Cost-effectiveness of levonorgestrel intrauterine system versus hysteroscopic niche resection for caesarean scar-related spotting in China: an economic evaluation alongside a randomised controlled trial.

OBJECTIVE

To evaluate the cost-effectiveness of the levonorgestrel intrauterine system (LNG-IUS) compared with hysteroscopic niche resection (HNR) for women with niche-related postmenstrual spotting.

DESIGN

Economic evaluation from a healthcare perspective, conducted alongside a randomised controlled trial with 12 months of follow-up.

SETTING

A single-centre study at a university hospital in Shanghai was carried out between October 2019 and January 2021.

PARTICIPANTS

A total of 208 women aged 18-48 years with niche-related spotting who were suitable for a HNR, defined as a residual myometrium of at least 2.2 mm confirmed by MRI.

INTERVENTION: Participants were randomly assigned to LNG-IUS insertion (n=104) or HNR (n=104).

MAIN OUTCOME MEASURES: The primary outcome was reduction in postmenstrual spotting at 6 months, defined as ≥50% decrease in spotting days compared with baseline. Cost-effectiveness was expressed as incremental cost-effectiveness ratios (ICERs), calculated by dividing cost differences in effective rate and spotting days.

STATISTICAL ANALYSES: Mean costs (diagnostic, examination, surgical) were compared between groups using Student's t-test, standardised to 2019 price levels. Uncertainty around cost-effectiveness was assessed with non-parametric bootstrapping and cost-effectiveness acceptability curves.

RESULTS

At 6 months, 78.4% (80/102) of women in the LNG-IUS group and 73.1% (76/104) in the HNR group reported improvement in spotting symptoms (RR 1.07, 95% CI 0.92 to 1.25). Spotting reduction was greater with LNG-IUS (0.0 days, IQR 0.0 to 2.8) compared with HNR (2.0 days, IQR 0.8 to 4.3; p<0.001). Mean costs were significantly lower in the LNG-IUS group (￥2273.8 RenMinBi (RMB)) versus the HNR group (￥6318.0 RMB), with a mean cost difference of -￥4044.2 RMB (95% CI -4367.3 to -3721.1). The ICER of LNG-IUS over HNR was -￥763.2 RMB per one-percentage-point effective rate gained. Each day reduction in spotting was associated with cost savings of ￥1833.8 RMB. The probability of LNG-IUS being dominant was 0.99 at a willingness-to-pay (WTP) of ￥0 RMB and 0.97 at WTP ￥10 000 RMB per effective rate point, and 0.99 and 0.60, respectively, per spotting day reduced.

CONCLUSIONS

LNG-IUS is highly cost-effective compared with HNR for the treatment of niche-related postmenstrual spotting at 6 months. These findings support LNG-IUS as first-line therapy for niche-related spotting in women with a residual myometrium ≥2.2 mm.

TRIAL REGISTRATION NUMBER: ChiCTR1900025677.