Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Prostate cancer.

Treatment: Genetic Testing of Prostate Tissue with Oncotype Dx for Prostate Cancer.

The insurer denied coverage for Genetic Testing of Prostate Tissue with Oncotype Dx for Prostate Cancer.

The denial is upheld. 

This is a male patient with history of prostate cancer. An Oncotype Dx prostate cancer (PCA) test with Genomic Prostate Score (GPS) was performed. The insurer has denied coverage for the genetic testing of prostate tissue with Oncotype Dx for prostate cancer as not medically necessary. The insurer states that the rationale for ordering the test, to help determine the aggressiveness of the cancer and to determine the need for additional treatment lacks robust clinical support. The insurer states that there is a lack of significant randomized trials in medical literature with peer reviewed literature showing a significant benefit or change in outcome for patients with prostate cancer by virtue of this test. 

While it is noted that both the American Society Clinical Oncology (ASCO) and the National Comprehensive Cancer Network (NCCN) guidelines state that tests such as Oncotype Dx GPS can be considered for further evaluation and risk stratification of patients with low risk and favorable intermediate risk prostate cancer, the NCCN guidelines also note the absence of any randomized prospective trials. The American Urological Association (AUA) guidelines are more guarded regarding the usage of these tests; stating that for management of localized prostate cancer; "tissue based genomic biomarkers (such as Oncotype Dx GPS) have not shown a clean role in active surveillance for localized prostate cancer and are not necessary  for follow up". There is no level 1 evidence to support use of these biomarkers. 

NCCN notes "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." As stated in the latest ASCO guideline "Tissue based genomic biomarkers have not shown a clear role in active surveillance for localized prostate cancer and are not necessary for follow up."	
	
Furthermore ASCO state in their guideline "There are currently commercially available biopsy-based multigene expression classifiers (i.e., Decipher, Oncotype Dx Prostate, and Prolaris) and one protein-based biomarker (ProMark). Each seems to independently improve the prognostic accuracy of clinical multivariable models for identifying men with biologically significant disease. The clinical benefit of integrating these classifiers in selecting patients for surveillance has not been prospectively demonstrated" (Eggener et al).	

The most common result of a genomic biomarker test is no change is the clinical risk profile. It is yet unknown whether treatments decisions made on the presence/ absence of this test are ultimately better/ worse in terms of long-term oncologic outcomes when compared to decision making using existing pathologic and clinical data. The impact of tissue based gene expression tests such as Oncotype Dx PCA, on clinical practice and long-term patient outcomes still remains to be empirically demonstrated.

The genetic testing of prostate tissue with Oncotype Dx for prostate cancer is not considered medically necessary for this patient.

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

The carrier's denial of coverage for Genetic Testing of Prostate Tissue with Oncotype Dx for Prostate Cancer should be upheld.  The medical necessity is not substantiated.