title: Levonorgestrel-releasing intrauterine system vs. usual medical treatment for menorrhagia: an economic evaluation alongside a randomised controlled trial.
abstract: OBJECTIVE
  To undertake an economic evaluation alongside the largest randomised controlled trial comparing Levonorgestrel-releasing intrauterine device ('LNG-IUS') and usual medical treatment for women with menorrhagia in primary care; and compare the cost-effectiveness findings using two alternative measures of quality of life.
  
  
  METHODS
  571 women with menorrhagia from 63 UK centres were randomised between February 2005 and July 2009. Women were randomised to having a LNG-IUS fitted, or usual medical treatment, after discussing with their general practitioner their contraceptive needs or desire to avoid hormonal treatment. The treatment was specified prior to randomisation. For the economic evaluation we developed a state transition (Markov) model with a 24 month follow-up. The model structure was informed by the trial women's pathway and clinical experts. The economic evaluation adopted a UK National Health Service perspective and was based on an outcome of incremental cost per Quality Adjusted Life Year (QALY) estimated using both EQ-5D and SF-6D.
  
  
  RESULTS
  Using EQ-5D, LNG-IUS was the most cost-effective treatment for menorrhagia. LNG-IUS costs £100 more than usual medical treatment but generated 0.07 more QALYs. The incremental cost-effectiveness ratio for LNG-IUS compared to usual medical treatment was £1600 per additional QALY. Using SF-6D, usual medical treatment was the most cost-effective treatment. Usual medical treatment was both less costly (£100) and generated 0.002 more QALYs.
  
  
  CONCLUSIONS
  Impact on quality of life is the primary indicator of treatment success in menorrhagia. However, the most cost-effective treatment differs depending on the quality of life measure used to estimate the QALY. Under UK guidelines LNG-IUS would be the recommended treatment for menorrhagia. This study demonstrates that the appropriate valuation of outcomes in menorrhagia is crucial.
authors.affiliation: Health Economics Unit, University of Birmingham, Birmingham, United Kingdom.
authors.forename: Sabina
authors.initials: S
authors.lastname: Sanghera
authors.affiliation: Health Economics Unit, University of Birmingham, Birmingham, United Kingdom.
authors.forename: Tracy Elizabeth
authors.initials: TE
authors.lastname: Roberts
authors.affiliation: Health Economics Unit, University of Birmingham, Birmingham, United Kingdom.
authors.forename: Pelham
authors.initials: P
authors.lastname: Barton
authors.affiliation: Health Economics Unit, University of Birmingham, Birmingham, United Kingdom.
authors.forename: Emma
authors.initials: E
authors.lastname: Frew
authors.affiliation: School of Clinical and Experimental Medicine, University of Birmingham, Birmingham, United Kingdom; Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, United Kingdom.
authors.forename: Jane
authors.initials: J
authors.lastname: Daniels
authors.affiliation: Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, United Kingdom.
authors.forename: Lee
authors.initials: L
authors.lastname: Middleton
authors.affiliation: Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, United Kingdom.
authors.forename: Laura
authors.initials: L
authors.lastname: Gennard
authors.affiliation: Division of Primary Care & National Institute for Health Research, University of Nottingham, Nottingham, United Kingdom.
authors.forename: Joe
authors.initials: J
authors.lastname: Kai
authors.affiliation: School of Clinical and Experimental Medicine, University of Birmingham, Birmingham, United Kingdom.
authors.forename: Janesh Kumar
authors.initials: JK
authors.lastname: Gupta
mesh_terms: D000328:Adult; D003271:Contraceptive Agents, Female / Q000008:administration & dosage*; D003362:Cost-Benefit Analysis; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007436:Intrauterine Devices, Medicated / Q000191:economics; D016912:Levonorgestrel / Q000008:administration & dosage*; D008595:Menorrhagia / Q000188:drug therapy*; D008875:Middle Aged; D015233:Models, Statistical; D011788:Quality of Life; D016896:Treatment Outcome
chemical_list: D003271:Contraceptive Agents, Female; D016912:Levonorgestrel