Appeal type: Experimental/Investigational
Decision: Upheld

This is a male patient who was diagnosed with a right posterior neck melanoma. 
The patient had an excision of the malignant melanoma of the right posterior neck and an attempted sentinel lymph node biopsy.  DecisionDx-Melanoma genetic testing was performed which indicted his risk classification was a class 1A which is associated with the lowest risk of recurrence.  
 
The genetic laboratory test DecisionDx-Melanoma rendered by Castle Biosciences Inc. is a 31 gene assay for predicting future recurrence of melanoma. It is still in funding stages and not yet Food and Drug Administration (FDA) approved.  To date, results remain inconclusive regarding the efficacy of this tool for improving health outcomes on a large scale.  Additionally, this tool is not for treating an active disease nor would any of its prognostics change the plan of care for this patient. The patient is diagnosed with malignant melanoma.  Melanoma is a deadly cancer. The American Joint Committee on Cancer (AJCC) divides melanoma into four stages, which takes into account tumor thickness and anatomical level of involvement (localized cutaneous disease) for stages I and II.  Stage III involves local regional lymph nodes and stage IV includes distant metastasis (skin, subcutaneous tissue, nodal, visceral, and skeletal or central nervous system [CNS]) (National Comprehensive Cancer Network, 2017).

Per Sondak & Messina (2016), "The clinical value of this test remains unclear, and the National Comprehensive Cancer Network (NCCN) Guidelines for Melanoma state "while there is interest in newer prognostic molecular techniques such as gene expression profiling to differentiate melanomas at low- versus high-risk for metastasis, routine (baseline) genetic testing of primary cutaneous melanomas (before or following sentinel lymph node biopsy [SLNB]) is not recommended outside of a clinical study (trial)."This admonition seems sound, particularly if we apply the same stringent criteria for validation that Mahar et al. applied to clinical prognostic tools that also claim to demonstrate independent prognostic value.  Nevertheless, practicing surgical oncologists are encountering patients with clinically localized invasive melanomas who have already undergone this test at the time of referral.  For the time being, until far more detailed data derived from prospective evaluations are available, there is insufficient evidence to propose that routine clinical management, including decision making regarding SLNB, should be altered by the results of gene expression profiling, although to reassure patients who have already received and are concerned about a "high-risk" determination, more intensive surveillance may be justified."

The DecisionDx-Melanoma assay does not have final approval from the Food and Drug Administration for predicting future recurrence of melanoma. The patient is not a good candidate for DecisionDx-Melanoma genetic testing and it is not the best available treatment for this patient at this time.  The scientific evidence in peer-reviewed literature does not support a result of improvement in health outcomes. Although the DecisionDx-Melanoma assay is promising, given the lack of evidence and based on National Comprehensive Cancer Network (NCCN) guidelines which do not support use of this test, the DecisionDx-Melanoma is not likely to be more beneficial than any standard treatments or procedures for this patient.

The carrier's denial of coverage for the DecisionDx-Melanoma genetic testing should be upheld.