The levonorgestrel intrauterine system versus endometrial ablation for heavy menstrual bleeding: a cost-effectiveness analysis

Objective To evaluate the costs and non-inferiority of a strategy starting with the LNG-IUS compared to endometrial ablation (EA) in the treatment of heavy menstrual bleeding (HMB). Design Cost-effectiveness analysis from a societal perspective alongside a multicentre randomised non-inferiority trial. Setting General practices and gynaecology departments in the Netherlands. Population 270 women with HMB, aged ≥34 years old, without intracavitary pathology or future child wish. Methods Randomisation to a strategy starting with the LNG-IUS (n=132) or EA (n=138). The incremental cost-effectiveness ratio (ICER) was estimated. Main outcome measures Direct medical costs and (in)direct non-medical costs were calculated. The primary outcome was menstrual blood loss after 24 months, measured with the mean Pictorial Blood Assessment Chart (PBAC)-score (non-inferiority margin 25 points). A secondary outcome was successful blood loss reduction (PBAC-score ≤75 points). Results Total costs per patient were €2,285 in the LNG-IUS strategy and €3,465 in the EA strategy (difference: €1,180). At 24 months mean PBAC-scores were 64.8 in the LNG-IUS group (N=115) and 14.2 in the EA group (N=132); difference 50.5 points (95% CI: 4.3-96.7). In the LNG-IUS group, 87% of women had a PBAC-score ≤75 points versus 94% in the EA group (RR 0.93, 95% CI: 0.85-1.01). The ICER was €23 (95% CI: €5-€111) per PBAC-point. Conclusions A strategy starting with the LNG-IUS was cheaper than starting with EA, but non-inferiority could not be demonstrated. The LNG-IUS is reversible and less invasive and can be a cost-effective treatment option, depending on the success rate women are willing to accept.