临床试验证实了在高危HER2阳性早期乳腺癌（HER2+BC）的（新）辅助设定中，添加帕珠单抗（P）到曲妥珠单抗化疗（TC）的组合疗法具有益处。我们在意大利评估了添加帕珠单抗到新辅助曲妥珠单抗化疗（TPC）的临床、经济和社会影响。通过开发一个基于队列的多状态Markov模型来比较TPC和TC，进行成本效益分析，以估计HER2+BC高复发风险患者新辅助治疗的临床、社会和经济影响。该模型采用1个月为周期长度，时间范围为5年。我们使用基于文献回顾的数据填充了该模型。估计了以下临床和经济结果：原位局部/远处复发的累积发生率，生命年和QALY，以及直接和间接成本（€）。最后，我们进行了敏感性分析。TPC与直接成本节约75,630 €相关。具体而言，它与治疗成本的初始增加（+4.8%）相关，随后出现了复发管理成本的降低（-20.4%）。TPC还与间接成本的降低（1.40%），远处复发的发生率的降低（-20.14%），工作失误天数的减少（-1.53%）和伴有残疾的生活天数的减少（-0.50%）相关。此外，与TC相比，TPC报告了10.47个QALY的增益（+2.77%）。在敏感性分析中，达到病理完全缓解（pCR）的概率是最影响结果的参数。我们的研究结果表明，对于存在高复发风险的HER2+BC患者，TPC组合可能是一种节省费用的选择。版权所有©2023该作者。由Elsevier Ltd发表。保留所有权利。

Clinical trials confirmed the beneficial effects of adding pertuzumab (P) to the combination of trastuzumab-chemotherapy (TC) in the (neo)adjuvant setting of high-risk HER2-positive early breast cancer (HER2+BC). We evaluated the clinical, economic and societal impact of adding pertuzumab to neoadjuvant TC combination (TPC) in Italy.A cost-consequence analysis comparing TPC vs. TC was performed developing a cohort-based multi-state Markov model to estimate the clinical, societal and economic impact of the neoadjuvant therapy of TPC versus TC in HER2+BC at high-risk of recurrence. The model works on a cycle length of 1 month and 5-years-time horizon. Literature review-based data were used to populate the model. The following clinical and economic outcomes were estimated: cumulative incidence of loco-regional/distant recurrences, life of years and QALY and both direct and indirect costs (€). Finally, sensitivity analyses were performed.TPC was associated with a 75,630 € saved of direct costs. Specifically, it was associated with an initial increase of treatment costs (+4.8%) followed by reduction of recurrence management cost (-20.4%). TPC was also associated with an indirect cost reduction of 1.40%, as well as decreased incidence of distant recurrence (-20.14%), days of work lost (-1.53%) and days lived with disability (-0.50%). Furthermore, TPC reported 10,47 QALY gained (+2.77%) compared to TC. The probability to achieve the pathological complete response (pCR) was the parameter that mostly affected the results in the sensitivity analysis.Our findings suggested that TPC combination could be a cost-saving option in patients with HER2+BC at high-risk of recurrence.Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.