Comparing the Cost-Effectiveness of Innovative Colorectal Cancer Screening Tests.

BACKGROUND: Colorectal cancer (CRC) screening with colonoscopy and the fecal immunochemical test (FIT) is underused. Innovative tests could increase screening acceptance. This study determined which of the available alternatives is most promising from a cost-effectiveness perspective. METHODS: The previously validated Microsimulation Screening Analysis-Colon model was used to evaluate the cost-effectiveness of screening with capsule endoscopy every 5 or 10 years, computed tomographic colonography every 5 years, the multi-target stool DNA test every 1 or 3 years, and the methylated SEPT9 DNA plasma assay (mSEPT9) every 1 or 2 years. We also compared these strategies with annual FIT screening and colonoscopy screening every 10 years. Quality-adjusted life-years gained (QALYG), number of colonoscopies, and incremental cost-effectiveness ratios were projected. We assumed a willingness-to-pay threshold of $100 000 per QALYG. RESULTS: Among the alternative tests, computed tomographic colonography every 5 years, annual mSEPT9, and annual multi-target stool DNA screening had incremental cost-effectiveness ratios of $1092, $63 253, and $214 974 per QALYG, respectively. Other screening strategies were more costly and less effective than (a combination of) these 3. Under the assumption of perfect adherence, annual mSEPT9 screening resulted in more QALYG, CRC cases averted, and CRC deaths averted than annual FIT screening but led to a high rate of colonoscopy referral (51% after 3 years, 69% after 5 years). The alternative tests were not cost-effective compared with FIT and colonoscopy. CONCLUSIONS: This study suggests that for individuals not willing to participate in FIT or colonoscopy screening, mSEPT9 is the test of choice if the high colonoscopy referral rate is acceptable to them.

Cost-effectiveness of surveillance with CT colonography after resection of colorectal cancer.

OBJECTIVE: Surveillance following colorectal cancer (CRC) resection uses optical colonoscopy (OC) to detect intraluminal disease and CT to detect extracolonic recurrence. CT colonography (CTC) might be an efficient use of resources in this situation because it allows for intraluminal and extraluminal evaluations with one test. DESIGN: We developed a simulation model to compare lifetime costs and benefits for a cohort of patients with resected CRC. Standard of care involved annual CT for 3 years and OC for years 1, 4 and every 5 years thereafter. For the CTC-based strategy, we replace CT+OC at year 1 with CTC. Patients with lesions greater than 6 mm detected by CTC underwent OC. Detection of an adenoma 10 mm or larger was followed by OC at 1 year, then every 3 years thereafter. Test characteristics and costs for CTC were derived from a clinical study. Medicare costs were used for cancer care costs as well as alternative test costs. We discounted costs and effects at 3% per year. RESULTS: For persons with resected stage III CRC, the standard-of-care strategy was more costly (US$293) and effective (2.6 averted CRC cases and 1.1 averted cancer deaths per 1000) than the CTC-based strategy, with an incremental cost-effectiveness ratio of US$55 500 per quality-adjusted life-year gained. Our analysis was most sensitive to the sensitivity of CTC for detecting polyps 10 mm or larger and assumptions about disease progression. CONCLUSION: In a simulation model, we found that replacing the standard-of-care approach to postdiagnostic surveillance with a CTC-based strategy is not an efficient use of resources in most situations.

An observational study to compare the utilisation of computed tomography colonography with optical colonoscopy as the first diagnostic imaging tool in patients with suspected colorectal cancer.

