Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Cutaneous melanoma 
Treatment: DecisionDX- Melanoma test 

The insurer denied the DecisionDX- Melanoma test. The denial is upheld. 

The patient is a man who has been diagnosed with a 2.2 mm melanoma of the right upper back. The request is for DecisionDx testing. 

No, the proposed DecisionDx-Melanoma test is not medically necessary. 

Gene expression profile signature (DecisionDx-Melanoma), to predict visceral metastatic risk in patients with stage I and stage II cutaneous melanoma, is currently not standard of care in the management of cutaneous melanoma and is considered unproven. 

To date, there is a paucity of evidence in the peer-reviewed published medical literature evaluating the clinical utility of the DecisionDx-Melanoma test. The National Comprehensive Cancer Network (NCCN, 2014) Clinical Practice Guideline (CPG) in Oncology recommendations for the clinical staging and workup of melanoma (principles of pathology), states: 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 melanomas (before or following sentinel lymph node biopsy [SLNB]) is not recommended outside of a clinical trial. 

A Cochrane report addressing the primary treatment of cutaneous melanoma (Sladden, 2009) states: standard treatment is surgical excision with a safety margin some distance from the borders of the primary tumor. The purpose of the safety margin is to remove both the complete primary tumor and any melanoma cells that might have spread into the surrounding skin. An evidence-based review performed by the American Society of Clinical Oncology (ASCO) and Society of Surgical Oncology (SSO) (Wong, 2012) states that SLNB is an acceptable method for lymph node staging of most individuals with newly diagnosed melanoma as it provides accurate staging for individuals with intermediate-thickness melanomas (Breslow thickness, 1 mm to 4 mm) of any anatomic site. For individuals with thick melanomas (T4, Breslow thickness, > 4 mm), SLNB may be recommended for staging purposes and to facilitate regional disease control. For individuals with thin melanoma (T1, Breslow thickness, < 1 mm), "there is insufficient evidence to support routine SLN biopsy although it may be considered in selected patients with high-risk features when staging benefits outweigh risks of the procedure." For individuals with a positive SLNB, complete lymph node dissection (CLND) is recommended and "achieves good regional disease control." 

In summary, there is insufficient evidence to evaluate the clinical validity and clinical utility of the DecisionDx-Melanoma test. Additional study is required to further validate if gene expression profiling of cutaneous melanoma will accurately identify which individuals are likely to have aggressive disease and how the results of testing would alter treatment plans and improve health outcomes in the surveillance and treatment of high-risk cutaneous melanoma. 

At this time, the test is considered unproven and not known to improve health outcomes. The consensus of opinion among experts regarding the test is that further studies or clinical trials are necessary to determine its maximum tolerated dose, its toxicity, its safety, is efficacy, or its efficacy as compared with the standard means of treatment or diagnosis. Thus, it is not medically necessary.