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Stool DNA Testing to Screen for Colorectal Cancer in the Medicare Population: A Cost-Effectiveness Analysis

Iris Lansdorp-Vogelaar, PhD; Karen M. Kuntz, ScD; Amy B. Knudsen, PhD; Janneke A. Wilschut, MS; Ann G. Zauber, PhD; and Marjolein van Ballegooijen, MD, PhD
[+] Article and Author Information

From Erasmus Medical Center, Rotterdam, the Netherlands; University of Minnesota, Minneapolis, Minnesota; Massachusetts General Hospital, Boston, Massachusetts; and Memorial Sloan-Kettering Cancer Center, New York, New York.


Disclaimer: The authors of this report are responsible for its contents. The findings and conclusions do not necessarily represent the views of the Agency for Healthcare Research and Quality. Statements in the report should not be construed as endorsement by the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services.

Acknowledgment: The authors thank Martin Brown, PhD, and Robin Yabroff, PhD, of the National Cancer Institute for their assistance with obtaining cancer treatment costs using SEER-Medicare data; Joan Warren, PhD, and Carrie Klabunde, PhD, of the National Cancer Institute for sharing their preliminary analysis of SEER-Medicare data on colonoscopy-related complications; John Allen, MD, of Minnesota Gastroenterology and Joel Brill, MD, of Predictive Health for their assistance in deriving coding for screening and complications; William Larson, Marjorie Baldo, and Marilu Hu of the CMS for providing CMS cost data; Chuck Shih of the Agency of Healthcare Research and Quality for interpreting the CMS cost data; William Lawrence, MD, and Kim Wittenberg, MA, of the Agency for Healthcare Research and Quality for contextual and administrative assistance, respectively; and Eric (Rocky) Feuer, PhD, of the National Cancer Institute for continued support of the work and infrastructure of the Cancer Intervention and Surveillance Modeling Network consortium.

Grant Support: By the Agency for Healthcare Research and Quality (HHSP233200700123P, HHSP233200700196P, HHSP233200700350P) and the National Cancer Institute (U01-CA-088204, U01-CA-097426, and U01-CA-115953).

Potential Conflicts of Interest: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M10-0564.

Reproducible Research Statement:Study protocol: Available to approved individuals with written agreement from Dr. Lansdorp-Vogelaar (e-mail, i.vogelaar@erasmusmc.nl). Statistical code and data set: Not available.

Requests for Single Reprints: Iris Lansdorp-Vogelaar, PhD, Department of Public Health, Erasmus Medical Center, PO Box 2040, 3000 CA Rotterdam, the Netherlands; e-mail, i.vogelaar@erasmusmc.nl.

Current Author Addresses: Dr. Lansdorp-Vogelaar, Ms. Wilschut, and Dr. van Ballegooijen: Department of Public Health, Erasmus Medical Center, Dr. Molewaterplein 50, Rotterdam 3000 CA, the Netherlands.

Dr. Kuntz: Division of Health Policy and Management, University of Minnesota, MMC 729 Mayo, 15-232 PWB, 516 Delaware Street Southeast, Minneapolis, MN 55455.

Dr. Knudsen: Institute for Technology Assessment, Massachusetts General Hospital, 101 Merrimac Street, Boston, MA 02114.

Dr. Zauber: Department of Epidemiology and Biostatistics, Memorial Sloan-Kettering Cancer Center, 307 East 63rd Street, New York, NY 10065.

Author Contributions: Conception and design: I. Lansdorp-Vogelaar, K.M. Kuntz, A.G. Zauber, M. van Ballegooijen.

Analysis and interpretation of the data: I. Lansdorp-Vogelaar, K.M. Kuntz, A.B. Knudsen, J.A. Wilschut, A.G. Zauber, M. van Ballegooijen.

Drafting of the article: I. Lansdorp-Vogelaar, K.M. Kuntz, A.B. Knudsen, A.G. Zauber, M. van Ballegooijen.

Critical revision of the article for important intellectual content: I. Lansdorp-Vogelaar, K.M. Kuntz, A.B. Knudsen, A.G. Zauber, M. van Ballegooijen.

Final approval of the article: I. Lansdorp-Vogelaar, K.M. Kuntz, A.B. Knudsen, J.A. Wilschut, M. van Ballegooijen.

Provision of study materials or patients: A.G. Zauber.

Statistical expertise: K.M. Kuntz, A.G. Zauber.

Obtaining of funding: I. Lansdorp-Vogelaar, K.M. Kuntz, A.G. Zauber, M. van Ballegooijen.

Administrative, technical, or logistic support: A.G. Zauber.

Collection and assembly of data: I. Lansdorp-Vogelaar, A.G. Zauber.