AIM: To evaluate the clinical and cost implications of using computed tomography colonography (CTC) compared to optical colonoscopy (OC) as the initial colonic investigation in patients with low-to-intermediate risk of colorectal cancer (CRC). MATERIALS AND METHODS: A non-randomised, prospective single-centre study recruited 180 participants to compare the cost implications of two clinical pathways used in the diagnosis of low-to-intermediate risk of CRC that differ in the initial diagnostic test, either CTC or OC. Costs were compared using generalised linear models (GLM) and combined with quality-adjusted life years (QALYs, based on the EQ-5D-5L) to estimate cost-effectiveness at 6 months post-recruitment. Secondary outcomes assessed access to care and patient satisfaction. RESULTS: Mean (SD, n) cost at 6 months post-recruitment per participant was £991 (£316, n=105) for the OC group and £645 (£607, n=68) for the CTC group, leading to an estimated cost difference of -£370 (95% CI: -£554, -£185, p<0.001). Assuming a £20,000 willingness-to-pay per QALY threshold, there was a 91.4% probability of CTC being cost-effective at month 6. The utilisation of CTC led to improved access to care, with a shorter mean time from referral from primary care to results (6.3 days difference, p=0.005). No differences in patient satisfaction were detected between both groups. CONCLUSION: The utilisation of CTC as the first-line investigation for patients with low-to-intermediate risk of CRC has the potential to release OC capacity, of pivotal importance for patients more likely to benefit from an invasive diagnostic approach.

Colon cancer screening with CT colonography: logistics, cost-effectiveness, efficiency and progress.

Colorectal cancer (CRC) incidence and mortality can be significantly reduced by population screening. Several different screening methods are currently in use, and this review focuses specifically on the imaging technique computed tomographic colonography (CTC). The challenges and logistics of CTC screening, as well as the importance of test accuracy, uptake, quality assurance and cost-effectiveness will be discussed. With comparable advanced adenoma detection rates to colonoscopy (the most commonly used whole-colon investigation), CTC is a less-invasive alternative, requiring less laxative, and with the potential benefit that it permits assessment of extra colonic structures. Three large-scale European trials have contributed valuable evidence supporting the use of CTC in population screening, and highlight the importance of selecting appropriate clinical management pathways based on initial CTC findings. Future research into CTC-screening will likely focus on radiologist training and CTC quality assurance, with identification of evidence-based key performance indicators that are associated with clinically-relevant outcomes such as the incidence of post-test interval cancers (CRC occurring after a presumed negative CTC). In comparison to other CRC screening techniques, CTC offers a safe and accurate option that is particularly useful when colonoscopy is contraindicated. Forthcoming cost-effectiveness analyses which evaluate referral thresholds, the impact of extra-colonic findings and real-world uptake will provide useful information regarding the feasibility of future CTC population screening.

Is the Virtual Colonoscopy a Replacement for Optical Colonoscopy?

OBJECTIVE: To examine the viability of colon cancer screening with computed tomography colonography, also known as virtual colonoscopy. DATA SOURCES: Clinical guidelines, published medical research. CONCLUSION: Virtual colonoscopy, under the right circumstances, is an accurate viable screening tool for patients who may not otherwise desire to or are not able to participate in traditional colonoscopy. IMPLICATIONS FOR NURSING PRACTICE: Nurses should be aware that routine colon cancer screening is recommended starting at age 50. In addition to the traditional colonoscopy, there are other options if a patient is unwilling or unable to undergo optical colon screening. Nurses should discuss the positive and negative aspects of different types of colon screening and teach proper bowel preparation for colon screening.

Colorectal Cancer: Cost-effectiveness of Colonoscopy versus CT Colonography Screening with Participation Rates and Costs.

