Enhancing Health Technology Assessment Establishment in Asia: Practical Issues From the Pharmaceutical and Medical Device Industry Perspectives

2021 ◽  
Vol 24 ◽  
pp. 31-32
Author(s):  
Hong Li ◽  
Larry Liu ◽  
Bo-Xiong Tang ◽  
Bruce Wang ◽  
Peng Dong ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Medical Device ◽  
Technology Assessment ◽  
Health Technology ◽  
Medical Device Industry ◽  
Device Industry

INTRODUCTION OF INNOVATIVE MEDICAL DEVICES AT FRENCH UNIVERSITY HOSPITALS: AN OVERVIEW OF HOSPITAL-BASED HEALTH TECHNOLOGY ASSESSMENT INITIATIVES

2015 ◽  
Vol 31 (1-2) ◽  
pp. 12-18 ◽  
Author(s):  
Nicolas Martelli ◽  
Mathilde Billaux ◽  
Isabelle Borget ◽  
Judith Pineau ◽  
Patrice Prognon ◽  
...  
Keyword(s):  
Decision Making ◽  
Health Technology Assessment ◽  
Medical Device ◽  
Medical Devices ◽  
Technology Assessment ◽  
Health Technology ◽  
Local Health ◽  
University Hospitals ◽  
Health Technologies ◽  
Management Processes

Objectives: Local health technology assessment (HTA) to determine whether new health technologies should be adopted is now a common practice in many healthcare organizations worldwide. However, little is known about hospital-based HTA activities in France. The objective of this study was to explore hospital-based HTA activities in French university hospitals and to provide a picture of organizational approaches to the assessment of new and innovative medical devices.Methods: Eighteen semi-structured interviews with hospital pharmacists were conducted from October 2012 to April 2013. Six topics were discussed in depth: (i) the nature of the institution concerned; (ii) activities relating to innovative medical devices; (iii) the technology assessment and decision-making process; (iv) the methodology for technology assessment; (v) factors likely to influence decisions and (vi) suggestions for improving the current process. The interview data were coded, collated and analyzed statistically.Results: Three major types of hospital-based HTA processes were identified: medical device committees, innovation committees, and “pharmacy & management” processes. HTA units had been set up to support medical device and innovation committees for technology assessment. Slow decision making was the main limitation to both these committee-based approaches. As an alternative, “pharmacy & management” processes emerged as a means of rapidly obtaining a formal assessment.Conclusions: This study provides an overview of hospital-based HTA initiatives in France. We hope that it will help to promote hospital-based HTA activities in France and discussions about ways to improve and harmonize practices, through the development of national guidelines and/or a French mini-HTA tool, for example.

Health Technology Assessment From a Canadian Device Industry Perspective

2009 ◽  
Vol 6 (5) ◽  
pp. 353-359 ◽  
Author(s):  
Ilia L. Ferrusi ◽  
David Ames ◽  
Morgan E. Lim ◽  
Ron Goeree
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Device Industry

Health technology assessment process of a cardiovascular medical device in four different settings

2017 ◽  
Vol 6 (7) ◽  
pp. 591-600
Author(s):  
Antonio Olry de Labry Lima ◽  
Jaime Espín Balbino ◽  
Alexandre Lemgruber ◽  
Araceli Caro Martínez ◽  
Leticia García-Mochón ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Medical Device ◽  
Technology Assessment ◽  
Health Technology ◽  
Assessment Process ◽  
Health Technology Assessment Process

PP32 Joint Early Dialogs Between Medical Device Regulation and Health Technology Assessment

2019 ◽  
Vol 35 (S1) ◽  
pp. 43-43
Author(s):  
Petra Schnell-Inderst ◽  
Claudia Wild
Keyword(s):  
High Risk ◽  
Health Technology Assessment ◽  
Medical Device ◽  
Technology Assessment ◽  
Health Technology ◽  
European Medicines Agency ◽  
Scientific Advice ◽  
Market Approval ◽  
Evidence Generation ◽  
Medical Device Regulation

IntroductionIn Europe, the new Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) that entered into force 2017 will have to be applied until 2020 and 2022, respectively. Under the old regulation, there was a large gap between evidence requirements for market approval and market access for high risk (class IIb and III) medical devices (MD). The MDR/IVDR will require appropriate clinical investigations for these MD classes. Despite the different purpose of market approval and surveillance and reimbursement decisions, there are possible synergies with regard to evidence generation, for example, design of pivotal trials and post-launch evidence generation with observational data. In the MDR, early scientific advice can be provided by expert panels of the European Commission if requested by MD developers. For medicinal products, the European network for Health Technology Assessment (EUnetHTA) has established joint early dialogs (JED) of HTA agencies with the European Medicines Agency and manufacturers. A similar approach might be possible with the Medical Device Coordination Group (MDCG). The objective was to explore possible synergies for JED with the MDCG and EUnetHTA.MethodsIn 2018, EUnetHTA established a task force for HTA and MDR/IVDR. A workshop, which will explore possible synergies and activities on JED as well as the viewpoints of stakeholders will be held in May 2019. Participants will be Directorate-Generals GROW (Internal Market, Industry, Entrepreneurship and SME) and SANTE (Health and Food Safety), EUnetHTA members assessing MD, representatives of national competent authorities, Team Notified Bodies, MedTech Europe, patient representatives and academia.ResultsA report on the presentations, the results of the discussion, and next steps in a possible collaboration will be presented.ConclusionsJoint early scientific advice to manufacturers on the European level for evidence generation by HTA agencies and the MDCG has the potential to streamline evidence generation in the life cycle of high risk MD.

