On April 28, 2021 Exact Sciences (NASDAQ: EXAS) reported study results published in Mayo Clinic Proceedings showing that Cologuard (mt-sDNA) is the most cost-effective colorectal cancer (CRC) screening option in the Alaska Native population, as compared to colonoscopy and the fecal immunochemical test (FIT), for a wide range of adherence scenarios (Press release, Exact Sciences, APR 28, 2021, View Source [SID1234578644]). According to the model, Cologuard produced the highest number of quality adjusted life years (QALYs) gained and the largest reduction in CRC incidence.1
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Colorectal cancer is the second leading cause of cancer death for men and women in the United States,2 in part because many cancers go undetected until later stages when treatment is less effective.3 Alaska Native (AN) people have among the nation’s highest reported incidence rates for CRC, at 89.0 per 100,000 people compared to 45.7 per 100,000 people for the entire United States. 4
Despite the clear need, screening AN people presents significant challenges, such as lower sensitivity for cancer and pre-cancer with other stool-based tests and obstacles around getting people from their remote homes to healthcare facilities, which requires significant time, expense, and support personnel.5 The Cologuard test provides a path to overcome these barriers by offering patients a CRC screening test that allows them to collect their sample at home.
An earlier study from lead author Diana Redwood, Ph.D. of the Alaska Native Tribal Health Consortium and Alaska Native Epidemiology Center, analyzed the performance of Cologuard, a U.S. Food & Drug Administration (FDA) approved stool DNA test for colorectal cancer, in AN people. The study showed the non-invasive Cologuard test had high sensitivity in detecting colorectal cancer and large pre-cancerous lesions making it a strong candidate for increasing the screening options available for AN people.5
"My earlier research showed that Cologuard is an effective screening test in Alaska Native people," Redwood said. "This study shows Cologuard would also be a cost-effective way to screen this unique and hard to reach population."
Each strategy reduced costs and increased QALYs in comparison with no screening, with Cologuard outperforming FIT and colonoscopy screening in all adherence scenarios. With perfect adherence assumed, all screening modalities examined (colonoscopy, FIT, and mt-sDNA) decreased CRC incidence relative to no screening, with Cologuard decreasing incidence the most.1,5
A Markov model was used to evaluate the effects of the 3 screening tests over 40 years. Outcomes included CRC incidence and mortality, costs, QALYs, and incremental cost-effectiveness ratios (ICERs). The study incorporated updated evidence on screening test performance and adherence and was conducted from December 15, 2016, through November 6, 2019.5
"Cologuard is supported by Exact Sciences’ built-in patient navigation system, which offers round the clock support for patients. Data shows this support increases test completion rates, especially among people, like many Alaska Native people, who haven’t been previously screened," said Paul Limburg, M.D., Chief Medical Officer, Screening at Exact Sciences
With perfect adherence, CRC incidence was reduced by 52% using 10-yearly colonoscopy, 61% using annual FIT, and 66% using triennial mt-sDNA screening. Compared with no screening, perfect adherence to screening added estimates of 0.19 QALYs with mt-sDNA, 0.17 QALYs with FIT, and 0.15 QALYs per person with colonoscopy. Colonoscopy was found to be the most expensive strategy: about $110 million more than mt-sDNA and $127 million more than FIT. With best-case imperfect adherence, which represents the highest estimated adherence rate based on the authors analysis, mt-sDNA resulted in improvement of 0.12 QALYs/person vs. 0.05 QALYs/person by FIT and 0.06 QALYs/person by colonoscopy. Under other adherence scenarios, mt-sDNA either dominated or was cost-effective as compared with FIT and colonoscopy.5
References:
Redwood DG, Dinh TA, Kisiel JB, et al. Cost-effectiveness of multitarget stool DNA testing vs colonoscopy or fecal immunochemical testing for colorectal cancer screening in Alaska Native people. Mayo Clin Proc. 2020; xx(x):1-15. doi:10.1016/j.mayocp.2020.07.035
Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2021. CA Cancer J Clin. 2021;71:7-33. doi:10.3322/caac/21654
Zauber AG, Winawer SJ, O’Brien M, et al. Colonoscopic polypectomy and long-term prevention of colorectal-cancer deaths. N Engl J Med. 2012;366(8):687-696. doi:10.1056/NEJMoa110370
ACS. Colorectal cancer facts and figures 2020-2022. Atlanta: American Cancer Society; 2020.
Redwood DG, Asay ED, Blake ID, et al. Stool DNA testing for screening detection of colorectal neoplasia in Alaska Native people. Mayo Clin Proc. 2016;91(1):61-70. doi:10.1016/j.mayocp.2015.10.008
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Financial support and conflict of interest disclosure: Dr. John Kisiel serves, and Dr. David Ahlquist served as scientific advisors to and research collaborators with Exact Sciences Corp., distributors of the multi-target stool DNA test (Cologuard). Exact Sciences also provides support for Dr. Kisiel’s lab and research team at Mayo Clinic. Exact Sciences Corp. had no role in the study design, data analyses, or manuscript preparation. Additional Information: Coauthor David A. Ahlquist, MD, died in November 2020.
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