Cologuard Screening for Colorectal Cancer

Transcription

1 Pending Policies - Medicine Cologuard Screening for Colorectal Cancer Print Number: MED Effective Date: Coverage: I.Cologuard stool DNA testing may be considered medically necessary for colorectal cancer screening once every 3 years for patients age when ALL of the following criteria are met: a. Patient has NOT HAD ANY of the following United States Preventive Services Task Force (USPSTF) recommended (A rating) colorectal cancer screening performed during the recommended screening interval: 1. Guaiac-based fecal occult blood test (gfobt) in the past year, OR 2. Fecal immunochemical test (FIT) in the past year, OR 3. Multitargeted stool DNA test (FIT-DNA) in the past 3 years, OR 4. Colonoscopy in the past 10 years, OR 5. CT colonography in the past 5 years, OR 6. Flexible sigmoidoscopy in the past 5 years, AND b. There are no signs or symptoms of colorectal disease, including lower gastrointestinal pain, blood in stool, positive guaiac fecal occult blood test or fecal immunochemical test), AND c. There is an average risk of developing colorectal cancer defined by the following:

2 1. No personal history of adenomatous polyps, colorectal cancer, or inflammatory bowel disease, including Crohn's Disease and ulcerative colitis, AND 2. No family history of colorectal cancers or adenomatous polyps, familial adenomatous polyposis, or hereditary nonpolyposis colorectal cancer. II.Cologuard stool DNA testing may be considered medically necessary for colorectal cancer screening once every 3 years for patients age when ALL of the following criteria are met: a. Patient has never been screened for colorectal cancer by any screening method, AND b. There are no signs or symptoms of colorectal disease, including lower gastrointestinal pain, blood in stool, positive guaiac fecal occult blood test or fecal immunochemical test (FIT), AND c. There is an average risk of developing colorectal cancer defined by the following: 1. No personal history of adenomatous polyps, colorectal cancer, or inflammatory bowel disease, including Crohn's Disease and ulcerative colitis, AND 2. No family history of colorectal cancers or adenomatous polyps, familial adenomatous polyposis, or hereditary nonpolyposis colorectal cancer, AND 3. Patient is healthy enough to undergo treatment if colorectal cancer is detected, AND 4. Patient does not have comorbid conditions that would significantly limit his/her life expectancy. NOTE 1: Cologuard stool DNA testing is not recommended for colorectal cancer screening in patients age 86 and older. (2) Description: Colorectal cancer (CRC) is one of the most common types of cancers, with over 134,490 new cases identified each year in the United States. It typically affects adults over 55 years old, with a median age at diagnosis of 68 years. Screening programs for CRC allow for its early detection. The earlier CRC is caught, the better chance a person has of surviving. Five-year survival rates are 90.1% for localized cancer, 71.2% for cancer that has spread regionally, and 13.5% for CRC with distant metastasis. (1) The standard recommended screening for CRC includes guaiac-

3 based fecal occult blood test (gfobt), fecal immunochemical test (FIT), multitargeted stool DNA test (FIT-DNA), colonoscopy, CT colonography, and flexible sigmoidoscopy. Screening begins at age 50 years and continues until at least age 75 for people at average risk for CRC. (2) Although several screening tests have been endorsed and found to be cost-effective, compliance with CRC screening recommendations is limited. According to data from the Centers for Disease Control and Prevention (CDC), the percentage of adults over the age of 50 reported 65% of U.S. adults were up-todate with colorectal cancer screening; 7% had been screened, but were not up-to-date; and 28% had never been screened. (3) Test Information Cologuard screening test (Exact Sciences) is a proprietary multiple molecular marker assay that measures the presence of certain markers in a stool sample. It is intended to identify people at increased risk for CRC. It offers an alternative to current CRC screening options. Cologuard is performed on a stool sample collected at home and sent to the laboratory for analysis. No bowel preparation or dietary or medication restrictions are required to complete the test. Cologuard analyzes 11 molecular markers, including hemoglobin and deoxyribonucleic acid (DNA) markers, in the stool sample. Three categories of markers are targeted for testing: (4) Hypermethylation of the promoter regions of the NDRG4 and BMP3 genes; Point mutations in the KRAS gene; Hemoglobin markers, which can be associated with the presence of blood in the colon. The non-dna immunochemical assay component used to detect blood is similar to other available FIT assays. Cologuard provides a single, combined result: positive or negative. People who receive positive results should be referred for a diagnostic colonoscopy. Those with negative results can continue with standard CRC screening recommendations. (4) Regulatory Status Fecal DNA testing includes the PreGen-26, PreGen-Plus, ColoSure and Cologuard tests. However, Cologuard is the only test currently available in the United States (U.S.) The U.S.

