On 2016 Aug 01, David Keller commented:

A Hybrid Non-Invasive Colon Cancer Screening Strategy Lowers Cost/Benefit With Medicare Coverage

Many patients prefer to avoid invasive procedures and radiation exposure when screening for colon cancer. Non-invasive fecal testing fits these preferences, and can achieve results nearly as beneficial as colonoscopy every 10 years, according to CISNET (the Cancer Intervention and Surveillance Modeling Network) model outcomes displayed in Figure 3 of the 2016 USPSTF Recommendation Statement [1]. Colonoscopy-based screening yields the highest benefit, with an estimated 270 life-years gained per 1000 persons screened, closely followed by non-invasive Multi-Target FIT-DNA ("ColoGuard") testing every year with 261 life-years gained. The next-best non-invasive no-radiation strategy is annual testing for occult fecal blood using either immunochemical testing (FIT) or high-sensitivity guaiac (HSg-FOBT), which gain 244 and 247 life-years, respectively, followed by FIT-DNA performed once every 3 years, which gains only 226 life-years per thousand screened, about 15% less benefit than gained with annual FIT-DNA screening.

Partly due to the high cost of FIT-DNA testing, up to $649 per test [2], Medicare covers it only once per 3 years [2]. Medicare beneficiaries who are not willing to pay over $1200 out-of-pocket for the additional two non-covered test kits required for annual FIT-DNA screening may wish to consider an alternative strategy not discussed by CISNET: FIT-DNA testing every 3 years, plus annual FIT testing in the off-years. This "hybrid" combination should yield a benefit larger than annual FIT testing alone but smaller than annual FIT-DNA testing, putting it in the range of 244 to 261 life-years. Weighted interpolation using 2/3 times the FIT-alone benefit plus 1/3 times the FIT-DNA benefit yields an estimated benefit of 251 life-years per thousand screened, which is about 91 days of life per person screened.

It is uncertain whether the cost of the two annual FIT tests would be covered by Medicare for beneficiaries during their 3-year waiting period for their next FIT-DNA test. If not, the retail price of two FIT kits is about $30 [3], probably acceptable to most beneficiaries. Harms of hybrid every-3-year FIT-DNA screening plus FIT screening in the off-years should be larger than for annual FIT testing, but less than for annual FIT-DNA testing, because FIT is significantly more specific than FIT-DNA, 96.4% versus 89.8% respectively per test [4]. The harms of fecal screening are complications of colonoscopy triggered by positive screening test results, estimated at 12 GI or CV events for annual FIT-DNA, 10 events for annual FIT, [1], with an interpolated estimate of about 10.7 events for the hybrid strategy (all harms are expressed in events per 1000 persons screened).

References

1: US Preventive Services Task Force. Screening for Colorectal Cancer: US Preventive Services Task Force Recommendation Statement. JAMA. 2016 Jun 21;315(23):2564-75. doi:10.1001/jama.2016.5989. PubMed PMID: 27304597. See Figure 3 on page 2569.

2: ColoGuard website, accessed on 7/2/2016. http://www.cologuardtest.com/what-to-expect-with-cologuard/faq/cologuard-cost-how-much-is-cologuard and, Medicare official website, accessed on 7/2/2016. https://www.medicare.gov/coverage/colorectal-cancer-screenings.html

3: Pinnacle Labs website Fecal Immunochemical Test 2-Pack $29.99, accessed on 7/2/2016. https://www.pblabs.com/collections/fit-fecal-immunochemical-test/products/second-generation-fit-fecal-immunochemical-test-2-pack

4: Imperiale TF, Ransohoff DF, Itzkowitz SH, Turnbull BA, Ross ME; Colorectal Cancer Study Group. Fecal DNA versus fecal occult blood for colorectal-cancer screening in an average-risk population. N Engl J Med. 2004 Dec 23;351(26):2704-14. PubMed PMID: 15616205.

