scholarly journals European network for Health Technology Assessment, EUnetHTA: Planning, development, and implementation of a sustainable European network for Health Technology Assessment

2009 ◽  
Vol 25 (S2) ◽  
pp. 107-116 ◽  
Author(s):  
Finn Børlum Kristensen ◽  
Marjukka Mäkelä ◽  
Susanna Allgurin Neikter ◽  
Nina Rehnqvist ◽  
Lise Lund Håheim ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Best Practice ◽  
Health Technology ◽  
Governance Structure ◽  
European Network ◽  
Independent Evidence ◽  
Planning Development ◽  
High Level ◽  
Financial Transactions

Objectives: The European network on Health Technology Assessment (EUnetHTA) aimed to produce tangible and practical results to be used in the various phases of health technology assessment and to establish a framework and processes to support this. This article presents the background, objectives, and organization of EUnetHTA, which involved a total of sixty-four partner organizations.Methods: Establishing an effective and sustainable structure for a transnational network involved many managerial, policy, and methodological tools, according to the objective of each task or Work Package. Transparency in organization, financial transactions, and decision making was a key principle in the management of the Project as was the commitment to appropriately involve stakeholders.Results: EUnetHTA activities resulted in a clear management and governance structure, efficient partnership, and transnational cooperation. The Project developed a model for sustainable continuation of the EUnetHTA Collaboration.Conclusions: The EUnetHTA Project achieved its goals by producing a suite of practical tools, a strong network, and plans for continuing the work in a sustainable EUnetHTA Collaboration that facilitates and promotes the use of HTA at national and regional levels. Responsiveness to political developments in Europe should be balanced with maintaining a high level of ambition to promote independent, evidence-based information and well-tested tools for best practice based on a strong network of HTA institutions.

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

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.

scholarly journals Determinants of Managed Entry Agreements in the context of Health Technology Assessment: a comparative analysis of oncology therapies in four countries

2021 ◽  
Vol 37 ◽  
Author(s):  
Olina Efthymiadou ◽  
Panos Kanavos
Keyword(s):  
Decision Making ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Best Practice ◽  
Health Technology ◽  
Future Research ◽  
Best Practice Guidelines ◽  
Chi Squared ◽  
Decision Making Factors ◽  
Managed Entry Agreements

Abstract Background Managed Entry Agreements (MEAs) are increasingly used to address uncertainties arising in the Health Technology Assessment (HTA) process due to immature evidence of new, high-cost medicines on their real-world performance and cost-effectiveness. The literature remains inconclusive on the HTA decision-making factors that influence the utilization of MEAs. We aimed to assess if the uptake of MEAs differs between countries and if so, to understand which HTA decision-making criteria play a role in determining such differences. Methods All oncology medicines approved since 2009 in Australia, England, Scotland, and Sweden were studied. Four categories of variables were collected from publicly available HTA reports of the above drugs: (i) Social Value Judgments (SVJs), (ii) Clinical/Economic evidence submitted, (iii) Interpretation of this evidence, and (iv) Funding decision. Conditional/restricted decisions were coded as Listed With Conditions (LWC) other than an MEA or LWC including an MEA (LWCMEA). Cohen's κ-scores measured the inter-rater agreement of countries on their LWCMEA outcomes and Pearson's chi-squared tests explored the association between HTA variables and LWCMEA outcomes. Results A total of 74 drug-indication pairs were found resulting in n = 296 observations; 8 percent (n = 23) were LWC and 55 percent (n = 163) were LWCMEA. A poor-to-moderate agreement existed between countries (−.29 < κ < .33) on LWCMEA decisions. Cross-country differences within the LWCMEA sample were partly driven by economic uncertainties and largely driven by SVJs considered across agencies. Conclusions A set of HTA-related variables driving the uptake of MEAs across countries was identified. These findings can be useful in future research aimed at informing country-specific, “best-practice” guidelines for successful MEA implementation.

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

2020 ◽  
Vol 36 (3) ◽  
pp. 191-196 ◽  
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

2018 ◽  
Vol 34 (1) ◽  
pp. 87-96 ◽  
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

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.

