Health Economics, Statesia, Le Mans, France.
Global Regulatory Affairs & Market Access, URGO Medical, Chenôve, France.
PLoS One. 2021 Jan 22;16(1):e0245652. doi: 10.1371/journal.pone.0245652. eCollection 2021.
This study assesses the cost-effectiveness of Technology Lipido-Colloid with Nano Oligo Saccharide Factor (TLC-NOSF) wound dressings versus neutral dressings in the management of diabetic foot ulcers (DFUs) from a French collective perspective. We used a Markov microsimulation cohort model to simulate the DFU monthly progression over the lifetime horizon. Our study employed a mixed method design with model inputs including data from interventional and observational studies, French databases and expert opinion. The demographic characteristics of the simulated population and clinical efficacy were based on the EXPLORER double-blind randomized controlled trial. Health-related quality of life, costs, and resource use inputs were taken from the literature relevant to the French context. The main outcomes included life-years without DFU (LYsw/DFU), quality-adjusted life-years (QALYs), amputations, and lifetime costs. To assess the robustness of the results, sensitivity and subgroup analyses based on the wound duration at treatment initiation were performed. Treatment with the TLC-NOSF dressing led to total cost savings per patient of EUR 35,489, associated with gains of 0.50 LYw/DFU and 0.16 QALY. TLC-NOSF dressings were established as the dominant strategy in the base case and all sensitivity analyses. Furthermore, the model revealed that, for every 100 patients treated with TLC-NOSF dressings, two amputations could be avoided. According to the subgroup analysis results, the sooner the TLC-NOSF treatment was initiated, the better were the outcomes, with the highest benefits for ulcers with a duration of two months or less (+0.65 LYw/DFU, +0.23 QALY, and cost savings of EUR 55,710). The results from the French perspective are consistent with the ones from the German and British perspectives. TLC-NOSF dressings are cost-saving compared to neutral dressings, leading to an increase in patients' health benefits and a decrease in the associated treatment costs. These results can thus be used to guide healthcare decisionmakers. The potential savings could represent EUR 3,345 per treated patient per year and even reach EUR 4,771 when TLC-NOSF dressings are used as first line treatment. The EXPLORER trial is registered with ClinicalTrials.gov, number NCT01717183.
本研究从法国集体角度评估了 Technology Lipido-Colloid with Nano Oligo Saccharide Factor (TLC-NOSF) 伤口敷料与中性敷料在治疗糖尿病足溃疡 (DFU) 方面的成本效益。我们使用马尔可夫微模拟队列模型来模拟终生范围内 DFU 的每月进展情况。我们的研究采用混合方法设计，模型输入包括干预性和观察性研究、法国数据库和专家意见的数据。模拟人群的人口统计学特征和临床疗效基于 EXPLORER 双盲随机对照试验。健康相关生活质量、成本和资源使用输入取自与法国背景相关的文献。主要结果包括无 DFU 的生命年 (LYsw/DFU)、质量调整生命年 (QALY)、截肢和终生成本。为了评估结果的稳健性，根据治疗开始时的伤口持续时间进行了敏感性和亚组分析。使用 TLC-NOSF 敷料治疗可使每位患者的总成本节省 35,489 欧元，同时获得 0.50 LYw/DFU 和 0.16 QALY 的增益。在基础病例和所有敏感性分析中，TLC-NOSF 敷料被确定为占主导地位的策略。此外，模型表明，每治疗 100 名 TLC-NOSF 敷料患者，就可以避免两次截肢。根据亚组分析结果，TLC-NOSF 治疗开始得越早，结果越好，对于持续时间为两个月或更短的溃疡，获益最高(+0.65 LYw/DFU、+0.23 QALY 和 55,710 欧元的成本节省)。从法国角度得出的结果与德国和英国角度的结果一致。与中性敷料相比，TLC-NOSF 敷料具有成本效益，可提高患者的健康效益，并降低相关治疗成本。因此，这些结果可用于指导医疗保健决策者。潜在节省额可能为每位治疗患者每年 3,345 欧元，当 TLC-NOSF 敷料作为一线治疗时，甚至可达到 4,771 欧元。EXPLORER 试验在 ClinicalTrials.gov 注册，编号为 NCT01717183。