Purpose To compare the cost-effectiveness of computed tomographic (CT) colonography and colonoscopy screening by using data on unit costs and participation rates from a randomized controlled screening trial in a dedicated screening setting. Materials and Methods Observed participation rates and screening costs from the Colonoscopy or Colonography for Screening, or COCOS, trial were used in a microsimulation model to estimate costs and quality-adjusted life-years (QALYs) gained with colonoscopy and CT colonography screening. For both tests, the authors determined optimal age range and screening interval combinations assuming a 100% participation rate. Assuming observed participation for these combinations, the cost-effectiveness of both tests was compared. Extracolonic findings were not included because long-term follow-up data are lacking. Results The participation rates for colonoscopy and CT colonography were 21.5% (1276 of 5924 invitees) and 33.6% (982 of 2920 invitees), respectively. Colonoscopy was more cost-effective in the screening strategies with one or two lifetime screenings, whereas CT colonography was more cost-effective in strategies with more lifetime screenings. CT colonography was the preferred test for willingness-to-pay-thresholds of €3200 per QALY gained and higher, which is lower than the Dutch willingness-to-pay threshold of €20 000. With equal participation, colonoscopy was the preferred test independent of willingness-to-pay thresholds. The findings were robust for most of the sensitivity analyses, except with regard to relative screening costs and subsequent participation. Conclusion Because of the higher participation rates, CT colonography screening for colorectal cancer is more cost-effective than colonoscopy screening. The implementation of CT colonography screening requires previous satisfactory resolution to the question as to how best to deal with extracolonic findings. © RSNA, 2018 Online supplemental material is available for this article.

Evaluation of the benefits, harms and cost-effectiveness of potential alternatives to iFOBT testing for colorectal cancer screening in Australia.

The Australian National Bowel Cancer Screening Program (NBCSP) will fully roll-out 2-yearly screening using the immunochemical Faecal Occult Blood Testing (iFOBT) in people aged 50 to 74 years by 2020. In this study, we aimed to estimate the comparative health benefits, harms, and cost-effectiveness of screening with iFOBT, versus other potential alternative or adjunctive technologies. A comprehensive validated microsimulation model, Policy1-Bowel, was used to simulate a total of 13 screening approaches involving use of iFOBT, colonoscopy, sigmoidoscopy, computed tomographic colonography (CTC), faecal DNA (fDNA) and plasma DNA (pDNA), in people aged 50 to 74 years. All strategies were evaluated in three scenarios: (i) perfect adherence, (ii) high (but imperfect) adherence, and (iii) low adherence. When assuming perfect adherence, the most effective strategies involved using iFOBT (annually, or biennially with/without adjunct sigmoidoscopy either at 50, or at 54, 64 and 74 years for individuals with negative iFOBT), or colonoscopy (10-yearly, or once-off at 50 years combined with biennial iFOBT). Colorectal cancer incidence (mortality) reductions for these strategies were 51-67(74-80)% in comparison with no screening; 2-yearly iFOBT screening (i.e. the NBCSP) would be associated with reductions of 51(74)%. Only 2-yearly iFOBT screening was found to be cost-effective in all scenarios in context of an indicative willingness-to-pay threshold of A$50,000/life-year saved (LYS); this strategy was associated with an incremental cost-effectiveness ratio of A$2,984/LYS-A$5,981/LYS (depending on adherence). The fully rolled-out NBCSP is highly cost-effective, and is also one of the most effective approaches for bowel cancer screening in Australia.

Cost analysis of colorectal cancer screening with CT colonography in Italy.

OBJECTIVE: Unit costs of screening CT colonography (CTC) can be useful for cost-effectiveness analyses and for health care decision-making. We evaluated the unit costs of CTC as a primary screening test for colorectal cancer in the setting of a randomized trial in Italy. METHODS: Data were collected within the randomized SAVE trial. Subjects were invited to screening CTC by mail and requested to have a pre-examination consultation. CTCs were performed with 64- and 128-slice CT scanners after reduced or full bowel preparation. Activity-based costing was used to determine unit costs per-process, per-participant to screening CTC, and per-subject with advanced neoplasia. RESULTS: Among 5242 subjects invited to undergo screening CTC, 1312 had pre-examination consultation and 1286 ultimately underwent CTC. Among 129 subjects with a positive CTC, 126 underwent assessment colonoscopy and 67 were ultimately diagnosed with advanced neoplasia (i.e., cancer or advanced adenoma). Cost per-participant of the entire screening CTC pathway was €196.80. Average cost per-participant for the screening invitation process was €17.04 and €9.45 for the pre-examination consultation process. Average cost per-participant of the CTC execution and reading process was €146.08 and of the diagnostic assessment colonoscopy process was €24.23. Average cost per-subject with advanced neoplasia was €3777.30. CONCLUSIONS: Cost of screening CTC was €196.80 per-participant. Our data suggest that the more relevant cost of screening CTC, amenable of intervention, is related to CTC execution and reading process.

