scholarly journals The Use Of Real World Evidence To Support Market Access Of Medical Devices – Implications For The German Setting

2015 ◽  
Vol 18 (7) ◽  
pp. A372 ◽  
Author(s):  
C Jacob ◽  
D Meise ◽  
T Mittendorf ◽  
S Braun
Keyword(s):  
Medical Devices ◽  
Real World ◽  
Market Access ◽  
Real World Evidence

scholarly journals Postlaunch evidence-generation studies for medical devices in Spain: the RedETS approach to integrate real-world evidence into decision making

2021 ◽  
Vol 37 (1) ◽  
Author(s):  
Pedro Serrano-Aguilar ◽  
Iñaki Gutierrez-Ibarluzea ◽  
Pilar Díaz ◽  
Iñaki Imaz-Iglesia ◽  
Jesús González-Enríquez ◽  
...  
Keyword(s):  
Decision Making ◽  
Medical Devices ◽  
Real World ◽  
Policy Decision ◽  
Assessment Process ◽  
The European Union ◽  
Political Commitment ◽  
Real World Evidence ◽  
Health Policy Decision ◽  
Regional Health Authorities

Abstract The Monitoring Studies (MS) program, the approach developed by RedETS to generate postlaunch real-world evidence (RWE), is intended to complement and enhance the conventional health technology assessment process to support health policy decision making in Spain, besides informing other interested stakeholders, including clinicians and patients. The MS program is focused on specific uncertainties about the real effect, safety, costs, and routine use of new and insufficiently assessed relevant medical devices carefully selected to ensure the value of the additional research needed, by means of structured, controlled, participative, and transparent procedures. However, despite a clear political commitment and economic support from national and regional health authorities, several difficulties were identified along the development and implementation of the first wave of MS, delaying its execution and final reporting. Resolution of these difficulties at the regional and national levels and a greater collaborative impulse in the European Union, given the availability of an appropriate methodological framework already provided by EUnetHTA, might provide a faster and more efficient comparative RWE of improved quality and reliability at the national and international levels.

scholarly journals RW3 The Use of Real-World Evidence in HTA of CLASS III Medical Devices in Europe

2020 ◽  
Vol 23 ◽  
pp. S758
Author(s):  
P. Klein ◽  
S. de Groot ◽  
H.M. Blommestein ◽  
B. Pongiglione ◽  
A. Torbica ◽  
...  
Keyword(s):  
Medical Devices ◽  
Real World ◽  
Class Iii ◽  
Real World Evidence

scholarly journals Do existing real-world data sources generate suitable evidence for the HTA of medical devices in Europe? Mapping and critical appraisal

2021 ◽  
Vol 37 (1) ◽  
Author(s):  
Benedetta Pongiglione ◽  
Aleksandra Torbica ◽  
Hedwig Blommestein ◽  
Saskia de Groot ◽  
Oriana Ciani ◽  
...  
Keyword(s):  
Decision Making ◽  
Medical Devices ◽  
Real World ◽  
Real World Data ◽  
Data Accessibility ◽  
World Data ◽  
Transcatheter Aortic Valve ◽  
Real World Evidence ◽  
Hip And Knee Arthroplasty ◽  
Valve Implantation

Abstract Aim Technological and computational advancements offer new tools for the collection and analysis of real-world data (RWD). Considering the substantial effort and resources devoted to collecting RWD, a greater return would be achieved if real-world evidence (RWE) was effectively used to support Health Technology Assessment (HTA) and decision making on medical technologies. A useful question is: To what extent are RWD suitable for generating RWE? Methods We mapped existing RWD sources in Europe for three case studies: hip and knee arthroplasty, transcatheter aortic valve implantation (TAVI) and mitral valve repair (TMVR), and robotic surgery procedures. We provided a comprehensive assessment of their content and appropriateness for conducting the HTA of medical devices. The identification of RWD sources was performed combining a systematic search on PubMed with gray literature scoping, covering fifteen European countries. Results We identified seventy-one RWD sources on arthroplasties; ninety-five on TAVI and TMVR; and seventy-seven on robotic procedures. The number, content, and integrity of the sources varied dramatically across countries. Most sources included at least one health outcome (97.5%), with mortality and rehospitalization/reoperation the most common; 80% of sources included resource outcomes, with length of stay the most common, and comparators were available in almost 70% of sources. Conclusions RWD sources bear the potential for the HTA of medical devices. The main challenges are data accessibility, a lack of standardization of health and economic outcomes, and inadequate comparators. These findings are crucial to enabling the incorporation of RWD into decision making and represent a readily available tool for getting acquainted with existing information sources.

