OP60 Challenges In Evaluating Smart Medical Devices

2019 ◽  
Vol 35 (S1) ◽  
pp. 15-15
Author(s):  
Mareike Mähs
Keyword(s):  
Economic Evaluation ◽  
Medical Devices ◽  
Mixed Method ◽  
Cost Effective ◽  
Health Technology ◽  
Complex Nature ◽  
Learning Effects ◽  
Existing Structures ◽  
Literature Reviews ◽  
Economic Studies

IntroductionSmart medical devices can empower elderly to live independently in their familiar surroundings. To enhance their dissemination, they have to be shown to be cost-effective. Economic studies evaluating such technologies are missing or are criticized for their low quality. There are several challenges in the evaluation of smart medical devices, including their complex nature and innovative character. The question arises: how can evaluations elicit the benefits and cost-effectiveness of smart medical devices. This research has the aim of outlining challenges and demands on the evaluation of smart medical devices.MethodsThe embedding of the technology in existing structures can influence the effectiveness of the technology. By comparing such a technology with a regular intervention, learning effects have to be considered. Regular modifications and further developments of these technologies can complicate the traceability of the effects. Complex cause-effect relationships with possible interactions arise that are difficult to quantify and express in standardized endpoints, utilities or monetary values. Demands on the evaluation of smart medical devices have been explored with literature reviews and scenario techniques using the example of intelligent rollators.ResultsIt is important to apply mixed-method approaches not only in the clinical but also practical setting and conduct observational as well as qualitative studies. Potential users, their relatives and care personnel should be involved in the evaluation of intelligent rollators and attention should be payed to subjects with disabilities. Prospective studies should be conducted at different stages along the lifecycle of the technology. A conceptual model should be developed and evaluated as well as adapted on a regular basis.ConclusionsThe research shows the need to adapt common methods used in economic evaluation to the characteristics of smart medical devices. As a next step, a framework for the economic evaluation of such technologies within the scope of Health Technology Assessment is developed based on these demands.

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.

OP89 Using Economic Evidence To Set Priorities In Ghana: The Case Of Malaria

2017 ◽  
Vol 33 (S1) ◽  
pp. 40-41
Author(s):  
Rebecca Addo ◽  
Jane Hall ◽  
Stephen Goodall ◽  
Marion Haas
Keyword(s):  
Economic Evaluation ◽  
Malaria Control ◽  
Control Strategies ◽  
Evaluation Studies ◽  
Cost Effective ◽  
Economic Evidence ◽  
Control Policies ◽  
International Agencies ◽  
Effective Manner ◽  
Economic Studies

INTRODUCTION:Malaria remains the number one cause of morbidity and mortality in Ghana. Since 1961, several malaria control strategies have been adopted, some of which were discontinued due to funding. In spite of the numerous malaria control strategies in place, its prevalence continues to rise. Priority setting using economic evidence has been proven to ensure efficient use of resources in a cost-effective manner (1). This study, therefore, sought to examine economic evaluation studies conducted on malaria in Ghana and their influence on malaria control policies.METHODS:A systematic search was conducted in databases including Medline and Embase to identify relevant Malaria economic evaluation studies conducted in Ghana up to December 2016. Malaria control policies formulated in Ghana over the years were also reviewed. The economic studies were examined alongside the policies to establish their influence on them.RESULTS:A total of eight studies were identified, all of which were conducted in response to a global directive on malaria control and funded by international agencies. All studies were cost-effective; five evaluating preventive measures and the remaining evaluating treatment. The studies used different methodological approaches, rendering the comparison between alternatives impossible.Most malaria control initiatives are funded by international agencies, hence its abandonment when funding ceases. Although the majority of economic studies addressed some of these policies, none of them directly influenced their adoption. These policies were rather influenced by global malaria control initiatives. Also, malaria chemoprophylaxis; demonstrated as cost-effective by three studies, is not on the Ghana malaria control policy (2,3).CONCLUSIONS:To ensure sustainability of malaria control strategies and subsequently reduce its prevalence, Ghana must invest financially into economic analysis for formulating and implementation of these policies. Also, the use of economic evidence by policy makers can be promoted, should researchers adopt a methodological guideline for its conduct that ensures comparability of results.

