A Cost-Effectiveness Analysis of Gonadotropins Used for Ovarian Stimulation during Assisted Reproductive Technology Based on Data from the French Nationwide Claims Database (SNDS).

IF 2 4区 医学 Q2 OBSTETRICS & GYNECOLOGY
Isabelle Borget, Mehdi Benchaib, Philippine Poignant, Laetitia Rey, Gerard Harty, Vivek Chaudhari, Thomas D'hooghe, Juan-Enrique Schwarze, Isabelle Cedrin Durnerin, Claudia Roeder, Michael Grynberg
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引用次数: 0

Abstract

Objective: Various gonadotropins are used for ovarian stimulation (OS). This study investigated the cost-effectiveness of different gonadotropins based on real-world data from the French National Health Database (SNDS) over a 7-year follow-up of assisted reproductive technology (ART) treatments.

Design: Cost-effectiveness analysis of different gonadotropins based on real-world data from the SNDS was conducted.

Participants: Women from SNDS undergoing OS leading to oocyte pick-up registered between January 31, 2013, and December 31, 2018 (N = 245,534 stimulations), and receiving either recombinant human follicle stimulating hormone (r-hFSH alfa originator; 110,439), its biosimilars (12,287), or urinaries (mainly highly purified human menopausal gonadotropin [HP-hMG; 65,654] and marginally highly purified urinary-human follicle stimulating hormone [7,821]) were included (follow-up: December 31, 2019).

Settings and methods: Clinical inputs for this model, including live birth (LB) and cumulative LB (CLB) were calculated from data as published in [Best Pract Res Clin Obstet Gynaecol. 2023;88:102308]. A decision-tree model was developed comprising pregnancy and live birth rate (LBR) states for a complete ART cycle, including one fresh and ≤4 frozen/thawed embryo transfers and related costs. Cost inputs included those of drugs, ART procedure, pregnancy and delivery, and adverse events. Cost per LB and CLB and incremental cost-effectiveness ratio (ICER) were assessed. Robustness of results was determined by comprehensive sensitivity analyses.

Results: Overall, r-hFSH alfa originator was found to be associated with a lower cost per LB and per CLB (cost per LB: EUR 26,010; CLB: EUR 22,278) versus its biosimilars (cost per LB: EUR 28,037; CLB: EUR 23,807) and versus urinaries (cost per LB: EUR 26,636; CLB: EUR 23,335). Calculated ICERs with r-hFSH alfa for LB were EUR 5,538 and EUR 14,090, whereas for CLB were EUR 1,945 and EUR 13,742 versus biosimilars and urinaries, respectively. Cost-effectiveness acceptability curve showed that in a majority of iterations, r-hFSH alfa originator had a probability of being cost-effective at a hypothetical threshold of EUR 20,000/LB. Sensitivity analyses showed that the most important variable impacting the outcome in fresh transfers was the probability of birth for biosimilars and the probability of pregnancy for urinaries, while for cumulative transfers, it was the probability of pregnancy for biosimilars and the probability of birth for urinaries.

Limitations: As the clinical data were obtained from a non-interventional study and not a randomized controlled trial, the results may still be susceptible to residual confounding or other biases.

Conclusions: r-hFSH alfa originator is cost-effective compared to its biosimilars and to urinaries (mainly HP-hMG) and is associated with a lower cost per LB compared to these gonadotropins, where the main driver is the higher LB efficacy rate achieved with it.

基于法国全国报销数据库(SNDS)的数据,对辅助生殖技术中用于刺激卵巢的促性腺激素进行成本效益分析。
目的:各种促性腺激素被用于卵巢刺激(OS)。本研究根据法国国家健康数据库(SNDS)的实际数据,对辅助生殖技术(ART)治疗的7年随访情况,对不同促性腺激素的成本效益进行了调查:设计:根据法国国家健康数据库(SNDS)的实际数据,对不同促性腺激素进行成本效益分析:纳入2013年1月31日至2018年12月31日期间(N=245,534次促排卵)登记的、接受r-hFSH alfa原体(110,439次)、其生物仿制药(12,287次)或尿液(主要为HP-hMG[65,654次],少量为u-hFSH-HP[7,821次])的接受OS导致卵母细胞拾取的SNDS妇女(随访时间:2019年12月31日):该模型的临床输入数据,包括活产(LB)和累积活产(CLB),均根据 Grynberg 等人在 2022 年发表的数据计算得出。建立的决策树模型包括一个完整 ART 周期(包括一次新鲜胚胎移植和≤4 次冷冻/解冻胚胎移植)的妊娠和活产率 (LBR) 状态以及相关成本。成本投入包括药物、ART 过程、妊娠和分娩以及不良事件的成本投入。评估了每 LB 和 CLB 的成本以及增量成本效益比 (ICER)。通过综合敏感性分析确定了结果的稳健性:总体而言,r-hFSH alfa原研药与生物仿制药(每LB成本:26,010欧元;每CLB成本:22,278欧元)和尿液(每LB成本:26,636欧元;每CLB成本:23,335欧元)相比,每LB和每CLB成本更低(每LB成本:26,010欧元;每CLB成本:22,278欧元)。与生物仿制药和尿液相比,r-hFSH alfa治疗LB的ICER计算值分别为5538欧元和14090欧元,而治疗CLB的ICER计算值分别为1945欧元和13742欧元。成本效益可接受性曲线显示,在大多数迭代中,r-hFSH alfa 原研药在假设阈值为 20,000 欧元/活产时具有成本效益。敏感性分析表明,在新鲜转移中,影响结果的最重要变量是生物仿制药的出生概率和尿液的怀孕概率,而在累积转移中,影响结果的最重要变量是生物仿制药的怀孕概率和尿液的出生概率:结论:与生物仿制药和尿液(主要是 HP-hMG)相比,r-hFSH alfa 原研药具有成本效益,与这些促性腺激素相比,其每 LB 成本较低,主要原因是其活产有效率较高。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
4.20
自引率
4.80%
发文量
44
审稿时长
6-12 weeks
期刊介绍: This journal covers the most active and promising areas of current research in gynecology and obstetrics. Invited, well-referenced reviews by noted experts keep readers in touch with the general framework and direction of international study. Original papers report selected experimental and clinical investigations in all fields related to gynecology, obstetrics and reproduction. Short communications are published to allow immediate discussion of new data. The international and interdisciplinary character of this periodical provides an avenue to less accessible sources and to worldwide research for investigators and practitioners.
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