Zeng Wanxian, Cao Xueqiong, Lin Jingwen, Zheng Bin, Li Na, Liu Maobai, Cai Hongfu
Affiliated Union Hospital of Fujian Medical University, Fuzhou, Fujian, China.
The School of Pharmacy, Fujian Medical University, Fuzhou, Fujian, China.
Front Oncol. 2023 Dec 19;13:1272586. doi: 10.3389/fonc.2023.1272586. eCollection 2023.
This study evaluated the cost-effectiveness of elacestrant (ELA) and standard-of-care (SOC) as second-/third-line treatment for pretreated estrogen receptor (ER)- positive/human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer (A/MBC) in the US.
The 3 health states partitioned survival model (PSM) was conducted from the perspective of the US third-party payers. The time horizon for the model lasted 10 years. Effectiveness and safety data were derived from the EMERALD trial (NCT03778931). Costs were derived from the pricing files of Medicare and Medicaid Services, and utility values were derived from published studies. One-way sensitivity analysis as well as probabilistic sensitivity analysis were performed to observe model stability.
ELA led to an incremental cost-effectiveness ratio (ICER) of $8,672,360/quality-adjusted life year (QALY) gained compared with SOC in the overall population and $2,900,560/QALY gained compared with fulvestrant (FUL) in the ESR1(estrogen receptor 1) mutation subgroup. The two ICERs of ELA were significantly higher than the willingness-to-pay (WTP) threshold values of $150,000/QALY.
ELA was not cost-effective for the second-/third-line treatment of patients with ER+/HER2-A/MBC compared with SOC in the US.
本研究评估了在美国，艾拉司群（ELA）和标准治疗（SOC）作为预处理过的雌激素受体（ER）阳性/人表皮生长因子受体2（HER2）阴性的晚期或转移性乳腺癌（A/MBC）二线/三线治疗的成本效益。
从美国第三方支付方的角度构建了三健康状态分区生存模型（PSM）。该模型的时间范围为10年。有效性和安全性数据来自EMERALD试验（NCT03778931）。成本来自医疗保险和医疗补助服务中心的定价文件，效用值来自已发表的研究。进行了单向敏感性分析和概率敏感性分析以观察模型稳定性。
在总体人群中，与SOC相比，ELA导致的增量成本效益比（ICER）为每获得一个质量调整生命年（QALY）8,672,360美元；在ESR1（雌激素受体1）突变亚组中，与氟维司群（FUL）相比，ELA导致的ICER为每获得一个QALY 2,900,560美元。ELA的这两个ICER均显著高于每QALY 150,000美元的支付意愿（WTP）阈值。
在美国，与SOC相比，ELA作为ER+/HER2- A/MBC患者的二线/三线治疗不具有成本效益。
