基于满足医疗保险和医疗补助服务中心覆盖范围决策的血液检测进行结直肠癌筛查的效果和成本效益。
Effectiveness and Cost-Effectiveness of Colorectal Cancer Screening With a Blood Test That Meets the Centers for Medicare & Medicaid Services Coverage Decision.
机构信息
Department of Public Health, Erasmus MC, University Medical Center, Rotterdam, the Netherlands.
RAND Corporation, Arlington, Virginia.
出版信息
Gastroenterology. 2024 Jul;167(2):368-377. doi: 10.1053/j.gastro.2024.02.012. Epub 2024 Mar 26.
BACKGROUND & AIMS: A blood-based colorectal cancer (CRC) screening test may increase screening participation. However, blood tests may be less effective than current guideline-endorsed options. The Centers for Medicare & Medicaid Services (CMS) covers blood tests with sensitivity of at least 74% for detection of CRC and specificity of at least 90%. In this study, we investigate whether a blood test that meets these criteria is cost-effective.
METHODS
Three microsimulation models for CRC (MISCAN-Colon, CRC-SPIN, and SimCRC) were used to estimate the effectiveness and cost-effectiveness of triennial blood-based screening (from ages 45 to 75 years) compared to no screening, annual fecal immunochemical testing (FIT), triennial stool DNA testing combined with an FIT assay, and colonoscopy screening every 10 years. The CMS coverage criteria were used as performance characteristics of the hypothetical blood test. We varied screening ages, test performance characteristics, and screening uptake in a sensitivity analysis.
RESULTS
Without screening, the models predicted 77-88 CRC cases and 32-36 CRC deaths per 1000 individuals, costing $5.3-$5.8 million. Compared to no screening, blood-based screening was cost-effective, with an additional cost of $25,600-$43,700 per quality-adjusted life-year gained (QALYG). However, compared to FIT, triennial stool DNA testing combined with FIT, and colonoscopy, blood-based screening was not cost-effective, with both a decrease in QALYG and an increase in costs. FIT remained more effective (+5-24 QALYG) and less costly (-$3.2 to -$3.5 million) than blood-based screening even when uptake of blood-based screening was 20 percentage points higher than uptake of FIT.
CONCLUSION
Even with higher screening uptake, triennial blood-based screening, with the CMS-specified minimum performance sensitivity of 74% and specificity of 90%, was not projected to be cost-effective compared with established strategies for colorectal cancer screening.
背景与目的
基于血液的结直肠癌（CRC）筛查试验可能会增加筛查参与度。然而，血液检测的效果可能不如当前指南推荐的检测方法。医疗保险和医疗补助服务中心（CMS）涵盖了用于检测 CRC 的血液检测，其灵敏度至少为 74%，特异性至少为 90%。在这项研究中，我们调查了符合这些标准的血液检测是否具有成本效益。
方法
使用三种用于 CRC 的微观模拟模型（MISCAN-Colon、CRC-SPIN 和 SimCRC）来估计每三年进行一次基于血液的筛查（年龄在 45 岁至 75 岁之间）与不筛查、每年进行粪便免疫化学检测（FIT）、每三年进行一次粪便 DNA 检测与 FIT 联合检测，以及每 10 年进行一次结肠镜检查筛查相比的有效性和成本效益。CMS 的覆盖标准被用作假设血液检测的性能特征。我们在敏感性分析中改变了筛查年龄、检测性能特征和筛查参与率。
结果
不进行筛查时，模型预测每 1000 人中会出现 77-88 例 CRC 病例和 32-36 例 CRC 死亡病例，成本为 530 万至 5800 万美元。与不筛查相比，基于血液的筛查具有成本效益，每获得一个质量调整生命年（QALYG）增加的额外成本为 25600 美元至 43700 美元。然而，与 FIT、三联粪便 DNA 检测联合 FIT 以及结肠镜检查相比，基于血液的筛查不具有成本效益，因为 QALYG 下降，成本增加。即使基于血液的筛查的参与率比 FIT 高 20 个百分点，FIT 仍然更有效（增加 5-24 个 QALYG）且成本更低（节省 320 万至 3500 万美元）。
结论
即使提高筛查参与率，基于血液的筛查，灵敏度至少为 74%，特异性至少为 90%，也不能与结直肠癌筛查的既定策略相比具有成本效益。
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