Comparative Effectiveness and Cost Effectiveness of a Multitarget Stool DNA Test to Screen for Colorectal Neoplasia

BACKGROUND & AIMS: We developed a model to determine whether a multitarget stool DNA (MT-sDNA) test that detects colorectal cancer (CRC) and polyps with higher sensitivity and lower specificity, but at a higher cost, than the fecal immunochemical test (FIT) can be used in screening. METHODS: We used a Markov model of average-risk CRC screening to compare the effectiveness and cost effectiveness of screening with the MT-sDNA test vs FIT or colonoscopy. We accounted for the complex longitudinal participation patterns observed in organized programs vs opportunistic screening, as well as organized programs' patient support costs and differential payment rates by commercial insurers vs Medicare. RESULTS: With optimal adherence, yearly FIT and colonoscopy every 10 years were dominant (more effective and less costly) than MT-sDNA every 3 years. Compared with successful organized FIT programs (50% consistent and 27% intermittent participation; patient support costs, $153/cycle), the patient support program for the MT-sDNA test would need 68% of subjects to participate consistently and 32% to participate intermittently every 3 years, or the MT-sDNA test would need to cost 60% less than in the base case ($260 commercial payment and $197 Medicare payment), for the MT-sDNA test to be preferred over FIT at a threshold of $100,000 per quality-adjusted life-year (QALY) gained. Compared with opportunistic yearly FIT screening (15% consistent and 30% intermittent participation), performing the MT-sDNA test every 3 years would cost less than $100,000 per QALY gained if the MT-sDNA test achieved a participation rate more than 1.7-fold that of FIT. The results were robust in sensitivity analyses. Assuming equal participation across strategies and a threshold of $100,000 per QALY gained, FIT was preferred in 99.3% of iterations in Monte Carlo simulation. CONCLUSIONS: In a Markov model, we found FIT and colonoscopy to be more effective and less costly than the MT-sDNA test when participation rates were equal for all strategies. For the MT-sDNA test to be cost effective, the patient support program included in its cost would need to achieve substantially higher participation rates than those of FIT, whether in organized programs or under the opportunistic screening setting that is more common in the United States than in the rest of the world.