Manufacturing cost analysis and exploratory economic evaluation of natural killer cell immunotherapy for paediatric solid tumors

IF 3.4 2区医学 Q2 IMMUNOLOGY

Clinical & Translational Immunology Pub Date : 2026-09-20 DOI:10.1002/cti2.70122

Sabera Tabassum Wahid, Melissa Elliott, Yufan Wang, Wayne Nicholls, Natacha Omer, Fernando Souza-Fonseca-Guimaraes, Haitham Tuffaha

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引用次数: 0

Abstract

Objectives

Natural killer (NK) cell therapy is a promising allogeneic, off-the-shelf immunotherapy for solid tumors, yet economic evidence to guide its clinical translation is absent. This study aimed to conduct a micro-costing analysis of their manufacturing and perform an exploratory economic evaluation of NK cell therapy for paediatric solid tumors from an Australian health system perspective.

Methods

A micro-costing analysis was conducted using primary laboratory production data across six manufacturing steps and categories. Hospitalisation costs were estimated by expert opinion. Effectiveness estimates were drawn from chimeric antigen receptor (CAR)-T cell therapy economic evaluations. Analyses included incremental cost-effectiveness ratios (ICERs), headroom analysis, net monetary benefit (NMB) and probabilistic sensitivity analysis.

Results

Manufacturing cost was AUD 58 681 (USD 38 143) per batch (AUD 9780; USD 6357 per dose). Eighty-eight per cent of costs were concentrated in three steps: NK cell expansion (50.8%), mRNA transfection (25.1%) and T-cell depletion (11.7%), with consumables/reagents comprising 85% of the total production cost. Combining manufacturing (AUD 58 681) and hospitalisation (AUD 75 000; USD 48 750) costs, the total NK cell therapy cost was AUD 133 681 (USD 86 893) per patient, yielding an illustrative ICER of AUD 35 167 (USD 22 859) per QALY gained, based on a proxy effectiveness estimate. Economic headroom was AUD 56 386 (USD 36 651) per patient. Probabilistic analysis showed 51.7% probability of cost-effectiveness at AUD 50 000/QALY, with a minimum of 2.67 QALYs required.

Conclusion

NK cell therapy shows indicative early economic signals warranting further clinical and economic investigation. Micro-costing identifies actionable manufacturing cost drivers to inform process optimisation, and these exploratory estimates provide a foundation for iterative economic evaluation as clinical evidence develops.

查看原文本刊更多论文

自然杀伤细胞免疫治疗小儿实体瘤的制造成本分析及探索性经济评价。

目的：自然杀伤（NK）细胞疗法是一种很有前途的同种异体、现成的实体肿瘤免疫疗法，但缺乏指导其临床转化的经济证据。本研究旨在对其制造进行微观成本分析，并从澳大利亚卫生系统的角度对儿童实体瘤的NK细胞治疗进行探索性经济评估。方法：微观成本分析进行了主要实验室生产数据跨越六个制造步骤和类别。住院费用是根据专家意见估计的。有效性评估来自嵌合抗原受体(CAR)-T细胞治疗的经济评估。分析包括增量成本-效果比（ICERs）、净额分析、净货币效益（NMB）和概率敏感性分析。结果：制造成本为每批58681澳元（38143美元）（9780澳元；6357美元/剂）。88%的成本集中在三个步骤：NK细胞扩增（50.8%）、mRNA转染（25.1%）和t细胞消耗（11.7%），耗材/试剂占总生产成本的85%。结合制造（58 681澳元）和住院（75 000澳元；48 750美元）成本，NK细胞治疗的总成本为每位患者133 681澳元（86 893美元），根据代理有效性估计，每个QALY获得的解释性ICER为35 167澳元（22 859美元）。每位患者的经济净额为56 386澳元（36 651美元）。概率分析显示，5万澳元/QALY的成本效益概率为51.7%，至少需要2.67个QALY。结论：NK细胞治疗显示出指示性的早期经济信号，值得进一步的临床和经济研究。微观成本确定了可操作的制造成本驱动因素，为流程优化提供信息，这些探索性估计为临床证据的发展提供了迭代经济评估的基础。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Clinical & Translational Immunology Medicine-Immunology and Allergy

CiteScore

12.00

自引率

1.70%

发文量

审稿时长

13 weeks

期刊介绍： Clinical & Translational Immunology is an open access, fully peer-reviewed journal devoted to publishing cutting-edge advances in biomedical research for scientists and physicians. The Journal covers fields including cancer biology, cardiovascular research, gene therapy, immunology, vaccine development and disease pathogenesis and therapy at the earliest phases of investigation.