Center for Health Outcomes, Policy, and Economics, Rutgers University, 160 Frelinghuysen Road, Suite 417, Piscataway, NJ, 08854, USA.
Center for Health Outcomes, Policy, and Economics, Rutgers University, 160 Frelinghuysen Road, Piscataway, NJ, 08854, USA.
Appl Health Econ Health Policy. 2021 Jul;19(4):487-499. doi: 10.1007/s40258-020-00612-6. Epub 2021 Feb 8.
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.
The objective of this systematic literature review was to summarize the current literature on the economic analyses of pathogen-reduction technologies (PRTs).
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).
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.
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.
全血和血液成分产品处理中使用的技术，包括病原体减少技术，正在不断被纳入输血工作流程，以提高处理效率。然而，这些技术的经济意义尚不清楚。随着这些新技术的出现以及关于细菌风险控制策略的监管指导意见的出现，有必要对这一主题进行更新的系统文献回顾。
本系统文献回顾的目的是总结目前关于病原体减少技术（PRT）经济分析的文献。
使用 PRISMA（系统评价和荟萃分析的首选报告项目）指南进行系统文献回顾，以确定从 2000 年 1 月 1 日至 2019 年 7 月 17 日在 PubMed、MEDLINE Complete 和 EconLit 中发表的与 PRT 经济评估相关的新发表文章。本综述仅纳入了以人类为研究对象、以英文发表的全文研究。包括预算影响和成本效益研究；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）。
最初的搜索确定了 433 篇原始摘要，其中 16 篇文章被纳入最终的数据提取和报告。7 篇文章报告了成本效益分析，9 篇评估了预算影响。PRT 的引入增加了总体成本，成本效益研究中的 ICER 值差异很大，从低于 150000 美元/QALY 到 20000000 美元/QALY 以上。结果的这种广泛差异是由于多种因素造成的，包括对照选择、目标患者人群以及包括的情景分析。
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高度依赖于当前的筛选方案。优化输血安全可能不会导致在制药评估中常见的支付意愿阈值下做出决策。鉴于血液制品的重要公共卫生作用以及新出现的风险控制策略带来的潜在安全益处，重要的是继续以更高的透明度和数据来源异质性来建立这一证据体系。本更新的文献综述在为新出现的细菌风险控制策略的覆盖范围做出本地决策时提供了全球背景。
