Colombo Giorgio Lorenzo, Valentino Maria Chiara, Fabi Alessandra, Dieci Maria Vittoria, Caruggi Mauro, Bruno Giacomo Matteo, Lombardi Gloria, Di Matteo Sergio
Department of Drug Sciences, University of Pavia, Pavia, Italy.
S.A.V.E. Studi Analisi Valutazioni Economiche S.r.l., Health Economics & Outcomes Research, Milan, Italy.
Ther Clin Risk Manag. 2023 Mar 28;19:301-312. doi: 10.2147/TCRM.S391769. eCollection 2023.
To date, no study evaluated the cost-effectiveness of palbociclib (PAL) plus fulvestrant (FUL) vs ribociclib (RIB) plus FUL and abemaciclib (ABM) plus FUL in Italy. Cost-effectiveness analysis comparing the three cyclin-dependent 4/6 kinase inhibitors in combination with endocrine therapies for the management of postmenopausal women with HR+, HER2- advanced or metastatic breast cancer in Italy was developed.
To assess the cost-effectiveness of PAL plus FUL vs RIB plus FUL and ABM plus FUL, a cost-minimization has been carried out with a conservative scenario considering three CDK4/6 inhibitors with equal effectiveness in terms of overall survival (OS) (MAIC, Rugo et al 2021). Adverse events (AEs) associated with all therapies were obtained from clinical trials. Ad-hoc analysis was performed to estimate the cost-effectiveness considering the quality-of-life (QoL) data (Lloyd et al 2006).
Cost-minimization inputs were drugs, visits and exams, AE monitoring and best supportive care (BSC) before the progression state, active and BSC in the progression and terminal phase of the last two weeks of life. Given the comparability of PAL, RIB and ABM in terms of efficacy, this analysis demonstrated slight economic savings over a lifetime for PAL. Results showed saving per patient of €305 (lifetime) when PAL is compared with RIB; for PAL vs ABM a saving of €243 (lifetime) in a conservative scenario. Results of a budget impact analysis showed a potential savings of €319,563 for PAL vs RIB and €297,544 for PAL vs ABM. When QoL data were considered, results may favor PAL due to the lower impact of AE with savings and improvement in the QoL related to fewer AE.
From the Italian perspective, a cost-saving profile associated with the use of PAL+FUL for the management of advanced/metastatic HR+/HER2- breast cancer compared to RIB+FUL and ABM+FUL emerged.
迄今为止，在意大利尚无研究评估哌柏西利（PAL）联合氟维司群（FUL）与瑞博西尼（RIB）联合FUL以及阿贝西利（ABM）联合FUL的成本效益。开展了一项成本效益分析，比较这三种细胞周期蛋白依赖性4/6激酶抑制剂与内分泌疗法联合用于意大利绝经后激素受体阳性（HR+）、人表皮生长因子受体2阴性（HER2-）晚期或转移性乳腺癌患者管理的情况。
为评估PAL联合FUL与RIB联合FUL以及ABM联合FUL的成本效益，采用成本最小化方法，在一个保守情景下进行分析，该情景考虑三种在总生存期（OS）方面疗效相同的细胞周期蛋白依赖性激酶4/6（CDK4/6）抑制剂（MAIC，Rugo等人，2021年）。所有疗法相关的不良事件（AE）均来自临床试验。进行了专项分析以考虑生活质量（QoL）数据来估计成本效益（Lloyd等人，2006年）。
成本最小化的投入包括药物、就诊和检查、AE监测以及疾病进展前的最佳支持治疗（BSC）、生命最后两周进展期和终末期的积极治疗和BSC。鉴于PAL、RIB和ABM在疗效方面具有可比性，该分析表明PAL在一生中有轻微的经济节省。结果显示，与RIB相比，PAL每位患者一生可节省305欧元；在保守情景下，与ABM相比，PAL每位患者一生可节省243欧元。预算影响分析结果显示，与RIB相比，PAL可能节省319,563欧元，与ABM相比，PAL可能节省297,544欧元。当考虑QoL数据时，由于AE影响较小且节省成本以及与较少AE相关的QoL改善，结果可能更倾向于PAL。
从意大利的角度来看，与使用RIB+FUL和ABM+FUL相比，使用PAL+FUL治疗晚期/转移性HR+/HER2-乳腺癌呈现出成本节约的情况。
