Medical Practice Evaluation Center, Massachusetts General Hospital, Boston, Massachusetts, USA.
Division of Pulmonary and Critical Care Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.
Clin Infect Dis. 2021 Oct 5;73(7):e2077-e2085. doi: 10.1093/cid/ciaa1698.
A novel urine lipoarabinomannan assay (FujiLAM) has higher sensitivity and higher cost than the first-generation AlereLAM assay. We evaluated the cost-effectiveness of FujiLAM for tuberculosis testing among hospitalized people with human immunodeficiency virus (HIV), irrespective of symptoms.
We used a microsimulation model to project clinical and economic outcomes of 3 testing strategies: (1) sputum Xpert MTB/RIF (Xpert), (2) sputum Xpert plus urine AlereLAM (Xpert+AlereLAM), (3) sputum Xpert plus urine FujiLAM (Xpert+FujiLAM). The modeled cohort matched that of a 2-country clinical trial. We applied diagnostic yields from a retrospective study (yields for Xpert/Xpert+AlereLAM/Xpert+FujiLAM among those with CD4 <200 cells/µL: 33%/62%/70%; among those with CD4 ≥200 cells/µL: 33%/35%/47%). Costs of Xpert/AlereLAM/FujiLAM were US$15/3/6 (South Africa) and $25/3/6 (Malawi). Xpert+FujiLAM was considered cost-effective if its incremental cost-effectiveness ratio (US$/year-of-life saved) was <$940 (South Africa) and <$750 (Malawi). We varied key parameters in sensitivity analysis and performed a budget impact analysis of implementing FujiLAM countrywide.
Compared with Xpert+AlereLAM, Xpert+FujiLAM increased life expectancy by 0.2 years for those tested in South Africa and Malawi. Xpert+FujiLAM was cost-effective in both countries. Xpert+FujiLAM for all patients remained cost-effective compared with sequential testing and CD4-stratified testing strategies. FujiLAM use added 3.5% (South Africa) and 4.7% (Malawi) to 5-year healthcare costs of tested patients, primarily reflecting ongoing HIV treatment costs among survivors.
FujiLAM with Xpert for tuberculosis testing in hospitalized people with HIV is likely to increase life expectancy and be cost-effective at the currently anticipated price in South Africa and Malawi. Additional studies should evaluate FujiLAM in clinical practice settings.
新型尿液脂阿拉伯甘露聚糖检测（FujiLAM）比第一代 AlereLAM 检测具有更高的灵敏度和更高的成本。我们评估了 FujiLAM 在住院的人类免疫缺陷病毒（HIV）感染者中进行结核病检测的成本效益，无论症状如何。
我们使用微观模拟模型来预测 3 种检测策略的临床和经济结果：（1）痰液 Xpert MTB/RIF（Xpert），（2）痰液 Xpert 加尿液 AlereLAM（Xpert+AlereLAM），（3）痰液 Xpert 加尿液 FujiLAM（Xpert+FujiLAM）。建模队列与一项 2 国临床试验相匹配。我们应用了一项回顾性研究的诊断效果（在 CD4<200 个/µL 的患者中，Xpert/Xpert+AlereLAM/Xpert+FujiLAM 的检出率：33%/62%/70%；在 CD4≥200 个/µL 的患者中：33%/35%/47%）。Xpert/AlereLAM/FujiLAM 的成本分别为 15 美元/3 美元/6 美元（南非）和 25 美元/3 美元/6 美元（马拉维）。如果 Xpert+FujiLAM 的增量成本效益比（US$/年生命延长）低于 940 美元（南非）和 750 美元（马拉维），则认为其具有成本效益。我们在敏感性分析中改变了关键参数，并对全国范围内实施 FujiLAM 的预算影响进行了分析。
与 Xpert+AlereLAM 相比，在南非和马拉维接受检测的患者中，Xpert+FujiLAM 使预期寿命延长了 0.2 年。Xpert+FujiLAM 在这两个国家都具有成本效益。与序贯检测和 CD4 分层检测策略相比，对所有患者进行 Xpert+FujiLAM 检测仍然具有成本效益。FujiLAM 的使用使接受检测的患者在 5 年内的医疗保健费用增加了 3.5%（南非）和 4.7%（马拉维），主要反映了幸存者持续的 HIV 治疗费用。
在南非和马拉维，住院的 HIV 感染者使用 Xpert 联合 FujiLAM 进行结核病检测，可能会延长预期寿命，并具有成本效益，预计目前的价格是合理的。还需要进一步的研究来评估 FujiLAM 在临床实践环境中的应用。