Recent diagnostic procedures for colorectal cancer screening: Are they cost-effective?

Colorectal cancer (CRC) is the third most common cancer worldwide and the fourth most common cause of death. Reduction in mortality rates in some countries worldwide are most likely ascribed to CRC screening and/or improved treatments. We reviewed the most relevant articles which discuss the cost-effectiveness of colorectal cancer screening procedures, in particular, the recent ones through the last eight years. The effectiveness of screening estimated by discounted life years gained (LYGs) compared to no screening, differed considerably between the studies. Despite these differences, all studies consistently emphasized that screening for CRC was cost-effective compared with no screening for each of the recognized screening strategies. Newer technologies for colorectal cancer screening, including computed tomographic colonography (CTC), faecal DNA test, and Pillcam Colon are less invasive and accurate, however, they are not cost-effective, as their cost was higher than all other established screening strategies. When compliance and adherence to such new techniques are increased more than the established strategies they would be more cost-effective particularly CTC.

Computer-Aided Detection of Colorectal Polyps at CT Colonography: Prospective Clinical Performance and Third-Party Reimbursement.

OBJECTIVE: We assessed the initial clinical performance and third-party reimbursement rates of supplementary computer-aided detection (CAD) at CT colonography (CTC) for detecting colorectal polyps 6 mm or larger in routine clinical practice. MATERIALS AND METHODS: We retrospectively assessed the prospective clinical performance of a U.S. Food and Drug Administration-approved CAD system in second-reader mode in 347 consecutive adults (mean age, 57.6 years; 205 women, 142 men) undergoing CTC evaluation over a 5-month period. The reference standard consisted of the prospective interpretation by experienced CTC radiologists combined with subsequent optical colonoscopy (OC), if performed. We also assessed third-party reimbursement for CAD for studies performed over an 18-month period. RESULTS: In all, 69 patients (mean [± SD] age, 59.0 ± 7.7 years; 32 men, 37 women) had 129 polyps ≥ 6 mm. Per-patient CAD sensitivity was 91.3% (63 of 69). Per-polyp CAD-alone sensitivity was 88.4% (114 of 129), including 88.3% (83 of 94) for 6- to 9-mm polyps and 88.6% (31 of 35) for polyps 10 mm or larger. On retrospective review, three additional polyps 6 mm or larger were seen at OC and marked by CAD but dismissed as CAD false-positives at CTC. The mean number of false-positive CAD marks was 4.4 ± 3.1 per series. Of 1225 CTC cases reviewed for reimbursement, 31.0% of the total charges for CAD interpretation had been recovered from a variety of third-party payers. CONCLUSION: In our routine clinical practice, CAD showed good sensitivity for detecting colorectal polyps 6 mm or larger, with an acceptable number of false-positive marks. Importantly, CAD is already being reimbursed by some third-party payers in our clinical CTC practice.

Insurance Coverage for CT Colonography Screening: Impact on Overall Colorectal Cancer Screening Rates.

