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卫生技术评估中间接治疗比较的选择:卫生经济学与结果研究科学家及临床医生实用指南

Selection of indirect treatment comparisons for health technology assessments: a practical guide for health economics and outcomes research scientists and clinicians.

作者信息

Guo Jennifer D, Gehchan Adel, Hartzema Abraham

机构信息

3ARx Solutions LLC, Boston, Massachusetts, USA

3ARx Solutions LLC, Boston, Massachusetts, USA.

出版信息

BMJ Open. 2025 Mar 25;15(3):e091961. doi: 10.1136/bmjopen-2024-091961.

DOI:10.1136/bmjopen-2024-091961
PMID:40132816
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11938225/
Abstract

BACKGROUND

Health technology assessment (HTA) bodies evaluate the clinical and economic values of health interventions to inform healthcare decision-making. They face the challenge of lacking head-to-head randomised clinical trial data against the standard of care. Indirect treatment comparison (ITC) methods are often used and accepted by HTA bodies worldwide, but there are numerous options with various and inconsistent terminologies. The selection and application of ITC methods are complex from methodological and clinical perspectives.

OBJECTIVES

This article (1) provides a comprehensive overview of ITC methods by clarifying used terminologies, including fundamental assumptions, frameworks, strengths, limitations, applications and specific considerations; (2) examines recent ITC guidelines with recommendations or preferences from major HTA bodies and (3) guides health economics and outcomes research (HEOR) scientists and clinicians in the strategic selection of ITC methods with case examples.

METHODS

The authors conducted a rapid review to identify the literature related to ITC methods and ITC-relevant HTA guidelines in various databases between 2009 and April 2024.

CONCLUSIONS

Comprehensive knowledge of the ITC methods landscape and the evolving ITC-relevant HTA guidelines are essential for ITC methods selection. Effective communication/collaboration between HEOR scientists and clinicians ensures that the selection and justification of ITC methods are robust for HTA submissions.

摘要

背景

卫生技术评估(HTA)机构评估卫生干预措施的临床和经济价值,以为医疗决策提供依据。它们面临着缺乏与标准治疗进行直接头对头随机临床试验数据的挑战。间接治疗比较(ITC)方法经常被全球HTA机构使用和接受,但有众多选择且术语多样且不一致。从方法学和临床角度来看,ITC方法的选择和应用都很复杂。

目的

本文(1)通过澄清所用术语,全面概述ITC方法,包括基本假设、框架、优势、局限性、应用和具体注意事项;(2)审查主要HTA机构最近的ITC指南及其建议或偏好;(3)通过案例引导卫生经济学与结果研究(HEOR)科学家和临床医生在战略上选择ITC方法。

方法

作者进行了快速回顾,以识别2009年至2024年4月期间各数据库中与ITC方法及与ITC相关的HTA指南相关的文献。

结论

全面了解ITC方法概况以及不断演变的与ITC相关的HTA指南对于选择ITC方法至关重要。HEOR科学家与临床医生之间的有效沟通/协作可确保ITC方法的选择和理由在提交给HTA时是有力的。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7940/11938225/e8c57e44e5d6/bmjopen-15-3-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7940/11938225/7001cb8f33dd/bmjopen-15-3-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7940/11938225/e8c57e44e5d6/bmjopen-15-3-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7940/11938225/7001cb8f33dd/bmjopen-15-3-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7940/11938225/e8c57e44e5d6/bmjopen-15-3-g002.jpg

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The Acceptance of Indirect Treatment Comparison Methods in Oncology by Health Technology Assessment Agencies in England, France, Germany, Italy, and Spain.英国、法国、德国、意大利和西班牙的卫生技术评估机构对肿瘤学中间接治疗比较方法的接受情况。
Pharmacoecon Open. 2024 Jan;8(1):5-18. doi: 10.1007/s41669-023-00455-6. Epub 2023 Dec 14.
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