4 Food and Drug Administration approved Cologuard through their Premarket Approval (PMA) pathway in August 2014 as an in vitro diagnostic. (5) Rationale: Performance characteristics of the Cologuard assay were determined by a large, prospective multicenter trial (DeeP-C Study) and published by Imperiale and colleagues. (6) Nine thousand nine hundred eighty-nine participants (n=9989) completed testing and were age years, asymptomatic, and at average risk for Colorectal Cancer (CRC). All participants provided a stool sample and underwent diagnostic colonoscopy. The primary outcome was the ability of the Cologuard test to detect CRC. Sensitivity: Sixty-five subjects had CRC. Sixty of these individuals had positive Cologuard results, giving a sensitivity of 92.3% for identifying cancer [95%CI: ]. Seven hundred fifty-seven individuals had advanced precancerous lesions. 321 of these people had positive Cologuard results, giving a sensitivity of 42.4% for identifying precancerous lesions [95%CI: ]. Comparable sensitivities of fecal immunochemical testing were 73.8% and 23.8%, respectively, in this trial. (6) Specificity: 9167 subjects had non-advanced adenomas, non-neoplastic findings, and negative results on colonoscopy of these people had negative Cologuard results, giving a specificity of 86.6% [95%CI ]. If only those with "true negative" colonoscopies are considered, the specificity was 89.8% [95%CI ]. Comparable specificities of fecal immunochemical testing were 94.9% and 96.4%, respectively, in this trial. (6) Ongoing Clinical Trials Ongoing clinical trials that might influence this policy are listed in Table 1. Table 1: Summary of Key Trials. NCT Number Title Study Status

5 NCT A Study Of Prospective, In process (7) Cologuard in longitudinal A Average study to Risk evaluate the Population impact of Assessing a repeat Three Year Cologuard Test Interval testing in an average-risk population at 3-year intervals. *NCT Molecular Prospective, Recruiting (8) Stool observational Testing for cohort study CRC to compare Surveillance the accuracy (MOCCAS) of an Trial established molecular stool test (Cologuard ) and FIT to colonoscopy for detection of advanced adenomas or CRC. * Sponsored by The Netherlands Cancer Institute. CRC: Colorectal Cancer Professional Guidelines and Position Statements United States Preventative Services Task Force (USPSTF) In 2016, the USPSTF updated their CRC screening guidelines (2) to recommend the use of gfobt, FIT, FIT-DNA (multitargeted stool DNA testing), colonoscopy, CT colonography, and flexible sigmoidoscopy for individuals ages 50 years to 75 years at average risk of colorectal cancer. For other age groups, the guidelines recommend the following: For older adults aged 76 to 85 years, the benefits of screening for colorectal cancer decline, and the risk of experiencing serious associated harms increases. The most important consideration for

