On May 5, 2020 New research from Exact Sciences Corp. (NASDAQ: EXAS) reported that uses real-world-adjusted adherence rates in a colorectal cancer microsimulation, the Colorectal Cancer and Adenoma Incidence and Mortality model (CRC-AIM), to reinforce the value of Cologuard (mt-sDNA) as an effective colorectal cancer screening test (Press release, Exact Sciences, MAY 5, 2020, View Source [SID1234557015]). Cologuard offers significant advantages over the fecal immunochemical test (FIT) and real-world adherence data further highlights those advantages. Cologuard has higher sensitivity, a longer interval, and higher observed adherence rates in real-world usage. The modeling also highlights the importance of improving access to colonoscopy following a positive Cologuard or FIT test.

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These results were accepted for presentation at DDW 2020 in a series of abstracts. They are now available on the DDW website.

Colorectal cancer (CRC) is the second leading cause of cancer death for men and women, in part because many cancers go undetected until later stages when treatment options are limited.1 Colorectal cancer can be prevented or detected early through screening; however, approximately 45 million Americans are not up to date with CRC screening.2

"Policymakers and other leaders often rely on modeling to make decisions about colorectal cancer screening," said Dr. Paul Limburg, Chief Medical Officer of Exact Sciences’ screening business. "Modeling that incorporates real-life patient behaviors, and the impact of those behaviors on health outcomes, is limited. This new suite of abstracts provides insight into the effect that complex and dynamic patient patterns have on colorectal cancer screening outcomes."

Included below are titles, abstract numbers, and a brief summary of each abstract accepted for presentation at DDW.

Estimating the Impact of Imperfect Adherence to Stool-based Colorectal Cancer Screening Strategies on Comparative Effectiveness using the CRC-AIM Microsimulation Model
Abstract Number: Mo1598

Real-life adherence rates for CRC screening are imperfect and can vary widely by modality, health system setting, and use of patient compliance navigation programs. Cologuard (mt-sDNA) was recently shown to have high population-level adherence in a Medicare population, which researchers theorized was attributable to its noninvasive approach, widespread accessibility, and embedded patient navigation system. Using real-world adherence rates of 70% for mt-sDNA3 and 40-50% for FIT,4 the CRC-AIM microsimulation model estimated that the use of mt-sDNA resulted in an 8.4% to 19.1% increase in life-years gained (LYG) compared with FIT for screening ages 50-75 years.

More Fecal Immunochemical Tests are Needed to Match the Clinical Benefit of Equivalent Numbers of Multitarget Stool DNA Tests: CRC-AIM Microsimulation Model Results
Abstract Number: Su1773

Patient adherence to the annual testing regimes of FIT has proven difficult to achieve in real world settings.5 Predicted outcomes of annual FIT and triennial mt-sDNA were simulated for 4 million individuals between 50 and 75. At least twice as many FIT tests are needed to match the same clinical benefit compared with mt-sDNA testing (21 vs. 9) using guideline recommended CRC screening initiation age and test interval.

Microsimulation Study of Life-Years Gained from Screening vs. Follow-up Colonoscopy using the CRC-AIM Model
Abstract Number: Sa1658

Health care providers often face a challenge ensuring patient adherence to follow-up colonoscopy after a positive stool-based test. Current reimbursement and coverage policies can trigger patient cost-sharing when patients seek necessary follow-up colonoscopy or when a screening colonoscopy turns diagnostic, depending upon health insurance benefits. In a third study leveraging the CRC-AIM model, the analysis showed that there are approximately 3-to-5 times more LYG per colonoscopy when the colonoscopy was performed as a diagnostic follow-up to a positive stool-based test rather than as a screening colonoscopy alone.

"All too often, colonoscopies following a positive stool-based test and screening colonoscopies that turn diagnostic do not receive full reimbursement from insurers, which can prevent patients from scheduling them," said Kevin Conroy, chairman and CEO. "These data show the urgent need to remove cost barriers for these colonoscopies as they have a measurable positive impact on patient lives."

Higher Impact on Clinical Outcomes from Delays in Colorectal Cancer Screening with the Fecal Immunochemical Test vs. Multitarget Stool DNA: CRC-AIM Microsimulation Model Results
Abstract Number: Tu1822

One obstacle to CRC screening is a delay in the start of screening or a lack of adherence to repeat testing. For example, screening rates among people 50 to 54 years old are only 50%, according to recent CDC data.6 The assumption in this modeling analysis was that recommended triennial mt-sDNA or annual FIT was delayed by 12, 18, or 24 months every time screening was due. The reduction in CRC-related mortality with a 12, 18, and 24-month delay for patients 50 to 75 was greater with triennial mt-sDNA (67%, 63%, and 59%, respectively) than annual FIT (65%, 59%, and 53%). The relative efficacy of mt-sDNA was better than FIT when considering these clinically realistic delayed screening adherence scenarios.

To promote transparency and the credibility of this new model, Exact Sciences has made available CRC-AIM’s formulas and parameters at View Source so other researchers and members of the modeling community can address outstanding questions related to CRC screening.