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基于抗体的预防呼吸道合胞病毒替代方案的评估:一种新的多标准决策分析框架和尼司特单抗在西班牙的评估。

Evaluation of antibody-based preventive alternatives for respiratory syncytial virus: a novel multi-criteria decision analysis framework and assessment of nirsevimab in Spain.

机构信息

Department of Economics, University Carlos III, Madrid, Spain.

Department of Management, Bioregión de Salud y Bienestar (BioMad), Madrid, Spain.

出版信息

BMC Infect Dis. 2024 Jan 18;24(1):99. doi: 10.1186/s12879-024-08988-9.

Abstract

BACKGROUND

Respiratory syncytial virus (RSV) is a highly infectious disease that poses a significant clinical and medical burden, as well as social disruption and economic costs, recognized by the World Health Organization as a public health issue. After several failed attempts to find preventive candidates (compounds, products, including vaccines), new alternatives might be available, one being nirsevimab, the first and only option approved for RSV prevention in neonates and infants during their first RSV season. The objective of this study was to develop a novel multi-criteria decision analysis (MCDA) framework for RSV antibody-based preventive alternatives and to use it to assess the value of nirsevimab vs. placebo as a systematic immunization approach to prevent RSV in neonates and infants during their first RSV season in Spain.

METHODS

Based on a pre-established model called Vaccinex, an ad-hoc MCDA framework was created to reflect relevant attributes for the assessment of current and future antibody-based preventive measures for RSV. The estimated value of nirsevimab was obtained by means of an additive linear model combining weights and scores assigned by a multidisciplinary committee of 9 experts. A retest and three sensitivity analyses were conducted.

RESULTS

Nirsevimab was evaluated through a novel framework with 26 criteria by the committee as a measure that adds value (positive final estimated value: 0.56 ± 0.11) to the current RSV scenario in Spain, by providing a high efficacy for prevention of neonates and infants. In addition, its implementation might generate cost savings in hospitalizations and to the healthcare system and increase the level of public health awareness among the general population, while reducing health inequities.

CONCLUSIONS

Under a methodology with increasing use in the health field, nirsevimab has been evaluated as a measure which adds value for RSV prevention in neonates and infants during their first RSV season in Spain.

摘要

背景

呼吸道合胞病毒(RSV)是一种高度传染性疾病,对临床和医疗造成重大负担,对社会造成干扰并产生经济成本,世界卫生组织已将其视为公共卫生问题。在寻找预防候选药物(化合物、产品,包括疫苗)的多次尝试失败后,可能会出现新的替代药物,其中之一是 nirsevimab,这是唯一一种被批准用于预防新生儿和婴儿在首个 RSV 季节 RSV 的药物。本研究旨在为 RSV 抗体预防替代品开发一种新的多标准决策分析(MCDA)框架,并使用该框架评估 nirsevimab 相对于安慰剂作为预防 RSV 的系统免疫接种方法在西班牙新生儿和婴儿在其首个 RSV 季节中的价值。

方法

基于称为 Vaccinex 的预先建立的模型,创建了一个特定的 MCDA 框架,以反映评估当前和未来 RSV 抗体预防措施的相关属性。通过对 9 位多学科专家组成的委员会分配的权重和分数进行加性线性模型,计算 nirsevimab 的估计值。进行了复测和三次敏感性分析。

结果

委员会通过一个新的框架对 nirsevimab 进行了评估,该框架包含 26 个标准,被评估为在西班牙目前的 RSV 情况下增加价值(最终估计的阳性价值:0.56±0.11)的措施,通过为预防新生儿和婴儿提供高功效。此外,它的实施可能会节省住院和医疗保健系统的成本,并提高普通民众对公共卫生的认识水平,同时减少健康不平等。

结论

在卫生领域越来越多地使用的方法学下,nirsevimab 被评估为在西班牙新生儿和婴儿在其首个 RSV 季节中预防 RSV 的增加价值的措施。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ac19/10797756/c16e3bac8182/12879_2024_8988_Fig1_HTML.jpg

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