Department of General Practice and Elderly Care Medicine, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.
Department of General Practice, University of Maastricht, Maastricht University Medical Centre, Maastricht, The Netherlands.
BJOG. 2021 Nov;128(12):2003-2011. doi: 10.1111/1471-0528.16836. Epub 2021 Jul 27.
To evaluate the costs and non-inferiority of a strategy starting with the levonorgestrel intrauterine system (LNG-IUS) compared with endometrial ablation (EA) in the treatment of heavy menstrual bleeding (HMB).
Cost-effectiveness analysis from a societal perspective alongside a multicentre randomised non-inferiority trial.
General practices and gynaecology departments in the Netherlands.
In all, 270 women with HMB, aged ≥34 years old, without intracavitary pathology or wish for a future child.
Randomisation to a strategy starting with the LNG-IUS (n = 132) or EA (n = 138). The incremental cost-effectiveness ratio was estimated.
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).
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 (relative risk [RR] 0.93, 95% CI 0.85-1.01). The ICER was €23 (95% CI €5-111) per PBAC-point.
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.
Treatment of heavy menstrual bleeding starting with LNG-IUS is cheaper but slightly less effective than endometrial ablation.
评估与子宫内膜消融术(EA)相比,以左炔诺孕酮宫内节育系统(LNG-IUS)作为起始治疗方案治疗重度月经过多(HMB)的成本和非劣效性。
从社会角度进行成本效益分析,同时进行多中心随机非劣效性试验。
荷兰的普通诊所和妇科。
共有 270 名年龄≥34 岁、无宫腔内病变或未来生育愿望的 HMB 妇女。
随机分为 LNG-IUS 起始治疗策略组(n=132)或 EA 起始治疗策略组(n=138)。估计增量成本效益比。
直接医疗成本和间接非医疗成本。主要结局指标为 24 个月后的月经失血量,采用平均图像出血评估图表(PBAC)评分(非劣效性边界 25 分)测量。次要结局指标为成功减少失血(PBAC 评分≤75 分)。
LNG-IUS 策略每位患者的总费用为 2285 欧元,EA 策略为 3465 欧元(差异:1180 欧元)。24 个月时,LNG-IUS 组的平均 PBAC 评分(n=115)为 64.8,EA 组(n=132)为 14.2;差异为 50.5 分(95%CI:4.3-96.7)。LNG-IUS 组中,87%的女性 PBAC 评分≤75 分,而 EA 组为 94%(相对风险 [RR] 0.93,95%CI:0.85-1.01)。ICER 为每 PBAC 点 23 欧元(95%CI:5-111 欧元)。
以 LNG-IUS 作为起始治疗的方案比以 EA 作为起始治疗的方案更便宜,但未能证明其非劣效性。LNG-IUS 是一种可逆转且侵袭性较小的治疗方法,可作为一种具有成本效益的治疗选择,具体取决于女性愿意接受的成功率。
与子宫内膜消融术相比,以左炔诺孕酮宫内节育系统作为起始治疗方案治疗重度月经过多更便宜,但效果略差。