Department of Public Health, Erasmus University Medical Centre, Rotterdam, The Netherlands.
Department of Public Health, Erasmus University Medical Centre, Rotterdam, The Netherlands.
Clin Gastroenterol Hepatol. 2018 Apr;16(4):504-512.e11. doi: 10.1016/j.cgh.2017.07.011. Epub 2017 Jul 18.
BACKGROUND & AIMS: Biomarker assays could increase the accuracy of noninvasive detection of colorectal cancer (CRC); fecal immunochemical tests (FITs) are estimated to miss 27%-47% of CRCs and 70%-80% of advanced adenomas per round of screening. We investigated the conditions under which biomarker screens would be cost-effective compared with FIT screens of average-risk individuals.
We used the MISCAN-Colon microsimulation model to estimate the effects of various CRC screening test characteristics on life-years gained (LYG) and; age-specific all-cause mortality was based on the 2010 Dutch life tables. Simulated CRC incidence rate and CRC stage distribution were calibrated to observed data in The Netherlands from 1999 through 2003 (before opportunities for screening). Survival rates after diagnosis of CRC at an age younger than 75 years were based on CRC relative survival data from 1985 through 2004; survival for individuals diagnosed at an age of 75 years or older was adjusted to fit the observed age-increasing mortality/incidence ratio. We modeled FIT along with hypothetical biomarker tests with different test performance levels. For each biomarker test we calculated the maximum unit cost for the test to be cost-effective compared with FIT, assuming a willingness-to-pay threshold of €50,000 ($56,000) per LYG.
Biennial FIT screening of subjects 55-75 years old provided 84.9 LYG at a cost of €122,000 ($137,000) per 1000 participants. Considering a unit cost of €7 ($8) for FIT (including kit and analysis only, excluding organizational costs), a biomarker test that detects CRC with higher levels of specificity and sensitivity (100%) and advanced adenomas at a proportionally higher level of sensitivity (53%) should never exceed a cost of €51 ($57). The threshold cost could increase to more than €200 ($224) for high-performing biomarker tests in cases of limited colonoscopy capacity or higher uptake of this test.
By using the MISCAN-Colon microsimulation model to estimate effects of CRC screening tests, we found that for a biomarker test with increased overall performance to be cost-effective, it should not exceed 7-fold the unit cost of FIT. This maximum would increase substantially if colonoscopy becomes more expensive or scarce, or if the new test has higher screening uptake. These values could be used to estimate the added value of new biomarkers compared with current FIT screening.
生物标志物检测可提高非侵入性检测结直肠癌（CRC）的准确性；粪便免疫化学检测（FIT）估计每轮筛查会遗漏 27%-47%的 CRC 和 70%-80%的高级腺瘤。我们研究了在何种条件下，与平均风险个体的 FIT 筛查相比，生物标志物筛查具有成本效益。
我们使用 MISCAN-Colon 微观模拟模型来估计各种 CRC 筛查测试特征对获得的生命年（LYG）的影响；年龄特异性全因死亡率基于 2010 年荷兰生命表。模拟 CRC 发病率和 CRC 分期分布根据 1999 年至 2003 年（筛查机会之前）荷兰的观察数据进行校准。75 岁以下诊断 CRC 的患者的生存率基于 1985 年至 2004 年的 CRC 相对生存率数据；对于 75 岁或以上诊断的患者，生存调整以适应观察到的随年龄增加的死亡率/发病率比值。我们对 FIT 以及具有不同测试性能水平的假设生物标志物测试进行了建模。对于每种生物标志物测试，我们计算了与 FIT 相比最具成本效益的测试的最大单位成本，假设支付意愿阈值为每获得 1 个 LYG 支付 50,000 欧元（56,000 美元）。
对 55-75 岁的受试者进行两年一次的 FIT 筛查，每 1000 名参与者的成本为 122,000 欧元（137,000 美元），可获得 84.9 个 LYG。考虑到 FIT 的单位成本为 7 欧元（8 美元）（仅包括试剂盒和分析，不包括组织成本），检测 CRC 的特异性和敏感性更高（100%）以及高级腺瘤的敏感性更高（53%）的生物标志物检测不应超过 51 欧元（57 美元）的成本。如果结肠镜检查的费用更高或更稀缺，或者如果新测试的筛查率更高，那么高绩效生物标志物测试的阈值成本可能会增加到 200 欧元（224 美元）以上。
通过使用 MISCAN-Colon 微观模拟模型来估计 CRC 筛查测试的效果，我们发现，对于具有更高整体性能的生物标志物测试，其成本效益不应超过 FIT 的单位成本的 7 倍。如果结肠镜检查变得更加昂贵或稀缺，或者新测试的筛查率更高，这个最大值将大幅增加。这些值可用于估计与当前的 FIT 筛查相比，新生物标志物的附加值。
