Appeal type: Experimental/Investigational
Decision: Upheld

Reviewer #2:

The patient is a female who had a skin shave of the left shin. Results included in situ and invasive melanoma. The clinical history was noted as 1.5 centimeter ulcerated papule and 5 millimeter excoriated papule. Per the Final Report the patient had Class 2 Sub-class: 2B.  

The scientific evidence in peer-reviewed literature does not support a result of improvement in health outcome.  Therefore, the 81599 -Unlisted chemistry procedure-DecisionDx-Melanoma is not considered likely be more beneficial for this patient's diagnosis than any standard treatment. The 81599 Unlisted chemistry procedure-DecisionDx-Melanoma does not have final approval from the appropriate regulatory bodies for this diagnosis, and the patient is not a good candidate for 81599 Unlisted chemistry procedure-DecisionDx-Melanoma. The DecisionDx-Melanoma is not the best available treatment for this patient at this time.     
  
Based on the results of the original biopsy and clinical findings, this testing would not be of value in treatment planning for this patient.  The DecisionDx-Melanoma assay is not known to be effective at this time, based on a lack of scientific evidence showing that the results will accurately guide patient care and health outcomes.  The testing would not have been considered effective or useful in treatment planning, and the use of this testing was not supported by scientifically based guidelines of national medical research or governmental agencies.

Per Abassi, L. (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 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).  There are 73,000 melanoma patients per year, so you need almost 400 to have a 95 percent confidence interval and that's without the worry about false positives.  To truly say that a patient previously thought of low risk should proceed with invasive procedures such as a sentinel lymph node biopsy (SLNB), increased scans or systemic treatments, a much larger trial is needed.  Right now there are only a few hundred cases of the GEP test  the AJCC has 60,000 cases."

Furthermore, per Cirenajwis, H., et al. (2015), "Cutaneous malignant melanoma (CMM) is the most lethal form of skin cancer and its incidence has increased faster than that of any other cancer, rendering it a major public health problem worldwide. In order to provide clinicians and patients with accurate prognostic information about the disease, a correct staging system is fundamental.  Since 1998, the American Joint Committee on Cancer (AJCC) melanoma staging system has served as a foundation for clinical classification and it was recently updated to the 7th edition after adding more tumor intrinsic factors with prognostic significance." Per Farberg, A. S., et al (2017), "However, the particular impact for the 31-GEP is still incompletely defined. Other substantial impacts include downstaging of management and prediction of tumor biologic behavior.  Such applications will require additional validation by clinical trials with additional CMM samples and long-term clinical follow-up."  

This test will not impact follow-up care of this individual and it is not likely to be more beneficial than any standard treatment or procedure for this patient.                                                      

The carrier's denial of coverage for 81599-Unlisted chemistry procedure-DecisionDx-Melanoma should be upheld.