There are multiple screening modalities available for colorectal cancer (CRC), including colonoscopy, fecal immunochemical testing (FIT), and multi-target stool DNA (mt-sDNA) testing. While all three options are cost-effective relative to no screening, colonoscopy and FIT are the dominant strategies, assuming perfect adherence.1 However, mt-sDNA becomes the dominant strategy if test adherence is 1.7-fold higher than FIT (without including patient support costs).1
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Clinical and Economic Outcomes for Hypothetical 100,000-Person Cohorts in Organized Fecal-Based Screening Programs
(100% Adherence from Age 50 to 80)1,a
| No Screening | FIT every 2 yrs | mt-sDNA every 3 years |
FIT yearly | |
|
CRC cases per 100,000 persons |
5927 | 4039 | 3714 | 3464 |
| CRC stage. number of cases per 100,000 persons (% of all cases) | ||||
| Localized | 2373 (40) | 2200 (54) | 1915 (52) | 1898 (55) |
| Regional | 2210 (37) | 1223 (30) | 1206 (32) | 1026 (30) |
| Distant | 1345 (23) | 615 (15) | 594 (16) | 539 (16) |
|
CRC deaths per 100,000 persons |
2316 | 1224 | 1173 | 1054 |
|
Quality-adjusted life years (QALYs)/person |
18.6687 | 18.7171 | 18.7181 | 18.7236 |
| Cost/person, $ | 3020 | 3212 | 4377 | 3806 |
| Incremental cost/QALY gained (column compared with row) | ||||
| No screening | - | $3970 | $27,500 | $14,300 |
| FIT every 2 years | - | - | $1,270,000 | $92,400 |
| mt-sDNA every 3 yrs | - | - | - | Dominates |
|
Lifetime tests/person, mean colonoscopies/person |
0.1 | 0.7 | 1 | 1 |
| Fecal tests/person | - | 6.8 | 4.3 | 11.4 |
- Quality-adjusted life years (QALY) and costs per person are shown1
- The researchers adapted a validated decision analytic Markov cohort model of CRC screening in the general US population1
- The potential effectiveness and cost effectiveness of screening with mt-sDNA at 1- to 5-year intervals was explored to select a testing interval for a mt-sDNA-based screening program1
- Different participation patterns were modeled over time and patient support costs for organized FIT programs were considered1
- Compared with organized high-participationa FIT programs, mt-sDNA (patient support program included) would need 68% of subjects to participate consistently and 32% to participate intermittently every 3 years, or the mt-sDNA test would need to cost 60% less than in the base case ($260 commercial payment and $197 Medicare payment) for the mt-sDNA test to be preferred over FIT at a threshold of $100,000 per QALY gained1
- Compared with opportunistic yearly FIT screening (15% consistent and 30% intermittent participation), performing the mt-sDNA test every 3 years would cost less than $100,000 per QALY gained if the mt-sDNA test achieved a participation rate more than 1.7-fold that of FIT1
- The same sensitivities of one-time testing may not be applicable in subsequent screening cycles after a lesion has been missed: a fraction of CRCs or advanced CRC precursors may be persistently silent with respect to the signals detected by a particular test1
- Most information on the performance of screening tests reflects one-time testing, and it is not clear if sensitivities apply during subsequent screening cycles1
- The model was based on the natural history of CRC assuming that all CRC arise from traditional adenoma–carcinoma sequence and none incorporate a separate path for sessile serrated lesions1
Study Assumptions1
- Persons entered the model at 50 years of age and followed up until 100 years of age or death
- Screening and surveillance are offered for persons aged 50 to 80 years
- Patients were placed into cohorts with different longitudinal screening participation patterns: consistent, intermittent, and consistent non-responders
Learn more about the full Indications/Contraindications for the mt-sDNA test.
Please see complete prescribing information for Cologuard in the Cologuard Clinician Brochure.
References
1 Ladabaum U, Mannalithara A. Comparative effectiveness and cost effectiveness of a multi-target stool DNA test to screen for colorectal neoplasia. Gastroenterol. 2016;151(3):427-439.
Footnotes
a 50% consistent screeners, 27% intermittent screeners and 23% never-screeners, at an additional cost of $153/patient per FIT testing cycle for “patient support”. The research team adapted their decision analytic Markov cohort model of CRC screening and validated against the United Kingdom Flexible Sigmoidoscopy Trial, Screening for Colon Rectum (SCORE) trial, and Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial.
Last updated: 3/1/2022