Purpose To compare overall colorectal cancer (CRC) screening rates for patients who were eligible and due for CRC screening and who were with and without insurance coverage for computed tomographic (CT) colonography for CRC screening. Materials and Methods The institutional review board approved this retrospective cohort study, with a waiver of consent. This study used longitudinal electronic health record data from 2005 through 2010 for patients managed by one of the largest multispecialty physician groups in the United States. It included 33 177 patients under age 65 who were eligible and due for CRC screening and managed by the participating health system. Stratified Cox regression models provided propensity-adjusted hazard ratios (HRs) and 95% confidence intervals (CIs) for the relationship between CT colonography coverage and CRC screening. Results After adjustment, patients who had insurance coverage for CT colonography and were due for CRC screening had a 48% greater likelihood of being screened for CRC by any method compared with those without coverage who were due for CRC screening (HR, 1.48; 95% CI: 1.41, 1.55). Similarly, patients with CT colonography coverage had a greater likelihood of being screened with CT colonography (HR, 8.35; 95% CI: 7.11, 9.82) and with colonoscopy (HR, 1.38; 95% CI: 1.31, 1.45) but not with fecal occult blood test (HR, 1.00; 95% CI: 0.91, 1.10) than those without such insurance coverage. Conclusion Insurance coverage of CT colonography for CRC screening was associated with a greater likelihood of a patient being screened and a greater likelihood of being screened with a test that helps both to detect cancer and prevent cancer from developing (CT colonography or colonoscopy). © RSNA, 2017.

The role of colonoscopy and CT colonography in patients presenting with symptoms of constipation.

OBJECTIVE: There is controversy whether constipation as a primary presenting complaint is an indication for diagnostic colonoscopy. CT colonography (CTC) is a less invasive and more acceptable alternative. We compared the completion and sensitivity of colonoscopy with CTC in patients who presented with the primary symptom of constipation. METHODS: A retrospective study was conducted which examined the first 100 colonoscopies and 100 CTCs carried out for the primary symptom of constipation from June 2012 to December 2013. The primary outcome measure was failure rate of the investigations. Secondary outcomes included reasons for failure and comparison of cost effectiveness between the two modalities. RESULTS: A total of 200 patients were included in this study. Of these, the first consecutive 100 colonoscopies and 100 CTCs were included. One colonic cancer was detected in each of the CTC and the colonoscopy arm, respectively. 37 (37%) attempted colonoscopies were incomplete examinations. The most common reasons were discomfort (51.4%) and poor bowel preparation (27%). There was no failure of CTC. For 100 patients, CTC as a primary investigation was a more cost-effective investigation (p ≤ 0.01) costing £55,016 as compared with colonoscopy costing £73,666. CONCLUSION: There is an unacceptably high failure rate of colonoscopy in patients who presented with the primary symptom of constipation. Hence, we propose that CTC may be an acceptable first-line investigation with a further colonoscopy/flexible sigmoidoscopy if lesions are detected. Advances in knowledge: First study to examine the use of CTC in patients with constipation.

Comparative effectiveness of screening strategies for colorectal cancer.

BACKGROUND: Screening for colorectal cancer (CRC) has been successful in decreasing the incidence and mortality from CRC. Although new screening tests have become available, their relative impact on CRC outcomes remains unexplored. This study compares the outcomes of various screening strategies on CRC outcomes. METHODS: A Markov model representing the natural history of CRC was built and validated against empiric data from screening trials as well as the Microstimulation Screening Analysis (MISCAN) model. Thirteen screening strategies based on colonoscopy, sigmoidoscopy, computed tomographic colonography, as well as fecal immunochemical, occult blood, and stool DNA testing were compared with no screening. A simulated sample of the US general population ages 50 to 75 years with an average risk of CRC was followed for up to 35 years or until death. Effectiveness was measured by discounted life years gained and the number of CRCs prevented. Discounted costs and cost-effectiveness ratios were calculated. A discount rate of 3% was used in calculations. The study took a societal perspective. RESULTS: Colonoscopy emerged as the most effective screening strategy with the highest life years gained (0.022 life years) and CRCs prevented (n = 1068) and the lowest total costs ($2861). These values were 0.012 life years gained, 574 CRCs prevented, and a total cost of $3164, respectively, for FOBT; and 0.011 life years gained, 647 CRCs prevented, and a total cost of $4296, respectively, for DNA testing. Improved sensitivity or specificity of a screening test for CRC detection was not sufficient to close the outcomes gap compared with colonoscopy. CONCLUSIONS: Improvement in CRC-detection performance is not sufficient to improve screening outcomes. Special attention must be directed to detecting precancerous adenomas. Cancer 2017;123:1516-1527. © 2017 American Cancer Society.

