Background The rising incidence of resistance to currently available antibiotics among pathogens, particularly Gram-negative pathogens, in complicated intra-abdominal infections (cIAIs) has become a challenge for clinicians. Ceftazidime/avibactam (CAZ-AVI) is a fixed-dose antibiotic approved in Europe and the United States for treating (in combination with metronidazole) cIAI in adult hospitalised patients who have limited or no alternative treatment options. The approval was based on the results of RECLAIM, a Phase III, parallel-group, comparative study (RECLAIM 1 [NCT01499290] and RECLAIM 2 [NCT01500239]). The objective of our study was to assess the cost-effectiveness of CAZ-AVI plus metronidazole compared with 1) ceftolozane/tazobactam plus metronidazole and 2) meropenem, as an empiric treatment for the management of cIAI in Italy. Methods A sequential, patient-level simulation model, with a 5-year time horizon and 3% annual discount rate (applied to both costs and health benefits), was developed using Microsoft Excel® to demonstrate the clinical course of the disease. The impact of resistant pathogens was included as an additional factor. Results In the base-case analysis, the CAZ-AVI sequence (CAZ-AVI plus metronidazole followed by a colistin + tigecycline + high-dose meropenem combination after treatment failure), when compared to sequences for ceftolozane/tazobactam (ceftolozane/tazobactam plus metronidazole followed by colistin + tigecycline + high-dose meropenem after treatment failure) and meropenem (meropenem followed by colistin + tigecycline + high-dose meropenem after treatment failure), had better clinical outcomes with higher cure rates (93.04% vs. 91.52%; 92.98% vs. 90.24%, respectively), shorter hospital stays (∆ = - 0.38 and ∆ = - 1.24 days per patient, respectively), and higher quality-adjusted life years (QALYs) gained per patient (4.021 vs. 3.982; 4.019 vs. 3.960, respectively). The incremental cost effectiveness ratio in the CAZ-AVI sequence was €4099 and €15,574 per QALY gained versus each comparator sequence, respectively, well below the willingness-to-pay threshold of €30,000 per QALY accepted in Italy. Conclusions The model results demonstrated that CAZ-AVI plus metronidazole could be a cost-effective alternative when compared with other antibiotic treatment options, as it is expected to provide better clinical benefits in hospitalised patients with cIAI in Italy.

中文翻译：

---

成本效益分析比较头孢他啶/ avibactam（CAZ-AVI）作为经验治疗与头孢洛赞/他唑巴坦和美罗培南比较，用于复杂的腹腔内感染（cIAI）。

背景技术在复杂的腹腔内感染（cIAI）中，病原体，特别是革兰氏阴性病原体对当前可用抗生素的抗药性上升的趋势已成为临床医生的挑战。头孢他啶/ avibactam（CAZ-AVI）是在欧洲和美国批准的固定剂量抗生素，用于治疗（或与甲硝唑联用）成年住院患者，其替代治疗选择有限或无替代治疗。该批准是基于RECLAIM的结果，该研究是一项III期平行组比较研究（RECLAIM 1 [NCT01499290]和RECLAIM 2 [NCT01500239]）。我们研究的目的是评估CAZ-AVI加甲硝唑与1）头孢洛赞/他唑巴坦加甲硝唑和2）美罗培南作为意大利cIAI管理的经验性治疗的成本效益。方法使用MicrosoftExcel®开发了具有5年时间跨度和3％年度贴现率（适用于成本和健康收益）的连续患者水平模拟模型，以证明该疾病的临床过程。抗药性病原体的影响被包括在内。结果在基础病例分析中，与头孢洛赞/他唑巴坦（头孢洛赞/他唑巴坦加甲硝唑的序列）相比，CAZ-AVI序列（CAZ-AVI加甲硝唑，然后是大肠菌素+ tigecycline +大剂量美罗培南组合）其次是大肠杆菌素+替加环素+大剂量美罗培南治疗失败后和美罗培南（美洛培南，然后是大肠杆菌素+替加环素+大剂量美罗培南治疗失败后），具有更好的临床疗效，治愈率更高（93.04％vs. 91.52％; 92） 。每位患者住院时间较短（分别为98％和90.24％）（每位患者分别为∆ =-0.38和∆ =-1.24天），每位患者获得的质量调整生命年（QALYs）更高（4.021 vs. 3.982; 4.019分别为3.960）。与每个比较器序列相比，CAZ-AVI序列中每个QALY获得的增量成本效益比分别为4099欧元和15574欧元，远低于意大利接受的每个QALY支付意愿阈值30,000欧元。结论该模型结果表明，与其他抗生素治疗方案相比，CAZ-AVI加甲硝唑可能是一种具有成本效益的替代方案，因为它有望为意大利的cIAI住院患者提供更好的临床益处。每位患者获得更高的质量调整生命年（QALYs）（分别为4.021对3.982； 4.019对3.960）。与每个比较序列相比，CAZ-AVI序列中每QALY获得的增量成本效益比分别为4099欧元和15574欧元，远低于意大利接受的每QALY支付意愿阈值30,000欧元。结论该模型结果表明，与其他抗生素治疗方案相比，CAZ-AVI加甲硝唑可能是一种具有成本效益的替代方案，因为它有望为意大利的cIAI住院患者提供更好的临床益处。每位患者获得更高的质量调整生命年（QALYs）（分别为4.021对3.982； 4.019对3.960）。与每个比较器序列相比，CAZ-AVI序列中每个QALY获得的增量成本效益比分别为4099欧元和15574欧元，远低于意大利接受的每个QALY支付意愿阈值30,000欧元。结论该模型结果表明，与其他抗生素治疗方案相比，CAZ-AVI加甲硝唑可能是一种具有成本效益的替代方案，因为有望在意大利的cIAI住院患者中提供更好的临床益处。分别低于意大利接受的每QALY 30,000欧元的支付意愿门槛。结论该模型结果表明，与其他抗生素治疗方案相比，CAZ-AVI加甲硝唑可能是一种具有成本效益的替代方案，因为它有望为意大利的cIAI住院患者提供更好的临床益处。分别远低于意大利接受的每QALY 30,000欧元的支付意愿门槛。结论该模型结果表明，与其他抗生素治疗方案相比，CAZ-AVI加甲硝唑可能是一种具有成本效益的替代方案，因为有望在意大利的cIAI住院患者中提供更好的临床益处。