Abstract

Objective: To investigate the cost-effectiveness of second-line pharmacological treatments for metastatic breast cancer (MBC) by comparing trastuzumab emtansine (T-DM1) versus a combination of lapatinib and capecitabine (LAP+CAP) from the perspective of the Brazilian health system, the Unified Health System (Sistema Único de Saúde–SUS).Methods: The results of each treatment were simulated based on a three-state Markov decision model applied to a hypothetical cohort of 1,000 women, aged 50 y old or older, with MBC and HER2 (human epidermal growth factor receptor 2) overexpression. The data on the effectiveness of treatments were taken from reports in the literature. The period considered for simulation was three years subdivided into monthly cycles of transition between health states. A discount rate of 5% per year was applied to costs and outcomes. Possible uncertainty was assessed by means of a sensitivity analysis.Results: Chemotherapy for women with refractory MBC using T-DM1 monotherapy was ruled out by extended dominance. Treatment with LAP+CAP proved to be the most efficient strategy because the cost in relation to the overall survival (BRL 72,035.43/quality-adjusted life year–QALY) was the lowest and fell within the acceptability threshold, BRL 86,628.00.Conclusion: T-DM1 demonstrated pharmacological superiority over other agents used for the treatment of MBC in clinical studies. However, the price set for T-DM1 in Brazil is the determinant variable that contraindicates its inclusion in the SUS, in agreement with other international assessments.

Highlights

  • Cancer, a generic term used to allude to a condition of quick and abnormal cell growth, is one of the main causes of morbidity and mortality worldwide, in developing countries

  • A simulation model was developed based on Markov chains and comprising three states in a hypothetical cohort of 1,000 women aged 50 y old or older diagnosed with metastatic breast cancer (MBC) and HER2 overexpression previously treated with TRA

  • Another cost-effectiveness analysis conducted from the United States perspective applied Markov models; the results showed that T-DM1 is not cost-effective compared to lapatinib and capecitabine (LAP+CAP) [30]; the incremental cost-effectiveness ratio (ICER) was USD 183,828/qualityadjusted life year (QALY) from the societal perspective and 220,385/QALY from the payer’s perspective

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Summary

Introduction

A generic term used to allude to a condition of quick and abnormal cell growth, is one of the main causes of morbidity and mortality worldwide, in developing countries. According to World Health Organization (WHO) estimates, 14 million new cases will occur every year, with a trend of increase of at least 70% until 2030 [1]. In Brazil, neoplasms and cardiovascular diseases have been the main causes of death in recent years, largely due to the local lifestyle and population ageing associated with continuous urbanisation and actions for health promotion and recovery [2, 3]. According to the José Alencar da Silva National Cancer Institute, excluding nonmelanoma skin cancer, approximately 430,000 new cases occurred in Brazil in 2016, with breast cancer having the highest prevalence among women, representing 28.1% of cases [4]. Its incidence rates are still high, the prognosis of breast cancer varies as a function of the stage of the disease at the time of diagnosis and onset of treatment. More frequent early diagnosis resulting from screening and timely systemic treatment increase the average survival of patients [5,6,7]

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