Clinical Policy Title: Fecal DNA for colorectal cancer detection

Transcription

1 Clinical Policy Title: Fecal DNA for colorectal cancer detection Clinical Policy Number: Effective Date: October 1, 2014 Initial Review Date: June 18, 2014 Most Recent Review Date: June 17, 2015 Next Review Date: June 2016 Policy contains: Colon cancer detection. Fecal DNA. Stool-based screening. Related policies: CP# CP# Viral oncogene mutation testing to select treatment in metastatic colorectal cancer. Familial polyposis gene testing. ABOUT THIS POLICY: AmeriHealth Caritas Pennsylvania has developed clinical policies to assist with making coverage determinations. AmeriHealth Caritas Pennsylvania s clinical policies are based on guidelines from established industry sources, such as the Centers for Medicare & Medicaid Services (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peerreviewed professional literature. These clinical policies along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including any state- or plan-specific definition of medically necessary, and the specific facts of the particular situation are considered by AmeriHealth Caritas Pennsylvania when making coverage determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws and/or regulatory requirements shall control. AmeriHealth Caritas Pennsylvania s clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment decisions for their patients. AmeriHealth Caritas Pennsylvania s clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, AmeriHealth Caritas Pennsylvania will update its clinical policies as necessary. AmeriHealth Caritas Pennsylvania s clinical policies are not guarantees of payment. Coverage policy AmeriHealth Caritas Pennsylvania considers the use of fecal DNA for colorectal cancer screening tests to be investigational and, therefore, not medically necessary. Limitations: All other uses of fecal DNA screening tests are not medically necessary. Alternative covered services: Colonscopy. Flexible sigmoidoscopy CT colonography. 1

2 Fecal immunochemical test (FIT). Background Colorectal cancer (CRC) is the second leading cause of cancer death and the fourth most diagnosed cancer in the United States. CRC can be detected early through screening. It can be prevented largely by the detection and removal of adenomatous polyps and is 90 percent curable when caught in its earliest stages. The American College of Physicians, American College of Gastroenterology and the American Gastroenterological Association recommend routine testing for CRC in average-risk individuals ages 50 and older (Levin 2008). Fecal DNA testing for CRC screening: New CRC screening tests of stool detect the presence of known DNA alterations shed from adenoma and carcinoma cells into the large bowel lumen and passed in the feces. Because DNA is stable in feces, it can be differentiated and isolated from bacterial DNA found in the feces. No single gene mutation is present in cells shed by every adenoma or cancer; therefore, a multitarget DNA stool assay is required to achieve adequate sensitivity (Levin 2008). Fecal DNA testing is not dependent on the detection of occult bleeding and requires only a single stool collection. Fecal DNA sampling is noninvasive and lacks physical harm. Patient and provider acceptance of this technique appears to be high, with available data indicating DNA is at least as acceptable to patients as testing with guaiac-based fecal occult blood tests (FOBT). Limitations of the test include its inability to detect all CRC, higher costs relative to other stool tests and the uncertain frequency at which the test should be performed (Levin 2008). Regulatory status: In August 2014, the U.S. Food and Drug Administration (FDA) approved Cologuard (Exact Sciences, Madison, WI), the first stool-based colorectal screening test that detects the presence of red blood cells and DNA mutations that may indicate the presence of colon cancer or precursors to cancer (FDA 2014). Cologuard is indicated to screen adults of either sex, 50 years or older, who are at average risk for CRC; it is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals. FDA approval was based on results of a clinical trial comparing the performance of Cologuard to FIT in 10,023 subjects (Imperiale 2014). Cologuard detected cancers and advanced adenomas more often than FIT. Cologuard detected 92 percent of colorectal cancers and 42 percent of advanced adenomas in the study population, while FIT detected 74 percent of cancers and 24 percent of advanced adenomas. Cologuard was less accurate than FIT at correctly identifying subjects negative for colorectal cancer or advanced adenomas. Cologuard correctly gave a negative screening result for 87 percent of the study subjects, while FIT provided accurate negative screening results for 95 percent of the study population. 2

