Center for Medical Technology Assessment, Department of Health, Medicine and Caring Sciences, Linköping University, Sweden.
Division of Diagnostics and Specialist Medicine, Department of Health, and Caring Sciences, Linköping University, Sweden.
Hepatol Commun. 2023 Jun 22;7(7). doi: 10.1097/HC9.0000000000000191. eCollection 2023 Jul 1.
Advanced fibrosis is associated with end-stage liver disease (ESLD) and mortality in NAFLD. As treatments specifically targeted at NAFLD are lacking, patient management focuses on surveillance for early detection of complications related to end-stage liver disease. Although current and emerging diagnostic tools for the detection of advanced fibrosis are crucial for surveillance, their added value is unclear. The aim of this study was to evaluate the costs and health outcomes of noninvasive tests in patient management strategies for diagnosing advanced fibrosis in NAFLD patients.
A decision analytical model was developed to evaluate 13 patient management strategies, including a no-testing strategy and 12 diagnostic algorithms with noninvasive tests (fibrosis 4- score, enhanced liver fibrosis, vibration controlled transient elastography), and liver biopsy. Model inputs were synthesized from the literature and Swedish registries. Lifetime health care costs, life years, quality-adjusted life years, clinical outcomes, and incremental cost-effectiveness ratios were calculated for a cohort of 55-year-old patients diagnosed with NAFLD.
The cost per quality-adjusted life year was above €50 000 for all diagnostic algorithms compared to no-testing. The cost per quality-adjusted life year of the most promising diagnostic algorithm (fibrosis 4- score, enhanced liver fibrosis, vibration controlled transient elastography, and liver biopsy) was ∼ €181 000 compared with no testing. Sensitivity analysis indicated that if treatment slowed down disease progression, the value of testing increased.
The result questions the overall value of comprehensive diagnostic testing in a broad NAFLD population in current routine clinical care. The role of noninvasive tests may change if evidence-based treatments to slow down disease progression emerge.
在非酒精性脂肪性肝病（NAFLD）中，晚期纤维化与终末期肝病（ESLD）和死亡率相关。由于缺乏专门针对 NAFLD 的治疗方法，患者管理的重点是监测早期发现与终末期肝病相关的并发症。尽管目前和新兴的用于检测晚期纤维化的诊断工具对于监测至关重要，但它们的附加值尚不清楚。本研究旨在评估非侵入性检测在 NAFLD 患者诊断晚期纤维化的患者管理策略中的成本和健康结果。
开发了一个决策分析模型，以评估 13 种患者管理策略，包括无检测策略和 12 种具有非侵入性检测（纤维化 4 分、增强型肝纤维化、振动控制瞬态弹性成像）和肝活检的诊断算法。模型输入是从文献和瑞典登记处综合得出的。为一组 55 岁诊断为 NAFLD 的患者计算了终生医疗保健成本、生命年、质量调整生命年、临床结果和增量成本效益比。
与无检测相比，所有诊断算法的每质量调整生命年成本均超过 50,000 欧元。最有前途的诊断算法（纤维化 4 分、增强型肝纤维化、振动控制瞬态弹性成像和肝活检）的每质量调整生命年成本约为 181,000 欧元，与无检测相比。敏感性分析表明，如果治疗减缓了疾病进展，检测的价值就会增加。
该结果质疑了在当前常规临床护理中广泛的 NAFLD 人群中进行全面诊断检测的总体价值。如果出现减缓疾病进展的循证治疗方法，非侵入性检测的作用可能会发生变化。