6 clinicians and patients in this age group is whether the patient has previously been screened. Patients in this age group who have never been screened for colorectal cancer are more likely to benefit than those who have been previously screened. Screening in adults aged 76 to 85 years would be most appropriate among adults who 1) Are healthy enough to undergo treatment if colorectal cancer is detected; and 2) Do not have comorbid conditions that would significantly limit their life expectancy. The USPSTF does not recommend routine screening for colorectal cancer in adults 86 years and older. In this age group, competing causes of mortality preclude a mortality benefit that would outweigh the harms. National Comprehensive Cancer Network (NCCN) The updated 2016 CRC screening guidelines from NCCN (9) state the following regarding Cologuard: A multi-target stool DNA combined with FIT test has recently been approved by the FDA as a primary screening modality for colorectal cancer. At this time, there are limited data available to determine an appropriate interval between screening; however, every 3 y has been suggested. The data in an average-risk individual indicates that stool DNA performs well. There are no or limited data in high-risk individuals and the use of stool DNA should be individualized. If a result is determined to be a false positive, clinical judgment and shared decision-making should be used. Contract: Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern. Coding:

7 CODING: Disclaimer for coding information on Medical Policies Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive. The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations. Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps. CPT/HCPCS/ICD-9/ICD-10 Codes The following codes may be applicable to this Medical policy and may not be all inclusive. CPT Codes HCPCS Codes [Deleted 1/2016: G0464, S3890] ICD-9 Diagnosis Codes Refer to the ICD-9-CM manual ICD-9 Procedure Codes Refer to the ICD-9-CM manual ICD-10 Diagnosis Codes Refer to the ICD-10-CM manual ICD-10 Procedure Codes Refer to the ICD-10-CM manual Medicare Coverage:

8 The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans. The Centers for Medicare and Medicaid Services (CMS) does have a national Medicare coverage position. A national coverage position for Medicare may have been changed since this medical policy document was written. See Medicare's National Coverage at < References: 1.SEER Cancer Statistics Factsheets: Colon and Rectum Cancer. National Cancer Institute. Bethesda, MD. Available at < (accessed July 26, 2016). 2.U.S. Preventive Services Task Force. Final Recommendation Statement: Colorectal Cancer: Screening (June 2016). Available at < (accessed July 13, 2016). 3.Centers for Disease Control Press Release. (2013) Available at < (accessed July 21, 2016). 4.Cologuard product information. Exact Sciences Corporation. Madison, WI. Available at < (accessed July 26,2016). 5.FDA FDA approves first non-invasive DNA screening test for colorectal cancer. Food and Drug Administration Center for Devices and Radiologic Health (1994). Available at < (accessed July 21,2016). 6.Imperiale TF, Ransohoff DF, Itzkowitz SH, et al. Multitarget stool DNA testing for colorectal-cancer screening. N Engl J Med. April ; 370(14): PMID A Study of Cologuard in an Average Risk Population Assessing a Three Year Test Interval. Available at < NCT (accessed July 21,2016). 8.Molecular Stool Testing for Colorectal Cancer Surveillance (MOCCAS). ClinicalTrials.gov. Available at < NCT (accessed July 21,2016).

9 9.National Comprehensive Cancer Network (NCCN). Practice Guidelines in Oncology: Colorectal Cancer Screening. V Available at < (accessed July 14, 2016). 10.Analysis of Human DNA in Stool Samples as a Technique for Colorectal Cancer Screening. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (November 2015) Medicine: eviCore healthcare. Clinical Guidelines: Lab Management Program (2016). Bluffton, South Carolina. V : (p ). Policy History: Date Reason 8/15/2016 Document updated with literature review. Coverage for Cologuard changed from experimental, investigational and/or unproven to may be considered medically necessary when stated criteria are met. Title changed from Analysis of Human DNA in Stool Samples as a Technique for Colorectal Cancer Screening. 6/15/2016 Document updated with literature review. Coverage statement revised, but intent remains unchanged and is considered experimental, investigational and/or unproven 1/1/2015 New medical document. DNA analysis of stool samples is considered experimental, investigational and/or unproven as a screening technique for colorectal cancer (CRC) in both patients with average to moderate risk and in patients considered at high risk for colorectal cancer. Archived Document(s): Title: Effective Date: End Date: Analysis of Human DNA in Stool Samples as a Technique for Colorectal Cancer Screening

10 A Division of Health Care Service Corporation, a Mutual Legal Reserve Company, an Independent Licensee of the Blue Cross and Blue Shield Association. Copyright 2014 Health Care Service Corporation. All Rights Reserved.