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A Path to Improve Colorectal Cancer Screening Outcomes: Faculty Roundtable Evaluation of Cost-Effectiveness and Utility
Richard H. Bone, MD; James D. Cross, MD; Andrea J. Dwyer, MPH; John L. Fox, MD, MHA; David M. Hyams, MD; Kristen Hassmiller Lich, PhD, MHSA; Thomas A. Mackey, PhD, APRN-BC; Ross M. Miller, MD, MPH; and A. Mark Fendrick, MD

A Path to Improve Colorectal Cancer Screening Outcomes: Faculty Roundtable Evaluation of Cost-Effectiveness and Utility

Richard H. Bone, MD; James D. Cross, MD; Andrea J. Dwyer, MPH; John L. Fox, MD, MHA; David M. Hyams, MD; Kristen Hassmiller Lich, PhD, MHSA; Thomas A. Mackey, PhD, APRN-BC; Ross M. Miller, MD, MPH; and A. Mark Fendrick, MD
The American Journal of Managed Care® and Exact Sciences Corporation hosted a roundtable meeting to discuss the impact of colorectal cancer (CRC) screening modalities on improving patient outcomes. The roundtable participants were a diverse panel of experts, including primary care, gastroenterology, and oncology providers; experts in health outcomes research and health policy; and managed care executives with commercial and public payer experience. Participants discussed CRC prevention and treatment strategies, screening modalities and adherence, molecular diagnostics, patient navigation, evaluation of large data sets, managed care, outcomes research, quality improvement, and reimbursement policies. They focused on developing better value-based medical policies and payment procedures, identifying knowledge, practice, and access deficits related to CRC screening. Participants also provided suggestions on how to improve care quality and patient outcomes through effective evidence-based approaches. They also discussed costeffectiveness modeling for CRC screening, specifically the advantages and the real-world limitations of these models.
Am J Manag Care. 2020;26:S123-S143. https://doi.org/10.37765/ajmc.2020.43732
For author information and disclosures, see end of text.
Note: The roundtable meeting described in this article took place in November 2017. To accurately reflect the best available evidence at that time, this article includes only publications that could have informed the opinions of the meeting participants (ie, that were published before the meeting date). The only newer information included in this article is composed of updated statistics on colorectal cancer incidence and mortality and updated guideline recommendations.

Background on Colorectal Cancer
Colorectal cancer (CRC) is the second-leading cause of cancer death in the United States, accounting for an estimated 51,020 deaths in 2019.1,2 Also, an estimated 147,950 Americans received a CRC diagnosis in 2019, making it the third most commonly diagnosed cancer in the United States.3 The risk of CRC increases with age, and the disease is most frequently diagnosed in those aged 65 to 74 years.2

The stage at which CRC is detected has a substantial effect on survival. Diagnosis at stage I or II allows surgical cure in a majority of cases; the 5-year survival rate is as high as 90% in patients diagnosed with localized-stage disease.4 However, lack of access to healthcare, underuse of CRC screening, and poor adherence to established clinical practice screening guidelines can lead to later-stage diagnosis and poor patient outcomes.5 Only a minority of patients (39%) are diagnosed at stage I; most cases (57%) are diagnosed at later stages (III or IV), and few (4%) are diagnosed at an unknown stage.2,4 The 5-year survival rate is lower in patients with distant CRC at diagnosis, as low as 14.2%, compared with that of patients with regional disease (71.3%), where the cancer has spread to the regional lymph nodes but has not metastasized.2

Most CRCs originate as adenomatous polyps.6 Polyps are evaluated based on appearance (pedunculated [stalked] or sessile [flat]), histology, and size.7 There is a span of approximately 10 years between the formation of most adenomatous polyps and the development of CRC.8,9 This lengthy development time provides multiple screening opportunities throughout the natural history of the disease. Adherent and systematic screening in eligible individuals ensures early detection and diagnosis of precancerous adenomas or early-stage CRC, when treatment is most effective, thereby improving patient health outcomes and reducing mortality rates.6,10 Early-stage CRC is often asymptomatic, with symptoms becoming clinically evident in later stages.4 With effective CRC screening, precancerous adenomatous polyps can be detected and surgically excised (polypectomy) before they progress to later-stage cancer.4

An Economic Proposition for CRC Screening
In 2018, CRC accounted for approximately $16.6 billion in national cancer care expenditures in the United States, making it the second most expensive cancer care cost after breast cancer.11 The total cost of care is even greater when both direct and indirect costs of screening and treatment of CRC are considered,12 with $10.7 billion in lost productivity due to CRC-associated mortality.11 Between 2005 and 2020, the total cost of lost productivity in the US population with CRC was predicted to reach $339 billion.13

Early detection and management of CRC is vital to improving patient outcomes and minimizing both short- and long-term healthcare expenses. Later-stage or metastatic CRC can present with bowel obstruction, perforation, sepsis, and complications from anemia.14 Emergency surgery, the need for bowel diversion, and potential anastomosis to reestablish bowel continuity are all expensive sequelae in symptom-associated CRC diagnoses.

Beyond emergency surgical and medical interventions, the potential savings associated with CRC screening are proportional to disease stage at diagnosis.15 With later-stage disease, simple operations become more complex, adjuvant therapies become more expensive, and the invariable adverse effects and potential complications of such treatments increase costs even more. The most expensive CRC treatments are those for patients with stage IV disease.16 Effective CRC screening through CRC prevention and enhanced early-stage detection can mitigate many of these adverse events and reduce the economic burden of CRC.

