Abstract
Objective
The aim of the study was to demonstrate the clinical and economic impact of two PD-L1 IHC assays, SP142 versus 22C3, to identify the eligibility of the patients with advanced triple negative breast cancer (aTNBC) to the treatment with atezolizumab plus nab-paclitaxel in the Brazilian private healthcare system (BPHS).
Methods
The study performed a cost-effectiveness analysis based on a partitioned-survival model with three mutually exclusive health states: progression-free (PF), progression, and death. Data of progression-free survival and overall survival were extracted from a retrospective exploratory analysis of IMpassion130, an analytical harmonization of PD-L1 IHC assays. The analyses included only direct costs (drug acquisition and management of adverse events) that were based on CBHPM (Classificação Brasileira Hierarquizada de Procedimentos Médicos) and CMED PF18% (Câmara de Regulação do Mercado de Medicamentos) tables. A probabilistic sensitivity analysis was performed as a second-order Monte Carlo Simulation in order to evaluate the uncertainties of the model.
Results
The SP142 assay has the potential to improve PFS and generate savings to the BPHS. The incremental cost-effectiveness ratio (ICER) was –USD 4,119.43 per month of progression-free survival.
Conclusions
The SP142 assay demonstrated to be a dominant alternative compared to 22C3 to guide the treatment with atezolizumab plus nab-paclitaxel in patients with aTNBC.
Transparency
Declaration of funding
This study was conducted internally by Roche Diagnostic Brazil.
Declaration of financial/other relationships
RSH, MMS, and MN are employed at Roche Diagnostics Brazil. JPVC and TN are employed at Roche Diagnostics LATAM. No other potential conflicts of interest were reported by the authors. JME peer reviewers on this manuscript have received an honorarium from JME for their review work, but have no other relevant financial relationships to disclose.
Acknowledgements
None reported.
Institution where the work was performed
Roche Diagnostic Brazil.