Background

Technologies used in the processing of whole blood and blood component products, including pathogen reduction, are continuously being adopted into blood transfusion workflows to improve process efficiencies. However, the economic implications of these technologies are not well understood. With the advent of these new technologies and regulatory guidance on bacterial risk-control strategies, an updated systematic literature review on this topic was warranted.

Objective

The objective of this systematic literature review was to summarize the current literature on the economic analyses of pathogen-reduction technologies (PRTs).

Methods

A systematic literature review was conducted using the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis) guidelines to identify newly published articles in PubMed, MEDLINE Complete, and EconLit from 1 January 2000 to 17 July 2019 related to economic evaluations of PRTs. Only full-text studies in humans published in English were included in the review. Both budget-impact and cost-effectiveness studies were included; common outcomes included cost, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs).

Results

The initial searches identified 433 original abstracts, of which 16 articles were included in the final data extraction and reporting. Seven articles presented cost-effectiveness analyses and nine assessed budget impact. The introduction of PRT increased overall costs, and ICER values ranged widely across cost-effectiveness studies, from below $US150,000/QALY to upwards of $US20,000,000/QALY. This wide range of results was due to a multitude of factors, including comparator selection, target patient population, and scenario analyses included.

Conclusions

Overall, the results of economic evaluations of bacterial risk-control strategies, regardless of mechanism, were highly dependent on the current screening protocols in place. The optimization of blood transfusion safety may not result in decisions made at the willingness-to-pay thresholds commonly seen in pharmaceutical evaluations. Given the critical public health role of blood products, and the potential safety benefits introduced by advancements, it is important to continue building this body of evidence with more transparency and data source heterogeneity. This updated literature review provides global context when making local decisions for the coverage of new and emerging bacterial risk-control strategies.

中文翻译：

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输血中病原体减少技术的经济分析：系统文献综述

背景

用于处理全血和血液成分产品的技术（包括病原体减少）不断被用于输血工作流程，以提高流程效率。然而，这些技术的经济影响尚不清楚。随着这些新技术和有关细菌风险控制策略的监管指南的出现，有必要对这一主题进行更新的系统文献综述。

客观的

本系统文献综述的目的是总结当前有关病原体减少技术 (PRT) 经济分析的文献。

方法

使用 PRISMA（系统评价和元分析的首选报告项目）指南进行了系统文献回顾，以确定 2000 年 1 月 1 日至 2019 年 7 月 17 日在 PubMed、MEDLINE Complete 和 EconLit 上发表的与 PRT 经济评估相关的新文章。该评价仅包括以英文发表的人类全文研究。预算影响和成本效益研究都包括在内；常见结果包括成本、质量调整生命年 (QALY) 和增量成本效益比 (ICER)。

结果

初步搜索确定了 433 篇原始摘要，其中 16 篇文章被纳入最终数据提取和报告。七篇文章介绍了成本效益分析和九篇评估的预算影响。PRT 的引入增加了总体成本，并且 ICER 值在成本效益研究中的范围很广，从低于 150,000 美元/QALY 到高于 20,000,000 美元/QALY。如此广泛的结果是由于多种因素造成的，包括比较选择、目标患者人群和情景分析。

结论

总体而言，无论机制如何，细菌风险控制策略的经济评估结果都高度依赖于当前的筛选方案。输血安全的优化可能不会导致在药物评估中常见的支付意愿阈值下做出决定。鉴于血液制品对公共健康的重要作用，以及进步带来的潜在安全益处，重要的是继续建立具有更高透明度和数据源异质性的证据体系。在为新的和新兴的细菌风险控制策略的覆盖范围做出本地决策时，此更新的文献综述提供了全球背景。