Abstract

(FOBT), fecal immunochemical testing (FIT), sigmoidoscopy and colonoscopy accounting for suboptimal screening uptake and longitudinal adherence to screening. Average risk persons were screened from ages 50-80 and followed until age 100 or death. Base case inputs derived from the PRESEPT study, a multicenter prospective investigation of mSEPT9 in the CRC screening environment, included: 3-well mSEPT9 sensitivity for small adenoma 10%, large adenoma 14%, localized CRC 51%, regional CRC 75%; specificity 88%; cost $150. Base Case Results: Under optimal uptake and adherence, mSEPT9 every 2 years decreased CRC incidence by 41% and CRC mortality by 61% at a cost of $8,400/quality-adjusted life year (QALY) gained vs. no screening. FIT was cost-saving and dominant over other strategies, and all other strategies were more effective than mSEPT9 (Table). Sensitivity Analyses: Under suboptimal uptake, mSEPT9 became more effective than FIT at a relative FIT uptake rate of ≤85% vs. mSEPT9. mSEPT9 was cost-effective vs. FIT at <$50,000/QALY gained at a relative FIT uptake rate of ≤60% vs. mSEPT9. Among persons taking up screening, assuming per-cycle adherence of 75% for mSEPT9, mSEPT9 cost <$50,000/QALY gained vs. FIT if per-cycle adherence of FIT was ≤25%. The costs of colonoscopy and CRC care were the most influential variables on the cost-effectiveness of all strategies. At the population level, mSEPT9 yielded the greatest incremental benefit at acceptable costs when it increased the fraction of the population screened, as opposed to substituting for current strategies. Conclusions: mSEPT9 appears effective and cost-effective compared with no screening. In order to be cost-effective vs. established strategies, mSEPT9 would need to achieve substantially higher uptake and adherence than the alternatives. At the population level, mSEPT9 may be an effective and cost-effective strategy if it reduced the proportion of currently unscreened persons. It remains to be proven whether CRC screening with a blood test can improve screening uptake or adherence.

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