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Cover of Cost-Effectiveness of DNA Stool Testing to Screen for Colorectal Cancer

Cost-Effectiveness of DNA Stool Testing to Screen for Colorectal Cancer

Technology Assessment Report

, PhD, , MS, , MS, , PhD, , MD, PhD, and , ScD; on behalf of Cancer Intervention and Surveillance Modeling Network (CISNET) for MISCAN and SimCRC Models.

Author Information and Affiliations

Structured Abstract

Background:

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.

Methods:

We used two microsimulation models from the National Cancer Institute (NCI)-funded Cancer Intervention and Surveillance Modeling Network (CISNET) consortium to assess the cost-effectiveness of screening for CRC with the DNA stool test in comparison to the currently recommended CRC screening strategies. We conducted incremental cost-effectiveness analyses by comparing the incremental costs and benefits with the next best strategy after eliminating dominated strategies (i.e., strategies that are more costly and less effective than another strategy or a combination of other strategies). We conducted a literature review of the evidence for the DNA stool test to obtain estimates of its sensitivity and specificity for adenomas by size and for CRC. We derived direct medical cost estimates using the Centers for Medicare and Medicaid Services (CMS) reimbursement for screening and treatment, as well as for complications of screening. We also derived direct beneficiary costs and time costs associated with screening and treatment to be used in analyses from the modified societal perspective. We assumed a per-test cost of $350 for the DNA stool test. We performed sensitivity and threshold analyses on the cost, diagnostic performance, and relative adherence of the DNA stool test. We considered the currently recommended CRC tests of annual Hemoccult II, Hemoccult SENSA®, and a fecal immunochemical test (FIT) with composite test characteristics of Magstream, HemeSelect, Flexsure, Monohaem, OC-Hemodia, and Insure; 5-year flexible sigmoidoscopy with and without biopsy and with and without FOBT annually; and 10-year colonoscopy.

Results:

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-Plus™) and with a per-test cost of $350, 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 $34 to $51 for 5-yearly DNA stool test screening and $40 to $60 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 $163–$187 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 $329–$364 if a perfect test. The threshold costs of the DNA stool test version 1.1 at 3-yearly intervals were $140 to $167 if the test performance parameters were 50% of the level between base case and a perfect test and $237–$302 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 $314–$391 at 3-yearly interval intervals of testing. With perfect adherence per-test costs could be $472–$740 at 5-yearly intervals and $730–$822 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.

Conclusions:

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 $34–$60 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 $350 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 ($88 to $134 for 5-yearly testing and $73 to $116 for 3-yearly testing).

Contents

We acknowledge Martin Brown, Ph.D. and Robin Yabroff, Ph.D. of the National Cancer Institute (NCI) for their assistance with obtaining cancer treatment costs using SEER-Medicare data; Joan Warren, Ph.D. and Carrie Klabunde, Ph.D. of NCI for sharing their preliminary analysis of SEER-Medicare data on colonoscopy-related complications; John Allen, M.D. of Minnesota Gastroenterology, Minneapolis, MN and Joel Brill, M.D. of Predictive Health of Phoenix, AZ for their assistance in estimating costs of screening and complications; and William Larson, Marjorie Baldo, and Marilu Hu of the Centers for Medicare and Medicaid Services (CMS) for providing CMS cost data.

None of the investigators has any affiliations or financial involvements related to the material presented in this report.

This report is based on research conducted by the CISNET modeling groups (MISCAN of Memorial Sloan-Kettering and ErasmusMC and SimCRC of University of Minnesota and Massachusetts General Hospital) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (HHSP233200700350P, Memorial Sloan-Kettering Cancer Center; HHSP233200700196P, ErasmusMC; and HHSP233200700123P, University of Minnesota). The findings and conclusions in this document are those of the authors who are responsible for its contents; the findings and conclusions do not necessarily represent the views of AHRQ. Therefore, no statement in this report should be construed as an official position of the Agency for Healthcare Research and Quality or of the U.S. Department of Health and Human Services.

The information in this report is intended to help health care decision-makers; patients and clinicians, health system leaders, and policymakers, make well-informed decisions and thereby improve the quality of health care services. This report is not intended to be a substitute for the application of clinical judgment. Decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent information, i.e., in the context of available resources and circumstances presented by individual patients.

This report may be used, in whole or in part, as the basis for development of clinical practice guidelines and other quality enhancement tools, or as a basis for reimbursement and coverage policies. AHRQ or U.S. Department of Health and Human Services endorsement of such derivative products may not be stated or implied.

Bookshelf ID: NBK285164PMID: 25879132

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