PP149 Assessment Of New Medical Devices With Administrative Databases

2017 ◽  
Vol 33 (S1) ◽  
pp. 139-140
Author(s):  
Giuditta Callea ◽  
Maria Caterina Cavallo ◽  
Rosanna Tarricone
Keyword(s):  
Clinical Practice ◽  
Medical Devices ◽  
Real World ◽  
Classification System ◽  
New Technologies ◽  
Diagnosis Related Groups ◽  
Classification Systems ◽  
Administrative Databases ◽  
Real World Evidence ◽  
Coding Guidelines

INTRODUCTION:Administrative data (for example, hospital discharge databases, HDDs) can be used as a real world source of clinical and economic evidence for assessing new medical devices (MDs), provided that their use can be identified in the data. In absence of updated classification systems for procedures and diagnoses, which allow to identify the use of new technologies in the data, traceability can still be achieved thanks to authorities coding guidelines (that is, indication on how to combine the existing codes for procedures and/or diagnoses when new technologies are used).In 2009 Italy adopted version 2007 of the International Classification System of Diseases (ICD-9-CM) and version 24 of Diagnosis Related Groups (DRGs), which are still in use. The aim of this work was to investigate the capacity of the classification system currently used in Italy, which is at high risk of obsolescence, to identify innovative MDs.METHODS:To achieve our goal, we performed a systematic search of all the national and regional coding guidelines published from 2009 (that is, the year of introduction of the new classification systems) to 2015. We extracted from each document the list of technologies for which the Ministry of Health and/or the Regional Authorities provided with coding indications.RESULTS:Our results show that only a few recent technological innovations can be identified in the Italian HDDs. This reduces the possibility for decision makers to measure new technologies outcomes and costs in the real world clinical practice.CONCLUSIONS:The traceability of new MDs' can support Heath Technology Assessment (HTA). Indeed, HTA programs should use real world evidence to re-assess MDs 2–3 years after their introduction in clinical practice. The use of routinely collected data, such as HDD, would allow to measure new technologies' “real” effectiveness in “real” world, on “real” patients in “real” hospitals to complement the evidence from Randomized Controlled Trials.

OP188 Post-Launch Evidence Generation Studies For Medical Devices In Spain: Integrating Real World Evidence Into Decision-Making

2021 ◽  
Vol 37 (S1) ◽  
pp. 4-5
Author(s):  
Inaki Imaz-Iglesia ◽  
Pedro Serrano ◽  
Eugenia Orejas ◽  
Anai Moreno ◽  
Janet Puñal-Ruibóo ◽  
...  
Keyword(s):  
Decision Making ◽  
Cost Effectiveness ◽  
Medical Devices ◽  
Real World ◽  
Left Ventricular ◽  
Ventricular Assist Devices ◽  
Repair System ◽  
Left Ventricular Assist Devices ◽  
Real World Evidence ◽  
Evidence Generation

IntroductionA national act (Order SSI/1356/2015) regulating Post-Launch Evidence Generation (PLEG) studies was set in Spain in 2015. These PLEG studies are to inform decisions about technologies already included in the Benefit Portfolio of the Spanish National Health System (SNHS) in order to confirm/exclude/modify their terms of use. Once a PLEG is established the selected hospitals provide the technology according to a common protocol and register outcomes until the required sample size is reached.MethodsThe PLEG studies are prospective, observational and single arm studies on safety, effectiveness and cost-effectiveness of a technology in real practice. The technology is selected because of the identification of an evidence gap, usually through a health technology assessment (HTA) report made by an agency of the Spanish Network of HTA Agencies (RedETS). The execution of a PLEG is assigned to one of the RedETS Agencies, which is responsible of delivering annual reports and a final report when the objectives are reached.ResultsThe following six PLEG studies, all of them on medical devices, have been launched in Spain so far, i) Endobronchial valve for patients with persistent air leak; ii) Biodegradable esophageal stent; iii) Percutaneous mitral valve repair system by clip; iv) Left Atrial Appendage Closure Device; v) Sensor-based glucose monitoring systems for children with type 1 diabetes mellitus; vi) Left ventricular assist devices for destination therapy. Five studies will finish their data collection by the end of 2020 or during 2021.ConclusionsA new national procedure using PLEG has been made available in Spain facilitating the use of real-world evidence to inform national decision-making on the financing of selected technologies due to uncertainties about their effectiveness, safety, cost-effectiveness and organizational impact. The studies are requiring a high amount of coordination tasks, as they are involving an average of 21 hospitals each. The usefulness and suitability of this procedure to achieve its objectives must be evaluated once their results are available.

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