Appeal type: Medical necessity
Decision: Upheld

Diagnosis:  Cancer.
Treatment:  Cancer Screening.
The insurer denied the genetic testing.  The denial was upheld in whole.

The patient is a male who underwent a prostate biopsy for an elevated prostate specific antigen (PSA).  Pathology showed Gleason 7 adenocarcinoma in 11 out of 33 cores.  The clinical stage was T1c.  An Oncotype Dx test was ordered on the biopsy specimens.  The subject under review is the medical necessity of the test.

The health plan's determination is upheld in whole.

No, the testing is not medically necessary for this patient.  The Oncotype DX Prostate Cancer Assay is a real time polymerase chain reaction (RT-PCR) assay designed for analysis of prostate core needle biopsies.  The assay measures the expression of 17 genes to calculate a Genomic Prostate Score (GPS).  A lower GPS score indicates a more favorable biology and less aggressive disease.  This test may be utilized to counsel men regarding the best course of therapy (active surveillance vs. treatment) in newly diagnosed low or low-intermediate prostate cancer.

Two recent studies have suggested that Oncotype Dx can predict adverse pathology and unfavorable outcomes after radical prostatectomy.  In both these studies, multiple authors are either employed by the manufacturer of the test or have a financial interest.  These studies are recently published and need continued validation from a widespread clinical use.  In addition, it is difficult to ascribe clinical utility of Oncotype Dx Prostate in patients planning to undergo active surveillance, as all patients in the above studies, regardless of clinical criteria, elected radical prostatectomy within 6 months of diagnostic biopsy.  Moreover, the validity of using different degrees of tumor pathology as "markers" to extrapolate the risk of progression of a tumor in vivo is unclear.  National Comprehensive Cancer Network (NCCN) guidelines for prostate cancer 2018 state, "Several tissue-based molecular assays have been developed in an effort to improve decision-making in newly diagnosed men considering active surveillance and in treated men considering adjuvant therapy or treatment for recurrence.  Retrospective case cohort studies have shown that these assays provide prognostic information independent of NCCN risk groups, which include likelihood of death with conservative management, likelihood of biochemical recurrence after radical prostatectomy or radiotherapy, and likelihood of developing metastasis after operation or salvage radiotherapy.  No randomized controlled trials have studied the utility of these tests.  These molecular biomarker tests have been developed with extensive industry support, guidance, and involvement, and have been marketed under the less rigorous Food and Drug Administration (FDA) regulatory pathway for biomarkers.  Although full assessment of their clinical utility requires prospective randomized clinical trials, which are unlikely to be done, the panel believes that men with clinically localized disease 'may' consider the use of tumor-based molecular assays at this time.  Future comparative effectiveness research may allow these tests and others like them to gain additional evidence regarding their utility for better risk stratification of men with prostate cancer."  European Association of Urology (EAU) Guidelines on Prostate cancer, 2019 state the following about Prolaris and Oncotype Dx test, "The results of prospective multicentre studies are awaited before a recommendation can be made regarding their routine application."
American Urological Association (AUA) Guidelines on Clinically Localized Prostate Cancer, 2017 states, "Among most low-risk localized prostate cancer patients, tissue based genomic biomarkers have not shown a clear role in the selection of candidates for active surveillance.  Tissue based genomic biomarkers have not shown a clear role in active surveillance for localized prostate cancer and are not necessary for follow up."  In summary, the testing is not considered standard of care and is not medically necessary.