Pharmacoeconomic evaluation of contemporary treatment, prevention, and screening strategies for melanoma: a review of evidence and implications for the Russian healthcare system

Background . The introduction of immune checkpoint inhibitors (ICIs) and targeted therapies (TTs) has fundamentally changed the clinical management of melanoma, significantly improving survival outcomes both in unresectable disease and in the adjuvant setting. At the same time, these therapeutic innovations have substantially increased healthcare expenditures, which raises the importance of pharmacoeconomic evaluation in clinical and policy decision-making. Objective : To analyze current methods for assessing the cost-effectiveness of pharmacotherapy using real-world data (RWD), to summarize international experience in their application, and to evaluate the prospects for implementing RWD-oriented pharmacoeconomic approaches in the healthcare system of the Russian Federation. Material and methods . Pharmacoeconomic studies published between 2010 and 2025 were analyzed using data from randomized clinical trials and RWD. Key outcomes assessed included costs, effectiveness, and utility, such as quality-adjusted life years and incremental cost-effectiveness ratios. Results . In most international models, ICIs – particularly anti-рrogrammed cell death protein 1 monotherapy – have more favorable costeffectiveness profiles in the treatment of unresectable melanoma compared with TTs, whereas combination regimens are characterized by a substantially higher budget impact. The cost-effectiveness of adjuvant therapy largely depends on the risk of recurrence and the cost of subsequent treatment for disease progression. Several studies show the high economic value of preventive and screening interventions aimed at early melanoma detection. The review highlights the need for cautious extrapolation of international pharmacoeconomic data to the Russian setting, taking into account national pricing policies, reimbursement mechanisms, and the absence of a formally established willingness-to-pay threshold. Conclusion . The performed analysis of published studies shows that the use of RWD in pharmacoeconomic evaluations of pharmacotherapy allows refinement of model parameters and improves the robustness of economic conclusions; however, the applied approaches vary substantially in study design and data quality. The applicability of these approaches within the Russian healthcare system requires consideration of limitations related to the availability and structure of domestic RWD.