Abstract

The use of immunotherapy in the second-line therapy of advanced non-small cell lung cancer (NSCLC) has demonstrated improvements in overall survival when compared to docetaxel. The aim of this study was to calculate the budget impact of implementing pembrolizumab associated with a PD-L1 biomarker-based treatment selection versus nivolumab in second-line therapy in patients with advanced NSCLC. Epidemiological data were used to obtain the number of eligible NSCLC cases in second-line therapy in a health maintenance organization (HMO) with 100,000 lives. All patients in the modeled PD-L1 testing arm were tested for PD-L1 expression, with 66% of positive patients (PD-1 ≥1%) receiving pembrolizumab and PD-L1 negative patients receiving docetaxel. Patients in non-PD-L1 testing arm were not tested for PD-L1 expression and received nivolumab. Cost of the test was zero as it is currently freely provided by MSD. Local drug prices (list price, 18% ICMS) were obtained from the Brazilian Pharmaceutical Market Regulation Chamber and are presented in BRL (2017 values). The cost of 40 weeks of immunotherapy for a 75 kilogram patient was assumed to be the same (378,935 BRL) and duration of treatment was obtained from a published study. The budget impact with pembrolizumab (66% of the eligible advanced NSCLC cases) was 1,646,559 BRL, plus 78,674 BRL for docetaxel, resulting in a total cost of 1,725,232 BRL in the PD-L1 testing arm. In non-PD-L1 testing arm, all patients used nivolumab, resulting in a total cost of 2,494,785 BRL. PD-L1 testing with pembrolizumab in PD-L1 positive patients versus non-PD-L1 testing could generate a saving of 769,553 BRL in an HMO with 100,000 lives. The inclusion of a test for PD-L1 expression, which selects the best patients responding to therapy, may decrease budget impact for payers in Brazil.

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