OBJECTIVES

Dabrafenib plus trametinib improved relapse-free survival versus placebo (hazard ratio, 0.49; P<0.001) in patients with resected BRAFV600–mutant stage III melanoma with estimated cure rate of 54% from the COMBI-AD trial. This study aims to assess the incremental cost of incorporating this treatment in the Brazilian private healthcare system (BPHS).

METHODS

: A budget impact model evaluated the incremental cost of incorporating dabrafenib plus trametinib in the BPHS. Pembrolizumab and a “watch and wait” approach were the comparators defined in this model. 29 patients were selected as population of interest after epidemiological filters were applied, including: incidence of newly diagnosed stage III cases (7.4%), successful complete resection rate (70%), proportion of BRAFV600-mutant patients (41%), prevalence of cases that progress from earlier stages to stage III (1.1%) and stage III patients (8.4%) with loco-regional recurrence (1.7%) who were able to receive other adjuvant treatments. The drugs’ purchase costs were based on CMED factory list price, updated March 2019. The costs of disease progression were based on health care provider databases. Two different scenarios were evaluated: the reference scenario assumed that dabrafenib plus trametinib was not considered a therapeutic option, estimating a pembrolizumab market share of 80-95% at the end of five years, while the projected scenario estimates 10% in the first year and 35% at the end of five years with the inclusion of dabrafenib plus trametinib.

RESULTS

: The estimated budget impact of dabrafenib plus trametinib as adjuvant treatment of BRAFV600-mutant stage III melanoma patients was BRL442,776 over five years, or approximately BRL88,500 per annum.

CONCLUSIONS

: The budget impact of dabrafenib plus trametinib is low considering clinical treatment benefits. It reduces recurrence risk, demonstrates a high cure rate, and patients remain relapse-free in the long term. The low investment required for its incorporation is due to its 12-month treatment regimen and the small number of patients.