Cost-effectiveness of novel noninvasive screening tests for colorectal neoplasia.

Abstract

Background and aims: This study assessed the economic and health impact of colorectal cancer (CRC) screening programs for average-risk individuals aged 45 and older.

Methods: A 10-year Markov model simulated disease progression, comparing multitarget stool RNA test (mt-sRNA, ColoSense®), two mt-sDNA tests (Cologuard® and Cologuard Plus®), a blood-based test (cfDNA, Shield), and a fecal immunochemical test (FIT). Clinical inputs leveraged age-weighted sensitivity and specificity from independent studies. Outcomes were compared to a colonoscopy-based program and no screening. Model calibration and validation used previously reported CISNET models.

Results: Among molecular tests, mt-sRNA detected the most advanced adenomas, referred the most individuals to surveillance, and prevented the highest number of CRC cases and deaths. At real-world adherence of 60%, mt-sRNA reduced CRC cases and deaths by 1% and 14% compared to FIT; 21% and 19% compared to mt-sDNA; 28% and 23% compared to mt-sDNA+; and 80% and 86% compared to cfDNA. For all adherence levels, FIT ($25/test) was the most cost effective strategy. For triennial molecular tests ($508/test), mt-sRNA was the most cost effective strategy. Relative to the mt-sRNA program, the cost to prevent a CRC case was 30% (mt-sDNA), 45% (mt-sDNA+), and 642% (cfDNA) more expensive. Relative to the mt-sRNA program, the cost to prevent a CRC death was 30% (mt-sDNA), 41% (mt-sDNA+), and 1,040% (cfDNA) more expensive.

Conclusions: FIT was the most cost-effective strategy for preventing CRC cases and deaths. At real-world adherence of 60%, mt-sRNA demonstrated the greatest clinical benefit and was more cost-effective than other molecular strategies.