EUnetHTA relative effectiveness assessments: efforts to increase usability, transparency and inclusiveness.

OBJECTIVES: The objective of the European Network for Health Technology Assessment (EUnetHTA) Joint Action 3 (JA3) was to develop a sustainable European model for future collaboration on HTA, by reducing duplication in HTA production and increasing patient access to health technologies. Compared to the previous JA2, several procedural changes were made aiming to increase usability, transparency, and inclusiveness of relative effectiveness assessments (REAs). This article presents and highlights these changes, explains their rationale as well as their influence on HTA production. METHODS: Feedback from REA teams and project managers was collected. At the end of JA3, all lessons learned were mapped, resulting in a set of recommendations for a future REA production process. RESULTS: In JA3, forty-three EUnetHTA REAs have been produced. Efforts to increase the usability of the REAs were made by focussing on the needs of REA producers and users (HTA agencies) and by increasing stakeholder involvement. Huge steps were taken with regard to transparency, which was achieved through publication of guidances, templates, and up-to-date information on the EUnetHTA website. In an attempt to improve inclusiveness, (stakeholder) interaction and involvement as well as feedback procedures were enhanced and streamlined. The fine-tuned project management brought all aspects together and facilitated a consistent and reliable workflow. CONCLUSIONS: Despite that HTA agencies have different national requirements, the procedural changes made in JA3 proved to counteract some of these challenges. Nevertheless, it is of utmost importance that further perceived methodological differences are being resolved to ensure a strong base for future European collaboration on REA production.

Developing a quality management system for the European Network for Health Technology Assessment (EUnetHTA): toward European HTA collaboration.

OBJECTIVES: The European Network for Health Technology Assessment (EUnetHTA) was established in 2006 and comprises over eighty organizations from thirty European countries. In its fifth project phase (Joint Action 3), EUnetHTA set up a quality management system (QMS) to improve the efficiency and standardization of joint work. This article presents EUnetHTA's new QMS and outlines experiences and challenges during its implementation. METHODS: Several working groups defined processes and methods to support assessment teams in creating high-quality assessment reports. Existing guidelines, templates, and tools were refined and missing parts were newly created and integrated into the new QMS framework. EUnetHTA has contributed to Health Technology Assessment (HTA) capacity building through training and knowledge sharing. Continuous evaluation helped to identify gaps and shortcomings in processes and structures. RESULTS: Based on a common quality management concept and defined development and revision procedures, twenty-seven partner organizations jointly developed and maintained around forty standard operating procedures and other components of the QMS. All outputs were incorporated into a web-based platform, the EUnetHTA Companion Guide, which was launched in May 2018. Concerted efforts of working groups were required to ensure consistency and avoid duplication. CONCLUSIONS: With the establishment of a QMS for jointly produced assessment reports, EUnetHTA has taken a significant step toward a sustainable model for scientific and technical collaboration within European HTA. However, the definition of processes and methods meeting the numerous requirements of healthcare systems across Europe remains an ongoing and challenging task.