A Call to Action to Increase Uptake of Follow-Up Colonoscopy After Initial Positive Stool-Based Colorectal Cancer Screening

Population Health ManagementAhead of Print Open AccessCreative Commons licenseA Call to Action to Increase Uptake of Follow-Up Colonoscopy After Initial Positive Stool-Based Colorectal Cancer ScreeningA. Mark Fendrick, John B. Kisiel, Durado Brooks, Vahab Vahdat, Chris Estes, Derek W. Ebner, and Paul LimburgA. Mark FendrickAddress correspondence to: A. Mark Fendrick, MD, Division of General Medicine, Department of Internal Medicine, University of Michigan, North Campus Research Complex, 2800 Plymouth Road, Building 16/4th Floor, Ann Arbor, MI 48109, USA E-mail Address: [email protected]Division of General Medicine, Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan, USA.Search for more papers by this author, John B. KisielDivision of Gastroenterology and Hepatology, Department of Medicine, Mayo Clinic, Rochester, Minnesota, USA.Search for more papers by this author, Durado BrooksExact Sciences Corporation, Madison, Wisconsin, USA.Search for more papers by this author, Vahab VahdatExact Sciences Corporation, Madison, Wisconsin, USA.Search for more papers by this author, Chris EstesExact Sciences Corporation, Madison, Wisconsin, USA.Search for more papers by this author, Derek W. EbnerDivision of Gastroenterology and Hepatology, Department of Medicine, Mayo Clinic, Rochester, Minnesota, USA.Search for more papers by this author, and Paul LimburgExact Sciences Corporation, Madison, Wisconsin, USA.Search for more papers by this authorPublished Online:7 Nov 2023https://doi.org/10.1089/pop.2023.0199AboutSectionsView articleSupplemental MaterialPDF/EPUBView Supplemental Data Permissions & CitationsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail View articleGuidelines for average-risk colorectal cancer (CRC) screening endorse several noninvasive modalities, including stool-based options. The 2021 US Preventive Services Task Force CRC recommendations state that positive results on stool-based screening tests require follow-up with colonoscopy,1 as patients with a positive test who do not undergo a follow-up colonoscopy have a 1.8-fold increased risk of CRC over a 6-year period.2 Nevertheless, a recent retrospective analysis demonstrated room for improvement in follow-up colonoscopy rates, especially among Black or Asian populations.3 The follow-up colonoscopy rate within 1 year after a positive stool-based test was only 56% in the total study population and differed by test type (48.7% after positive fecal immunochemical test [FIT]; 66.6% after positive multitarget stool DNA [mt-sDNA]).3Financial barriers are a likely contributor to low follow-up colonoscopy completion rates. A 2021 study reported that 48% of commercially insured and 78% of Medicare beneficiaries paid nontrivial out-of-pockets costs for follow-up colonoscopy.4 Thus, in an effort to promote higher CRC screening completion rates and reduce disparities, federal regulations require commercial insurers and Medicare to eliminate out-of-pocket costs for follow-up colonoscopy as of January 2023. The objective of this analysis was to estimate the clinical and financial outcomes of this policy change.Using the validated Colorectal Cancer and Adenoma Incidence and Mortality Microsimulation Model,5 a cohort of average-risk individuals who received mt-sDNA or FIT at age 45 for commercially insured patients and at age 65 for Medicare beneficiaries was modeled. For only those simulated patients with a positive mt-sDNA or FIT test, 2 scenarios were analyzed: (1) received follow-up colonoscopy ($0 cost sharing) or (2) no follow-up colonoscopy. The payer costs of follow-up colonoscopy were assumed to be $2,057 ($2,816 with polypectomy) for commercially insured patients and $1,118 ($1,624 with polypectomy) for Medicare beneficiaries.6 The clinical inputs for colonoscopy, mt-sDNA, and FIT sensitivity, specificity, and complication risk, as well as cost and utility inputs are listed in Supplementary Table S1. Outcomes measured included life-years gained (LYG), number of colonoscopies, CRC incidence and mortality reduction, quality-adjusted life years, and total lifetime costs. Total lifetime costs include screening costs, costs for complications from colonoscopy, and CRC medical costs.Commercially insured and Medicare patients undergoing follow-up colonoscopy after a positive stool-based screening test experienced more LYG per 1000 individuals (83 and 80, respectively, with mt-sDNA; 43 and 46, respectively, with FIT; Table 1) compared with those who did not undergo follow-up colonoscopy. The commercially insured and Medicare patients undergoing a follow-up colonoscopy also experienced reduced CRC incidence (14% and 19% reduction, respectively, with mt-sDNA; 7% and 9% reduction, respectively, with FIT) and CRC-related mortality (16% and 23% reduction, respectively, with mt-sDNA; 8% and 12% reduction, respectively, with FIT; Table 1).Table 1. Differences in Estimated Outcomes and Costs of Individuals with Positive MT-sDNA Test or FIT Who Undergo a Follow-Up Colonoscopy versus No Follow-Up ColonoscopyPositive test: populationΔ LYGaΔ CRC incidence reductiona (%)Δ CRC mortality reductiona (%)Δ COLbΔ Screening costb,cΔ Colonoscopy complication costbΔ CRC-Medical costbΔ Total costb,dmt-sDNA: Commercially insured8314162.47$4,177$105−$8,891−$4,609mt-sDNA: Medicare8019232.28$2,669$236−$7,659−$4,755FIT: Commercially insured43782.72$4,545$126−$11,110−$6,439FIT: Medicare469122.35$2,768$239−$7,762−$4,755aPer 1000 individuals.bLifetime per person.cScreening costs include cost of stool-based CRC test, follow-up colonoscopy, repeat colonoscopy if full reach not achieved, surveillance, and symptomatic colonoscopy.dTotal