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一项关于白蛋白结合型紫杉醇(纳米白蛋白紫杉醇)联合吉西他滨与单用吉西他滨治疗转移性胰腺癌患者的意大利成本效益分析:APICE研究

An Italian cost-effectiveness analysis of paclitaxel albumin (nab-paclitaxel) + gemcitabine vs gemcitabine alone for metastatic pancreatic cancer patients: the APICE study.

作者信息

Lazzaro Carlo, Barone Carlo, Caprioni Francesco, Cascinu Stefano, Falcone Alfredo, Maiello Evaristo, Milella Michele, Pinto Carmine, Reni Michele, Tortora Giampaolo

机构信息

a Studio di Economia Sanitaria , Milan , Italy.

b Policlinico Gemelli , Rome , Italy.

出版信息

Expert Rev Pharmacoecon Outcomes Res. 2018 Aug;18(4):435-446. doi: 10.1080/14737167.2018.1464394. Epub 2018 Apr 20.

DOI:10.1080/14737167.2018.1464394
PMID:29641931
Abstract

BACKGROUND

the APICE study evaluates the cost-effectiveness of nanoparticle albumin-bound paclitaxel (nab-paclitaxel - Nab-P) + gemcitabine (G) vs G alone in metastatic pancreatic cancer (MPC) from the Italian National Health Service (INHS) standpoint.

RESEARCH DESIGN AND METHODS

A 4-year, 4 health states (progression-free; progressed; end of life; death) Markov model based on the MPACT trial was developed to estimate costs (Euro [€], 2017 values), and quality-adjusted life years (QALYs). Patients were assumed to receive intravenously Nab-P 125 mg/m + G 1000 mg/m on days 1, 8, and 15 every 4 weeks or G alone 1000 mg/m weekly for 7 out of 8 weeks (cycle 1) and then on days 1, 8, and 15 every 4 weeks (cycle 2 and subsequent cycles) until progression. One-way and probabilistic sensitivity analyses explored the uncertainty surrounding the baseline incremental cost-utility ratio (ICUR).

RESULTS

Nab-P + G totals 0.154 incremental QALYs and €7082.68 incremental costs vs G alone. ICUR (€46,021.58) is lower than the informal threshold value of €87,330 adopted by the Italian Medicines Agency during 2010-2013 for reimbursing oncological drugs. Sensitivity analyses confirmed the robustness of the baseline findings.

CONCLUSIONS

Nab-P + G in MPC patients can be considered cost-effective for the INHS.

摘要

背景

APICE研究从意大利国家医疗服务体系(INHS)的角度评估了纳米白蛋白结合型紫杉醇(nab - 紫杉醇 - Nab - P)+吉西他滨(G)与单独使用G相比在转移性胰腺癌(MPC)中的成本效益。

研究设计与方法

基于MPACT试验开发了一个为期4年、具有4种健康状态(无进展;进展;生命末期;死亡)的马尔可夫模型,以估算成本(欧元[€],2017年价值)和质量调整生命年(QALYs)。假设患者每4周的第1、8和15天静脉注射Nab - P 125mg/m² + G 1000mg/m²,或单独使用G,第1周期8周中的7周每周1000mg/m²,然后每4周的第1、8和15天(第2周期及后续周期),直至疾病进展。单向和概率敏感性分析探讨了基线增量成本效用比(ICUR)周围的不确定性。

结果

与单独使用G相比,Nab - P + G的增量QALYs总计为0.154,增量成本为7082.68欧元。ICUR(46,021.58欧元)低于意大利药品管理局在2010 - 2013年期间采用的用于报销肿瘤药物的87,330欧元的非正式阈值。敏感性分析证实了基线结果的稳健性。

结论

对于INHS而言,MPC患者使用Nab - P + G可被认为具有成本效益。

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