Ann Intern Med. 2010;153(6):368-377. doi:10.7326/0003-4819-153-6-201009210-00004
Text Size: A A A

Background: The Centers for Medicare & Medicaid Services considered whether to reimburse stool DNA testing for colorectal cancer screening among Medicare enrollees.

Objective: To evaluate the conditions under which stool DNA testing could be cost-effective compared with the colorectal cancer screening tests currently reimbursed by the Centers for Medicare & Medicaid Services.

Design: Comparative microsimulation modeling study using 2 independently developed models.

Data Sources: Derived from literature.

Target Population: A cohort of persons aged 65 years. A sensitivity analysis was also conducted, in which a cohort of persons aged 50 years was studied.

Time Horizon: Lifetime.

Perspective: Third-party payer.

Intervention: Stool DNA test every 3 or 5 years in comparison with currently recommended colorectal cancer screening strategies.

Outcome Measures: Life expectancy, lifetime costs, incremental cost-effectiveness ratios, and threshold costs.

Results of Base-Case Analysis: Assuming a cost of $350 per test, strategies of stool DNA testing every 3 or 5 years yielded fewer life-years and higher costs than the currently recommended colorectal cancer screening strategies. Screening with the stool DNA test would be cost-effective at a per-test cost of $40 to $60 for stool DNA testing every 3 years, depending on the simulation model used. There were no levels of sensitivity and specificity for which stool DNA testing would be cost-effective at its current cost of $350 per test. Stool DNA testing every 3 years would be cost-effective at a cost of $350 per test if the relative adherence to stool DNA testing were at least 50% better than that with other screening tests.

Results of Sensitivity Analysis: None of the results changed substantially when a cohort of persons aged 50 years was considered.

Limitation: No pathways other than the traditional adenoma–carcinoma sequence were modeled.

Conclusion: Stool DNA testing could be a cost-effective alternative for colorectal cancer screening if the cost of the test substantially decreased or if its availability would entice a large fraction of otherwise unscreened persons to receive screening.

Primary Funding Source: Agency for Healthcare Research and Quality.

Figures

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Figure 1.
Discounted costs and discounted life-years gained per 1000 persons aged 65 years for 18 colorectal cancer screening strategies and the efficient frontier connecting the efficient strategies.

Discounted costs and life-years reflect total costs and life-years gained of a screening program (SimCRC [top] or MISCAN [bottom]), accounting for time preference for present over future outcomes. Life-years gained are plotted on the y-axis, and total costs are plotted on the x-axis. Each possible screening strategy is represented by a point (50). Strategies that form the solid line connecting the points lying left and upward are the economically rational subset of choices. This line is called the efficient frontier. The inverse slope of the line represents the incremental cost-effectiveness ratio of the connected strategies (values presented in Appendix Table 2). Points lying to the right and beneath the line represent the dominated strategies. Stool DNA testing has higher costs and fewer life-years gained than Hemoccult SENSA, and the stool DNA strategies are therefore strongly dominated. Hemoccult II and Hemoccult SENSA are manufactured by Beckman Coulter, Fullerton, California. COL = colonoscopy every 10 y; HII = annual Hemoccult II; HS = annual Hemoccult SENSA; HS (3 y) = Hemoccult SENSA every 3 y; iFOBT = annual immunochemical fecal occult blood test; iFOBT (3 y) = immunochemical fecal occult blood test every 3 y; SIG = sigmoidoscopy without biopsy every 5 y; SIGB = sigmoidoscopy with biopsy every 5 y.

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Figure 2.
Cost thresholds of stool DNA tests at which the stool DNA strategies are more efficient than other reimbursed colorectal cancer screening strategies for different levels of test characteristics (top) and adherence (bottom).

All sensitivities and the specificity for stool DNA were improved from their baseline value up to 100%; the percentage on the x-axis represents the relative improvement over that interval, and the absolute improvement varies depending on the baseline value for sensitivity and specificity. Adherence for stool DNA was improved from its baseline value of 57% up to 100%; the percentage on the x-axis represents the relative improvement over that interval.

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Appendix Figure 1.
MISCAN and SimCRC modeling of natural history into life history.
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Appendix Figure 2.
MISCAN and SimCRC modeling of screening into life history.
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Comments

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noninvasive
Posted on September 22, 2010
Rajasree Pai Ramachandra Pai
University of Connecticut Health Center, Farmington
Conflict of Interest: None Declared

The idea of using stool DNA for screening is a good one as it is non invasive and increases the likelihood of patients getting screened. The expenses of patients getting treated surgically and with chemotherapeutic agents over a certain period of time versus costs of using stool DNA for screening needs to be taken into account while discussing cost effectiveness.

Conflict of Interest:

None declared

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