Appeal type: Experimental/Investigational
Decision: Upheld

Skin Disorders - Other
Cancer Screening

The patient is a male who was diagnosed with malignant melanoma involving his left calf. Specifically, the pathology report indicated that this was an invasive malignant melanoma measuring approximately 2.5 millimeter (mm) in Breslow depth, Clark's level IV, non-ulcerated, with 5 mitoses per square millimeter, T3a, stage IIa. His tumor was sent for the  # 1DecisionDX Melanoma gene expression profile test.
The question at hand is whether or not the DecisionDX Melanoma gene expression profile test is likely to be more beneficial for the patient than standard treatment.

The health plan's determination is upheld.

No, the DecisionDx-Melanoma gene expression profile test is not likely to be more beneficial than any standard treatment or treatments for the patient's malignant melanoma.
The DecisionDX Melanoma gene expression profile test evaluates 28 discriminating gene targets and 3 endogenous control genes within primary melanoma specimens. The resulting gene expression profiles are used to identify patients who are at increased risk of recurrence or metastasis (Class II result), versus those at lower risk (Class I result) than what would be predicted by the current American Joint Committee on Cancer (AJCC) staging system. The prognostic accuracy of this test has been validated and published in peer-reviewed journals. (1,2)
In order for this test to be incorporated into our staging and risk stratification schema for melanoma patients, there will need to be evidence to show that specific interventions for patients with class II results provide a clinical benefit. At the present time, it is not clear that the results of this test provide clinically meaningful information for patients. The argument has been made that patients with a high-risk result could benefit from more intensive clinical surveillance, imaging surveillance and/or administration of adjuvant therapy. There is currently no evidence showing that more intensive clinical surveillance provides a benefit to patients with melanoma. Even for patients known to be at high risk for recurrence/metastasis as defined by our current criteria, the use of routine surveillance imaging is controversial because of its low yield and the significant incidence of indeterminate findings unrelated to melanoma. Similarly, the use of adjuvant interferon (the only Food and Drug Administration [FDA] approved adjuvant therapeutic agent that would be available for this patient given his stage of disease, based on the medical records provided) for patients with known high-risk resected melanoma is controversial because of its toxicity and lack of proven overall survival benefit (although there is a 10% improvement in disease-free survival). Finally, the National Comprehensive Cancer Network clinical practice guidelines for melanoma (3) state that "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."
For these reasons, the DecisionDx Melanoma gene expression profile test is currently considered experimental/investigational and does not provide a clinical benefit to GL over and above the standard diagnostic tests used for this disease.