VP76 European Collaboration In Health Technology Assessment – Experiences And Possible Benefits

2017 ◽  
Vol 33 (S1) ◽  
pp. 184-185
Author(s):  
Julia Mayer ◽  
Sabine Ettinger ◽  
Anna Nachtnebel
Keyword(s):  
Health Care ◽  
Health Technology Assessment ◽  
Medical Device ◽  
National Health ◽  
Medical Devices ◽  
Technology Assessment ◽  
Patient Involvement ◽  
Health Technology ◽  
Cross Border ◽  
European Collaboration

INTRODUCTION:Consistently high-quality health care is expected throughout Europe while concurrently, financial resources of member states are decreasing. National Health Technology Assessment (HTA) institutes are informing evidence-based reimbursement decisions in the national context, leading to redundancies in HTA production and tying up limited resources. Since 2006, the European Union project, the European Network for HTA (EUnetHTA) is aiming at enhancing the efficient use of HTA resources and facilitating transnational collaboration. Our aim is to present previous experience in joint assessment of medical devices. Furthermore, possible benefits of European collaboration for stakeholders will be discussed.METHODS:Processes and challenges of the completed EUnetHTA Joint Action (JA) 2 are summarized and discussed. Benefits, aims and opportunities of the ongoing EUnetHTA JA 3 are described.RESULTS:Six rapid assessments of medical devices, focusing on the assessment of effectiveness and safety, were published during EUnetHTA JA 2. Challenges in European medical device assessment encompass the choice of topics, the time point of assessments and the lack of European standards for systematic patient involvement. Characteristics of medical devices, like learning curves, call for monitoring them throughout their lifecycle.The benefit of European collaboration for stakeholders is manifold: uncertainty with regard to actual added value of a technology is minimized through Early Dialogues; harmonized and transparent assessment processes increase the quality of reports; work division among HTA organizations allows a resource-efficient assessment of a bigger amount of technologies; patient involvement ensures consideration of patient relevant endpoints.The importance of cross-border collaboration in HTA is shown in the continuation of the EUnetHTA project, which aims to sustainably strengthen international collaboration even after expiration of EU-funding.CONCLUSIONS:European collaboration in medical device assessment can ensure cross-border health care and efficient cooperation of national health systems. The focus should be set on a wide implementation of jointly established methods and quality standards. The European collaboration can lead to a concrete benefit for various stakeholders.

scholarly journals HEALTH TECHNOLOGY ASSESSMENT METHODS GUIDELINES FOR MEDICAL DEVICES: HOW CAN WE ADDRESS THE GAPS? THE INTERNATIONAL FEDERATION OF MEDICAL AND BIOLOGICAL ENGINEERING PERSPECTIVE

2018 ◽  
Vol 34 (3) ◽  
pp. 276-289 ◽  
Author(s):  
Julie Polisena ◽  
Rossana Castaldo ◽  
Oriana Ciani ◽  
Carlo Federici ◽  
Simone Borsci ◽  
...  
Keyword(s):  
Focus Group ◽  
Health Technology Assessment ◽  
Medical Device ◽  
Medical Devices ◽  
Technology Assessment ◽  
Health Technology ◽  
International Federation ◽  
Assessment Methods ◽  
Delphi Survey ◽  
Clinical Engineers

Objectives:Current health technology assessment (HTA) methods guidelines for medical devices may benefit from contributions by biomedical and clinical engineers. Our study aims to: (i) review and identify gaps in the current HTA guidelines on medical devices, (ii) propose recommendations to optimize the impact of HTA for medical devices, and (iii) reach a consensus among biomedical engineers on these recommendations.Methods:A gray literature search of HTA agency Web sites for assessment methods guidelines on devices was conducted. The International Federation of Medical and Biological Engineers (IFMBE) then convened a structured focus group, with experts from different fields, to identify potential gaps in the current HTA guidelines, and to develop recommendations to fill these perceived gaps. The thirty recommendations generated from the focus group were circulated in a Delphi survey to eighty-five biomedical and clinical engineers.Results:Thirty-two panelists, from seventeen countries, participated in the Delphi survey. The responses showed a strong agreement on twenty-seven of thirty recommendations. Some uncertainties remain about the methods to accurately assess the effectiveness and safety, and interoperability of a medical device with other devices or within the clinical setting.Conclusions:As medical devices differ from drug therapies, current HTA methods may not accurately reflect the conclusions of their assessment. Recommendations informed by the focus group discussions and Delphi survey responses aimed to address the perceived gaps, and to provide a more integrated approach in medical device assessments in combining engineering with other perspectives, such as clinical, economic, patient, human factors, ethical, and environmental.

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