Lapatinib in patients with metastatic breast cancer following initial treatment with trastuzumab: an economic analysis from the Brazilian public health care perspective

d Objective: To evaluate, from the perspective of the Brazilian public health care system, the cost-effectiveness of lapatinib plus capecitabine (LAP/CAP) versus capecitabine alone (CAP) or trastuzumab plus capecitabine (TRAST/CAP) in the treatment of women with human epidermal growth factor receptor-2-positive metastatic breast cancer previously treated with trastuzumab. Methods: An economic model was developed to compare costs and clinical outcomes over a 5-year time horizon. Both costs and outcomes were discounted at a 5% rate, in accordance with Brazilian pharmacoeconomic guidelines. Clinical inputs were determined using indirect treatment comparisons. Costs were derived from public reimbursement databases and reported in 2010 Brazilian real (R$ 1 = USD$ 0.52). Clinical outcomes included progression-free survival years (PFYs), life-years (LYs) and quality-adjusted life-years (QALYs). The economic outcome was the incremental cost per LY, PFY, or QALY gained. The impact of variations in individual inputs (eg, drug cost, drug effectiveness) was examined using one-way sensitivity analyses. Overall model robustness was tested using probabilistic sensitivity analyses, varying the ranges of all input parameters within their standard distributions. Results: Expected cost per patient was R$ 41,195 for CAP, R$ 95,256 for LAP/CAP, and R$ 113,686 for TRAST/CAP. Respective LYs were 1.406, 1.695, and 1.465; PFYs were 0.473, 0.711, and 0.612; and QALYS were 0.769, 0.958, and 0.827. LAP/CAP dominated TRAST/CAP for all outcomes. Incremental cost-effectiveness ratios of LAP/CAP over CAP were R$ 186,563 for LYs, R$ 226,403 for PFYs, and R$ 284,864 for QALYs. Results remained unchanged in one-way sensitivity analyses. In probabilistic analyses, LAP/CAP was dominant over TRAST/CAP in 93.5% of simulations. Conclusion: LAP/CAP increases survival for women with human epidermal growth factor receptor-2-positive metastatic breast cancer. LAP/CAP is cost-effective against TRAST/CAP (ie, produces more benefits at a lower cost) and can be considered cost-effective over CAP at a willingness-to-pay of about R$ 290,000 (US$ 151,000) per QALY gained.