Division for Assessment and Access to Innovation (DEAI), International Coordination Unit, French National Authority for Health, Saint-Denis, France.
French National Authority for Health, La Plaine, Saint-Denis, France.
Int J Technol Assess Health Care. 2022 Mar 24;38(1):e30. doi: 10.1017/S0266462322000083.
The aim of this article is to describe the process, results, and experiences of European Network for Health Technology Assessment (EUnetHTA) Joint Action 3's (JA3) Early Dialogue (ED) activities and to highlight opportunities for improving the processes.
A descriptive analysis of the steps of the EUnetHTA ED process and evaluation of the data from the EDs conducted by EU health technology assessment (HTA) bodies, published guidelines, and documents, as well as internal statistics.
In JA3, an Early Dialogues Working Party (EDWP) was established, responsible for developing and improving processes and providing advice to pharmaceutical companies, supported by the ED Secretariat. From June 2017 to May 2021, 113 requests for pharmaceutical EDs were received and 38 conducted. The process was continuously optimized, and different approaches for involving patients were tested. Finally, a centralized procedure was chosen with the key documents produced by two responsible agencies and reviewed by the EDWP. Patient involvement was primarily done by interviewing a national patient representative to obtain general feedback on the disease and the planned study design.
During JA3, EDs were established as an efficient, successful product. Pharmaceutical companies benefited not only from the positions of the individual agencies for the national HTA, but also from the recommendations that were common to all HTA authorities. In addition, regarding the European HTA Regulation, it will be important to conduct Joint Scientific Consultations with a view toward future Joint Clinical Assessments and to further develop processes aligned with the high demand for consultation.
本文旨在描述欧洲卫生技术评估网络（EUnetHTA）联合行动 3（JA3）早期对话（ED）活动的过程、结果和经验，并强调改进流程的机会。
对 EUnetHTA ED 流程的步骤进行描述性分析，并对欧盟卫生技术评估（HTA）机构进行的 ED 数据、已发布的指南和文件以及内部统计数据进行评估。
在 JA3 中，成立了一个早期对话工作组（EDWP），负责开发和改进流程，并为制药公司提供建议，由 ED 秘书处提供支持。从 2017 年 6 月到 2021 年 5 月，共收到 113 份制药 ED 请求，并进行了 38 项。该流程不断得到优化，并测试了不同的方法来让患者参与。最终，选择了一种集中式程序，由两个负责机构制作关键文件，并由 EDWP 进行审查。患者参与主要是通过采访一位国家患者代表来获得对疾病和计划研究设计的一般性反馈。
在 JA3 期间，ED 作为一种高效、成功的产品得以建立。制药公司不仅受益于各个国家 HTA 机构的立场，还受益于所有 HTA 机构的共同建议。此外，根据欧洲 HTA 法规，与未来的联合临床评估相比，进行联合科学咨询将非常重要，并且需要进一步开发与咨询高需求相匹配的流程。
