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日本代谢相关脂肪性肝病(MASLD)伴糖尿病患者,根据肥胖程度和向肝硬化进展进行风险分层的肝细胞癌筛查:成本效益研究。

Risk-stratified hepatocellular carcinoma screening according to the degree of obesity and progression to cirrhosis for diabetic patients with metabolic dysfunction-associated steatotic liver disease (MASLD) in Japan: a cost-effectiveness study.

机构信息

Kitasato University Graduate School of Medical Sciences, Sagamihara, Kanagawa, Japan

出版信息

BMJ Open. 2024 Nov 5;14(11):e080549. doi: 10.1136/bmjopen-2023-080549.

Abstract

OBJECTIVE

To evaluate the cost-effectiveness of risk-stratified hepatocellular carcinoma (HCC) screening in diabetic patients with metabolic dysfunction-associated steatotic liver disease (MASLD).

DESIGN

A state-transition model from a healthcare payer perspective on a lifetime horizon.

SETTING

Japan.

POPULATION

A hypothetical cohort of 50-year-old diabetic patients with MASLD risk-stratified according to degree of obesity and progression to cirrhosis. Metabolic dysfunction-associated steatotic liver (MASL), metabolic dysfunction-associated steatohepatitis (MASH) and MASH cirrhosis are progressive manifestations of this specific type of liver disease.

INTERVENTION

Abdominal ultrasound (US), US with alpha-fetoprotein (AFP), US with AFP and lectin-reactive alpha-fetoprotein (AFP-L3), CT, extracellular contrast-media-enhanced MRI (ECCM-MRI), gadoxetic acid-enhanced MRI (EOB-MRI) and no screening.

MAIN OUTCOME MEASURE

Costs, quality-adjusted life-years (QALYs), incremental cost-effectiveness ratios (ICERs), early-stage HCC cases, advanced-stage HCC cases and HCC-related deaths.

RESULTS

EOB-MRI is the most cost-effective screening method for non-obese diabetic patients with MASH cirrhosis and for obese diabetic patients with MASH and MASH cirrhosis. Cost-effectiveness was sensitive to HCC incidence in non-obese diabetic patients with MASH cirrhosis and obese diabetic patients with MASH, and the adherence rate of HCC screening in obese diabetic patients with MASH. When the semiannual HCC incidence was between 0.008 and 0.0138 in non-obese diabetic patients with MASH cirrhosis, US with AFP was more cost-effective than EOB-MRI. Cost-effectiveness acceptability curves showed that EOB-MRI was 50.7%, 96.0% and 99.9% cost-effective in obese diabetic patients with MASH and non-obese diabetic patients with MASH cirrhosis, and obese diabetic patients with MASH cirrhosis at a willingness-to-pay level of $50 000 per QALY gained. Compared with no screening in 100 000 non-obese diabetic patients with MASH cirrhosis and obese diabetic patients with MASH cirrhosis, EOB-MRI reduced total costs by US$69 million and by US$142 million, increased lifetime effectiveness by 12 546 QALYs and by 15 815 QALYs, detected 17 873 and 21 014 early-stage HCC cases, and averted 2068 and 2471 HCC-related deaths, respectively.

CONCLUSIONS

Of all HCC screening methods for diabetic patients with MASH cirrhosis, EOB-MRI yields the greatest cost-saving with the highest QALYs, detects the greatest number of early-stage HCC cases and averts the greatest number of advanced-stage HCC cases and HCC-related deaths. The findings provide important insights for the precise implementation of risk-stratified HCC surveillance to reduce morbidity and mortality and improve the quality of life in diabetic patients with MASLD.

摘要

目的

评估代谢相关脂肪性肝病伴肝纤维化(MASLD)合并糖尿病患者采用风险分层肝细胞癌(HCC)筛查的成本效益。

设计

基于终生时间范围的状态转移模型,从医疗保健支付方角度进行分析。

设置

日本。

人群

50 岁合并 MASLD 风险分层的糖尿病患者队列,依据肥胖程度和进展为肝硬化的情况进行分层。代谢相关脂肪性肝病(MASL)、代谢相关脂肪性肝炎(MASH)和 MASH 肝硬化是该特定类型肝病的进展表现。

干预

腹部超声(US)、US 联合甲胎蛋白(AFP)、US 联合 AFP 和凝集素反应性 AFP(AFP-L3)、CT、细胞外对比剂增强 MRI(ECCM-MRI)、钆塞酸增强 MRI(EOB-MRI)和不进行筛查。

主要结局测量指标

成本、质量调整生命年(QALYs)、增量成本效益比(ICER)、早期 HCC 病例数、晚期 HCC 病例数和 HCC 相关死亡数。

结果

EOB-MRI 是针对非肥胖合并 MASH 肝硬化的糖尿病患者和肥胖合并 MASH 及 MASH 肝硬化的糖尿病患者最具成本效益的筛查方法。成本效益对非肥胖合并 MASH 肝硬化的糖尿病患者的 HCC 发生率和肥胖合并 MASH 的糖尿病患者的 HCC 筛查依从率敏感。当非肥胖合并 MASH 肝硬化的糖尿病患者的 HCC 半年发生率在 0.008 至 0.0138 之间时,US 联合 AFP 比 EOB-MRI 更具成本效益。成本效益可接受性曲线显示,EOB-MRI 在肥胖合并 MASH 及非肥胖合并 MASH 肝硬化的糖尿病患者中,分别有 50.7%、96.0%和 99.9%的概率具有成本效益,在支付意愿为每 QALY 5 万美元的情况下,这一概率可提升至 100.0%。与非肥胖合并 MASH 肝硬化和肥胖合并 MASH 肝硬化的 100 000 例糖尿病患者不进行筛查相比,EOB-MRI 可降低 6900 万美元的总成本,增加 12546 个 QALYs 的终生效益,发现 17873 例和 21014 例早期 HCC 病例数,分别减少 2068 例和 2471 例 HCC 相关死亡数。

结论

在所有针对 MASH 肝硬化合并糖尿病患者的 HCC 筛查方法中,EOB-MRI 具有最大的成本节约,带来最高的 QALYs,检测到最大数量的早期 HCC 病例数,避免了最大数量的晚期 HCC 病例数和 HCC 相关死亡数。这些发现为实施风险分层 HCC 监测提供了重要依据,有助于降低发病率和死亡率,并改善 MASLD 合并糖尿病患者的生活质量。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f7c9/11552604/313104b9ef53/bmjopen-14-11-g001.jpg

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