Authors' objectives:

"Despite recent declines in both incidence and mortality, colorectal cancer (CRC) is the second most common cause of cancer death in the United States. CRC screening reduced CRC mortality by 15-33% in randomized controlled trials with Hemoccult II fecal occult blood tests (FOBTs). Novel CRC screening technologies, such as the DNA stool test have been developed but need to be evaluated in terms of their comparability of diagnostic performance (sensitivity and specificity) in detecting adenomatous polyps and CRC, acceptability to patients, and test-related complications and costs. Accordingly, we conducted a cost-effectiveness analysis of the DNA stool test and other currently recommended CRC screening strategies." (from abstract)

Authors' results and conclusions: The screening benefit for the DNA stool test, measured in terms of life-years gained compared with no screening, was lower than that of annual Hemoccult II testing except for 3-year testing with version 1.1 (i.e., PreGen-PlusTM) and with a per-test cost of USD350, the overall costs were higher than all of the other screening strategies. All DNA stool test strategies considered were dominated by other recommended CRC screening tests. Screening with the DNA stool test version 1.1 would be cost-effective (i.e., be a non-dominated strategy) at per-test cost of USD34 to USD51 for 5-yearly DNA stool test screening and USD40 to USD60 for 3-yearly DNA stool testing, depending on the simulation model used. The threshold costs of the DNA stool test version 1.1 increased to USD163-USD187 for 5-yearly DNA stool testing if the test performance was at a level that was 50% between base-case values and a perfect test (i.e., sensitivity and specificity equal to 1.0) and USD329-USD364 if a perfect test. The threshold costs of the DNA stool test version 1.1 at 3-yearly intervals were USD140 to USD167 if the test performance parameters were 50% of the level between base case and a perfect test and USD237-USD302 if the DNA stool test had perfect test parameters. If the DNA stool test version 1.1 was able to increase screening adherence to 75%, while adherence for all other strategies remained at 50%, the threshold costs could increase to $83-$141 at 5-yearly intervals of testing and to USD314-USD391 at 3-yearly interval intervals of testing. With perfect adherence per-test costs could be USD472-USD740 at 5-yearly intervals and USD730-USD822 at 3-yearly intervals, assuming an adherence of 50% for all other tests. Analyses conducted from a modified societal perspective yielded threshold per-test costs that were approximately 2 to 3 times greater than the analyses from the CMS perspective.

Authors' recommendations: These results suggest that screening for CRC with the DNA stool test version 1.1 does provide a benefit in terms of life-years gained compared with no screening but the cost, relative to the benefit derived and to the availability and costs of other CRC screening tests, would need to be in the range of USD34-USD60 to be a non-dominated option. Only if significant improvements for the DNA stool test characteristics or relative adherence with DNA stool testing compared with other available options can be demonstrated, will stool DNA testing at the current costs of USD350 be cost-effective. These estimates are based on a third-party payer analysis on an unscreened 65-year old cohort. Threshold costs are similar for a 50-year old cohort, but can be somewhat higher from a modified societal perspective (USD88 to USD134 for 5-yearly testing and USD73 to USD116 for 3-yearly testing).

Authors' methods: Systematic review

Project Status: Completed

URL for project: http://www.cms.gov/mcd/viewtechassess.asp?where=index&tid=52

Year Published: 2007

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: United States

Organisation Name: Agency for Healthcare Research and Quality

Contact Address: Center for Outcomes and Evidence Technology Assessment Program, 540 Gaither Road, Rockville, MD 20850, USA. Tel: +1 301 427 1610; Fax: +1 301 427 1639;

Contact Name: martin.erlichman@ahrq.hhs.gov

Contact Email: martin.erlichman@ahrq.hhs.gov

Copyright: Agency for Healthcare Research and Quality (AHRQ)