PP096 European Union-Health Technology Assessments For Medical Devices - How To Overcome Reimbursement Divergence

2017 ◽  
Vol 33 (S1) ◽  
pp. 116-117
Author(s):  
Jana Hemmerling ◽  
Karolin Eberle ◽  
Sara Hogger ◽  
Maike Gupta ◽  
Anna Ullraum ◽  
...  
Keyword(s):  
Health Care ◽  
Medical Device ◽  
Medical Devices ◽  
Small Body ◽  
Health Technology ◽  
Surrogate Endpoints ◽  
European Network ◽  
Gemeinsamer Bundesausschuss ◽  
Real World Data ◽  
Clinical Reality

INTRODUCTION:National Health Technology Assessments (HTAs) for medical devices are crucial to regulate the quality and costs of healthcare systems. However, there is diversity in several aspects among European countries. Consequently, controversial results might arise, generating contrary reimbursement decisions. The European Network for Health Technology Assessment (EUnetHTA) is an interface platform for the harmonization of HTA information across Europe. The European Commission expects national uptake of a European HTA. Thus, European HTAs might overcome the diversity of national HTA requirements.METHODS:We aimed to compare German and European HTAs for medical devices regarding processes, methods, timelines, and involvement of medical device companies. Therefore we analyzed guidelines, requirements, and output of EUnetHTA and compared those aspects with the German G-BA (Federal Joint Committee, Gemeinsamer Bundesausschuss) standard and IQWiG (Institute for Quality and Efficiency in Health Care, Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen) methods.RESULTS:We found differences between the European and German HTAs for medical devices regarding timelines, involvement of medical device companies, body of evidence, use of surrogate endpoints, and methodology. European HTAs for medical devices reflect the clinical reality by integrating the existing evidence (including real world data) and by using comprehensive statistical methods for medical devices. In contrast, German HTAs for medical device-based technologies are long lasting and are often restricted to a small body of evidence.CONCLUSIONS:As a conclusion, similar to pharmaceuticals, the European HTA framework might also become a worldwide platform for HTAs of medical device-based technologies with the potential to harmonize reimbursement decisions and patients health care across countries on the basis of clinical reality.

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 Negative Pressure Wound Therapy: Reimbursement situation of this medical device 15 years after entering the European Market

2016 ◽  
Vol 3 (1) ◽  
Author(s):  
Joerg Linder
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Negative Pressure ◽  
Negative Pressure Wound Therapy ◽  
Clinical Evidence ◽  
Health Technology ◽  
Wound Therapy ◽  
Outpatient Sector ◽  
Fully Functioning ◽  
Economic Studies

Getting adequate reimbursement for new and innovative medical devices is crucial for a successful uptake of the product in the market. However in the last years payers and authorities pushed for more detailed evaluations of the actual benefits of new medical devices before granting reimbursement. These assessment are often based on established Health-Technology-Assessments methods developed for pharmaceuticals. But as medical devices and pharmaceuticals differ in many ways these processes often do not work as smoothly as hoped and necessary. The history and current reimbursement situation of Negative-Pressure-Wound-Therapy (NPWT) is an example for these issues. Despite being on the market for over fifteen years in Europe and backed up by clinical and economic studies only Germany, Switzerland, Netherland, Sweden and Slovakia do have a dedicated reimbursement for NPWT in the inpatient sector. In the outpatient sector the reimbursement situation is even bleaker as only Switzerland and Austria have a fully functioning reimbursement in place. In Germany reimbursement decision are taken on a case-by-case base while in England only the dressings are reimbursed but not the equipment itself. In France only usage in the home hospitalisation sector is reimbursed. This situation cannot be satisfying for patients, physicians, payers and manufacturers. In order to improve the uptake of new medical devices manufacturer need to focus earlier on creating solid clinical evidence while payers also have to adapt their health-technology-assessments and take the differences of medical devices compared to pharmaceuticals into account.

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.

Trends in software as a medical device (Preprint)

2020 ◽  
Author(s):  
Aaron Ceross ◽  
Jeroen Bergmann
Keyword(s):  
Health Care ◽  
Data Analysis ◽  
High Risk ◽  
Adverse Events ◽  
Medical Device ◽  
Empirical Analysis ◽  
Medical Devices ◽  
Digital Revolution ◽  
The Us ◽  
Software Registration

UNSTRUCTURED Software-as-a-medical-device (SaMD) has gained popularity as a type of medical device. However, to date, empirical analysis of SaMD trends have been lacking. Using databases managed by the US medical device regulator (the Food and Drug Administration), we map the path SaMD takes towards classification and recorded adverse events. The findings show that while SaMD has been identified in literature as an area of development, the data analysis suggests that this growth has been modest. These devices are overwhelming classified as moderate to high risk and they take a very particular path to that classification. The digital revolution in health care is less pronounced when evidence is considered of SaMD. In general, the trend for software registration mimics that of medical devices.

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.

OP15 Actions Arising From The 2017 Health Technology Assessment International Asia Policy Forum

2018 ◽  
Vol 34 (S1) ◽  
pp. 7-7
Author(s):  
Brendon Kearney ◽  
Rebecca Trowman
Keyword(s):  
Health Care ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Real World ◽  
Health Technology ◽  
Universal Health Care ◽  
Real World Data ◽  
Public And Private ◽  
Policy Forum ◽  
Universal Health

Introduction:Universal health care (UHC) leads to better health, educational outcomes and productivity. However, Asian healthcare systems are experiencing huge pressures and are striving to achieve UHC. With this in mind, the Health Technology Assessment International (HTAi) Asia Policy Forum (APF) tackled, ‘Universal Health Care in the Asia Region: Overcoming the Barriers using HTA and Real World Data (RWD)’.Methods:The HTAi APF convened forty-four senior representatives from HTA agencies and industry from Asia. Through a mixture of keynote presentations and guided group discussions, APF members spent two days grappling with the topic.Results:There were a number of key messages from the APF, plus actions that were identified by APF members. The actions included: (i) A standardized HTA methodology for the prioritization of technologies in the Asia region should be developed to support health care systems; (ii) HTAi need to define what real-world data means in the HTA glossary; (iii) Members of the APF should develop a catalogue of what public and private data is available across countries in the region; (iv) A policy statement that agencies can use with a common approach to the release of data needs to be developed.Conclusions:HTA and access to RWD were identified as essential tools to be used in achieving the goal of UHC; this goal should indeed be pursued in the Asia region. However, issues such as transparency and accountability of HTA, and trust and collaboration between the public and private sectors are important concerns which need to be addressed in order to progress this goal. The recommendations for actions resulting from this successful APF update on progress towards these identified actions will be presented.

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