Palbociclib 和 Ribociclib 是细胞周期蛋白依赖性激酶 4/6 口服分子抑制剂，有可能改善转移性乳腺癌 (MBC) 患者的总生存期 (OS)、无进展生存期 (PFS) 和生活质量。本研究的目的是分析 Palbociclib 和 Ribociclib 与来曲唑单一疗法作为激素受体阳性 (HR )/人表皮生长因子受体 2 阴性 (HER2-) MBC 患者一线治疗的成本效益从伊朗医疗保健系统的角度，使用分区生存模型（PSM）进行了成本效用分析（CUA）。考虑的比较策略是 Palbociclib  来曲唑、Ribociclib  来曲唑和来曲唑单一疗法。该模型的结构周期为 1 个月，时间范围为 15 年。 Palbociclib  来曲唑和 Ribociclib 来曲唑的临床安全性、有效性和 PFS 和 OS 生存数据分别从 PALOMA-1、2 和 MONALEESA-2 研究的最新更新中获得。考虑了直接医疗费用，包括药物费用、就诊、住院、CT 扫描、骨 X 光、监测和实验室检测以及药物副作用。通过确定性敏感性分析和概率性敏感性分析进行不确定性评估。 Excel 2016和TreeAge 2020用于评估的所有阶段。基本案例结果表明，尽管来曲唑单一疗法的有效性较低，但它是最具成本效益的策略，而Palbociclib  来曲唑和Ribociclib  来曲唑不具有成本效益。与来曲唑单药治疗相比，Palbociclib  来曲唑和 Ribociclib  来曲唑的增量成本效益比 (ICER) 估计分别为每个质量调整生命年 (QALY) 137,302 美元和 120,478 美元，超过了 4565 美元的目标阈值。确定性敏感性分析表明，CUA 结果对不确定变量值的变化不敏感。概率敏感性分析还表明，基于各种参数和模拟的变化，Palbociclib  来曲唑和 Ribociclib  来曲唑没有机会具有成本效益。Palbociclib 和 Ribociclib 与来曲唑联合使用显示出显着的疗效，正如 PFS 的改善所证明的那样。然而，在伊朗的 MBC 一线治疗中，与来曲唑单一疗法相比，这些策略并不具有成本效益。© 2023。作者。

Palbociclib and Ribociclib are cyclin-dependent kinase 4/6 oral molecular inhibitors that have the potential to improve overall survival (OS), progression-free survival (PFS), and quality of life in patients with metastatic breast cancer (MBC). The objective of this study was to analyze the cost-utility of Palbociclib and Ribociclib in comparison with Letrozole monotherapy as the first-line treatment for hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) MBC patients in Iran.A Cost-Utility Analysis (CUA) was conducted using a partitioned survival model (PSM) from the perspective of the Iranian healthcare system. The comparative strategies considered were Palbociclib + Letrozole, Ribociclib + Letrozole, and Letrozole monotherapy. The model was structured with a 1-month cycle length and a 15-year time horizon. Clinical safety, efficacy, and survival data in terms of PFS and OS for Palbociclib + Letrozole and Ribociclib + Letrozole were obtained from the latest updates of the PALOMA-1, 2, and MONALEESA-2 studies, respectively. Direct medical costs, including drug costs, visits, hospitalization, CT scans, bone x-rays, monitoring and laboratory testing, as well as medication side effects, were considered. Uncertainty evaluations were performed through deterministic sensitivity analysis and probabilistic sensitivity analysis. Excel 2016 and TreeAge 2020 were used for all stages of the evaluation.The base case results indicated that, despite its lower effectiveness, Letrozole monotherapy was the most cost-effective strategy, while Palbociclib + Letrozole and Ribociclib + Letrozole were not cost-effective. The incremental cost-effectiveness ratios (ICERs) for Palbociclib + Letrozole and Ribociclib + Letrozole compared to Letrozole monotherapy were estimated at $137,302 and $120,478 per quality-adjusted life-year (QALY), respectively, which exceeded the target threshold of $4565. Deterministic sensitivity analysis demonstrated that the CUA results were not sensitive to changes in the values of uncertain variables. Probabilistic sensitivity analysis also indicated that Palbociclib + Letrozole and Ribociclib + Letrozole had no chance of being cost-effective based on changes in various parameters and simulations.Palbociclib and Ribociclib showed significant efficacy in combination with Letrozole, as evidenced by improvements in PFS. However, in the first-line treatment of MBC in Iran, these strategies were not cost-effective compared to Letrozole monotherapy.© 2023. The Author(s).