costs include screening costs, costs for complications from colonoscopy, and CRC medical costs.COL, number of colonoscopies; CRC, colorectal cancer; FIT, fecal immunochemical test; LYG, life-years gained; mt-sDNA, multitarget stool DNA.The total lifetime cost per patient for those receiving follow-up colonoscopy compared with stool-test-positive patients who did not receive follow-up colonoscopy was $4,609–$6,439 less for commercially insured patients and $4,755 less for Medicare beneficiaries. Total spending for patients receiving follow-up colonoscopy after a positive stool-based test was cost-saving when compared with no follow-up colonoscopy as long as the colonoscopy costs were less than $6,448 for commercial plans and $5,652 paid by Medicare.These modeling analyses demonstrate that follow-up colonscopy after a positive stool-based test is an essential and necessary step in realizing the clinical and economic benefits of CRC screening. The findings that those who undergo follow-up colonoscopy are estimated to have improved CRC-related outcomes and lower total medical expenditures compared with those who do not receive follow-up colonoscopy should compel stakeholders to further invest in patient education, navigation, transportation, and other support services that facilitate completion of the overall CRC screening process, along with ensuring adequate and efficient access to follow-up colonoscopy. Such investments are urgently needed and will undoubtedly yield positive impacts at multiple levels.AcknowledgmentsMedical writing and editorial assistance were provided by Erin P. Scott, PhD, of Maple Health Group, LLC, funded by Exact Sciences Corporation.Authors' ContributionsA.M.F.: Conceptualization, methodology, writing–review and editing. J.B.K., D.B., D.W.E. and P.J.L.: Conceptualization, writing–review and editing. V.V.: Methodology, data curation, formal analysis, investigation, software, writing–review and editing. C.E.: Formal analysis, software, writing–review and editing.Author Disclosure StatementA.M.F. has been a consultant for AbbVie, Amgen, Centivo, Community Oncology Association, Covered California, EmblemHealth, Exact Sciences, Freedman Health, GRAIL, Harvard University, Health and Wellness Innovations, Health at Scale Technologies, MedZed, Penguin Pay, Risalto, Sempre Health, the States of Minnesota and Michigan, US Department of Defense, Virginia Center for Health Innovation, Wellthy, and Zansors; has received research support from the Agency for Healthcare Research and Quality, Gary and Mary West Health Policy Center, Arnold Ventures, National Pharmaceutical Council, Patient-Centered Outcomes Research Institute, Pharmaceutical Research and Manufacturers of America, the Robert Wood Johnson Foundation, and the Centers for Medicare and Medicaid Services. J.B.K. has received research support from Exact Sciences through a contracted services agreement and is an inventor of Mayo Clinic intellectual property, licensed to Exact Sciences, for which he could receive royalties, paid to Mayo Clinic. D.W.E. has a professional service agreement with Exact Sciences serving as an independent contractor to provide guidance on study design and analysis. D.B., V.V., C.E., and P.L. are employees of Exact Sciences Corporation.Funding InformationFinancial support for this study was provided by a contract with Exact Sciences Corporation. The funding agreement ensured the authors' independence in designing the study, interpreting the data, writing, and publishing the report.Supplementary MaterialSupplementary Table S1References1. Davidson KW, Barry MJ, Mangione CM, et al. Screening for colorectal cancer: US Preventive Services Task Force Recommendation Statement. JAMA 2021;325:1965–1977. Crossref, Medline, Google Scholar2. Lee YC, Li-Sheng Chen S, Ming-Fang Yen A, et al. Association between colorectal cancer mortality and gradient fecal hemoglobin concentration in colonoscopy noncompliers. J Natl Cancer Inst 2017;109:djw269. Crossref, Medline, Google Scholar3. Mohl JT, Ciemins EL, Miller-Wilson L-A, et al. Rates of follow-up colonoscopy after a positive stool-based screening test result for colorectal cancer among health care organizations in the US, 2017–2020. JAMA Netw Open 2023;6:e2251384. Crossref, Medline, Google Scholar4. Fendrick AM, Princic N, Miller-Wilson LA, et al. Out-of-pocket costs for colonoscopy after noninvasive colorectal cancer screening among US adults with commercial and Medicare insurance. JAMA Netw Open 2021;4:e2136798. Crossref, Medline, Google Scholar5. Vahdat V, Alagoz O, Chen JV, et al. Calibration and validation of the colorectal cancer and adenoma incidence and mortality (CRC-AIM) microsimulation model using deep neural networks. Med Decis Making 2023;43:719–736. Crossref, Medline, Google Scholar6. Fisher DA, Princic N, Miller-Wilson L-A, et al. Healthcare costs of colorectal cancer screening and events following colonoscopy among commercially insured average-risk adults in the United States. Curr Med Res Opin 2022;38:427–434. Crossref, Medline, Google ScholarFiguresReferencesRelatedDetails Volume 0Issue 0 Information© A. Mark Fendrick et al., 2023; Published by Mary Ann Liebert, Inc.To cite this article:A. Mark Fendrick, John B. Kisiel, Durado Brooks, Vahab Vahdat, Chris Estes, Derek W. Ebner, and Paul Limburg.A Call to Action to Increase Uptake of Follow-Up Colonoscopy After Initial Positive Stool-Based Colorectal Cancer Screening.Population Health Management.ahead of printhttp://doi.org/10.1089/pop.2023.0199creative commons licenseOnline Ahead of Print:November 7, 2023Open accessThis Open Access article is distributed under the terms of the Creative Commons License [CC-BY] ( http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.PDF download