评估五个高收入国家医药产品创新的定义和激励措施:系统文献综述。

IF 3.1 Q2 PHARMACOLOGY & PHARMACY
Naohiko Wakutsu, Emi Hirose, Naohiro Yonemoto, Sven Demiya
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引用次数: 1

摘要

背景:卫生保健创新的概念因组织和国家而异。统一创新的定义可以增加新疗法的发现,最大限度地降低成本,并简化药物开发和批准过程。通过系统的文献回顾(SLR),我们收集了美国、英国、法国、德国和日本不同创新要素的见解。SLR确定了已经定义了创新的研究,并抓住了为促进创新提供的激励类型。方法:于2020年10月22日通过OVID SP平台检索MEDLINE、Embase和EconLit数据库。进行二次桌面检索文献回顾,以确定对法语、德语和日语等地区语言感兴趣的附加信息。所有相关的英文文献都使用Linguamatics自然语言处理(NLP)工具进行筛选,除了EconLit的文章,这些文章使用结构化搜索策略进行人工筛选。描述创新定义或引用已发表的创新定义的文章被包括在内。所有的全文文章都是人工审查的,两位审稿人独立地筛选了全文的资格。结果:筛选后,90篇文章被认为符合单反目标。最常见的创新维度是将治疗效益作为创新的衡量标准,其次是创新的新颖性和新颖性。研究发现,在数据集中,围绕排他性的激励最为普遍,其次是奖励和奖金。在不同的治疗领域中,最多的创新是针对肿瘤的。结论:该SLR突出了五个国家的监管当局和卫生技术评估机构对创新缺乏统一的定义,以及与创新相关的激励类型存在差异。目标国家涵盖不同层面的定义和创新激励的不同方面,少数国家侧重于具体的治疗领域。各国需要在创新方面达成协调和共识,因为药物开发是一项全球性的事业。该SLR设想了一种更全面的评估方法,其中考虑到为患者和卫生系统提供的价值。本次SLR的结果将有助于促进各国不同利益攸关方和决策者之间进行更广泛的讨论,以确定政策差距并制定促进药品创新的可持续战略。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Assessing Definitions and Incentives Adopted for Innovation for Pharmaceutical Products in Five High-Income Countries: A Systematic Literature Review.

Assessing Definitions and Incentives Adopted for Innovation for Pharmaceutical Products in Five High-Income Countries: A Systematic Literature Review.

Assessing Definitions and Incentives Adopted for Innovation for Pharmaceutical Products in Five High-Income Countries: A Systematic Literature Review.

Assessing Definitions and Incentives Adopted for Innovation for Pharmaceutical Products in Five High-Income Countries: A Systematic Literature Review.

Background: The concept of health care innovation varies across organizations and countries. Harmonizing the definitions of innovation can augment the discovery of new therapies, minimize costs, and streamline drug development and approval processes. A systematic literature review (SLR) was conducted to gather insights surrounding different elements of innovation in the USA, the UK, France, Germany, and Japan. The SLR identified studies that have defined innovation and captured the types of incentives provided to promote innovation.

Methods: The MEDLINE, Embase, and EconLit databases were searched via the OVID SP platform on October 22, 2020. A secondary desk search literature review was performed to identify additional information of interest in regional languages: French, German, and Japanese. All the relevant literature in English was screened using the Linguamatics natural language processing (NLP) tool, except for articles from EconLit, which were screened manually using structured search strategies. Articles that describe a definition of innovation or refer to a definition of innovation published were included. All full-text articles were reviewed manually, and two reviewers independently screened the full texts for eligibility.

Results: After screening, 90 articles were considered to meet the SLR objectives. The most common dimension of innovation identified was therapeutic benefit as a measure of innovation, followed by newness and novelty aspects of innovations. Incentives around exclusivities were found to be the most prevalent in the data set, followed by rewards and premiums. Among the different therapy areas, the largest number of innovations was targeted at oncology.

Conclusions: This SLR highlights the lack of a unified definition of innovation among regulatory authorities and health technology assessment bodies in five countries, and variation in the types of incentives associated with innovation. The targeted countries cover different dimensions of definition and incentives of innovation at varying levels, with a few focused on specific therapy areas. Harmonization and consensus for innovation would be needed across countries because drug development is a global undertaking. This SLR envisages a more holistic approach to evaluation, wherein the value provided to patients and health systems is accounted for. The results of this SLR will help to promote broader discussion among different stakeholders and decision makers across countries to identify gaps in policies and develop sustainable strategies to promote innovation for pharmaceutical products.

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来源期刊
Pharmaceutical Medicine
Pharmaceutical Medicine PHARMACOLOGY & PHARMACY-
CiteScore
5.10
自引率
4.00%
发文量
36
期刊介绍: Pharmaceutical Medicine is a specialist discipline concerned with medical aspects of the discovery, development, evaluation, registration, regulation, monitoring, marketing, distribution and pricing of medicines, drug-device and drug-diagnostic combinations. The Journal disseminates information to support the community of professionals working in these highly inter-related functions. Key areas include translational medicine, clinical trial design, pharmacovigilance, clinical toxicology, drug regulation, clinical pharmacology, biostatistics and pharmacoeconomics. The Journal includes:Overviews of contentious or emerging issues.Comprehensive narrative reviews that provide an authoritative source of information on topical issues.Systematic reviews that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by PRISMA statement.Original research articles reporting the results of well-designed studies with a strong link to wider areas of clinical research.Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Pharmaceutical Medicine may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.All manuscripts are subject to peer review by international experts. Letters to the Editor are welcomed and will be considered for publication.
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