Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Melanoma
Treatment: DecisionDx-Melanoma gene expression profile assay 
 
The insurer denied the DecisionDx-Melanoma gene expression profile assay. The denial was upheld.

This is a female patient who underwent a skin biopsy from the left inner thigh. Pathology was significant for invasive melanoma with a Breslow depth of 0.9 mm. Per the Decision DX Melanoma report the patient Decision DX Melanoma class was 1 and sub-class was 1A. 

The initial evaluation for risk of metastasis in patients with cutaneous melanoma uses the American Joint Committee on Cancer (AJCC) staging criteria, which includes Sentinel Lymph Node status. Per Trotter, et al (2013), "The stage at presentation of melanoma has a significant impact on the course of the disease. Most melanoma patients present with localized disease 82 to 85 percent of the time, followed by regional involvement 10 to 13 percent of the time, and distant metastatic disease 2 to 5 percent of the time.  The staging of melanoma holds prognostic value and dictates the recommendation in treatment. Staging is determined by the tumor, node, and metastasis (TMN) system developed by the American Joint Committee on Cancer (AJCC) (Table 1). Criteria include microstaging of the primary melanoma and pathologic information about the regional lymph nodes after partial or complete lymphadenectomy as well as a new emphasis on dermal mitotic index (measured in mm2) for T1 melanoma (=1 mm).  Survival and recurrence rates for melanoma follow the pathologic stages set forth by the AJCC (Table 2) and are used to guide follow-up recommendations." 

Furthermore, per Weiss, S., 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." 

Lastly, as per Up to Date  "A commercial gene expression profile test (DecisionDX-Melanoma) has been developed in patients with local (stage I and II) or locoregional (stage III) cutaneous melanoma. However, there are no definitive data regarding its use for risk classification in patients with cutaneous melanoma, and this test does not currently have a role in determining which patients are candidates for adjuvant immunotherapy, either as a standard of care or as part of clinical trials." 

The results of the DecisionDX Melanoma test revealed that the patient had a class 1A, which suggested a very low risk of metastatic potential. This testing would not be of value in treatment planning for this patient. The DecisionDX Melanoma assay was not known to be effective at the time it was performed, based on a lack of scientific evidence showing that the results would accurately guide patient care and health outcomes. The health plan acted reasonably with sound medical judgment, and in the best interest of the patient. 

The carrier's denial of coverage for the DecisionDx-Melanoma gene expression profile assay should be upheld. The medical necessity is not substantiated.