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.

scholarly journals The use of nonrandomized evidence to estimate treatment effects in health technology assessment

2021 ◽  
Author(s):  
Seamus Kent ◽  
Maximilian Salcher-Konrad ◽  
Stefania Boccia ◽  
Jacoline C Bouvy ◽  
Chiara de Waure ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Treatment Effects ◽  
Health Technology ◽  
Evidence Based ◽  
Work Package ◽  
Real World Data ◽  
Horizon 2020 ◽  
Evidence Quality ◽  
Collaborative Efforts

Health technology assessment (HTA) is increasingly informed by nonrandomized studies, but there is limited guidance from HTA bodies on expectations around evidence quality and study conduct. We developed recommendations to support the appropriate use of such evidence based on a pragmatic literature review and a workshop involving 16 experts from eight countries as part of the EU’s Horizon-2020 IMPACT-HTA program (work package six). To ensure HTA processes remain rigorous and robust, HTA bodies should demand clear, extensive and structured reporting of nonrandomized studies, including an in-depth assessment of the risk of bias. In recognition of the additional uncertainty imparted by nonrandomized designs in estimates of treatment effects, HTA bodies should strengthen early scientific advice and engage in collaborative efforts to improve use of real-world data.

scholarly journals Practical tools and methods for health technology assessment in Europe: Structures, methodologies, and tools developed by the European network for Health Technology Assessment, EUnetHTA

2009 ◽  
Vol 25 (S2) ◽  
pp. 1-8 ◽  
Author(s):  
Finn Børlum Kristensen ◽  
Kristian Lampe ◽  
Deborah L. Chase ◽  
Sun Hae Lee-Robin ◽  
Claudia Wild ◽  
...  
Keyword(s):  
Health Policy ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
New Technologies ◽  
Good Practice ◽  
Health Technology ◽  
Public Consultation ◽  
Consensus Methods ◽  
European Network ◽  
Structured Information

Objectives: This article presents an overview of the practical methods and tools to support transnational Health Technology Assessment (HTA) that were developed and pilot tested by the European network for HTA (EUnetHTA), which involved a total of sixty-four Partner organizations.Methods: The methods differ according to scope and purpose of each of the tools developed. They included, for example, literature reviews, surveys, Delphi and consensus methods, workshops, pilot tests, and internal/public consultation.Results: Practical results include an HTA Core Model and a Handbook on the use of the model, two pilot examples of HTA core information, an HTA Adaptation Toolkit for taking existing reports into new settings, a book about HTA and health policy making in Europe, a newsletter providing structured information about emerging/new technologies, an interactive Web-based tool to share information about monitoring activities for emerging/new technologies, and a Handbook on HTA capacity building for Member States with limited institutionalization of HTA.Conclusions: The tools provide high-quality information and methodological frameworks for HTA that facilitate preparation of HTA documentation, and sharing of information in and across national or regional systems. The tools will be used and further tested by partners in the EUnetHTA Collaboration aiming to (i) help reduce unnecessary duplication of HTA activities, (ii) develop and promote good practice in HTA methods and processes, (iii) share what can be shared, (iv) facilitate local adaptation of HTA information, (v) improve the links between health policy and HTA.

scholarly journals Real-world evidence: perspectives on challenges, value, and alignment of regulatory and national health technology assessment data collection requirements

2021 ◽  
Vol 37 ◽  
Author(s):  
Hannah Sievers ◽  
Angelika Joos ◽  
Mickaël Hiligsmann
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Real World ◽  
Health Technology ◽  
Practical Experience ◽  
Added Value ◽  
Real World Data ◽  
Conflicting Demands ◽  
Real World Evidence ◽  
Semistructured Interviews

Abstract Objective This study aims to assess stakeholder perceptions on the challenges and value of real-world evidence (RWE) post approval, the differences in regulatory and health technology assessment (HTA) real-world data (RWD) collection requirements under the German regulation for more safety in drug supply (GSAV), and future alignment opportunities to create a complementary framework for postapproval RWE requirements. Methods Eleven semistructured interviews were conducted purposively with pharmaceutical industry experts, regulatory authorities, health technology assessment bodies (HTAbs), and academia. The interview questions focused on the role of RWE post approval, the added value and challenges of RWE, the most important requirements for RWD collection, experience with registries as a source of RWD, perceptions on the GSAV law, RWE requirements in other countries, and the differences between regulatory and HTA requirements and alignment opportunities. The interviews were recorded, transcribed, and translated for coding in Nvivo to summarize the findings. Results All experts agree that RWE could close evidence gaps by showing the actual value of medicines in patients under real-world conditions. However, experts acknowledged certain challenges such as: (i) heterogeneous perspectives and differences in outcome measures for RWE generation and (ii) missing practical experience with RWD collected through mandatory registries within the German benefit assessment due to an unclear implementation of the GSAV. Conclusions This study revealed that all stakeholder groups recognize the added value of RWE but experience conflicting demands for RWD collection. Harmonizing requirements can be achieved through common postlicensing evidence generation (PLEG) plans and joint scientific advice to address uncertainties regarding evidence needs and to optimize drug development.

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.

R WE ready for reimbursement? A round up of developments in RWE relating to health technology assessment: part 2

2021 ◽  
Author(s):  
Alex Simpson ◽  
Sreeram V Ramagopalan
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Real World ◽  
Health Technology ◽  
Health Inequity ◽  
Real World Data ◽  
World Data

In this round up, we cover how COVID-19 has been beneficial for improved access to real-world data, as well as how real-world data can be used to address health inequity, an area of increasing interest for health technology assessment.

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.

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.

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