CELL INTELLIGENCE · 肿瘤细胞治疗研究

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.