Appeal type: Experimental/Investigational
Decision: Upheld

Skin Disorders - Other
Cancer Screening
The patient is a male who was found to have a skin lesion on his left calf. A biopsy was performed which demonstrated a 2.5 millimeter (mm) deep, Clark's Level IV, invasive melanoma with no ulceration (T3a). Clinical staging was T3aN0 (Stage IIA). The melanoma specimen was sent for DecisionDx-melanoma and resulted in a Class 2B classification.
The subject under review is whether the DecisionDx-Melanoma testing is more beneficial for the patient's condition than any standard treatment.

The health plan's determination is upheld.

The DecisionDx-Melanoma testing is not more beneficial than standard treatments for the patient's medical condition.
The standard treatment algorithm for a patient with Stage IIA (T3aN0) melanoma is wide excision surgically in addition to a sentinel lymph node biopsy. While there is data to suggest that the DecisionDx-melanoma test can predict recurrence and distant metastases, there is no established evidence or society recommendation or treatment algorithm that would eliminate the sentinel lymph node biopsy in the clinical Stage IIA patient. Thus, there is no deviation from the standard treatment plan regardless of the result. For example, if the DecisionDx-melanoma resulted in a Class 1A classification, it would be outside the standard to recommend elimination of sentinel lymph node biopsy. The strongest predictor of survival remains sentinel lymph node positivity and is specifically mentioned in National Comprehensive Cancer Network (NCCN) guideline recommendations for cutaneous melanoma. These guidelines were updated for 2020 and include recent data from MSLTII and DeCOG trials, demonstrating review of available and recent literature, presumably including that relevant to this testing. In addition, NCCN and the American Academy of Dermatology recommended genetic expression profiling in the context of clinical trial only (2019). Recall that in DecisionDx validation studies, there is a subset of sentinel lymph node positive patients that classified as Class 1, 39% of which recurred and would not have received adjuvant therapy based on Class alone if the sentinel lymph node procedure was not done (Zager JS, BMC Cancer, 2018). This would be outside the standard treatment algorithm for stage III melanoma, and thus result in potential harm to the patient.
Furthermore, for this patient specifically, the surveillance plan and adjuvant treatment plan would not be altered by the results of the testing in question, and thus the clinical utility does not exist. It may perhaps add some prognostic information as suggested in the studies attached to the appeal, but management would be exactly the same.
In addition, there are 20+ studies presented by the Castle Biosciences appeals manager in response to the initial denial, but the applicability to this patient is limited. For example, the studies that investigate eliminating sentinel node biopsy for Class 1 patients include only T1 and T2 primary melanomas. This patient has a T3 melanoma, and it would be dangerous to extrapolate the data to this patient.
The clinical staging and the sentinel node procedure provide adequate information for clinical decision making and accurate staging according to available data and society/NCCN recommendations.