scholarly journals How has implementation been incorporated in health technology assessments in the United Kingdom? A systematic rapid review

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Robert Heggie ◽  
Kathleen Boyd ◽  
Olivia Wu
Keyword(s):  
Economic Evaluation ◽  
Health Research ◽  
Research Question ◽  
Behavioural Change ◽  
Complex Interventions ◽  
Cost Effective ◽  
Health Technology ◽  
Rapid Review ◽  
Routine Practice ◽  
Effective Interventions

Abstract Objectives Health interventions in a clinical setting may be complex. This is particularly true of clinical interventions which require systems reorganization or behavioural change, and/or when implementation involves additional challenges not captured within a clinical trial setting. Medical Research Council guidance on complex interventions highlights the need to consider economic evaluation alongside implementation. However, the extent to which this guidance has been adhered to, and how, is unclear. The failure to incorporate implementation within the evaluation of an intervention may hinder the translation of research findings into routine practice. This will have consequences for patient care. This study examined the methods used to address implementation within health research conducted through funding from the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme. Methods We conducted a rapid review using a systematic approach. We included all NIHR HTA monographs which contained the word “implementation” within the title or abstract published between 2014 and 2020. We assessed the studies according to existing recommendations for specifying and reporting implementation approaches in research. Additional themes which were not included in the recommendation, but were of particular relevance to our research question, were also identified and summarized in a narrative synthesis. Results The extent to which implementation was formally incorporated, and defined, varied among studies. Methods for examining implementation ranged from single stakeholder engagement events to the more comprehensive process evaluation. There was no obvious pattern as to whether approaches to implementation had evolved over recent years. Approximately 50% (22/42) of studies included an economic evaluation. Of these, two studies included the use of qualitative data obtained within the study to quantitatively inform aspects relating to implementation and economic evaluation in their study. Discussion A variety of approaches were identified for incorporating implementation within an HTA. However, they did not go far enough in terms of incorporating implementation into the actual design and evaluation. To ensure the implementation of clinically effective and cost-effective interventions, we propose that further guidance on how to incorporate implementation within complex interventions is required. Incorporating implementation into economic evaluation provides a step in this direction.

Qualitative comparative analysis of health economic evaluation guidelines for health technology assessment in European countries

2020 ◽  
pp. 1-8
Author(s):  
Konstantinos Zisis ◽  
Panagiota Naoum ◽  
Kostas Athanasakis
Keyword(s):  
Sensitivity Analysis ◽  
Content Analysis ◽  
Economic Evaluation ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Evaluation Method ◽  
Outcome Measure ◽  
Health Technology ◽  
European Countries ◽  
Common Practices

Abstract Objective To classify, analyze, and compare published guidelines for economic evaluation within health technology assessment (HTA) in European countries and highlight differences and similarities. Methods We performed a literature review to identify published guidance for the conduct and assessment of economic evaluation studies that are undertaken within the context of HTA processes in European countries. Organizations and working groups were identified via the ISPOR, INAHTA, and EUnetHTA databases. Following the identification of official documents, we performed a qualitative content analysis to highlight discrepancies or common practices under the following categories: comparator, perspective on costs/benefits, time horizon, economic evaluation method, instrument used for utility measurement, outcome measure, source for efficacy, modeling, sensitivity analysis, discounting, and incremental cost-effectiveness ratio. Results A total of nineteen guidance documents were identified (in English) providing data for the analysis in nineteen countries. The comparative content analysis identified common practices in most countries regarding the approaches to the choice of comparator, source of data, the preferred economic evaluation method, the option for a lifetime analytical horizon, discounting, and the choice of key outcome measure—for which, most countries recommend the use of the EQ-5D instrument. Differences were mainly found in the choice of perspective, dealing with uncertainty and sensitivity analysis, the use of end points, and the required use of modeling. Conclusions The use of economic evaluation constitutes one of the key pillars of the HTA process in Europe. Although a methodological convergence has occurred during the last few years, notable differences still remain.

