Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Colon cancer. 
Treatment: Guardant360 Testing. 

The insurer denied the Guardant360 Testing. 
The denial is upheld. 

The patient is a male with colon cancer. A Guardant360 tumor mutation panel test was performed on the patient's blood. This test detected no tumor deoxyribonucleic acid (DNA). 

No, the proposed testing is not medically necessary. 
The patient had colon cancer. A Guardant360 test was performed on the tumor. This testing failed to detect any tumor deoxyribonucleic acid (DNA). 

The National Comprehensive Cancer Network ([NCCN]; URL: www.nccn.org) is an organization whose members are drawn from the nation's National Cancer Institute (NCI) designated comprehensive cancer centers. The National Comprehensive Cancer Network (NCCN) provides detailed practice guidelines for the treatment of individual cancers. Guidelines are written by panels of experts drawn from the member institutions. The National Comprehensive Cancer Network (NCCN) Guidelines for the treatment of colon cancer do not support Guardant360 testing (NCCN Colon Cancer). 

The standard of care in the United States does not yet include selecting chemotherapy for cancer based on the genomic profile of circulating cell free deoxyribonucleic acid (DNA). 

There are no peer-reviewed published clinical studies of the use of the Guardant360 assay to direct therapy of metastatic colorectal cancer (www.pubmed.gov). 

The use of liquid biopsy assays to manage colorectal cancer is considered unproven: "The use of non-standardized methods, the small cohorts of patients analyzed, the lack of demonstration of a clear clinical benefit are the main limitations of the studies with liquid biopsy in [colorectal cancer] reported up to now." (Normanno) 

The use of somatic mutation panel test results to select targeted therapies for cancer was studied in a randomized clinical trial that compared the outcomes of treating patients with targeted agents based on panel test results versus conventional treatments (Le Tourneau). The conclusions of this phase III study was that, "The use of molecularly targeted agents outside their indications does not improve progression-free survival compared with treatment at physician's choice in heavily pretreated patients with cancer. Off-label use of molecularly targeted agents should be discouraged, but enrolment in clinical trials should be encouraged to assess predictive biomarkers of efficacy." 

The use of next-generation sequencing panels for treatment selection for solid tumors was reviewed (Marrone ). This review concludes: "Currently, there is little information available on the post-analytic processes unique to next-generation sequencing platforms used by the companies offering these tests. Additionally, evidence of clinical validity showing an association between the genetic markers curated in these tests with treatment response to approved molecularly targeted therapies is lacking across all solid-tumor types. To date, there is no published data of improved outcomes when using the commercially available tests to guide treatment decisions." 

Reviews of liquid biopsies conclude: "We discuss the advantages and limitations of various leading ctDNA/CTC analysis technologies. Finally, guided by the results of clinical trials, we discuss the readiness of cell-free DNA and CTC as routine biomarkers in the context of various common types of neoplastic disease. At this moment, one cannot conclude whether or not liquid biopsy will become a mainstay in oncology practice." (Hench) 

As the efficacy of this testing is unproven, it would not be considered medically necessary.