Merkel cell carcinoma (MCC) is a rare primary malignant skin tumor with epithelial and neuroendocrine differentiation. According to the Russian clinical recommendations, MCC accounts for around 650 new cases per year in Russia. Avelumab is a human IgG1 monoclonal antibody that targets cancer cells through the inhibition of the immune checkpoint protein PD-L1 and can be used as a 2nd line treatment of metastatic MCC (mMCC). The aim of the study is to conduct a clinical and economic evaluation of avelumab as a second-line treatment in patients with mMCC from the perspective of Russian health care. Methods. Standard chemotherapy regimens were considered as a comparator for avelumab. We proposed a mathematical model of MCC progression and calculated direct medical costs during 6 years of treatment. Incremental cost-effectiveness ratios for avelumab (vs chemotherapy) were compared with the corresponding ratios for another PD-1 inhibitor included in Vital and Essential Drug List (VEDL). Results. Life-years gained (LYG) for avelumab were 2.21 years, compared to 0.39 LYG for chemotherapy. The average costs of using avelumab were 9 156 731 RUB per patient, compared to 60 743 RUB when using chemotherapy. Incremental cost-effectiveness ratio (ICER) for avelumab (vs chemotherapy) was 5 012 867.70 RUB per one LYG, which was 54.8% lower than ICER for pembrolizumab (vs docetaxel) as a second-line treatment in patients with non-small cell lung cancer. ICER for avelumab vs chemotherapy was 11,940,043.38 RUB per one progression-free LYG, which was 40.9% lower than ICER for pembrolizumab (vs chemotherapy) as a treatment in patients with ipilimumab-refractory advanced melanoma.
Immunohistochemical analysis of sentinel lymph nodes from patients with Merkel cell carcinoma