On 2016 Aug 01, David Keller commented:

A Hybrid Non-Invasive Colon Cancer Screening Strategy Lowers Cost/Benefit With Medicare Coverage

Many patients prefer to avoid invasive procedures and radiation exposure when screening for colon cancer. Non-invasive fecal testing fits these preferences, and can achieve results nearly as beneficial as colonoscopy every 10 years, according to CISNET (the Cancer Intervention and Surveillance Modeling Network) model outcomes displayed in Figure 3 of the 2016 USPSTF Recommendation Statement [1]. Colonoscopy-based screening yields the highest benefit, with an estimated 270 life-years gained per 1000 persons screened, closely followed by non-invasive Multi-Target FIT-DNA ("ColoGuard") testing every year with 261 life-years gained. The next-best non-invasive no-radiation strategy is annual testing for occult fecal blood using either immunochemical testing (FIT) or high-sensitivity guaiac (HSg-FOBT), which gain 244 and 247 life-years, respectively, followed by FIT-DNA performed once every 3 years, which gains only 226 life-years per thousand screened, about 15% less benefit than gained with annual FIT-DNA screening.

Partly due to the high cost of FIT-DNA testing, up to $649 per test [2], Medicare covers it only once per 3 years [2]. Medicare beneficiaries who are not willing to pay over $1200 out-of-pocket for the additional two non-covered test kits required for annual FIT-DNA screening may wish to consider an alternative strategy not discussed by CISNET: FIT-DNA testing every 3 years, plus annual FIT testing in the off-years. This "hybrid" combination should yield a benefit larger than annual FIT testing alone but smaller than annual FIT-DNA testing, putting it in the range of 244 to 261 life-years. Weighted interpolation using 2/3 times the FIT-alone benefit plus 1/3 times the FIT-DNA benefit yields an estimated benefit of 251 life-years per thousand screened, which is about 91 days of life per person screened.

It is uncertain whether the cost of the two annual FIT tests would be covered by Medicare for beneficiaries during their 3-year waiting period for their next FIT-DNA test. If not, the retail price of two FIT kits is about $30 [3], probably acceptable to most beneficiaries. Harms of hybrid every-3-year FIT-DNA screening plus FIT screening in the off-years should be larger than for annual FIT testing, but less than for annual FIT-DNA testing, because FIT is significantly more specific than FIT-DNA, 96.4% versus 89.8% respectively per test [4]. The harms of fecal screening are complications of colonoscopy triggered by positive screening test results, estimated at 12 GI or CV events for annual FIT-DNA, 10 events for annual FIT, [1], with an interpolated estimate of about 10.7 events for the hybrid strategy (all harms are expressed in events per 1000 persons screened).

References

1: US Preventive Services Task Force. Screening for Colorectal Cancer: US Preventive Services Task Force Recommendation Statement. JAMA. 2016 Jun 21;315(23):2564-75. doi:10.1001/jama.2016.5989. PubMed PMID: 27304597. See Figure 3 on page 2569.

2: ColoGuard website, accessed on 7/2/2016. http://www.cologuardtest.com/what-to-expect-with-cologuard/faq/cologuard-cost-how-much-is-cologuard and, Medicare official website, accessed on 7/2/2016. https://www.medicare.gov/coverage/colorectal-cancer-screenings.html

3: Pinnacle Labs website Fecal Immunochemical Test 2-Pack $29.99, accessed on 7/2/2016. https://www.pblabs.com/collections/fit-fecal-immunochemical-test/products/second-generation-fit-fecal-immunochemical-test-2-pack

4: Imperiale TF, Ransohoff DF, Itzkowitz SH, Turnbull BA, Ross ME; Colorectal Cancer Study Group. Fecal DNA versus fecal occult blood for colorectal-cancer screening in an average-risk population. N Engl J Med. 2004 Dec 23;351(26):2704-14. PubMed PMID: 15616205.