Improving Interactions Between Health Technology Assessment Bodies and Regulatory Agencies: A Systematic Review and Cross-Sectional Survey on Processes, Progress, Outcomes, and Challenges.
Improving Interactions Between Health Technology Assessment Bodies and Regulatory Agencies: A Systematic Review and Cross-Sectional Survey on Processes, Progress, Outcomes, and Challenges.
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DOI：
10.3389/fmed.2020.582634
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发表时间：
2020
影响因子：
3.9
通讯作者：
De Bruin ML
中科院分区：
文献类型：
--
作者：
Ofori-Asenso R;Hallgreen CE;De Bruin ML
优化药物开发和促进患者更快获得药物的必要性引发了围绕改善卫生技术评估机构与监管机构之间互动重要性的讨论。在本研究中，我们进行了系统回顾，以检查HTA机构和监管机构之间协调/互动倡议的过程、进展、结果和挑战。截至2019年10月21日，检索了MEDLINE、EMBASE和国际药物摘要数据库。搜索灰色文献（工作论文、委托报告、政策文件等）通过谷歌学者和几个机构网站进行。一项在线横断面调查也在欧洲的HTA （n = 22）和监管机构（n = 6）中进行，以补充系统评价。总体而言，我们发现，尽管存在分歧，但随着时间的推移，在缩小HTA机构和监管机构在证据要求方面的差距方面取得了进展。大多数监管机构（4/6;67%）和一半（11/ 22,50 %）的HTA机构报告与其他机构有“合作”的正式联系。一些机制，如早期三方对话、并行提交（审查）、自适应许可途径和授权后数据生成，已被探索作为改善协作的途径。一些试点项目已经显示出这些模式在缩短监管和HTA决策之间的时间方面的积极作用，这可能转化为患者更快地获得挽救生命的治疗。因此，未来旨在改善卫生事务管理局和管理机构之间的协调/相互作用的办法应以这些现有模式/机制为基础，同时审查其长期影响。还确定了一些障碍，包括法律、组织和资源相关因素，需要解决这些障碍，以便在当前的监管和报销环境中实现更大的一致性。
The need to optimize drug development and facilitate faster access for patients has ignited discussions around the importance of improving interactions between health technology assessment (HTA) bodies and regulatory agencies. In this study, we conducted a systematic review to examine processes, progress, outcomes, and challenges of harmonization/interaction initiatives between HTA bodies and regulatory agencies. MEDLINE, EMBASE, and the International Pharmaceutical Abstracts database were searched up to 21 October 2019. Searches for gray literature (working papers, commissioned reports, policy documents, etc.) were performed via Google scholar and several institutional websites. An online cross-sectional survey was also conducted among HTA (n = 22) and regulatory agencies (n = 6) across Europe to supplement the systematic review. Overall, we found that while there are areas of divergence, there has been progress over time in narrowing the gap in evidentiary requirements for HTA bodies and regulatory agencies. Most regulatory agencies (4/6; 67%) and half (11/22, 50%) of the HTA bodies reported having a formal link for “collaborating” with the other. Several mechanisms such as early tripartite dialogues, parallel submissions (reviews), adaptive licensing pathways, and postauthorization data generation have been explored as avenues for improving collaboration. A number of pilot initiatives have shown positive effects of these models to reduce the time between regulatory and HTA decisions, which may translate into faster access for patients to life-saving therapies. Thus, future approaches aimed at improving harmonization/interaction between HTA bodies and regulatory agencies should build on these existing models/mechanisms while examining their long-term impacts. Several barriers including legal, organizational, and resource-related factors were also identified, and these need to be addressed to achieve greater alignment in the current regulatory and reimbursement landscape.
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影响因子：
6.7
作者：
Eichler, H-G;Baird, L. G.;Hirsch, G.
通讯作者：
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影响因子：
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作者：
Clark, Daniel;Dean, Gerard;Beeson, Beth
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Beeson, Beth
DOI：
10.1017/s0266462318000545
发表时间：
2018-01-01
影响因子：
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作者：
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通讯作者：
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作者：
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通讯作者：
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影响因子：
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作者：
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通讯作者：
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