Barry M Berger1, Paul C Schroy2, Tuan A Dinh3. 1. Exact Sciences Corporation, Madison, WI. Electronic address: bbexact@yahoo.com. 2. Department of Gastroenterology, Boston University School of Medicine, Boston, MA. 3. Archimedes Inc., San Francisco, CA.
Abstract
BACKGROUND: A multitarget stool DNA (mt-sDNA) test was recently approved for colorectal cancer (CRC) screening for men and women, aged ≥ 50 years, at average risk of CRC. The guidelines currently recommend a 3-year interval for mt-sDNA testing in the absence of empirical data. We used clinical effectiveness modeling to project decreases in CRC incidence and related mortality associated with mt-sDNA screening to help inform interval setting. MATERIALS AND METHODS: The Archimedes model (Archimedes Inc., San Francisco, CA) was used to conduct a 5-arm, virtual, clinical screening study of a population of 200,000 virtual individuals to compare the clinical effectiveness of mt-sDNA screening at 1-, 3-, and 5-year intervals compared with colonoscopy at 10-year intervals and no screening for a 30-year period. The study endpoints were the decrease in CRC incidence and related mortality of each strategy versus no screening. Cost-effectiveness ratios (US dollars per quality-adjusted life year [QALY]) of mt-sDNA intervals were calculated versus no screening. RESULTS: Compared with 10-year colonoscopy, annual mt-sDNA testing produced similar reductions in CRC incidence (65% vs. 63%) and related mortality (73% vs. 72%). mt-sDNA testing at 3-year intervals reduced the CRC incidence by 57% and CRC mortality by 67%, and mt-sDNA testing at 5-year intervals reduced the CRC incidence by 52% and CRC mortality by 62%. At an average price of $600 per test, the annual, 3-year, and 5-year mt-sDNA screening costs would be $20,178, $11,313, and $7388 per QALY, respectively, compared with no screening. CONCLUSION: These data suggest that screening every 3 years using a multitarget mt-sDNA test provides reasonable performance at acceptable cost.
BACKGROUND: A multitarget stool DNA (mt-sDNA) test was recently approved for colorectal cancer (CRC) screening for men and women, aged ≥ 50 years, at average risk of CRC. The guidelines currently recommend a 3-year interval for mt-sDNA testing in the absence of empirical data. We used clinical effectiveness modeling to project decreases in CRC incidence and related mortality associated with mt-sDNA screening to help inform interval setting. MATERIALS AND METHODS: The Archimedes model (Archimedes Inc., San Francisco, CA) was used to conduct a 5-arm, virtual, clinical screening study of a population of 200,000 virtual individuals to compare the clinical effectiveness of mt-sDNA screening at 1-, 3-, and 5-year intervals compared with colonoscopy at 10-year intervals and no screening for a 30-year period. The study endpoints were the decrease in CRC incidence and related mortality of each strategy versus no screening. Cost-effectiveness ratios (US dollars per quality-adjusted life year [QALY]) of mt-sDNA intervals were calculated versus no screening. RESULTS: Compared with 10-year colonoscopy, annual mt-sDNA testing produced similar reductions in CRC incidence (65% vs. 63%) and related mortality (73% vs. 72%). mt-sDNA testing at 3-year intervals reduced the CRC incidence by 57% and CRC mortality by 67%, and mt-sDNA testing at 5-year intervals reduced the CRC incidence by 52% and CRC mortality by 62%. At an average price of $600 per test, the annual, 3-year, and 5-year mt-sDNA screening costs would be $20,178, $11,313, and $7388 per QALY, respectively, compared with no screening. CONCLUSION: These data suggest that screening every 3 years using a multitarget mt-sDNA test provides reasonable performance at acceptable cost.
Authors: Derek W Ebner; Jason D Eckmann; Kelli N Burger; Douglas W Mahoney; Thomas J Whitaker; Ivy A Petersen; John B Kisiel Journal: Gastro Hep Adv Date: 2022-05-16
Authors: Derek W Ebner; Jason D Eckmann; Kelli N Burger; Douglas W Mahoney; Jamie Bering; Allon Kahn; Eduardo A Rodriguez; David O Prichard; Michael B Wallace; Sunanda V Kane; Lila J Finney Rutten; Suryakanth R Gurudu; John B Kisiel Journal: Clin Transl Gastroenterol Date: 2021-06-18 Impact factor: 4.488