Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, California; Division of Digestive and Liver Diseases, Cedars-Sinai Medical Center, Los Angeles, California; Division of Health Services Research, Cedars-Sinai Medical Center, Los Angeles, California; Cedars-Sinai Center for Outcomes Research and Education (CS-CORE), Los Angeles, California.
Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, California; Cedars-Sinai Center for Outcomes Research and Education (CS-CORE), Los Angeles, California.
Clin Gastroenterol Hepatol. 2018 Sep;16(9):1434-1441.e21. doi: 10.1016/j.cgh.2018.03.025. Epub 2018 Mar 27.
BACKGROUND & AIMS: Diagnosis of diarrhea-predominant irritable bowel syndrome (IBS-D) relies on the Rome IV symptom-based criteria, which are imperfect for separating functional vs organic disease. Biomarker tests for IBS-D might be added to symptom data to allow clinicians to make more accurate and precise diagnoses in a cost-effective manner. We tested the economic consequences of using a range of hypothetical IBS-D biomarkers, and explored at what cost and level of accuracy a biomarker becomes cost effective. We produced a framework for payers to evaluate the return on an investment of implementing IBS-D biomarkers of varying accuracy and cost.
We used decision analysis software to evaluate a hypothetical cohort of patients who met Rome IV criteria for IBS-D. We conducted cost-utility and budget impact analyses of 2 competing approaches: usual care or an IBS biomarker-based diagnostic approach. Patients in the usual care group received empiric IBS treatment; non-responders received additional diagnostic tests for organic disease. In the group evaluated with a biomarker test, those with a positive result received IBS treatment before additional diagnostic analyses, whereas patients with a negative result underwent upfront diagnostic testing. Outcomes were incremental cost per quality-adjusted life year gained (third-party payer perspective) and incremental per-member per-month cost.
In the base-case analysis, using a willingness-to-pay threshold of $100,000/quality-adjusted life year, we found that biomarkers are not cost effective when the biomarker test costs more than $846, even if the test is 100% accurate in detecting IBS-D. In probabilistic analysis using 1,000 simulations, most trials (75% or more) show that the biomarker-based diagnostic approach is cost effective above the following accuracy thresholds: a $100 biomarker test with 51% accuracy, a $200 test with 57% accuracy, a $300 test with 63% accuracy, a $400 test with 69% accuracy, a $500 test with 76% accuracy, a $600 test with 82% accuracy, a $700 test with 89% accuracy, and a $800 test with 94% accuracy.
In decision analysis of a hypothetical cohort of patients who met Rome IV criteria for IBS-D, we identified cost and accuracy thresholds that can guide investigators and payers as they develop, validate, price, and/or reimburse IBS-D biomarker tests for use in everyday clinical practice.
腹泻型肠易激综合征（IBS-D）的诊断依赖于基于罗马 IV 症状的标准，这些标准对于区分功能性疾病与器质性疾病并不完美。用于 IBS-D 的生物标志物检测可以与症状数据结合使用，以帮助临床医生以更具成本效益的方式做出更准确和精确的诊断。我们测试了使用一系列假设的 IBS-D 生物标志物的经济后果，并探讨了生物标志物在何种成本和准确性水平下具有成本效益。我们为支付者制作了一个框架，以评估实施具有不同准确性和成本的 IBS-D 生物标志物的投资回报。
我们使用决策分析软件评估符合罗马 IV IBS-D 标准的假设患者队列。我们对两种竞争方法进行了成本-效用和预算影响分析：常规护理或 IBS 生物标志物诊断方法。常规护理组的患者接受经验性 IBS 治疗；非应答者接受器质性疾病的额外诊断测试。在接受生物标志物测试的组中，阳性结果的患者在接受额外的诊断分析之前接受 IBS 治疗，而阴性结果的患者则进行预先的诊断测试。结果是每获得一个质量调整生命年的增量成本（第三方支付者视角）和每成员每月的增量成本。
在基础案例分析中，使用 100,000 美元/质量调整生命年的意愿支付阈值，我们发现当生物标志物测试成本超过 846 美元时，即使该测试在检测 IBS-D 方面的准确率达到 100%，生物标志物也不具有成本效益。在使用 1,000 次模拟的概率分析中，大多数试验（75%或更多）表明，在以下准确性阈值之上，基于生物标志物的诊断方法具有成本效益：100 美元的生物标志物测试，准确率为 51%；200 美元的测试，准确率为 57%；300 美元的测试，准确率为 63%；400 美元的测试，准确率为 69%；500 美元的测试，准确率为 76%；600 美元的测试，准确率为 82%；700 美元的测试，准确率为 89%；800 美元的测试，准确率为 94%。
在对符合罗马 IV IBS-D 标准的假设患者队列进行决策分析中，我们确定了成本和准确性阈值，这可以为研究人员和支付者在开发、验证、定价和/或报销用于日常临床实践的 IBS-D 生物标志物测试时提供指导。
