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.

Patient involvement in relative effectiveness assessments in the European Network for Health Technology Assessment.

Patient involvement in the process of producing health technology assessments has become increasingly important. In the European Network for Health Technology Assessment (EUnetHTA), several approaches to patient involvement were explored. The outcome was a document on "Patient Input in Relative Effectiveness Assessments" that is available for access and was published in 2019.The aim of this article is to analyze the experience gained by EUnetHTA in patient involvement for EUnetHTA assessment production, describe and quantify the approaches used, and outline the challenges and avenues for the improvement of current processes.Patients were involved in twenty-three of thirty-six pharmaceutical and other technology EUnetHTA assessments from June 2016 until the end of November 2019. Approaches to patient involvement included using a patient input template, one-on-one conversations, group conversations, scoping meeting with patients, and other approaches.Although it is recognized that patient involvement is important to understand the needs of the target patient population, challenges remain with timely patient involvement. Additionally, further efforts are needed to guide assessment teams on how to implement and enhance the visibility of patient input in assessments.

European Collaboration in Health Technology Assessment (HTA): goals, methods and outcomes with specific focus on medical devices.

The European Network for Health Technology Assessment (EUnetHTA) was founded to support efficient production and use of health technology assessments (HTAs) across Europe by reducing redundancies through collaboration. To facilitate collaboration, a range of practical tools, methods and process definitions were developed. The article describes when and how these tools and methods are used along the HTA process with specific focus on "other technologies", that is medical devices and non-pharmaceutical procedures. EUnetHTA was able to deliver tangible achievements complying with its goals. The practical tools and the developed methods formed a basis for close collaboration among over 70 agencies at a European level. The activities of EUnetHTA laid a strong foundation for sustainable cooperation. In the long run, jointly produced assessments could realise economies of scale with improved quality, consistency and transparency for the health systems in Europe.

[European Collaboration in Medical Device Assessment: One Step Towards Cross-Border Health Care]. / Europäische Zusammenarbeit in der Bewertung von Medizinprodukten ­ ein Schritt zur grenzüberschreitenden Gesundheitsversorgung.

AIM: The aim of this paper was to present the legal framework as well as previous experience in transnational collaboration regarding the assessment of medical devices for reimbursement decisions. Furthermore, the possible benefit of transnational collaboration for various stakeholders will be discussed. METHODS: Experiences gathered with the compilation of overall 6 joint rapid assessments of medical devices within the completed European Network for Health Technology Assessment (EUnetHTA) Joint Action 2 (JA2) are summarised and discussed. Benefits, aims and opportunities of the ongoing EUnetHTA Joint Action 3 (JA3) are described. RESULTS: Challenges in joint European assessment of medical devices encompass the choice of topics and the time point of assessments, the non-transparency of the medical devices market as well as the lack of European standards for systematic patient involvement. Characteristics of medical devices such as incremental changes and learning curves call for monitoring of medical devices through their whole lifecycle. The concrete benefit of European collaboration for stakeholders is manifold: uncertainties with regard to the actual added value of a technology, caused by a lack of evidence, may be reduced by Early Dialogues; harmonized and transparent assessment processes throughout Europe increase the reproducibility and quality of reports; the division of work among the health technology assessment (HTA) organisations allows a resource efficient assessment of a larger amount of technologies; patient involvement facilitates consideration of patient-relevant endpoints. The importance of cross-border collaboration in the field of HTA is shown in the continuation of the EUnetHTA project, which aims to further strengthen international collaboration even after expiration of EU funding. CONCLUSION: A sustainable transnational collaboration in the assessment of medical devices can ensure cross-border health care as well as efficient collaboration of national health systems. The focus should be on a wide implementation of jointly established methods and quality standards. The European collaboration can lead to a concrete benefit for patients, physicians, HTA organisations and national decision makers.

Wearable cardioverter defibrillators for the prevention of sudden cardiac arrest: a health technology assessment and patient focus group study.

AIM: To summarize the evidence on clinical effectiveness and safety of wearable cardioverter defibrillator (WCD) therapy for primary and secondary prevention of sudden cardiac arrest in patients at risk. METHODS: We performed a systematic literature search in databases including MEDLINE via OVID, Embase, the Cochrane Library, and CRD (DARE, NHS-EED, HTA). The evidence obtained was summarized according to GRADE methodology. A health technology assessment (HTA) was conducted using the HTA Core Model® for rapid relative effectiveness assessment. Primary outcomes for the clinical effectiveness domain were all-cause and disease-specific mortality. Outcomes for the safety domain were adverse events (AEs) and serious adverse events (SAEs). A focus group with cardiac disease patients was conducted to evaluate ethical, organizational, patient, social, and legal aspects of the WCD use. RESULTS: No randomized- or non-randomized controlled trials were identified. Non-comparative studies (n=5) reported AEs including skin rash/itching (6%), false alarms (14%), and palpitations/light-headedness/fainting (9%) and discontinuation due to comfort/lifestyle issues (16-22%), and SAEs including inappropriate shocks (0-2%), unsuccessful shocks (0-0.7%), and death (0-0.3%). The focus group results reported that experiencing a sense of security is crucial to patients and that the WCD is not considered an option for weeks or even months due to expected restrictions in living a "normal" life. CONCLUSION: The WCD appears to be relatively safe for short-to-medium term, but the quality of existing evidence is very low. AEs and SAEs need to be more appropriately reported in order to further evaluate the safety of the device. High-quality comparative evidence and well-described disease groups are required to assess the effectiveness of the WCD and to determine which patient groups may benefit most from the intervention.