European network for Health Technology Assessment Joint Action (EUnetHTA JA): a process evaluation performed by questionnaires and documentary analysis

INTRODUCTION:The French National Authority for Health (HAS) has participated in the work of the European Network for Health Technology Assessment (EUnetHTA) since its creation in 2006. HAS has been an active partner in most EUnetHTA activities, and the lead partner of specific work packages.METHODS:This report presents a summary of the main contribution of HAS to the two latest EUnetHTA projects (Joint Action (JA) 1 and Joint Action 2 (JA2)), their impact on national production, and Health Technology Assessment (HTA) doers feedback as to the opportunities and challenges of participating to the network and using its outputs.RESULTS:In JA 1 and JA 2 projects, HAS has: coordinated activities related to Early Dialogues and Additional Evidence Generation; coordinated the development of nine JA1 methodological guidelines for rapid relative effectiveness assessment (REA) of pharmaceuticals; participated in the production of two JA2 methodological guidelines; participated in the production of one JA1 and seven JA2 rapid REA reports, and two JA2 full HTAs.The national uptake of EUnetHTA outputs included entire adoptation of one REA report and adaptation of another. EUnetHTA templates and methodological guidelines have been taken into account when updating or developing national ones. Thanks to the network, HAS HTA doers could exchange on ongoing assessments with European colleagues, have enhanced their methodological know-how and enlarged their professional network.As for the challenges encountered, it turned out that the re-use of EUnetHTA reports for a technology of interest to HAS was not always possible, mainly due to discordances in deadlines or assessment questions between EUnetHTA and national productions.CONCLUSIONS:HAS has actively participated in different EUnetHTA projects since the network's creation. This collaboration has enabled HAS HTA doers, among others, to optimize national assessments and enhance their methodological know-how.

Europäische Zusammenarbeit in der Bewertung von Medizinprodukten – ein Schritt zur grenzüberschreitenden Gesundheitsversorgung

Das Gesundheitswesen ◽

10.1055/s-0043-109859 ◽

2017 ◽

Vol 57 (03) ◽

pp. 210-216

Author(s):

Julia Mayer ◽

Sabine Ettinger ◽

Anna Nachtnebel

Keyword(s):

Health Technology Assessment ◽

Technology Assessment ◽

Joint Action ◽

Health Technology ◽

European Network ◽

Europäische Zusammenarbeit

Zusammenfassung Ziel Ziel des Artikels ist die Darstellung rechtlicher Rahmenbedingungen sowie Erfahrungen in der grenzüberschreitenden Zusammenarbeit bei der Bewertung von Medizinprodukten als Grundlage für Erstattungsentscheidungen. Der mögliche Nutzen transnationaler Kooperation für verschiedene Stakeholdergruppen soll erläutert werden. Methodik Prozesse und Herausforderungen der abgeschlossenen European Network for Health Technology Assessment (EUnetHTA) Joint Action 2 (JA2) werden zusammengefasst und diskutiert. Die dem Artikel zugrunde liegenden Erfahrungen beruhen auf der Erstellung und Evaluierung von insgesamt 6 Rapid Assessments zu Medizinprodukten, welche während der EUnetHTA JA2 in internationaler Kollaboration verfasst und publiziert wurden. Nutzen, Ziele und Chancen der laufenden EUnetHTA Joint Action 3 (JA3) werden dargestellt. Ergebnisse Herausforderungen in der europäischen Medizinproduktebewertung umfassen die Themenauswahl und den Zeitpunkt der Bewertung, die Intransparenz des Medizinproduktemarkts sowie das Fehlen europäischer Standards zum systematischen Einbeziehen von PatientInnen. Charakteristika wie inkrementelle Veränderungen und Lernkurven machen es notwendig, Medizinprodukte über ihren gesamten Lebenszyklus hinweg zu begleiten. Der Nutzen der europäischen Zusammenarbeit für Stakeholder ist vielfältig: die aufgrund fehlender Evidenz herrschende Unsicherheit zum Zusatznutzen einer Technologie kann durch Early Dialogues reduziert werden; ein europaweit harmonisierter, transparenter Bewertungsprozess steigert die Nachvollziehbarkeit und Qualität der Berichte; die Arbeitsteilung unter den Health Technology Assessment (HTA)-Organisationen ermöglicht eine ressourcenschonende Bewertung einer größeren Anzahl an Technologien; die Patientenbeteiligung gewährleistet die Berücksichtigung patientenrelevanter Endpunkte. Die Wichtigkeit der grenzübergreifenden Zusammenarbeit im Bereich HTA zeigt sich in der Weiterführung des EUnetHTA Projekts, welches die Festigung der internationalen Kollaboration auch nach Auslaufen der EU-Förderungen zum Ziel hat. Schlussfolgerung Eine nachhaltige transnationale Kooperation in der Bewertung von Medizintechnologien kann die grenzüberschreitende Gesundheitsversorgung und die effiziente Zusammenarbeit der nationalen Gesundheitssysteme sichern. Der Fokus sollte dabei auf einer flächendeckenden Implementierung gemeinsam entwickelter Methoden und Qualitätsstandards liegen. Die europäische Zusammenarbeit kann zu einem konkreten Nutzen für PatientInnen, ÄrztInnen, HTA-Organisationen und nationale EntscheidungsträgerInnen führen.