The potential of imaging techniques as a screening tool for colorectal cancer: a cost-effectiveness analysis.

OBJECTIVE: Imaging may be promising for colorectal cancer (CRC) screening, since it has test characteristics comparable with colonoscopy but is less invasive. We aimed to assess the potential of CT colonography (CTC) and MR colonography (MRC) in terms of (cost-effectiveness) using the Adenoma and Serrated pathway to Colorectal CAncer model. METHODS: We compared several CTC and MRC strategies with 5- or 10-yearly screening intervals with no screening, 10-yearly colonoscopy screening and biennial faecal immunochemical test (FIT) screening. We assumed trial-based participation rates in the base-case analyses and varied the rates in sensitivity analyses. Incremental lifetime costs and health effects were estimated from a healthcare perspective. RESULTS: The health gain of CTC and MRC was similar and ranged from 0.031 to 0.048 life-year gained compared with no screening, for 2-5 screening rounds. Lifetime costs per person for MRC strategies were €60-110 higher than those for CTC strategies with an equal number of screening rounds. All imaging-based strategies were cost-effective compared with no screening. FIT screening was the dominant screening strategy, leading to most LYG and highest cost-savings. Compared with three rounds of colonoscopy screening, CTC with five rounds was found to be cost-effective in an incremental analysis of imaging strategies. Assumptions on screening participation have a major influence on the ordering of strategies in terms of costs and effects. CONCLUSION: CTC and MRC have potential for CRC screening, compared with no screening and compared with three rounds of 10-yearly colonoscopy screening. When taking FIT screening as the reference, imaging is not cost-effective. Participation is an important driver of effectiveness and cost estimates. ADVANCES IN KNOWLEDGE: This is the first study to assess the cost-effectiveness of MRC screening for CRC.

Reassessing medicare trends in diagnostic CT colonography after achieving CPT code category I status.

PURPOSE: Compare national trends in utilization and coverage of diagnostic (non-screening) computed tomography colonography (CTC) in the Medicare population before and after achieving Current Procedural Terminology(®) (CPT) Category I code status in 2010. METHODS: Claims by provider type and location for diagnostic CTC were identified between 2005 and 2013 using Medicare Physician Supplier Procedure Summary Master Files. Frequencies of billed and denied services were used to calculate denial rates for CTC and abdominal computed tomography (CT). PubMed search for articles with "CT colonography" in abstract or title during 1997-2013 was performed. Publications were recorded yearly and matched to CTC denial rates. RESULTS: Annual Medicare claims for diagnostic CTC increased 212% during 2005-2009 in Category III status and increased 27.4% during 2009-2013 after implementation of Category I codes. Claims for abdominal CT rose 13.4% over the same overall period. Denial rates decreased from 70% to 32.8% between 2005 and 2009, and fluctuated between 24.7 and 30.6% thereafter. Denial rates for abdominal CT remained constant (4.1%-4.6%). From 2005 to 2013, services grew most in the private office (1678-7293) and hospital outpatient (1644-6449) settings with radiologists performing 93.3% of CTC. 1037 CTC publications were identified which increased 3567% between 1997 (3) and 2008 (107), plateaued until 2010 (114) and declined thereafter (75 in 2013). CONCLUSIONS: Diagnostic CTC grew dramatically from 2005 to 2009, but slowed thereafter; even after achieving CPT Category I code status in 2010. Medicare denial rates declined during early years but later stabilized which paralleled a slowing in new peer-reviewed research. CTC continues to be performed predominately by radiologists in the outpatient setting.

Willingness to Pay for CT Colonography: A Survey of Patient Preferences.

