Novel Noninvasive Tests for Colorectal Cancer Screening - A Cost-Effectiveness Analysis.

Background: To compare cost-effectiveness of three novel noninvasive tests [multitarget stool RNA (mt-sRNA), multitarget stool DNA 2.0, and cell-free DNA] with guideline-recommended tests for colorectal cancer screening from payer's perspective.

Methods: Outcomes of a hypothetical cohort of 100,000 individuals aged 45 years with average colorectal cancer risk (no prior colorectal cancer diagnosis, adenomatous polyps, or other disorders associated with a high lifetime risk of colorectal cancer) in the United States were simulated by a lifelong Markov model. Screening strategies included guideline-recommended strategies (colonoscopy, flexible sigmoidoscopy, computed tomographic colonography, fecal immunochemical test, high-sensitivity guaiac-based fecal occult blood testing, and multitarget stool DNA), three novel noninvasive tests, and no screening. Scenario analyses on perfect (100%) and test-specific adherence (reported real-world adherence) were conducted. Outcomes included direct cost, quality-adjusted life-years (QALY), and incremental cost-effectiveness ratios (ICER).

Results: All screening strategies (vs. no screening) reduced colorectal cancer cases and deaths. In the perfect adherence scenario, every-10-year colonoscopy was the preferred strategy (ICER = US$261/QALY). In the test-specific adherence scenario, every-3-year mt-sRNA was the preferred cost-effective strategy (ICER = US $95,250/QALY). Testing cost, performance, adherence, and colorectal cancer prevalence, progression rate, and utility were influential factors. Every-3-year mt-sRNA showed the highest probability (37.6%) to be cost-effective in the test-specific adherence scenario at a willingness to pay US $100,000/QALY.

Conclusions: All strategies were cost-effective compared with no screening. Every-3-year mt-sRNA (preferred strategy in the real-world adherence scenario) provides a cost-effective alternative when adherence to colorectal cancer screening or follow-up was not perfect in clinical practice.

Impact: This is the first study to demonstrate cost-effectiveness of novel noninvasive tests versus all guideline-recommended colorectal cancer screening tests. See related In the Spotlight, p. 1053.