Evidence-Based Recommendations for CRC Screening and Available Screening Modalities
CRC screening guidelines in the United States are developed by multiple organizations, including the US Preventive Services Task Force (USPSTF), the American Cancer Society (ACS), and the National Comprehensive Cancer Network, among others. In general, the guidelines recommend regular screening by a variety of modalities in average-risk, asymptomatic individuals aged 50 to 75 years, although the ACS updated their recommendation in 2018 to begin screening average-risk adults at age 45.8,17-19 Notably, nongrandfathered health insurance plans, with plan-years beginning on or after September 23, 2010, are required to provide coverage without patient cost sharing for preventive services that have a rating of A or B in the recommendations of the USPSTF.20

Currently, screening recommendations are based on data-informed modeling (see Characteristics of CRC Screening Models). Although published results of several randomized controlled trials (RCTs) demonstrate a slight reduction in CRC mortality with sigmoidoscopy and guaiac-based fecal occult blood test (gFOBT) screening, no published RCTs currently exist on the long-term impact of fecal immunochemical test (FIT) and colonoscopy on reducing CRC incidence and mortality.21 However, several RCTs designed to answer this question with respect to colonoscopy are in progress, including COLONPREV (NCT00906997), SCREESCO (NCT02078804), US CONFIRM trials (NCT01239082), and NordICC (NCT00883792).22-28 Roundtable participants pointed out that with increasingly younger ages at CRC diagnosis, dropping the age threshold in the ACS’ CRC screening guidelines is expected to capture more cases earlier; however, the impact of this recommendation on CRC and related healthcare practices, outcomes, and finances is yet to be determined.

In contrast with its 2008 recommendations, the USPSTF did not grade specific screening modalities in the 2016 update. Instead, the USPSTF broadly recommended that maximizing participation of the eligible population by screening programs using a variety of recommended options will have the greatest effect on reducing CRC morbidity and mortality, regardless of the screening modality used.22 As such, USPSTF assigned grade A to the overall evidence-based recommendation for CRC screening in adults aged 50 to 75 years. This recommendation was based on a systematic review of the available evidence regarding several CRC screening modalities, including reports of their harms, their ability to reduce CRC incidence and mortality, and their performance.22 Comparative effectiveness assessments were performed using Cancer Intervention and Surveillance Modeling Network (CISNET) analyses and observational evidence on the benefits of screening when trial evidence was unavailable.22

In its 2016 recommendations, the USPSTF suggested that 7 recommended screening strategies provided similar benefits with respect to life-years gained, CRC deaths averted, and improvement in benefit-to-harm ratio when evaluated against colonoscopy as the control comparator (Table 1).4,6,22,29-31 The USPSTF equally recommended each of these screening modalities: (1) flexible sigmoidoscopy every 5 years; (2) multitarget stool (mt-sDNA; referred to as FIT-DNA by the USPSTF) test every 1 or 3 years; (3) FIT every year; (4) gFOBT every year; (5) CT colonography every 5 years; (6) flexible sigmoidoscopy every 10 years plus FIT every year; and (7) colonoscopy every 10 years.22 Colonoscopy and flexible sigmoidoscopy were considered invasive screening technologies, whereas noninvasive screening technologies were CT colonography, gFOBT, FIT, and mt-sDNA. The functionality, limitations, and other characteristics of each screening modality are explored next.

Invasive Screening Modalities
In 2015, the National Health Interview Survey found that 58.3% of eligible Americans had been screened by colonoscopy in the past 10 years, an increase from 46.9% in 2008.32 Before the widespread use of colonoscopy, flexible sigmoidoscopy was a commonly used CRC screening method. This technique allows direct visualization of the rectum and sigmoid colon, but for most practitioners, it leaves more than two-thirds of a normal-length colon unvisualized. The use of flexible sigmoidoscopy in the United States has declined substantially since the widespread adoption of colonoscopy.4

The available USPSTF-recommended CRC screening methods have different sensitivities and specificities (Table 2).4,6,29,33,34 Although all CRC tests increase survival rates, colonoscopy is most commonly used because it has the highest performance rate of all the tests. It is the preferred follow-up diagnostic strategy for all other positive CRC screening tests because of its ability to visualize, biopsy, and ablate or remove small- to moderate-sized lesions. However, colonoscopy quality can vary depending on the endoscopist, the medical facility, time of day, or quality of bowel preparation, and it still can fail to detect certain adenomas.4

Invasive procedures can drive the morbidity and costs associated with CRC screening. Colonoscopy is associated with the highest risk of harms compared with the other CRC screening modalities included in the 2016 USPSTF recommendations.22 These include potential complications such as colonic perforations and hemorrhage, which are more frequent when pathology is biopsied or removed.6,35-37

To prepare for an invasive CRC screening procedure with flexible sigmoidoscopy or colonoscopy, individuals require bowel cleansing—generally only an enema for flexible sigmoidoscopy and a more extensive preprocedure bowel cleansing for colonoscopy—and temporary dietary restrictions.4 In up to 26.4% of individuals, bowel preparation is inadequate, which can reduce the ability to detect polyps and CRC lesions.38,39 Such events can lead to additional testing or repeat procedures, accompanied by their own associated morbidity.40 Unlike CRC screening with flexible sigmoidoscopy, the colonoscopy procedure involves sedation with narcotics, hypnotics, and/or general anesthesia, requiring a chaperone to and from the procedure. Colonoscopies also are associated with work disruption during the 24 hours of bowel preparation and during the 12-hour postprocedural window.4 On average, caregivers provide 5.3 hours of their time in support of the colonoscopy procedure.41



 
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