曲妥珠单抗初始治疗后的转移性乳腺癌患者应用拉帕替尼：巴西公共医疗视角的经济学分析。
Lapatinib in patients with metastatic breast cancer following initial treatment with trastuzumab: an economic analysis from the Brazilian public health care perspective.
机构信息
GlaxoSmithKline Brasil Ltd, Rio de Janeiro, Brazil.
Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Canada.
出版信息
Breast Cancer (Dove Med Press). 2012 Nov 13;4:173-82. doi: 10.2147/BCTT.S37003. eCollection 2012.
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.
目的
从巴西公共医疗保健系统的角度评估曲妥珠单抗联合卡培他滨（TRAST/CAP）与卡培他滨单药（CAP）或拉帕替尼联合卡培他滨（LAP/CAP）治疗曲妥珠单抗治疗后人类表皮生长因子受体 2 阳性转移性乳腺癌女性的成本效益。
方法
开发了一种经济模型，以比较 5 年时间内的成本和临床结果。根据巴西药物经济学指南，成本和结果均以 5%的贴现率贴现。临床投入使用间接治疗比较确定。成本来自公共报销数据库，并以 2010 年巴西雷亚尔（R$1=USD$0.52）报告。临床结果包括无进展生存期（PFYs）、生命年（LYs）和质量调整生命年（QALYs）。经济结果是每获得一个 LY、PFY 或 QALY 的增量成本。使用单因素敏感性分析检查了个体投入（例如药物成本、药物效果）变化的影响。使用概率敏感性分析测试了整个模型的稳健性，即在标准分布范围内改变所有输入参数的范围。
结果
CAP 的每位患者预期成本为 R$41,195，LAP/CAP 为 R$95,256，TRAST/CAP 为 R$113,686。相应的 LYs 分别为 1.406、1.695 和 1.465；PFYs 分别为 0.473、0.711 和 0.612；QALYs 分别为 0.769、0.958 和 0.827。对于所有结果，LAP/CAP 均优于 TRAST/CAP。与 CAP 相比，LAP/CAP 的增量成本效益比 LYs 为 R$186,563，PFYs 为 R$226,403，QALYs 为 R$284,864。在单因素敏感性分析中结果保持不变。在概率分析中，LAP/CAP 在 93.5%的模拟中优于 TRAST/CAP。
结论
LAP/CAP 可提高曲妥珠单抗治疗后人类表皮生长因子受体 2 阳性转移性乳腺癌女性的生存率。与 TRAST/CAP 相比，LAP/CAP 具有成本效益（即，以更低的成本产生更多的收益），并且在获得每 QALY 约 290,000 雷亚尔（151,000 美元）的意愿支付时，相对于 CAP 可能具有成本效益。
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