Policy Analysis Inc. (PAI), Four Davis Court, Brookline, MA 02445, USA.
Eur J Health Econ. 2012 Oct;13(5):589-603. doi: 10.1007/s10198-011-0323-1. Epub 2011 Jun 24.
In a phase III trial of women with HER2+ metastatic breast cancer (MBC) previously treated with trastuzumab, an anthracycline, and taxanes (EGF100151), lapatinib plus capecitabine (L+C) improved time to progression (TTP) versus capecitabine monotherapy (C-only). In a trial including HER2+ MBC patients who had received at least one prior course of trastuzumab and no more than one prior course of palliative chemotherapy (GBG 26/BIG 03-05), continued trastuzumab plus capecitabine (T+C) also improved TTP.
An economic model using patient-level data from EGF100151 and published results of GBG 26/BIG 03-05 as well as other literature were used to evaluate the incremental cost per quality-adjusted life-year [QALY] gained with L+C versus C-only and versus T+C in women with HER2+ MBC previously treated with trastuzumab from the UK National Health Service (NHS) perspective.
Expected costs were £28,816 with L+C, £13,985 with C-only and £28,924 with T+C. Corresponding QALYs were 0.927, 0.737 and 0.896. In the base case, L+C was estimated to provide more QALYs at a lower cost compared with T+C; cost per QALY gained was £77,993 with L+C versus C-only. In pairwise probabilistic sensitivity analyses, the probability that L+C is preferred to C-only was 0.03 given a threshold of £30,000. The probability that L+C is preferred to T+C was 0.54 regardless of the threshold.
When compared against capecitabine alone, the addition of lapatinib has a cost-effectiveness ratio exceeding the threshold normally used by NICE. Compared with T+C, L+C is dominant in the base case and approximately equally likely to be cost-effective in probabilistic sensitivity analyses over a wide range of threshold values.
在一项针对先前接受曲妥珠单抗、蒽环类药物和紫杉烷治疗的 HER2+转移性乳腺癌(MBC)女性的 III 期试验中,拉帕替尼联合卡培他滨(L+C)较卡培他滨单药治疗(C-仅)改善了无进展生存期(TTP)。在一项包括先前接受过至少一次曲妥珠单抗治疗且不超过一次姑息化疗的 HER2+MBC 患者的试验中(GBG 26/BIG 03-05),继续曲妥珠单抗联合卡培他滨(T+C)也改善了 TTP。
使用来自 EGF100151 的患者水平数据以及已发表的 GBG 26/BIG 03-05 结果和其他文献中的经济模型,从英国国家医疗服务体系(NHS)的角度评估先前接受过曲妥珠单抗治疗的 HER2+MBC 女性中,L+C 对比 C-仅和 T+C 的增量成本每获得一个质量调整生命年(QALY)。
L+C 的预期成本为 28816 英镑,C-仅为 13985 英镑,T+C 为 28924 英镑。相应的 QALYs 分别为 0.927、0.737 和 0.896。在基础病例中,L+C 与 T+C 相比,预计能提供更多的 QALYs,且成本更低;L+C 比 C-仅每获得一个 QALY 的成本为 77993 英镑。在成对概率敏感性分析中,当阈值为 30000 英镑时,L+C 比 C-仅更优的概率为 0.03。无论阈值如何,L+C 比 T+C 更优的概率为 0.54。
与卡培他滨单药治疗相比,添加拉帕替尼的成本效果比超过了 NICE 通常使用的阈值。与 T+C 相比,在基础病例中,L+C 是主导方案,并且在广泛的阈值范围内,在概率敏感性分析中具有同等可能的成本效益。