OP163 European Network for Health Technology Assessment Joint Action 3 Relative Effectiveness Pilots: Pharma Company Experience

International Journal of Technology Assessment in Health Care ◽

10.1017/s026646231800168x ◽

2018 ◽

Vol 34 (S1) ◽

pp. 59-60

Author(s):

Ansgar Hebborn ◽

André Oberdiek ◽

Jennifer Cain Birkmose ◽

Marlene Gyldmark ◽

Pierre Ducournau ◽

...

Keyword(s):

Health Technology Assessment ◽

Technology Assessment ◽

Joint Action ◽

Relative Effectiveness ◽

Health Technology ◽

Positive Development ◽

European Network ◽

Clinical Value ◽

Process Improvements ◽

Rules And Principles

Introduction:More than 50 HTA agencies evaluate the clinical value of medicines in Europe, resulting in duplication of work for HTA agencies and manufacturers, and lengthy and variable time to reimbursement for patients across Europe. A consistent, single European relative clinical scientific benefit assessment of medicines could become a key element in ensuring patients get equitable and timely access across Europe. The European Network for Health Technology Assessment (EUnetHTA) is responsible under Joint Action 3 (JA3, 2016–2020) to pilot more than 30 Relative Effectiveness Assessments (REAs) of medicines. The first EUnetHTA JA3 REA pilots are now being completed and Roche, with its participation in the REA pilot for alectinib, has gathered relevant experience.Methods:The goal of this analysis is to summarize and reflect upon the experience with one of the first EUnetHTA REA assessments in JA3. The authors also propose potential process improvements.Results:The experience with the alectenib REA shows that EUnetHTA processes have improved compared to JA2. The timing of the assessment has been aligned with the EU regulatory marketing authorization process by shortening the duration of the scoping phase. More EUnetHTA members than in JA2 seem to be committed to use the reports in national HTA, pricing and reimbursement processes. At the same time, the REA pilots have identified other areas that could benefit from further refinement, for example the active engagement of patient group representatives and clinical experts, rules and principles related to the handling of confidential information.Conclusions:Based on the limited number of REA pilots for medicines it is too early to draw final conclusions on the state of EU-level collaboration. But first signals indicate a positive development compared to REA pilots conducted in JA2. Interim evaluations are recommended to assess progress, and capture learnings for future pilots.

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

International Journal of Technology Assessment in Health Care ◽

10.1017/s0266462321000313 ◽

2021 ◽

Vol 37 (1) ◽

Author(s):

Miriam Luhnen ◽

Sari Susanna Ormstad ◽

Anne Willemsen ◽

Chaienna Schreuder-Morel ◽

Catharina Helmink ◽

...

Keyword(s):

Quality Management ◽

Health Technology Assessment ◽

Technology Assessment ◽

Management System ◽

Quality Management System ◽

Health Technology ◽

European Network ◽

Joint Work ◽

Working Groups ◽

Assessment Reports

Abstract 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.

The fourth edition of the European Network for Health Technology Assessment Forum: highlights and outcomes

International Journal of Technology Assessment in Health Care ◽

10.1017/s0266462320000185 ◽

2020 ◽

Vol 36 (3) ◽

pp. 191-196 ◽

Cited By ~ 1

Author(s):

Giovanni Tafuri ◽

Chantal Bélorgey ◽

Carlo Favaretti ◽

Edith Frénoy ◽

Flora Giorgio ◽

...

