OBJECTIVES: Despite the availability of novel treatment options for patients with advanced melanoma, adjuvant treatment selection and hence prognosis for these patients continues to be suboptimal. Sentinel lymph node biopsy (SLNB), the standard practice to classify patients’ melanoma stage and guide adjuvant treatment decisions, can fail to accurately identify a significant proportion of patients that require adjuvant treatment with immunotherapy. A new biomarker, LY75, could be used in the diagnostic pathway to improve adjuvant treatment decisions, patient outcomes and cost-effectiveness. The aim of this study was to perform an early health technology assessment to evaluate the potential added value of LY75 in terms of costs and quality-adjusted life-years (QALY).

METHODS: A decision tree combined with a probabilistic state-transition model was constructed to compare care as usual (CAU) to six strategies that included LY75 testing in different positions in the diagnostic pathway. We performed a fully incremental analysis and examined uncertainty through sensitivity and scenario analyses.

RESULTS: Five of the six strategies resulted in QALY gains and higher costs compared to CAU, with incremental cost-effectiveness ratios between €1,608 and €26,900 per QALY gained. Deterministic and probabilistic sensitivity analyses showed that the most valuable strategies added LY75 testing for patients ineligible for adjuvant treatment under CAU. Sensitivity and specificity of LY75 and SLNB, and prevalence of low severity disease were the most influential drivers of cost-effectiveness.

CONCLUSIONS: Compared with CAU, LY75 can be a cost-effective add-on or even replacement of SLNB to guide adjuvant treatment decisions, given Dutch willingness to pay thresholds. Given the early stage of the LY75 evidence, not all diagnostic strategies can be readily implemented, or even researched (including the most cost-effective strategy); hence, our future study will explore the optimal research and development roadmap for LY75 testing in patients with melanoma.