Summary: Objective of this study was to determine cost-effectiveness of vemurafenib in treatment of inoperable or metastatic melanoma in patients with BRAFV600 mutation from Russian healthcare system perspective and a long-term use. Cost-effectiveness analysis (CEA) has been used and cost-effectiveness ratio (CER) has been calculated. Incremental analysis has been conducted with calculation of incremental cost-effectiveness ratio (ICER) when exceeding the costs and effectiveness of one of the studied regimens as compared to the other one. Cost analysis included calculation of the following direct costs (DC): the cost of the main disease treatment (cutaneous melanoma, CM) -costs of the drug; the cost of laboratory and instrumental methods of investigation as well as hospitalizations and out-patient treatment; the cost required to determine exon 15 BRAF mutation in melanoma; the cost of the drug therapy aimed at management of adverse events (AEs) caused by the drug when treating the main disease. Two medical technologies have been assessed (anti-tumor regimens depending on the chosen method): vemurafenib at a dose of 960 mg twice a day; dacarbazine at a dose of 1000 mg/m 2 i/v every 3 weeks. Mathematical modelling underlies this study. As a result it has been demonstrated that the use of vemurafenib strategy in treatment of metastatic melanoma in patients with BRAF V600 mutation had better progression-free survival (PFS) rate throughout the entire modelling horizon. The use of vemurafenib in treatment of metastatic and inoperable melanoma in patients with BRAF V600 mutation is economically advisable taking into account the data on effectiveness (PFS). The use of vemurafenib in patients with BRAF V600 mutation is an absolutely innovative medical technology which currently does not have any alternative. Vemurafenib may be indicated for inclusion in reimbursement lists for treatment of patients with this mutation.

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Pharmacoeconomics

The aim: to provide a comprehensive pharmacoeconomic evaluation of the maintenance therapy with antipsychotics in outpatients diagnosed with schizophrenia.Materials and methods. The analysis was conducted by two mutually complementary steps: an epidemiological study on outpatients with schizophrenia, and a subsequent pharmacoeconomic modeling. Two medical technologies were evaluated and compared: treatment with classical antipsychotics (kA) and treatment with atypical antipsychotics (AA). For the clinical and economic analysis of these treatments, we used a number of indices derived from our retrospective study of patients’ medical records. The cost-effectiveness analysis, incremental analysis, and «budget impact» analysis were performed taking into account the direct and indirect costs of the treatments.Results. We determined the costs of managing outpatients with schizophrenia from the perspective of the healthcare budget and the social burdens; we also looked into the relevance and effectiveness of the current costs at various time intervals – 6, 12 and 24 months. As shown, the treatment strategies involving AA were more budget-consumptive than the kA treatments. even if the treatments were switched to the reproduced AA (up to 100% replacement), the costs would remain to be higher than those for the kA. The «cost-effectiveness» analysis related to «the proportion of stable patients» for the horizons of 6 and 12 months indicated that the reproduced AA would be more economically effective than the kA. However, when the observation period was increased to 24 months, this economic advantage of AA diminished, and the kA drugs had a lower CeR instead. For the «number of hospitalization-free days per year», the use of AA was more cost-effective only versus the 100% use of reproduced AA at the simulated horizon of 12 months. When the use of 100% reference AA or the combined use of reference + reproduced AA was simulated, the treatment with kA remained more economically effective, regardless of the simulated period.Conclusion. The pharmacoeconomic simulation of the antipsychotic therapy in outpatients with schizophrenia suggests the ways to optimize the treatment. Among them, (a) using AA for the treatment of at least 15.6% of patients (those who are employed); keeping the ≥60% use of kA to ensure the optimal resource-saving effect of the treatment; (b) using reproduced AA at the level of ≥70% (instead of the reference AA similar in efficacy and safety) to keep the treatment economically feasible.

государственный медицинский университет имени академика И.П. Павлова» Минздрава России 2 ФГБОУ ВПО «Санкт-Петербургский Государственный Университет» 3 Департамент лекарственного обеспечения и регулирования обращения медицинских изделий Министерства Здравоохранения РФ 4 ГОУ ВПО Санкт-Петербургская государственная химико-фармацевтическая академия федерального агентства по здравоохранению и социальному развитию (СПХФА)