Keyword(s):

Health Technology Assessment ◽

Technology Assessment ◽

Healthcare Professionals ◽

Health Technology ◽

Joint Production ◽

European Network ◽

Fourth Edition ◽

Patient Organizations ◽

Medical Need ◽

To Receive

The European Network for Health Technology Assessment (EUnetHTA) organizes an annual Forum with stakeholders to receive feedback on its activities, processes, and outputs produced. The fourth edition of the EUnetHTA Forum brought together representatives of HTA bodies, patient organizations, healthcare professionals (HCPs), academia, payers, regulators, and industry. The aim of this paper is to provide an overview of the highlights presented at the 2019 EUnetHTA Forum, reporting the main items and themes discussed in the plenary panel and breakout sessions. The leading topic was the concept of unmet medical need seen from different stakeholders' perspectives. Breakout sessions covered the joint production of assessment reports and engagement with payers, patients, and HCPs. Synergies, pragmatism, and inclusiveness across Member States and stakeholders were emphasized as leading factors to put in place a collaboration that serves the interest of patients and public health in a truly European spirit.

HEALTH TECHNOLOGY ASSESSMENT EVIDENCE ON E-HEALTH/M-HEALTH TECHNOLOGIES: EVALUATING THE TRANSPARENCY AND THOROUGHNESS

International Journal of Technology Assessment in Health Care ◽

10.1017/s0266462317004512 ◽

2018 ◽

Vol 34 (1) ◽

pp. 87-96 ◽

Cited By ~ 5

Author(s):

Vladimir Vukovic ◽

Carlo Favaretti ◽

Walter Ricciardi ◽

Chiara de Waure

Keyword(s):

Economic Evaluation ◽

Health Technology Assessment ◽

Technology Assessment ◽

Health Technology ◽

Healthcare Systems ◽

Core Model ◽

Social Aspects ◽

European Network ◽

Health Technologies ◽

Research Questions

Objectives:Evaluation is crucial for integration of e-Health/m-Health into healthcare systems and health technology assessment (HTA) could offer sound methodological basis for these evaluations. Aim of this study was to look for HTA reports on e-Health/m-Health technologies and to analyze their transparency, consistency and thoroughness, with the goal to detect areas that need improvement.Methods:PubMed, ISI-WOS, and University of York – Centre for Reviews and Dissemination–electronic databases were searched to identify reports on e-Health/m-Health technologies, published up until April 1, 2016. The International Network of Agencies for Health Technology Assessment (INAHTA) checklist was used to evaluate transparency and consistency of included reports. Thoroughness was assessed by checking the presence of domains suggested by the European network for Health Technology Assessment (EUnetHTA) HTA Core Model.Results:Twenty-eight reports published between 1999 and 2015 were included. Most were delivered by non-European countries (71.4 percent) and only 35.7 percent were classified as full reports. All the HTA reports defined the scope of research whereas more than 80 percent provided author details, summary, discussed findings, and conclusion. On the contrary, policy and research questions were clearly defined in around 30 percent and 50 percent of reports. With respect to the EUnetHTA Core Model, around 70 percent of reports dealt with effectiveness and economic evaluation, more than 50 percent described health problem and approximately 40 percent organizational and social aspects.Conclusions:E-Health/m-Health technologies are increasingly present in the field of HTA. Yet, our review identified several missing elements. Most of the reports failed to respond to relevant assessment components, especially ethical, social and organizational implications.

