Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Low-Grade Prostate Cancer. 
Treatment: Genetic testing of prostate tissue with Oncotype DX. 
The insurer denied coverage for genetic testing of prostate tissue with Oncotype DX. 

The denial is upheld. 

The patient is a male with low-grade prostate cancer and Oncotype Prostate. The pathology report showed Gleason of 6. 

Genomic Health, Inc. (GHDX) published positive results from its analytical validation study demonstrating that its Oncotype DX (likelihood of cancer returning test) prostate cancer test is a reliable assay, even with very limited RNA (riboneucleic acid) inputs, which enables successful performance using small amounts of cancer tissue typically available from prostate needle biopsies. Conducted in collaboration with Cleveland Clinic, the aim of this study was to validate the accuracy of the Oncotype DX prostate cancer test by analyzing the test's precision and accuracy in measuring gene expression over a wide range of conditions commonly encountered with diagnostic prostate biopsies. The Oncotype DX prostate cancer test measures the level of expression of 17 genes across four biological pathways to predict prostate cancer aggressiveness. The test results are reported as a Genomic Prostate Score (GPS) that ranges from 0 to 100 and is combined with other clinical factors, such as prostate specific antigen (PSA) and biopsy Gleason Score, to further clarify a man's risk prior to deciding on a treatment plan. The positive results from a large validation study of this test were presented at the American Urological Association Annual Meeting. The study suggested that individual biological information from the Oncotype DX prostate cancer test tripled the number of patients who can more confidently consider active surveillance and avoid unnecessary treatment and its potential side effects. The test also identified a smaller number of patients who, despite seemingly low-risk clinical factors, had more aggressive disease and would suggest that they consider immediate treatment, the group that represented about 10 percent of patients (Genomic Health, Inc.). Although intriguing, this is a validation study and not a prospective trial that used this information to prospectively plan treatment. 

According to Spratt DE, Yousefi K, Deheshi S, et al. (2017), "The genomic classifier test, Decipher, can independently improve prognostication of patients postprostatectomy, as well as within nearly all clinicopathologic, demographic, and treatment subgroups. Future study of how to best incorporate genomic testing in clinical decision-making and subsequent treatment recommendations is warranted." 

Genomic Health's Oncotype DX Prostate Cancer test, according to National Comprehensive Cancer Network (NCCN), may provide prognostic information beyond standard clinical data for patients who have Gleason score 7 or disease that extends beyond the prostatic capsule on radical prostatectomy. In this case, Gleason score was only 6. Therefore, the request for Oncotype DX for prostate cancer was not considered medically necessary for this patient. 

The health care plan acted reasonably and with sound medical judgment and in the best interest of the patient. 

The insurer's denial of coverage for the genetic testing of prostate tissue with Oncotype DX for prostate cancer is upheld. Medical Necessity is not substantiated.