3 Methods Searches (June 10, 2014; updated May 26, 2015): AmeriHealth Caritas Pennsylvania searched PubMed and the databases of: UK National Health Services Centre for Reviews and Dissemination. Agency for Healthcare Research and Quality s National Guideline Clearinghouse and other evidencebased practice centers. The Centers for Medicare & Medicaid Services (CMS). Search terms were "feces" (MeSH) AND "DNA" (MeSH). We included: Systematic reviews, which pool results from multiple studies to achieve larger sample sizes and greater precision of effect estimation than in smaller primary studies. Systematic reviews use predetermined transparent methods to minimize bias, effectively treating the review as a scientific endeavor, and are thus rated highest in evidence-grading hierarchies. Guidelines based on systematic reviews. Economic analyses, such as cost-effectiveness, and benefit or utility studies (but not simple cost studies), reporting both costs and outcomes sometimes referred to as efficiency studies which also rank near the top of evidence hierarchies. Findings: Evidence indicates a multi-panel stool DNA test is capable of identifying specific mutations of DNA signifying cancer. However, the percent of testable DNA in the stool from a human is only 0.05 percent. Fecal DNA test showed higher sensitivity but lower specificity than FIT (Imperiale 2014). Fecal DNA tests are not able to identify all types of CRC and all types of advanced lesions and could allow undetected cancers to metastasize and develop into more harmful stages. Fecal DNA testing has no established testing interval. Comparatively, FOBT and FIT tests have a recommended routine/annual screening interval, proving their ability to catch colorectal cancer in its earliest stages. The diagnostic characteristics of fecal DNA testing are consistent with reduced colorectal cancer mortality if used in a longitudinal screening program. However, it remains to be determined how effective the test would be when used at a particular frequency within a screening program, and thus its efficacy and impact on resource use compared with established methods are unknown (BCBS TEC 2014). There is currently only one commercially available fecal DNA test. The effectiveness and standards of fecal DNA testing programs using this test have not been verified outside of one trial, and evidence-based recommendations for fecal DNA testing vary. The United States Preventive Services Task Force (USPSTF) does not recommend fecal DNA testing as a method to screen for CRC, as the evidence is insufficient to assess its benefits and harms as a screening modality (USPSTF 2008). Other guidelines include fecal DNA 3

4 testing as an acceptable alternative to colonoscopy for CRC screening (Levin 2008, Qaseem 2012, Rex 2009), but all guidelines acknowledge the evidence for the optimal testing interval is uncertain at this time. Summary of clinical evidence: Citation Imperiale (2014) Robertson (2014) Tagore (2003) Osborn (2005) Content, Methods, Recommendations Key points: FIT testing is more specific for the detection of both colorectal cancer and precancerous lesions (FIT has better specificity and ability to correctly identify those who do not have CRC as negative). Sensitivity of the DNA test for detecting precancerous lesions was approximately half compared to the detection of colorectal cancer. Key points: Stool DNA tests are not likely to be performed every year because of lower specificity and greater cost, whereas FIT is performed annually. High false positive rate (10%). Key points: Colonoscopy is the most sensitive and specific test available. Key points: Human DNA is only 0.01% of total DNA in stool, 99.99% is nonhuman DNA. Stool contains PCR inhibitors, making testing very difficult. Recognition of colorectal cancer depends on the markers included on the panel. Multipanel stool DNA tests could detect more mutations. Glossary Colonoscopy A visual test of a patient s colon performed by inserting a scope to search for possible signs of cancer. Flexible sigmoidoscopy A visual test of the patient s sigmoid colon and rectum for possible signs of cancer.this test does not search the entire colon. FOBT Fecal occult blood test, a test which detects the presence of colorectal cancer by testing stool blood. Medically Necessary- A service or benefit is Medically Necessary if it is compensable under the MA Program and if it meets any one of the following standards: The service or benefit will, or is reasonably expected to, prevent the onset of an illness, condition or disability. The service or benefit will, or is reasonably expected to, reduce or ameliorate the physical, mental or developmental effects of an illness, condition, injury or disability. 4

