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来曲唑或阿那曲唑联合 CDK4/6 抑制剂一线治疗 HR+/HER2-晚期乳腺癌的成本效果分析:MONALEESA-2 和 PALOMA-2 研究最终 OS 结果分析

Cost-effectiveness of ribociclib versus palbociclib in combination with an aromatase inhibitor as first-line treatment of postmenopausal women with HR+/HER2- advanced breast cancer: analysis based on final OS results of MONALEESA-2 and PALOMA-2.

机构信息

Edinburgh Cancer Research Centre, University of Edinburgh, Edinburgh, UK.

Novartis Healthcare Pvt Ltd, Hyderabad, India.

出版信息

J Med Econ. 2023 Jan-Dec;26(1):357-365. doi: 10.1080/13696998.2023.2182051.

DOI:10.1080/13696998.2023.2182051
PMID:36797664
Abstract

BACKGROUND AND AIMS

Combination of a cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor and an aromatase inhibitor is the standard of care first-line (1L) treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC). Updated clinical data have become available from the MONALEESA-2 and PALOMA-2 trials for ribociclib and palbociclib, respectively. This analysis with updated data assessed the cost-effectiveness of ribociclib versus palbociclib, both in combination with letrozole, in the setting of 1L therapy of postmenopausal women with HR+/HER2- ABC, from a United Kingdom (UK) National Health Service perspective.

METHODS

A three state (progression-free, progressed disease, and death) partitioned survival model with a 1-month cycle was developed. Clinical data were derived from MONALEESA-2 (NCT01958021) and PALOMA-2 (NCT01740427). The treatment effect was modeled using hazard ratios (HRs) for progression-free survival and overall survival derived through a matched-adjusted indirect comparison. Trial data and published literature were used to derive utility values. Cost inputs included drug acquisition, disease monitoring, subsequent therapies, and adverse events. Costs and outcomes were discounted by 3.5%, over a 40-year lifetime horizon. One-way and probabilistic sensitivity analyses were performed.

RESULTS

Ribociclib dominated palbociclib, and was both overall cost saving (-£3,273) and more effective (+1.251 quality-adjusted life years [QALYs]). Ribociclib total drug costs were £17,156 lower than palbociclib. At a £30,000 per QALY willingness-to-pay threshold, the probability of ribociclib being cost-effective was almost 100%. Ribociclib remained cost-effective when varying HRs, utilities, drug cost, and health state costs.

CONCLUSIONS

Ribociclib is both cost-saving and cost-effective compared with palbociclib for the 1L treatment of postmenopausal women with HR+/HER2- ABC in the UK.

摘要

背景与目的

细胞周期蛋白依赖性激酶 4 和 6(CDK4/6)抑制剂联合芳香酶抑制剂是激素受体阳性(HR+)、人表皮生长因子受体 2 阴性(HER2-)晚期乳腺癌(ABC)一线(1L)治疗的标准方案。来自 MONALEESA-2 和 PALOMA-2 试验的更新临床数据分别可用于评估瑞博西利和哌柏西利。本分析采用来自 MONALEESA-2(NCT01958021)和 PALOMA-2(NCT01740427)试验的更新数据,从英国国家医疗服务体系(NHS)的角度评估了 CDK4/6 抑制剂(瑞博西利或哌柏西利)联合来曲唑在 HR+/HER2-ABC 绝经后女性 1L 治疗中的成本效益。

方法

建立了一个三状态(无进展、疾病进展和死亡)分区生存模型,周期为 1 个月。临床数据来自 MONALEESA-2(NCT01958021)和 PALOMA-2(NCT01740427)试验。使用通过匹配调整间接比较得出的无进展生存期和总生存期的风险比(HRs)来建模治疗效果。试验数据和已发表的文献用于推导效用值。成本投入包括药物获取、疾病监测、后续治疗和不良反应。在 40 年的生命周期内,成本和结果均以 3.5%贴现。进行了单因素敏感性分析和概率敏感性分析。

结果

瑞博西利优于哌柏西利,总体上节省成本(节省£3273)且更有效(增加 1.251 个质量调整生命年[QALY])。瑞博西利的总药物成本比哌柏西利低£17156。在 £30000 每 QALY 的支付意愿阈值下,瑞博西利具有成本效益的概率接近 100%。当改变 HR、效用、药物成本和健康状态成本时,瑞博西利仍具有成本效益。

结论

与哌柏西利相比,瑞博西利可节省成本并具有成本效益,可用于治疗英国 HR+/HER2-ABC 绝经后女性的 1L 治疗。

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