Az egészségügyi technológiaértékelés múltja, jelene és jövője – nemzetközi perspektívából

IME - Az egészségügyi vezetők szaklapja ◽

10.53020/ime-2021-206 ◽

2021 ◽

Vol 20 (2) ◽

pp. 38-41

Author(s):

Péter Szegner

Keyword(s):

Health Technology Assessment ◽

Technology Assessment ◽

Health Technology ◽

Core Model ◽

European Network

Az egészségügy finanszírozása és fenntarthatósága kapcsán kiemelt fontosságú a bizonyítékokon alapuló döntéshozatal. Napjaink diszruptív trendjei – például a digitalizáció, az adatvezérelt rendszerek, és természetesen a COVID-19 járvány – illetve az egészségügyi rendszerek átalakulása következtében kiemelt szerep juthat a multidiszciplináris egészségügyi technológiaértékelés (Health Technology Assessment, HTA) területének. Magyar országon 2004 óta működik a HTA-val kapcsolatos feladatokat ellátó, társadalombiztosítási befogadási folyamatban döntéstámogató szereppel bíró Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézet Technológia-értékelő Főosztálya (TÉF). Európai szinten a European Network for Health Technology Assessment (EUnetHTA) tekinthető az egyik legnagyobb volumenű nemzetközi kezdeményezésnek a területen, mely 2021-ben 29 országból 81 szervezetet ölelt fel. Az EUnetHTA számos eszköze és közös értékelése segíti a tagállamokat, ennek keretében jött létre a HTA Core Model, a gyártókkal folytatott korai tudományos konzultációk, vagy a befogadást követő tudományos bizonyítékok előállítását célzó pilotok. A jövőt illetően kiemelendő, hogy 2021 második felét követően jelentős átalakulás veszi kezdetét az európai technológiaértékelésben – így az EUnetHTA hálózat évtizedes együttműködése nem folytatódik tovább jelen formájában. Az átalakulás egyik fő hajtóereje az Európai Parlament és az Európai Unió Tanácsa által 2021 júniusában elfogadott HTA szabályozás. Az EUnetHTA által kidolgozott jövőbeli HTA együttműködés modellje (FMC) és az elmúlt 15 év nemzetközi tapasztalatai alapján állítható, hogy az ellátórendszerben megjelenő számos lehetőségre és kihívásra megfelelő választ tud majd adni az európai HTA közösség. A végső cél pedig továbbra is a betegek számára hozzáférhető és fenntartható egészségügyi szolgáltatások biztosítása, illetve a társadalom egészségi állapotának javítása lesz.

PP14 Development Of The European Network For Health Technology Assessment Standards Tool For Registries In Health Technology Assessment

International Journal of Technology Assessment in Health Care ◽

10.1017/s0266462318001861 ◽

2018 ◽

Vol 34 (S1) ◽

pp. 70-70

Author(s):

Emmanuel Gimenez Garcia ◽

Mireia Espallargues ◽

Jae Long ◽

Maja Valentic ◽

Irena Guzina ◽

...

Keyword(s):

Health Technology Assessment ◽

Technology Assessment ◽

Good Practice ◽

Health Technology ◽

Registry Data ◽

European Network ◽

Real World Data ◽

The Third ◽

Evidence Quality ◽

Evidence Generation

Introduction:Bridging gaps between registry-holders, Health Technology Assessment (HTA) producers and users is one of the aims of the European Network for HTA (EUnetHTA) Joint Action 3. In this context, a post-launch evidence generation tool is being developed, including a quality standards tool for registries in HTA. The standards tool for registries in HTA will enable, among others, registry owners to consistently collect high quality registry data, and HTA agencies to use proper registry data collected by others as evidence for their assessments. The objective is to present the first draft version of the tool structure, which is going to be piloted during the forthcoming months.Methods:A review and description of the currently available first version (November 2017) sections, items and criteria for HTA studies.Results:The tool is divided in three sections; “Methodological Information”, “Essential Standards” and “Additional Requirements”. The first section enables users to analyze not only the ability of the registry to answer to research questions but also to check the registry transparency. The second section encloses the essential elements of good practice and evidence quality (therefore all of them must be met before an HTA report can use the registry data). Finally, the third section includes elements of good practice and evidence quality useful to consider in planning and evaluating registries for specific purposes. Although suggestions are defined, the third section item requirements could depend on the individual HTA agency perspectives and needs.Conclusions:There is a clear growing availability and requirement for real world data for health technology assessment. A piloted and robust registry standards tool for HTA can provide a relevant basis to improve both the evidence generation but also to make more trustful and excellent evaluations.

