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.
Highlights
Menorrhagia, or heavy menstrual bleeding, places a considerable burden on healthcare resources, with around 6% of women per year consulting their general practitioners [1]
Non-hormonal and hormonal medical treatments are available as first line therapy for women presenting with menorrhagia in primary care
571 women with menorrhagia from 63 UK centres were randomised between February 2005 and July 2009
Summary
Menorrhagia, or heavy menstrual bleeding, places a considerable burden on healthcare resources, with around 6% of women per year consulting their general practitioners [1]. The condition can be defined as ‘‘Excessive menstrual blood loss which interferes with a woman’s social, emotional, physical and material quality of life’’ [2]. Treatment is prompted predominantly by a woman’s subjective assessment of interference in her quality of life, rather than solely by clinical assessment of volume of blood loss [3]. Women often progressed quickly to a surgical solution; either hysterectomy, resulting in the permanent cessation of bleeding and sterility, or since the 1990s, endometrial ablation, which uses electrical or thermal energy to destroy the endometrium, causing amenorrhea in 34% of women [4]. Non-hormonal and hormonal medical treatments are available as first line therapy for women presenting with menorrhagia in primary care
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