Levonorgestrel-Releasing Intrauterine System vs. Usual Medical Treatment for Menorrhagia: An Economic Evaluation Alongside a Randomised Controlled Trial

Abstract

ObjectiveTo 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.Methods571 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.ResultsUsing 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.ConclusionImpact 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.

Levonorgestrel-releasing intrauterine system versus a low-dose combined oral contraceptive for treatment of adenomyotic uteri: a randomized clinical trial

“…A C C E P T E D M A N U S C R I P T ACCEPTED MANUSCRIPT 5 Other inclusion criteria included the participant's request for contraception for at least 6 months, an age between 20 and 45 years, a resident in the nearby vicinity to make the follow-up easy and feasible and acceptance of use of either type of management. Exclusion criteria included history of ectopic pregnancy, puerperal sepsis, pelvic inflammatory disease (PID), evidence of coagulopathy and/or abnormalities of the uterine cavity such as submucous fibroids distorting the cavity.…”

Pharmaceutical treatments to prevent recurrence of endometriosis following surgery: a model-based economic evaluation

“…The estimates for resource use were taken from a recent parallel primary study exploring the treatment for a related condition. 16 Thus, LNG-IUS is estimated to take 20 min to fit, requires disposable items and both a GP and nurse to be present. Follow-up consultations for treatment with the GP are assumed to last 10 min.…”

Sensitivity to scale of willingness‐to‐pay within the context of menorrhagia

“…The ECLIPSE trial is a pragmatic, multicentre, randomized trial, comparing the clinical and cost‐effectiveness of levonorgestrel‐releasing intrauterine device (LNG‐IUS) against usual medical treatment in the primary care setting . Women between 25 and 50 years of age that presented to their general practitioner (GP) with menorrhagia, occurring over at least three consecutive cycles, were randomized to a treatment group by telephone or web‐based central randomization service.…”

“…As the assessment of the validity of WTP is the aim of this study, and not the incremental difference between treatment arms, the WTP values for both treatments were combined. The CUA and CBA which consider the treatment effect by group are presented elsewhere . Thus, the WTP for overall treatment (both LNG‐IUS and oral treatment) for menorrhagia is used to assess the convergent validity.…”