scholarly journals PMD172 - HOSPITAL-BASED HEALTH TECHNOLOGY ASSESSMENT OF MEDICAL DEVICES IN FRANCE: A COLLABORATION WITH MEDICAL DEVICE MANUFACTURERS OR NATIONAL AGENCY?

2018 ◽  
Vol 21 ◽  
pp. S272-S273
Author(s):  
C. Fradet ◽  
C. Tardivel ◽  
H. Cawston
Keyword(s):  
Health Technology Assessment ◽  
Medical Device ◽  
Medical Devices ◽  
Technology Assessment ◽  
Health Technology ◽  
National Agency ◽  
Medical Device Manufacturers

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.

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.

OP25 Evidence Gathering Across Key Stakeholders Involved In Early Health Technology Assessment

2017 ◽  
Vol 33 (S1) ◽  
pp. 12-12
Author(s):  
Stefania Manetti ◽  
Richéal Burns ◽  
Giuseppe Turchetti
Keyword(s):  
Health Technology Assessment ◽  
Medical Device ◽  
Medical Devices ◽  
Technology Assessment ◽  
Health Technology ◽  
Early Assessment ◽  
Key Stakeholders ◽  
Early Health Technology Assessment ◽  
Two Samples ◽  
Early Health

INTRODUCTION:The adoption and reimbursement of a new or novel medical device frequently occurs after an economic evaluation of the innovation. One important factor for reimbursement rejections by the English National Institute for Health and and Care Excellence (NICE) Medical Technologies Evaluation Programme (MTEP) appears to be the little or no attention to early assessment (1). The aim of this study is to achieve a more in-depth and comprehensive understanding of the value of early Health Technology Assessment (HTA) for new medical devices.METHODS:This study employs a mixed methods research strategy. Our informant interviews involved two types of key stakeholders: health economists in academia and professionals in medical devices firms with a professional role in research and development or market access departments. Our qualitative analysis focused on two samples from six universities (five in the United Kingdom, UK, and one in Italy) and six small to medium-sized enterprises (five in the UK, and one in Italy). Insights from field work interviews helped to design our complementary quantitative analysis.RESULTS:During thematic analysis, barriers to adoption of early HTA emerged across three domains. First, educational barriers (that is, what HTA/early HTA is and how to conduct it) influenced the foundation for the reimbursement strategy. Second, interviewees highlighted the presence of intrinsic barriers (for example, resources for translational and early preclinical research, reliability and reproducibility, evidence, and dissemination of sensitive information) within existing practices and knowledge. Third, several research gaps (that is, medical device classification, standardization of methods, guidelines for developers, and alignment of stakeholders perspectives) were identified. Finally, academics adopted early HTA to assess different aspects of a medical device early in development; however, developers were focused on the assessment of investment and safety/usability factors, especially for in-house evaluations.CONCLUSIONS:If decision makers expect developers to produce better quality evidence and society aims to optimize resources that is, not investing in non-cost-effective technologies, then the incorporation of a more robust analytical framework including a societal perspective is necessary to understand how early HTA can be embedded into all aspects of the development process.

PP206 Health Technology Assessment Guidance In The United Kingdom: Addressing Issues Specific To Medical Devices

2021 ◽  
Vol 37 (S1) ◽  
pp. 26-26
Author(s):  
Scott Gibson ◽  
Sita Saunders ◽  
Amanda Hansson Hedblom ◽  
Maximilian Blüher ◽  
Rafael Torrejon Torres ◽  
...  
Keyword(s):  
United Kingdom ◽  
Health Technology Assessment ◽  
Medical Devices ◽  
Technology Assessment ◽  
Healthcare Providers ◽  
Economic Assessment ◽  
Health Technology ◽  
Training Costs ◽  
Medical Technologies ◽  
The United Kingdom

IntroductionThe United Kingdom spends approximately GBP4.2 billion (USD5.6 billion; EUR4.7 billion) each year on medical devices, but healthcare providers receive little health technology assessment (HTA) guidance on cost-effective device procurement. Our objective was to assess the availability of HTA guidance for medical technologies and to identify key challenges related to the economic assessment of these technologies.MethodsNational Institute for Health and Care Excellence technology appraisal (TA) and Medical Technologies Evaluation Programme (MTEP) appraisals published online between November 2009 and October 2020 were identified. The “case for adoption” recommendation, type of devices, and critiques of economic analyses for each MTEP appraisal were extracted and categorized.ResultsIn comparison to 415 publicly available TAs for pharmaceuticals, only 45 medical technologies have been appraised through the MTEP. MTEP-submitted technologies can be categorized into diagnostic (7), monitoring (3), prophylaxis (5), therapeutic (28), and other (2). Furthermore, 11 were implants, seven were used by patients, and 27 had provider interaction. Major points of MTEP criticism were a failure to model cost consequences, training costs, and organizational impact. There was also the barrier of transferring costs across budgeting divisions.ConclusionsIn comparison to HTA guidance for pharmaceuticals, there is a dearth of medical device guidance. Therapeutic and implantable devices appear to be disproportionately overrepresented in the MTEP process. This may be because their appraisal is most akin to pharmaceuticals, for which HTA processes are well established. To encourage more HTAs of medical devices, HTA guidance should elaborate on issues specifically related to medical devices.

scholarly journals The development of health technology assessment in Brazil

2009 ◽  
Vol 25 (S1) ◽  
pp. 255-259 ◽  
Author(s):  
David Banta ◽  
Rosimary T. Almeida
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Descriptive Analysis ◽  
Institutional Development ◽  
Health Technology ◽  
National Agency ◽  
Private Companies ◽  
Considerable Impact ◽  
The Impact ◽  
Growing Network

Objectives: The aim of this study was to describe the developing health technology assessment (HTA) activities in Brazil, both historically and in the present day.Methods: This report is a descriptive analysis based on personal experiences of the authors and on selected literature.Results: Interest in HTA in Brazil began in the mid-1980s. Several seminars and consultations were held, often with invited foreign participants. A cadre of people with knowledge and expertise in HTA was gradually developed. In 2003, several policies were developed by the federal government of Brazil to encourage HTA and base clinical, management, and policy decisions on HTA. During the past 5 years, institutional development has been rapid in government, private companies (mainly prepaid health plans), academia, and research institutes. Further policy changes are needed to maximize the impact of these developments. Nevertheless, although the growing network of HTA programs will have a considerable impact on Brazilian health care, further institutional development could stimulate this change.Conclusions: It would be desirable if the Federal Ministry of Health of Brazil were to proceed to develop a national agency for HTA.

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