(4):379-85
references.pmid: 16293801
references.citation: N Engl J Med. 2010 Mar 18;362(11):975-85
references.pmid: 20197425
references.citation: BMJ. 2007 Sep 29;335(7621):622-3
references.pmid: 17872931
references.citation: Med Care. 1997 Nov;35(11):1095-108
references.pmid: 9366889
references.citation: Treat Respir Med. 2005;4(2):129-38
references.pmid: 15813665