Xiang Zuojuan, Ma Ling, Li Zhengxiong, Fu Yingzhou, Pan Yong
Department of Pharmacy, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Hunan Cancer Hospital, Changsha, China.
Department of Clinical pharmacy, The First People's Hospital of Yunnan Province, The Affiliated Hospital of Kunming University of Science and Technology, Kunming, China.
Front Pharmacol. 2024 Dec 20;15:1488645. doi: 10.3389/fphar.2024.1488645. eCollection 2024.
The phase III NAPOLI-3 trial, which upgraded FOLFIRINOX (leucovorin, fluorouracil, irinotecan and oxaliplatin) to NALIRIFOX (liposomal irinotecan, oxaliplatin, leucovorin, and fluorouracil), demonstrated the superiority of NALIRIFOX over GEMNABP (gemcitabine and nab-paclitaxel) as the first-line treatment for metastatic pancreatic ductal adenocarcinoma. The purpose of this study was to assess the cost-effectiveness of NALIRIFOX, FOLFIRINOX, and GEMNABP, and to simulate the price of liposomal irinotecan at which NALIRIFOX could achieve cost-effectiveness.
A partitioned survival model was performed to evaluate the cost-effectiveness of NALIRIFOX, FOLFIRINOX and GEMNABP from the perspective of the Chinese healthcare system. Survival data was obtained from a recently published network meta-analysis (NMA). Drug prices were collected from the database of the Hunan Province Drug and Medical Consumables Procurement Management Subsystem. Other cost and utility values were sourced from established literature. Cumulative costs, LYs (life-years), quality-adjusted life years (QALYs), incremental cost-effectiveness ratios (ICERs), net monetary benefits (NMBs) and incremental net monetary benefits (INMBs) were the main outputs. Furthermore, the variations in ICER were analyzed as the price of liposomal irinotecan gradually decreased when comparing NALIRIFOX with FOLFIRINOX or GEMNABP. The robustness of the model was assessed by sensitivity analysis and scenario analysis.
At the willingness-to-pay (WTP) threshold of $38,223.34, GEMNABP was the favored treatment. NALIRIFOX was associated with the highest LYs, QALYs, and cost. The cost-effectiveness of NALIRIFOX would be obtained if the price of liposomal irinotecan was less than $3.36/mg and $2.08/mg compared to FOLFIRINOX and GEMNABP, respectively, without considering the patient assistance program (PAP). Sensitivity analysis and scenario analysis revealed that the results of the model were stable.
From an economic standpoint, GEMNABP represents the favored choice in the prevailing market conditions among these three first-line combination chemotherapy regimens. The price simulation of liposomal irinotecan conducted in this study could provide valuable evidence for healthcare decision-making. Further evidence regarding the budget impact is still needed.
III期NAPOLI-3试验将FOLFIRINOX（亚叶酸钙、氟尿嘧啶、伊立替康和奥沙利铂）升级为NALIRIFOX（脂质体伊立替康、奥沙利铂、亚叶酸钙和氟尿嘧啶），证明了NALIRIFOX作为转移性胰腺导管腺癌一线治疗方案优于GEMNABP（吉西他滨和白蛋白结合型紫杉醇）。本研究的目的是评估NALIRIFOX、FOLFIRINOX和GEMNABP的成本效益，并模拟NALIRIFOX实现成本效益时脂质体伊立替康的价格。
采用分区生存模型，从中国医疗保健系统的角度评估NALIRIFOX、FOLFIRINOX和GEMNABP的成本效益。生存数据来自最近发表的网络荟萃分析（NMA）。药品价格从湖南省药品和医用耗材采购管理子系统数据库中收集。其他成本和效用值来自已发表的文献。主要输出指标包括累计成本、生命年（LYs）、质量调整生命年（QALYs）、增量成本效益比（ICERs）、净货币效益（NMBs）和增量净货币效益（INMBs）。此外，在比较NALIRIFOX与FOLFIRINOX或GEMNABP时，随着脂质体伊立替康价格逐渐降低，分析ICER的变化情况。通过敏感性分析和情景分析评估模型的稳健性。
在支付意愿（WTP）阈值为38,223.34美元时，GEMNABP是首选治疗方案。NALIRIFOX的生命年、质量调整生命年和成本最高。在不考虑患者援助计划（PAP）的情况下，如果脂质体伊立替康的价格分别低于FOLFIRINOX和GEMNABP的3.36美元/毫克和2.08美元/毫克，NALIRIFOX将具有成本效益。敏感性分析和情景分析表明，模型结果稳定。
从经济角度来看，在这三种一线联合化疗方案中，GEMNABP是当前市场条件下的首选。本研究中对脂质体伊立替康的价格模拟可为医疗保健决策提供有价值的证据。仍需要关于预算影响的进一步证据。
