David Geffen School of Medicine, University of California, Los Angeles, 1250 16th Street, 2304 Central Wing, Santa Monica, CA, 90404, USA.
Anderson School of Management, University of California, Los Angeles, Santa Monica, CA, USA.
Breast Cancer Res Treat. 2019 Jun;175(3):775-779. doi: 10.1007/s10549-019-05190-3. Epub 2019 Mar 7.
Three CDK4/6 inhibitors, palbociclib (PAL), ribociclib (RIB), and abemaciclib, when combined with letrozole (LET), have been approved as first-line therapy for postmenopausal women with metastatic HR+, HER2- breast cancer. However, an economic evaluation of these newer therapies is currently lacking. The purpose of this article is to evaluate the cost-effectiveness of PAL or RIB for the treatment of advanced HR+, HER2- breast cancer in the United States.
A Markov simulation model was constructed using data from published clinical trials evaluating PAL and RIB. Three simulated treatment strategies included PAL + LET, RIB + LET, or LET alone. The main outcome measures were simulated progression-free survival (PFS), overall survival (OS), costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs).
Simulated median OS was 38.9 months for PAL + LET and 33.0 months for LET alone. Simulated median OS for RIB + LET was 43.3 months. Compared to LET alone, PAL + LET provided an additional 0.48 QALYs, on average, with an ICER of $634,000 per QALY gained; RIB + LET provided an additional 0.86 QALYs, on average, with an ICER of $440,000 per QALY gained. At current prices, neither PAL nor RIB was cost-effective, assuming a willingness-to-pay threshold of $100,000 per QALY gained. To reach such a cost-effectiveness threshold, PAL and RIB prices must decrease by approximately 70%.
Despite significant gains in progression-free survival over letrozole alone, the addition of palbociclib or ribociclib in the treatment of advanced HR+, HER2- breast cancer is not cost-effective in the United States given current drug prices.
三种 CDK4/6 抑制剂，帕博西尼（PAL）、瑞博西尼（RIB）和阿贝西利，与来曲唑（LET）联合应用已被批准用于治疗转移性 HR+、HER2-乳腺癌的绝经后女性的一线治疗药物。然而，目前还缺乏对这些新疗法的经济评估。本文旨在评估 PAL 或 RIB 治疗美国晚期 HR+、HER2-乳腺癌的成本效益。
使用来自评估 PAL 和 RIB 的已发表临床试验数据构建了一个 Markov 模拟模型。三种模拟治疗策略包括 PAL+LET、RIB+LET 或 LET 单药治疗。主要的结局测量是模拟无进展生存期（PFS）、总生存期（OS）、成本、质量调整生命年（QALYs）和增量成本效益比（ICERs）。
PAL+LET 的模拟中位 OS 为 38.9 个月，LET 单药治疗为 33.0 个月。RIB+LET 的模拟中位 OS 为 43.3 个月。与 LET 单药治疗相比，PAL+LET 平均增加了 0.48 个 QALYs，ICER 为每 QALY 增加 634,000 美元；RIB+LET 平均增加了 0.86 个 QALYs，ICER 为每 QALY 增加 440,000 美元。在当前价格下，假设愿意支付的阈值为每 QALY 增加 10 万美元，PAL 和 RIB 均不具有成本效益。要达到这样的成本效益阈值，PAL 和 RIB 的价格必须降低约 70%。
尽管与来曲唑单药治疗相比，无进展生存期有显著提高，但考虑到目前的药物价格，在治疗晚期 HR+、HER2-乳腺癌时，添加帕博西尼或瑞博西尼并不具有成本效益。
