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奥拉帕利辅助治疗西班牙生殖系BRCA1/2突变、高危HER2阴性早期乳腺癌的成本-效用分析

Cost-Utility Analysis of Adjuvant Olaparib for Germline BRCA1/2-Mutated, High-Risk HER2-Negative Early Breast Cancer in Spain.

作者信息

Cedillo Sergio, González-Domínguez Almudena, Ivanova-Markova Yoana, López López Rafael, López-Tarruella Cobo Sara, Peña Pedrosa José Alberto

机构信息

AstraZeneca Farmacéutica Spain S.A., Puerto de Somport 21-23, 28050, Madrid, Spain.

Weber, Calle Moreto, 17, 28014, Madrid, Spain.

出版信息

Pharmacoecon Open. 2024 Nov;8(6):887-896. doi: 10.1007/s41669-024-00518-2. Epub 2024 Aug 19.

DOI:10.1007/s41669-024-00518-2
PMID:39160415
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11499548/
Abstract

OBJECTIVE

Here we estimate the cost-effectiveness of olaparib in the Spanish National Health Service (SNHS) as adjuvant treatment of early germline mutations in the BRCA1/2 genes (gBRCAm) HER2-negative (HER2neg) breast cancer (BC) with high risk of recurrence.

METHODS

A semi-Markov model was adapted to the Spanish healthcare setting, using the perspective of the SNHS, and a lifetime horizon. Two scenarios were compared: receiving olaparib versus standard of care (SoC) treatment. The model comprised five health states and included the clinical results of the OlympiA trial, along with the direct healthcare costs associated with the use of early BC and subsequent treatment resources (€2023). A discount rate of 3% was applied for future cost and quality-of-life outcomes. A probabilistic sensitivity analysis (PSA) was carried out.

RESULTS

The introduction of olaparib as adjuvant treatment for patients with early gBRCAm HER2neg BC with high risk of recurrence could involve an incremental cost of €44,273 and €50,164, with an improvement of 1.14 and 1.28 quality-adjusted life years (QALYs) for hormone receptor-positive (HR) and triple-negative (TN) patients, respectively. Therefore, adjuvant olaparib could be cost-effective for early gBRCAm HER2neg BC, with an incremental cost-effectiveness ratio of €38,839/QALY and €39,084/QALY for HR and TN patients, respectively. The results from the PSA showed that 75.7% and 82.2% of the simulations fell below the €60,000/QALY threshold.

CONCLUSIONS

Olaparib as adjuvant treatment could be cost-effective in gBRCAm patients with early HER2neg BC in Spain.

摘要

目的

在此,我们评估奥拉帕利在西班牙国家卫生服务体系(SNHS)中作为辅助治疗手段,用于治疗具有高复发风险的早期BRCA1/2基因种系突变(gBRCAm)、人表皮生长因子受体2阴性(HER2neg)乳腺癌(BC)的成本效益。

方法

采用半马尔可夫模型,从SNHS的角度出发,设定终身时间范围,并使其适用于西班牙的医疗环境。比较了两种方案:接受奥拉帕利治疗与接受标准治疗(SoC)。该模型包含五种健康状态,纳入了OlympiA试验的临床结果,以及与早期BC治疗和后续治疗资源使用相关的直接医疗成本(2023年欧元)。对未来成本和生活质量结果应用3%的贴现率。进行了概率敏感性分析(PSA)。

结果

将奥拉帕利作为具有高复发风险的早期gBRCAm HER2neg BC患者的辅助治疗手段,可能会使激素受体阳性(HR)和三阴性(TN)患者的增量成本分别为44,273欧元和50,164欧元,质量调整生命年(QALY)分别改善1.14和1.28。因此,辅助使用奥拉帕利对于早期gBRCAm HER2neg BC可能具有成本效益,HR和TN患者的增量成本效益比分别为38,839欧元/QALY和39,084欧元/QALY。PSA结果显示,75.7%和82.2%的模拟结果低于60,000欧元/QALY的阈值。

结论

在西班牙,奥拉帕利作为辅助治疗手段对于早期HER2neg BC的gBRCAm患者可能具有成本效益。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5d03/11499548/e793789fbf04/41669_2024_518_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5d03/11499548/1e9ceab711ed/41669_2024_518_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5d03/11499548/e793789fbf04/41669_2024_518_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5d03/11499548/1e9ceab711ed/41669_2024_518_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5d03/11499548/e793789fbf04/41669_2024_518_Fig2_HTML.jpg

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本文引用的文献

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JAMA Netw Open. 2024 Jan 2;7(1):e2350067. doi: 10.1001/jamanetworkopen.2023.50067.
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Cost-Effectiveness Analysis of Adjuvant Olaparib Versus Watch and Wait in the Treatment of Germline BRCA1/2-Mutated, High-Risk, HER2-Negative Early Breast Cancer in Sweden.奥拉帕利辅助治疗与观察等待策略在瑞典治疗胚系BRCA1/2突变、高危、HER2阴性早期乳腺癌中的成本效益分析
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Cost-effectiveness analysis of abemaciclib with endocrine therapy (ET) versus ET alone for HR+, HER2-, node-positive, high-risk early breast cancer in Italy.在意大利,阿贝西利联合内分泌治疗(ET)与单纯内分泌治疗相比,用于HR +、HER2 -、淋巴结阳性、高危早期乳腺癌的成本效益分析。
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