Abstract
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.
Original language | English |
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Number of pages | 9 |
Journal | BJOG : An International Journal of Obstetrics and Gynaecology |
DOIs | |
Publication status | Published - 27-Jul-2021 |
Keywords
- Cost-effective analysis
- economic evaluation
- excessive uterine bleeding
- intrauterine device
- menorrhagia
- menstruation
- mirena
- noninferiority trial
- novasure
- QUALITY-OF-LIFE
- CLINICAL EFFECTIVENESS
- MENORRHAGIA
- HEALTH
- HYSTERECTOMY
- OUTCOMES
- WOMEN
- UTILITY
- SF-36
- BURDEN