History of Health Technology Assessment in Iran

2020 ◽  
Vol 36 (1) ◽  
pp. 34-39 ◽  
Author(s):  
Morteza Arab-Zozani ◽  
Mobin Sokhanvar ◽  
Edris Kakemam ◽  
Tahereh Didehban ◽  
Soheil Hassanipour
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
New Technologies ◽  
Conflicts Of Interest ◽  
Health Technology ◽  
Lessons Learned ◽  
Policy Makers ◽  
History Of ◽  
Systematic Structure ◽  
High Level

This article describes the characteristics of the health system and reviews the history of health technology assessment (HTA) in Iran, including its inception, processes, challenges, and lessons learned. This study was conducted by analyzing existing documents, reports, and guidelines related to HTA and published articles in the field. HTA in Iran has been established since the late 2000s and was first introduced as a secretariat by the Deputy of Health at the Ministry of Health and Medical Education. The mission of the HTA office is to systematically assess technologies to improve evidence-informed decision making. Despite its 10 years of existence, HTA in Iran still faces some challenges. The most pressing problems currently facing HTA in Iran include conflicts of interest among researchers performing the HTAs, the absence of a systematic structure for identifying and introducing new technologies, the lack of interest in HTA results among high-level policy makers, and the lack of external oversight for HTA projects.

VP67 The Value Of The European Network For Health Technology Assessment (EUnetHTA) Outputs For National Health Technology Assessment: The French Experience

2017 ◽  
Vol 33 (S1) ◽  
pp. 180-180
Author(s):  
Irena Guzina ◽  
François Meyer
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Joint Action ◽  
Relative Effectiveness ◽  
Health Technology ◽  
Specific Work ◽  
European Network ◽  
Know How ◽  
French Experience ◽  
Methodological Guidelines

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.

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

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.

OP04 Lessons Learnt When Implementing A Health Technology Assessment Institution In Costa Rica

2017 ◽  
Vol 33 (S1) ◽  
pp. 3-4
Author(s):  
Iñaki Gutiérrez-Ibarluzea ◽  
James Cercone ◽  
Daniel Bronstein ◽  
Luis Tacsan ◽  
Pablo Morales ◽  
...  
Keyword(s):  
Health Care ◽  
Costa Rica ◽  
Social Security ◽  
Health Technology Assessment ◽  
Health System ◽  
Technology Assessment ◽  
Access To Health Care ◽  
Health Technology ◽  
Right To Health ◽  
Independent Evidence

INTRODUCTION:Faced with increasing financial challenges to the single-payer social security system and constitutional challenges supporting all citizen's right to health, Costa Rica has endeavored to introduce Health Technology Assessment (HTA) to ensure sustainability and promote the timely introduction of technology innovations in the health system. The Ministry of Health initiated a process to establish an independent, external institution providing leadership in the process of HTA.METHODS:Based on a survey developed by REDETSA/PAHO (HTA Network of the Americas/Pan American Health Organization), an inclusive method of stakeholders participation was used to analyze the strengths, weaknesses, opportunities and threats regarding the implementation of an HTA entity. This was combined with qualitative research methods, market access situation analysis and the review of coverage and provision processes to define the elements for the new HTA institution. The “in-depth” interviews extended to manufacturers, ministry representatives, services providers, purchasers, patients and citizens representatives, judiciary court, professional colleges, academia and non-governmental organizations (NGOs). Analysis of the professional competencies required for the HTA institution was carried out based on best practice analysis of international HTA institutions.RESULTS:The implementation of an HTA unit in Costa Rica was identified by all the actors as crucial to ensuring the health system's sustainability. Costa Rica's health system is based on all citizens right to health and all inputs required delivering health services, judicialization and access to health care have become a big issue. Two main issues were identified as essential to implement an HTA institution: the establishment of a clear framework to provide legal and financial support and the need to have sufficient independence from the Ministry and the Social Security, including maximum transparency and methodological robustness.CONCLUSIONS:The business model for the new HTA institution should consider the participation of all the interested actors. The HTA institution should bridge the gap between technology regulation and health technology management and aim to improve both processes. It should also provide third party independent evidence to inform the constitutional court around health care claims.

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

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.

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