Pharmacoeconomic analysis of vemurafenib in treatment of inoperable or metastatic melanoma in patients with BRAF V600 mutation

Abstract

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.

Selection of a comparison technology for pharmacoeconomic analysis of innovative drugs

“…The pharmacoeconomic analysis implies a competitive comparative approach, and there is a problem of choosing a comparison technology for the pharmacoeconomic evaluation of the drug. An analysis of practical experience with pharmacoeconomics shows [1-12, [16][17][18][19][20][21][22][23][24][25][26][27] that the following options are traditionally chosen as comparison technologies:…”