OBJECTIVES: The aim of this study was to conduct a cost-effectiveness analysis in terms of cost per objective response with dabrafenib+trametinib compared to vemurafenib+cobimetinib and pembrolizumab, as the first line of treatment in patients with unresectable or metastatic melanoma with BRAF V600 mutation, from the perspective of the Colombian health system.

METHODS: A partitioned survival model was constructed to estimate the costs associated with three health states (pre-progression, post-progression and death) and a five-year time horizon. Direct medical costs for medications (1st line and post-progression therapies) and their administration, follow-up, adverse events and palliative care were included. Local experts validated resource usage. Costs sources were SISMED, price control circulars, reference values (maximum budgets) and ISS and SOAT tariff manuals (1 USD = 3,477 COP, years 2018-2020). A 5% discount rate was applied for costs. The measure of effectiveness was the objective response rate according to RECIST at five years of follow-up (percentage of patients with reduction or disappearance of tumor size after treatment, which includes the complete response plus partial response). Objective response frequencies were obtained from a review of clinical trials.

RESULTS: The average costs per objective response in the base case / maximum budget scenario for the year 2020 are: USD$ 341,109 / USD$ 360,353 with dabrafenib+trametinib, USD$ 407,530 / USD$ 400,108 with vemurafenib+cobimetinib, and USD$ 471,059 / USD$ 478,326 with pembrolizumab. From the perspective of maximum budgets, dabrafenib+trametinib has a cost 10% lower (USD$ -39,755) versus vemurafenib+cobimetinib, and 25% lower (USD$ -117,973) compared to pembrolizumab.

CONCLUSIONS: From the perspective of the Colombian health system, dabrafenib+trametinib represents a cost-saving therapeutic option as the first line of treatment in patients with unresectable or metastatic melanoma with BRAF V600 mutation.