scholarly journals Economic evaluation of Australian acute care accreditation (ACCREDIT-CBA (Acute)): study protocol for a mixed-method research project

BMJ Open ◽  
2013 ◽  
Vol 3 (2) ◽  
pp. e002381 ◽  
Author(s):  
Virginia Mumford ◽  
David Greenfield ◽  
Reece Hinchcliff ◽  
Max Moldovan ◽  
Kevin Forde ◽  
...  
Keyword(s):  
Economic Evaluation ◽  
Acute Care ◽  
Study Protocol ◽  
Mixed Method ◽  
Mixed Method Research ◽  
Research Project ◽  
Acute Study

HEALTH TECHNOLOGY ASSESSMENT AND PERSONALIZED MEDICINE: ARE ECONOMIC EVALUATION GUIDELINES SUFFICIENT TO SUPPORT DECISION MAKING?

2014 ◽  
Vol 30 (2) ◽  
pp. 179-187 ◽  
Author(s):  
Don Husereau ◽  
Deborah A. Marshall ◽  
Adrian R. Levy ◽  
Stuart Peacock ◽  
Jeffrey S. Hoch
Keyword(s):  
Decision Making ◽  
Economic Evaluation ◽  
Personalized Medicine ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Population Based ◽  
New Paradigm ◽  
Current Guidance ◽  
Support Decision Making

Background: Many jurisdictions delivering health care, including Canada, have developed guidance for conducting economic evaluation, often in the service of larger health technology assessment (HTA) and reimbursement processes. Like any health intervention, personalized medical (PM) interventions have costs and consequences that must be considered by reimbursement authorities with limited resources. However, current approaches to economic evaluation to support decision making have been largely developed from population-based approaches to therapy—that is, evaluating the costs and consequences of single interventions across single populations. This raises the issue as to whether these methods, as they are or more refined, are adequate to address more targeted approaches to therapy, or whether a new paradigm for assessing value in PM is required.Objectives: We describe specific issues relevant to the economic evaluation of diagnostics-based PM and assess whether current guidance for economic evaluation is sufficient to support decision making for PM interventions.Methods: Issues were identified through literature review and informal interviews with national and international experts (n = 10) in these analyses. This article elaborates on findings and discussion at a workshop held in Ottawa, Canada, in January 2012.Results: Specific issues related to better guiding economic evaluation of personalized medicine interventions include: how study questions are developed, populations are characterized, comparators are defined, effectiveness is evaluated, outcomes are valued and how resources are measured. Diagnostics-based PM also highlights the need for analyses outside of economic evaluation to support decision making.Conclusions: The consensus of this group of experts is that the economic evaluation of diagnostics-based PM may not require a new paradigm. However, greater complexity means that existing approaches and tools may require improvement to undertake these more analyses.

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.

scholarly journals 5G Wireless/Wired Convergence of UFMC Based Modulation for Intensity Modulation Direct Detection

2021 ◽  
Author(s):  
Keerthivasan K ◽  
Shibu S
Keyword(s):  
Network Architecture ◽  
Direct Detection ◽  
Low Cost ◽  
Cost Effective ◽  
Theoretical Work ◽  
Base Stations ◽  
Complex Nature ◽  
Implementation Model ◽  
Effective Manner ◽  
Media Applications

Faster data speeds, shorter end-to-end latencies, improved end-user service efficiency, and a wider range of multi-media applications are expected with the new 5G wireless services. The dramatic increase in the number of base stations required to meet these criteria, which undermines the low-cost constraints imposed by operators, demonstrates the need for a paradigm shift in modern network architecture. Alternative formats will be required for next-generation architectures, where simplicity is the primary goal. The number of connections is expected to increase rapidly, breaking the inherent complexity of traditional coherent solutions and lowering the resulting cost percentage. A novel implementation model is used to migrate complex-nature modulation structures in a highly efficient and cost-effective manner. Theoretical work to analyses modulations’ behavior over a wired/fiber setup and wireless mode is also provided. The state-of-the-art computational complexity, simplicity, and ease of execution while maintaining efficiency throughput and bit error rate.

Sign in / Sign up

Export Citation Format

Share Document