Desmet Thomas, Julian Elaine, Van Dyck Walter, Huys Isabelle, Simoens Steven, Giuliani Rosa, Toumi Mondher, Dierks Christian, Dierks Juliana, Cardone Antonella, Houÿez Francois, Pavlovic Mira, Berntgen Michael, Mol Peter, Schiel Anja, Goettsch Wim, Gianfrate Fabrizio, Capri Stefano, Ryan James, Ducournau Pierre, Solà-Morales Oriol, Ruof Jörg
Healthcare Management Centre, Vlerick Business School, 1210 Brussels, Belgium.
Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, 3000 Leuven, Belgium.
J Mark Access Health Policy. 2024 Mar 14;12(1):21-34. doi: 10.3390/jmahp12010004. eCollection 2024 Mar.
Stakeholder involvement has long been considered a success factor for a joint European health technology assessment (HTA) process, and its relevance is now anchored in the EU HTA Regulation's (EU HTAR) legislative wording. Therefore, we aimed to explore the roles, challenges, and most important activities to increase the level of involvement per stakeholder group.
At the 2022 Fall Convention of the European Access Academy (EAA), working groups addressed the involvement of patients, clinicians, regulators, health technology developers (HTD), and national HTA bodies and payers within the EU HTA process. Each working group revisited the pre-convention survey results, determined key role characteristics for each stakeholder, and agreed on the most important activities to fulfill the role profile. Finally, the activities suggested per group were prioritized by plenary group.
The prioritized actions for patients included training and capacity building, the establishment of a patient involvement committee, and the establishment of a patient unit at the EC secretariat. For clinicians, it included alignment on evidence assessment from a clinical vs. HTA point of view, capacity building, and standardization of processes. The most important actions for regulators are to develop joint regulatory-HTA guidance documents, align processes and interfaces under the regulation, and share discussions on post-licensing evidence generation. HTDs prioritized scientific advice capacity and the review of the scoping process, and further development of the scope of the assessment report fact checks. The top three actions for national HTA bodies and payers included clarification on the early HTD dialogue process, political support and commitment, and clarification on financial support.
Addressing the activities identified as the most important for stakeholders/collaborators in the EU HTA process (e.g., in the implementation of the EU HTA Stakeholder Network and of the guidance documents developed by the EUnetHTA 21 consortium) will be key to starting an "", as suggested by the European Commission's Pharmaceutical Strategy.
长期以来，利益相关者的参与一直被视为欧洲联合卫生技术评估（HTA）过程的一个成功因素，其相关性现已体现在欧盟HTA法规（EU HTAR）的立法措辞中。因此，我们旨在探讨各利益相关者群体提高参与度的角色、挑战及最重要的活动。
在欧洲准入学会（EAA）2022年秋季大会上，各工作组讨论了患者、临床医生、监管机构、卫生技术开发商（HTD）以及国家HTA机构和支付方在欧盟HTA过程中的参与情况。每个工作组重新审视了会前调查结果，确定了每个利益相关者的关键角色特征，并就履行角色概况的最重要活动达成一致。最后，全会对各小组提出的活动进行了优先排序。
针对患者的优先行动包括培训和能力建设、设立患者参与委员会以及在欧盟委员会秘书处设立患者单元。对临床医生而言，包括从临床与HTA角度对证据评估进行协调、能力建设以及流程标准化。监管机构最重要的行动是制定联合监管-HTA指导文件、协调监管下的流程和接口，以及分享关于上市后证据生成的讨论。卫生技术开发商将科学建议能力、范围界定过程审查以及评估报告事实核查范围的进一步拓展列为优先事项。国家HTA机构和支付方的前三项行动包括明确早期卫生技术开发商对话流程、政治支持和承诺，以及明确财政支持。
正如欧盟委员会《制药战略》所建议的，落实在欧盟HTA过程中被确定为对利益相关者/合作伙伴最重要的活动（例如，在欧盟HTA利益相关者网络的实施以及EUnetHTA 21联盟制定的指导文件方面）将是开启“”的关键。