5 The service or benefit will assist the Member to achieve or maintain maximum functional capacity in performing daily activities, taking into account both the functional capacity of the Member and those functional capacities that are appropriate for Members of the same age. Sensitivity A measure of the true positives in a study. This is the percentage of people the test identifies as positive that are truly positive for the disease. Specificity A measure of the true negatives in a study. This is the percentage of people that the test identifies as negative that are truly negative for the disease. Stool Waste traveling through the gastrointestinal tract. References Professional society guidelines/other: Levin B, Lieberman DA, McFarland B, et al. Screening and surveillance for the early detection of colorectal cancer and adenomatous polyps, 2008: a joint guideline from the American Cancer Society, the US Multi- Society Task Force on Colorectal Cancer, and the American College of Radiology. Gastroenterology. May 2008;134(5): Qaseem A, Denberg TD, Hopkins RH, Jr., et al. Screening for colorectal cancer: a guidance statement from the American College of Physicians. Annals of internal medicine. Mar ;156(5): Rex DK, Johnson DA, Anderson JC, et al. American College of Gastroenterology guidelines for colorectal cancer screening 2009 [corrected]. The American journal of gastroenterology. Mar 2009;104(3): Screening for colorectal cancer: U.S. Preventive Services Task Force recommendation statement. Annals of internal medicine. Nov ;149(9): Peer-reviewed references: Berger BM, Schroy PC III, Rosenberg JL, et al. Colorectal cancer screening using stool DNA analysis in clinical practice: early clinical experience with respect to patient acceptance and colonoscopic follow-up of abnormal tests. Clin Colorectal Canc. January 2006;5(5): Blue Cross Blue Shield Technology Evaluation Center. Fecal DNA analysis for colorectal cancer screening. Technology Evaluation Center Assessment Program. Executive summary. December 2014;29(8):1 2. Chu E. The role of stool DNA analysis in the early detection and screening of colorectal cancer. Clin Colorectal Canc. May 2003;3(1):9. 5

6 Imperiale TF, Ransohoff DF, Itzkowitz SH, et al. Multitarget stool DNA testing for colorectal-cancer screening. New Engl J Med. April ;370(14): Lin JS WE, Beil TL, Goddard KA, Whitlock EP. Fecal DNA Testing in Screening for Colorectal Cancer in Average-Risk Adults. Comparative Effectiveness Review No. 52. Prepared by the Oregon Evidence-based Practice Center under Contract No. HHS I. AHRQ Publication No. 12-EHC022-EF. February 2012; available at: Accessed May 26, Osborn NK, Ahlquist DA. Stool screening for colorectal cancer: molecular approaches. Gastroenterology. January 2005;128(1): Robertson DJ, Dominitz JA. Stool DNA and colorectal-cancer screening. New Engl J Med. April ;370(14): Song K, Fendrick AM, Ladabaum U. Fecal DNA testing compared with conventional colorectal cancer screening methods: a decision analysis. Gastroenterology. May 2004;126(5): Tagore KS, Lawson MJ, Yucaitis JA, et al. Sensitivity and specificity of a stool DNA multitarget assay panel for the detection of advanced colorectal neoplasia. Clin Colorectal Canc. May 2003;3(1): U.S. Food and Drug Administration (FDA). FDA News Release. FDA approves first non-invasive DNA screening test for colorectal cancer. Collaboration with CMS contributed to proposed Medicare coverage. August 11, 2014; available at: Accessed May 26, Clinical trials: NCT Screening and Risk Factors of Colon Neoplasia. Available at: May 26, CMS National Coverage Determinations (NCDs): Decision Memo for Screening for Colorectal Cancer - Stool DNA Testing (CAG-00440N). Available at: Accessed May 26, Local Coverage Determinations (LCDs): No LCDs were found as of the writing of this policy. 6

7 Commonly submitted codes Below are the most commonly submitted codes for the service(s)/item(s) subject to this policy. This is not an exhaustive list of codes. Providers are expected to consult the appropriate coding manuals and bill in accordingly. HCPCS Code Description Comment S3890 DNA analysis, fecal, for colorectal cancer ICD-9 Code Description Comment V76.51 Screening for colorectal cancer V16.0 Family history, colorectal cancer ICD-10 Code Description Comment Z12.11 Encounter for screening for malignant neoplasm of colon Z12.10 Encounter for screening for malignant neoplasm of intestinal tract code range Z80.0 Family history of malignant neoplasm of digestive organs HCPCS Level II Description Comment 7

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