常用人类细胞和组织产品治疗糖尿病足溃疡的成本效益分析。

Cost effectiveness analysis for commonly used human cell and tissue products in the management of diabetic foot ulcers.

作者信息

Nherera Leo M, Banerjee Jaideep

机构信息

Global Market Access; Smith + Nephew 5600 Clearfork Main St Fort Worth 76107 TX USA.

Medical Science Liaisons and Clinical Strategy Global Clinical Affairs, R&D 5600 Clearfork Main St Fort Worth 76107 TX USA.

出版信息

Health Sci Rep. 2024 Mar 22;7(3):e1991. doi: 10.1002/hsr2.1991. eCollection 2024 Mar.

DOI:10.1002/hsr2.1991

PMID:38524772

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10958527/

Abstract

BACKGROUND AND AIMS

This study considers the cost-effectiveness of commonly used cellular, acellular, and matrix‑like products (CAMPs) of human origin also known as human cell and tissue products (HCT/Ps) in the management of diabetic foot ulcers.

METHODS

We developed a 1-year economic model assessing six CAMPs [cryopreserved placental membrane with viable cells (vCPM), bioengineered bilayered living cellular construct (BLCC), human fibroblast dermal substitute (hFDS), dehydrated human amnion chorion membrane (dHACM), hypothermically stored amniotic membrane (HSAM) and human amnion membrane allograft (HAMA) which had randomized controlled trial evidence compared with standard of care (SoC). CAMPs were compared indirectly and ranked in order of cost-effectiveness using SoC as the baseline, from a CMS/Medicare's perspective.

RESULTS

The mean cost, healed wounds (hw) and QALYs per patient for vCPM is $10,907 (0.914 hw, 0.783 QALYs), for HAMA $11,470 (0.903 hw, 0.780 QALYs), for dHACM $15,862 (0.828 hw, 0.764 QALYs), for BLCC $18,430 (0.816 hw, 0.763 QALYs), for hFDS $19,498 (0.775 hw, 0.757 QALYs), for SoC $19,862 (0.601 hw, 0.732 QALYs) and $24, 214 (0.829, 0.763 QALYs) for HSAM respectively. Over 1 year, vCPM results in cheaper costs overall and better clinical outcomes compared to other CAMPs. Following probabilistic sensitivity analysis, vCPM has a 60%, HAMA 40% probability of being cost-effective then dHACM, hFDS, BLCC, and lastly HSAM using a $100,000/healed wound or QALY threshold.

CONCLUSIONS

All CAMPs were shown to be cost-effective when compared to SoC in managing DFUs. However, vCPM appears to be the most cost-effective CAMP over the modelled 52 weeks followed by HAMA, dHACM, hFDS, BLCC, and HSAM. We urge caution in interpreting the results because we currently lack head-to-head evidence comparing all these CAMPs and therefore suggest that this analysis be updated when more direct evidence of CAMPs becomes available.

摘要

背景与目的

本研究探讨了常用于治疗糖尿病足溃疡的人源细胞、无细胞和基质样产品（CAMPs），即人细胞和组织产品（HCT/Ps）的成本效益。

方法

我们建立了一个为期1年的经济模型，评估六种CAMPs[带活细胞的冷冻保存胎盘膜（vCPM）、生物工程双层活细胞构建体（BLCC）、人成纤维细胞真皮替代物（hFDS）、脱水人羊膜绒毛膜（dHACM）、低温保存羊膜（HSAM）和人羊膜同种异体移植（HAMA）]，这些产品与标准治疗（SoC）相比有随机对照试验证据。从医疗保险和医疗补助服务中心（CMS）/医疗保险的角度出发，以SoC为基线，对CAMPs进行间接比较并按成本效益排序。

结果

vCPM每位患者的平均成本、愈合伤口数（hw）和质量调整生命年（QALYs）分别为10,907美元（0.914 hw，0.783 QALYs），HAMA为11,470美元（0.903 hw，0.780 QALYs），dHACM为15,862美元（0.828 hw，0.764 QALYs），BLCC为18,430美元（0.816 hw，0.763 QALYs），hFDS为19,498美元（0.775 hw，0.757 QALYs），SoC为19,862美元（0.601 hw，0.732 QALYs），HSAM为24,214美元（0.829，0.763 QALYs）。在1年时间里，与其他CAMPs相比，vCPM总体成本更低，临床结果更好。经过概率敏感性分析，使用100,000美元/愈合伤口或QALY阈值时，vCPM具有成本效益的概率为60%，HAMA为40%，然后是dHACM、hFDS、BLCC，最后是HSAM。

结论

与SoC相比，所有CAMPs在治疗糖尿病足溃疡方面均具有成本效益。然而，在模拟的52周内，vCPM似乎是最具成本效益的CAMPs，其次是HAMA、dHACM、hFDS、BLCC和HSAM。我们敦促在解释结果时谨慎，因为我们目前缺乏比较所有这些CAMPs的直接证据，因此建议在有更多CAMPs的直接证据时更新此分析。