Appeal type: Experimental/Investigational
Decision: Upheld

Reviewer #2:

This patient has malignant melanoma (MM), to the left (L) scapula Breslow .7 mm. There is no ulceration, the mitotic index is less than one. (1) The patient also has two (2) other malignant melanoma. This is a review for coverage of the Decision DX melanoma assay.

The scientific evidence in peer-reviewed literature does not support a result of improvement in health outcome. There is insufficient evidence to determine how gene expression profiling may be used to guide clinical decisions related to the diagnosis and treatment of cutaneous melanoma. Specifically, it is not known how or whether decisions concerning treatment and surveillance are improved over the current standards, and it is unknown whether health outcomes are improved as a result of those decisions. Further, the clinical practice guidelines from the NCCN recommend against routine prognostic testing for low versus high metastatic risk outside of a clinical trial. The standard prognostic indicators for melanoma include age, gender, Breslow thickness, ulceration, and mitotic rate. Gene expression profiling has not been shown to have independent prognostic value within the context of the other known prognostic factors for melanoma. Its independent prognostic value has not been confirmed in a large population of patients with average to low risk disease. There is insufficient clinical evidence in the peer-reviewed medical literature to demonstrate improved long term health outcomes.

"A gene expression profile (GEP) test able to accurately identify risk of metastasis for patients with cutaneous melanoma has been clinically validated" (Gerami, P. et al. 2015).
"Most conventional staging parameters used for prognosis in cutaneous melanoma have limited applicability to PDM. The melanoma prognostic assay may be a useful tool for distinguishing [primary dermal melanoma (PDM)] PDM from [cutaneous metastatic melanoma (CMM)] CMM" Sidiropoulos, M. et al. 2014). "The GEP test is an objective predictor of metastatic risk and provides additional independent prognostic information to traditional staging to help estimate an individual's risk for recurrence. The assay identified 70% of stage I and II patients who ultimately developed distant metastasis. Its role in consideration of patients for adjuvant therapy should be examined prospectively" (Zager, J. S. et al. 2018).      

There is insufficient evidence to determine how gene expression profiling may be used to guide clinical decisions related to the diagnosis and treatment of cutaneous melanoma. Specifically, it is not known how or whether decisions concerning treatment and surveillance are improved over the current standards, and it is unknown whether health outcomes are improved as a result of those decisions. Further, the clinical practice guidelines from the NCCN recommend against routine prognostic testing for low versus high metastatic risk outside of a clinical trial. The standard prognostic indicators for melanoma include age, gender, Breslow thickness, ulceration, and mitotic rate. Gene expression profiling has not been shown to have independent prognostic value within the context of the other known prognostic factors for melanoma. Its independent prognostic value has not been confirmed in a large population of patients with average to low risk disease. Therefore, genetic testing for melanoma provided is not the best available treatment for this patient at this time.     
  
The requested service is not likely to be more beneficial than any of the standard treatments/procedures for this patient as there is insufficient evidence to determine how gene expression profiling may be used to guide clinical decisions related to the diagnosis and treatment of cutaneous melanoma.                                                     

The carrier's denial of coverage for genetic testing for melanoma provided should be upheld.