OBJECTIVE: CT colonography (CTC) has received mixed reviews both in the radiology literature and in clinical practice. CTC is less invasive than optical colonoscopy (OC), is better for identifying polyps, and does not require sedation. However, its cost-effectiveness has been called into question, and there is a residual need for OC if the CTC findings are positive. Some radiologists are hesitant to perform CTC because of the time-intensive nature of its interpretation. Results of willingness-to-pay surveys can be informative about preferences and value placed on intangibles. The purpose of this study was to use such a survey to elicit the preferences of radiologists about CTC versus OC. SUBJECTS AND METHODS: A vignette was presented in which the insurer covered OC at no charge but required out-of-pocket payment for CTC. The strengths and weaknesses of OC and CTC were listed. The respondents were asked how much they would be willing to pay for CTC; for CTC with perfect sensitivity, specificity, and accuracy; and for CTC that required no bowel preparation. RESULTS: Twenty-eight of 42 radiologists preferred OC to CTC. One radiologist was indifferent. Four radiologists would reverse their preference and choose CTC if it had 100% sensitivity. Sixteen radiologists said they would prefer CTC if it had 100% specificity. If CTC eliminated the need for bowel preparation, 57% would prefer it to OC. Thirty-one (74%) radiologists preferred perfect sensitivity to perfect specificity. CONCLUSION: Despite the less invasive nature of CTC, most radiologists who responded to the survey preferred OC for colorectal cancer screening, mostly because of the definitive nature of OC due to the capability of immediate biopsy of suspicious lesions and the lack of requirement for a second round of bowel preparation.

Colon Capsule Endoscopy for the Detection of Colorectal Polyps: An Economic Analysis.

BACKGROUND: Colorectal cancer is a leading cause of mortality and morbidity in Ontario. Most cases of colorectal cancer are preventable through early diagnosis and the removal of precancerous polyps. Colon capsule endoscopy is a non-invasive test for detecting colorectal polyps. OBJECTIVES: The objectives of this analysis were to evaluate the cost-effectiveness and the impact on the Ontario health budget of implementing colon capsule endoscopy for detecting advanced colorectal polyps among adult patients who have been referred for computed tomographic (CT) colonography. METHODS: We performed an original cost-effectiveness analysis to assess the additional cost of CT colonography and colon capsule endoscopy resulting from misdiagnoses. We generated diagnostic accuracy data from a clinical evidence-based analysis (reported separately), and we developed a deterministic Markov model to estimate the additional long-term costs and life-years lost due to false-negative results. We then also performed a budget impact analysis using data from Ontario administrative sources. One-year costs were estimated for CT colonography and colon capsule endoscopy (replacing all CT colonography procedures, and replacing only those CT colonography procedures in patients with an incomplete colonoscopy within the previous year). We conducted this analysis from the payer perspective. RESULTS: Using the point estimates of diagnostic accuracy from the head-to-head study between colon capsule endoscopy and CT colonography, we found the additional cost of false-positive results for colon capsule endoscopy to be $0.41 per patient, while additional false-negatives for the CT colonography arm generated an added cost of $116 per patient, with 0.0096 life-years lost per patient due to cancer. This results in an additional cost of $26,750 per life-year gained for colon capsule endoscopy compared with CT colonography. The total 1-year cost to replace all CT colonography procedures with colon capsule endoscopy in Ontario is about $2.72 million; replacing only those CT colonography procedures in patients with an incomplete colonoscopy in the previous year would cost about $740,600 in the first year. LIMITATIONS: The difference in accuracy between colon capsule endoscopy and CT colonography was not statistically significant for the detection of advanced adenomas (≥ 10 mm in diameter), according to the head-to-head clinical study from which the diagnostic accuracy was taken. This leads to uncertainty in the economic analysis, with results highly sensitive to changes in diagnostic accuracy. CONCLUSIONS: The cost-effectiveness of colon capsule endoscopy for use in patients referred for CT colonography is $26,750 per life-year, assuming an increased sensitivity of colon capsule endoscopy. Replacement of CT colonography with colon capsule endoscopy is associated with moderate costs to the health care system.