Economic impact of the 31-gene expression profile test in the Medicare-eligible population with cutaneous melanoma.

Abstract

6630 Background: Sentinel lymph node biopsy (SLNB) is recommended as a staging procedure for patients with cutaneous melanoma (CM), but SLNB is associated with additional surgical risks and costs. The SLN positivity rate is approximately 12-16% overall and varies by age. Older patients have lower SLN positivity rates despite a higher metastatic rate. A 31-gene expression profile (31-GEP) test classifies 5-year metastatic risk (Classes 1A [lowest risk], 1B, 2A, and 2B [highest risk]), including SLN metastasis. As previously demonstrated using a large multicenter database, patients with Class 1A, T1-T2 (≤2.0 mm thickness) CM have an overall SLN positivity likelihood < 5%, below the NCCN guideline threshold for SLNB. The aim of this study was to determine the relative cost impact of patient management via traditional care versus using the 31-GEP test to guide SLNB and surveillance plans for 16,572 patients ≥65 years (Medicare-eligible) with T1-T2 CM who are SLNB-eligible. Methods: Decision tree models were used to compare management strategies (surveillance, SLNB) according to traditional care based on SLNB staging and with 31-GEP test utilization. Models used T category from AJCC TNM staging guidelines and SEER data for incidence estimations. Model outcomes included total Medicare costs of melanoma treatment and patient management. Cost impact of the 31-GEP test was calculated based on the difference in Medicare costs between the traditional care and 31-GEP test paradigms. Results: Under the paradigm in which the 31-GEP guided SLNB and surveillance in patients ≥65 years with T1-T2 CM who are eligible for SLNB, 11,157 fewer SLNBs would be performed per year, a 67% reduction in SLNB procedures in this population. This would result in a net annual cost savings of $68M, a 31% reduction in total costs. Use of the 31-GEP testing to guide surveillance in patients ≥65 with T3-T4 melanoma, in addition to T1-T2 melanoma, were also analyzed and also demonstrated a reduction in costs. Conclusions: Results from this study suggest that using the 31-GEP test to guide SLNB and surveillance offers substantial cost savings compared to traditional care for Medicare-eligible patients.