OP51 Thrombectomy In France: A National Use Of European Network for Health Technology Assessment (EUnetHTA) Joint Assessment

International Journal of Technology Assessment in Health Care ◽

10.1017/s0266462317001428 ◽

2017 ◽

Vol 33 (S1) ◽

pp. 24-24

Author(s):

Huguette Lhuillier-Nkandjeu ◽

Michèle Morin-Surroca

Keyword(s):

Health Insurance ◽

Ischaemic Stroke ◽

Health Technology Assessment ◽

National Health Insurance ◽

National Health ◽

Technology Assessment ◽

Acute Ischaemic Stroke ◽

Health Technology ◽

List Type ◽

European Network

INTRODUCTION:Mechanical thrombectomy (MT) is used in patients with acute ischaemic stroke due to occlusion of a proximal cerebral artery. Over the years endovascular techniques have been used to re-canalise blocked vessels, but are not currently reimbursed by National Health Insurance in France.The aim was to assess the efficacy and safety of MT in combination with intravenous tissue plasminogen activator (IV t-PA), or as an alternative to it, in adults with an acute ischaemic stroke who are not eligible for thrombolysis or in whom thrombolysis has failed; to support the reimbursement decision by National Health Insurance.METHODS:Within the scope of The European Network for Health Technology Assessment (EUnetHTA), a rapid assessment of “Endovascular therapy using devices for acute ischaemic stroke” was jointly produced with Haute Autorité de santé (HAS) as a reviewer.RESULTS:The EUnetHTA report provided a systematic review based on eight randomized controlled trials (RCT) for effectiveness and all available published data for safety.To produce its assessment, HAS has adapted the EUnetHTA report by: 1.Updating the systematic literature review including the latest published trials2.Retaining the subgroup analysis of the five most recent trials considered more relevant in the EUnetHTA report for the assessment of effectiveness3.Analysing specifically the different endovascular interventions studied in the five RCTs4.Taking into account contributions from stakeholders.CONCLUSIONS:This horizontal collaboration among European HTA doers has facilitated and shortened the assessment of the clinical benefit of this technology, confirming the relevance of EUnetHTA cooperation.This clinical assessment of thrombectomy is to be completed by the evaluation of its organizational impact in the management of acute ischemic stroke.

Involving stakeholders and developing a policy for stakeholder involvement in the European network for Health Technology Assessment, EUnetHTA

International Journal of Technology Assessment in Health Care ◽

10.1017/s0266462309990729 ◽

2009 ◽

Vol 25 (S2) ◽

pp. 84-91 ◽

Cited By ~ 18

Author(s):

Camilla Palmhøj Nielsen ◽

Sarah Wadmann Lauritsen ◽

Finn Børlum Kristensen ◽

Marie Louise Bistrup ◽

Americo Cecchetti ◽

...

Keyword(s):

Health Technology Assessment ◽

Technology Assessment ◽

Web Site ◽

Stakeholder Involvement ◽

Health Technology ◽

General Information ◽

European Network ◽

Site Analysis ◽

Stakeholder Groups ◽

Stakeholder Representation

Objectives: This article explains how the issue of stakeholder involvement was addressed in the European network for Health Technology Assessment (EUnetHTA) Project and describes the structures of future stakeholder involvement in the EUnetHTA Collaboration.Methods: Initiatives led to a dialogue with stakeholders and exchanging views and expectations on health technology assessment (HTA) processes and the future development of EUnetHTA. The methods of involving different stakeholder groups in EUnetHTA included general information to stakeholders about EUnetHTA, targeted information on a Web site, analysis of stakeholder opinions on HTA and EUnetHTA, and development of a draft stakeholder policy.Results: First steps were taken to organize processes to consolidate the legitimacy of EUnetHTA and its products and encourage the representation of interests, thus contributing to promoting the utilization of HTA in national/regional policy making. A stakeholder Web site, analyses of stakeholder opinions on HTA and EUnetHTA in a discussion topic catalog, and a draft stakeholder policy resulted from the work.Conclusions: Stakeholder involvement in EUnetHTA is necessary to ensure the legitimacy and prospects for utilization of EUnetHTA and its products. The described activities and results create the foundation for a continued dialogue with, and involvement of, stakeholders. The EUnetHTA stakeholder meeting can be considered as a successful experience of dialogue between EUnetHTA and stakeholders, which should be continued. Our experience shows the challenge of obtaining balanced stakeholder representation across the identified stakeholder groups. Continued attention should be given to achieving balanced stakeholder representation.