CMS COVERAGE DECISION: IMPLICATIONS FOR COST-EFFECITVENESS OF BLOOD-BASED COLORECTAL CANCER SCREENING

Background and aims
A blood-based colorectal cancer (CRC) screening test may increase screening participation. However, blood-based screening tests may be less effective than current guideline-endorsed options. The Centers for Medicare & Medicaid Services (CMS) issued a coverage decision that states that triennial blood-based screening tests for individuals aged 50-85 will be covered if the blood test meets a minimum performance sensitivity of 74% for detection of CRC and specificity of 90%, and if the test is FDA approved. 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, SimCRC) were used to estimate the effectiveness and cost-effectiveness of triennial blood-based screening (from age 45 to 75 years) compared to no screening, annual fecal immunochemical testing (FIT), and 10-yearly colonoscopy screening (from age 45 to 75 years). The minimum performance characteristics of the CMS coverage criteria were used as performance characteristics of the blood test. A blood test was assumed to cost $500 per test and was assumed to have a disutility equal to that of a FIT. In a one-way sensitivity analysis, we also varied screening ages for blood-based screening (age 50 to 85, in line with the CMS recommendation), test performance characteristics (i.e., that of the Epi proColon and Shield test), and screening uptake (60, 70 and 80%).
Results
Without screening, the models predicted 77-88 CRC cases and 32-36 CRC deaths per 1,000 individuals, costing $5.3-5.8 million (Figure 1). 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) (Figure 2). However, compared to annual FIT and to 10-yearly 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 QALYs gained) and less costly (-$3.2-3.5 million) than blood-based screening even when uptake of blood-based screening was assumed to be 20 percentage-points higher than uptake of FIT. The Epi proColon test performed best among the blood tests, but was still less effective and considerably more costly than FIT screening.
Conclusion
In an otherwise unscreened population, CRC screening with blood tests is likely to be cost-effective. However, compared with currently recommended annual FIT screening and 10-yearly colonoscopy screening, blood-based screening would result in lower effect and higher costs. 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 FIT screening and colonoscopy screening.