Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Melanoma
 
Treatment: DecisionDx-Melanoma Genetic Testing

The insurer denied the DecisionDx-Melanoma Genetic Testing. The denial was upheld.   

Reviewer #1:

This is a male patient with a right lateral neck melanoma. Genetic testing preformed on the melanoma that revealed a low risk score of 1A on DecisionDx-Melanoma.

According to Weiss et al. (2015), "Recently, Castle Biosciences released the DecisionDx Melanoma gene panel which predicts the risk (high (69%) or low (3%) of distant metastasis at 5 years for stage I-III patients.  This panel may be used in clinical practice, however it is not currently recommended by any standard treatment guidelines, including the National Comprehensive Cancer Network (NCCN).  Definitive assessment of the sensitivity and specificity of this test should be conducted in prospective analyses of patients who are representative of the general primary melanoma patient population.  Moreover, guidance on interpretation of DecisionDx results is of critical importance.  Clinicians may suggest that patients predicted by this test to be at high risk for metastasis undergo more frequent clinical evaluations and surveillance imaging, particularly in patients who have negative sentinel lymph node biopsies.  However, in settings in which adjuvant therapies are either contraindicated or not available, this categorization may increase patient anxiety without real benefit to the patient."

Per Abbasi et al. (2015), "Clearly, the greatest potential benefit is in those patients with intermediate risk melanomas (Stage I and II) as there is no consensus on how to manage them. In a study conducted by Pedram Gerami, MD, Associate Professor in Dermatology, Pathology, and Pediatrics-Dermatology at Northwestern University Feinberg School of Medicine, as compared to having a high-risk American Joint Committee on Cancer [AJCC] score a Class 2 gene expression profile [GEP] score has been shown to be 1.5 times more likely to have a poor outcome.  This means these patients could receive life-saving preventive therapies.  As promising as this sounds, the data is based on a small sample size (n=217)According to Boland & Gershenwald (2016), "The revisions to the American Joint Committee on Cancer (AJCC) melanoma staging system over time reflect changes in our understanding of the biology of the disease.  Since the 1st edition, where tumor thickness was defined anatomically by its relationship to the reticular or papillary dermis (Clark level) as well as tumor thickness (Breslow thickness), there have been significant strides in our use of clinicopathological variables to stratify low- versus high-risk patients.  Management of the regional nodal basin has also changed dramatically over time, impacted by techniques such as lymphatic mapping and sentinel lymph node biopsy (SLNB) and changes in pathological evaluation of the regional lymph nodes.  Additionally, stratification of distant metastases has evolved as survival outcomes have been shown to vary based upon anatomic site of metastases and serum lactate dehydrogenase levels.  The variables in use in the current (7th edition) AJCC staging system are surrogate markers of biology with validated impact of survival outcomes." 

The DecisionDx-Melanoma assay has not had sufficient testing prospectively and in a randomized controlled study to make it standard of care. There is no Food and Drug Administration (FDA) approval for the test. Additionally, the literature has not borne out who is a good candidate for testing and who is not.  It is not evident that the DecisionDx-Melanoma is the best treatment at this time and it is not likely to be more beneficial than any standard procedures or treatments for this patient.    
 
The carrier's denial of coverage for the DecisionDx-Melanoma genetic testing should be upheld.