Objective: to perform a cost-effectiveness analysis of using encorafenib and binimetinib combination in the first-line therapy for metastatic or unresectable BRAF V600-mutated melanoma in the Russian Federation. Material and methods. The comparators included “dabrafenib + trametinib” combination and vemurafenib monotherapy, which are listed in the Russian clinical guidelines and the Vital and Essential Drugs List. Since “encorafenib and binimetinib” combination demonstrated superior overall response rate compared to “dabrafenib + trametinib” and vemurafenib monotherapy, the method of cost-effectiveness analysis was used. We developed a disease progression model based on data from the COLUMBUS randomized control trial and published network meta-analysis. The model was used to calculate the direct medical costs associated with the considered alternatives over a 3-year modeling horizon. We compared the incremental cost-effectiveness ratio for “encorafenib + binimetinib” vs. “dabrafenib + trametinib” to the same ratio calculated for “dabrafenib + trametinib” vs. vemurafenib monotherapy.Results. Mean costs of using “encorafenib + binimetinib” combination over a 3-year period, considering the discontinuation of treatment as the disease progresses, was 6,547,693.07 rubles. Meanwhile, it was 5,962,742.52 rubles for “dabrafenib + trametinib” and 2,581,781.45 rubles for vemurafenib monotherapy. The incremental cost-effectiveness ratio of “encorafenib + binimetinib” vs. “dabrafenib + trametinib” was 3,846,818.71 rubles per 1 patient with a response to therapy. This was 85.14% lower than the same ratio estimated for “dabrafenib + trametinib” vs. vemurafenib monotherapy (25,890,022.64 rubles per 1 patient with a response to therapy).Conclusion. The “encorafenib + binimetinib” combination is a cost-effective treatment method for patients with unresectable or metastatic BRAF V600-mutated melanoma in the Russian Federation.
