Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis:  Malignant melanoma with a Breslow depth of 0.95 mm

Treatment:  DecisionDx-Melanoma testing 

The insurer denied coverage for DecisionDx-Melanoma testing. The denial was upheld.

This patient is a female who has a melanoma of 0.95 mm in greatest thickness on the left lateral arm, Stage T1B.  She has also undergone a sentinel lymph node biopsy, which was negative for metastatic disease.  The requested test is the DecisionDx-Melanoma.

Scientific evidence does not support a result in improvement of health outcome in regards to this testing.

DecisionDx is a gene expression profile test that is used to stratify risk of metastasis in patients with melanoma.  Gene expression profiling like that undertaken by this provider has not yet been accepted as standard of care in treating cutaneous melanoma patients.  The American Joint Committee on Cancer (AJCC) and National Comprehensive Cancer Network (NCCN) guidelines for clinical decision making and follow-up for patients with cutaneous melanoma do not currently incorporate gene expression profiling.  In fact, at the NCCN Guidelines for Melanoma V.1.2018 Panel Meeting on 6/28/17, 22/22 dermatologists voted not to include Decision DX in the NCCN guidelines.  Given that these assays are not recommended in clinical guidelines and the data pertaining to this assay's use is not yet accepted, the information gleaned from the assay itself would not materially or appropriately affect the treatment or follow-up approach of most practicing dermatologists.  DecisionDx is not recommended by any institution which publishes guidelines for melanoma, including the American Academy of Dermatology and the National Comprehensive Cancer Network.

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)."

Similarly, according to 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)."

Lastly, per Swetter, S. M., et al. (2019), "Importantly, changes to clinical practice (e.g., SLNB, intensity of surveillance/imaging, and/or therapeutic choice) based on Gene Expression Profile [GEP] results should be avoided until more data from the requisite clinical trials and an assessment of clinical utility are available...".

DecisionDx is not the best available treatment and is not likely to be more beneficial than any standard therapy.                                                    

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