Economic Evaluation Of Medical Devices Research Articles

EE235 Economic Evaluations of Medical Devices Used in the Treatment of Breast Cancer: A Systematic Review

EE235 Economic Evaluations of Medical Devices Used in the Treatment of Breast Cancer: A Systematic Review

HTA65 Economic Evaluation of Medical Devices By the French National Authority (2014-2022): Where Do We Stand?

HTA65 Economic Evaluation of Medical Devices By the French National Authority (2014-2022): Where Do We Stand?

Resilience of a Supply Chain-Based Economic Evaluation of Medical Devices From an Industry Perspective

Health budget allocation choices are increasingly aided by medical technology's economic evaluation (EE). With thousands of new items launched each year, the medical device (MD) business is one of the most active domains of medical advancement among providers of innovation. Some of these considerations have to do with the specifics of how the gadget works. The paper examines the investment assessment of new medical devices from an industrial viewpoint. The strategy EE-MD presented should lead to more inventive and cost-effective surgical supplies for the medical industry. The study's purpose is to better the decision-making process for medical device development. Small and medium-sized firms are a crucial source of innovation for the future, and the research focuses mostly on them. Design economy and professional engineering literature are linked in the article. The proposed multi-attribute and team method to construct selection discusses the financial factor and provides a strong foundation for ongoing program management by identifying project-specific risks and strategic alliances.

A Pragmatic Solution to the Economic Evaluation of Medical Devices From an Industry Perspective

Through the use of a multiattribute model, this article addresses the investment appraisal of innovative medical devices from an industry perspective. The model proposed aims to reduce the effect of team conflict, groupthink, project champion bias, leadership influences, and authoritarianism. The approach suggested should lead to more innovative and economically viable medical devices being made available to the healthcare community. The study aims to improve the decision-making process with respect to the development of medical devices. In particular, it focuses on small/medium enterprises, as they are an important source of innovation for the future. Our article provides a link between the engineering economics, engineering management, and project management literature, in which the proposed multiattribute and team approach to project selection not only addresses the economic aspect but also provides a firm foundation for ongoing project management through the identification, at the outset, of project specific risks and strategic alliances. The model should help project and engineering managers, as a part of the selection team, to make optimal project selections and improve project commitment among the various management team players.

Why is There Discordance between the Reimbursement of High-Cost 'Life-Extending' Pharmaceuticals and Medical Devices? The Funding of Ventricular Assist Devices in Australia.

New health technologies often yield health benefits, but often at a high cost. In Australia, the processes for public reimbursement of high-cost pharmaceuticals and medical devices are different, potentially resulting in inequity in support for new therapies. We explore how reimbursement is different for medical devices compared with pharmaceuticals, including whether higher cost-effectiveness thresholds are accepted for pharmaceuticals. A literature review identified the challenges of economic evaluations for medical devices compared with pharmaceuticals. We used the ventricular assist device as a case study to highlight specific features of medical device funding in Australia. We used existing guidelines to evaluate whether ventricular assist devices would fulfil the requirements for the "Life-Saving Drugs Program", which is usually reserved for expensive life-extending pharmaceutical treatments of serious and rare medical conditions. The challenges in conducting economic evaluations of medical devices include limited data to support effectiveness, device-operator interaction (surgical experience) and incremental innovations (miniaturisation). However, whilst high-cost pharmaceuticals may be funded by a single source (federal government), the funding of high-cost devices is complex and may be funded via a combination of federal, state and private health insurance. Based on the Life-Saving Drugs Program criteria, we found that ventricular assist devices could be funded by a similar mechanism to that which funds high-cost life-extending pharmaceuticals. This article highlights the complexities of medical device reimbursement. Whilst differences in available evidence affect the evaluation process, differences in funding methods contribute to inequitable reimbursement decisions between medical devices and pharmaceuticals.

PP166 RedETS: 10 Years Of Economic HTA (Medical Devices) In Spain, 2006–2016

Introduction:RedETS, created in 2006, is the Spanish network of health technology assessment agencies. The objective of this work is to describe and assess the quality of the full economic evaluation reports on medical devices (FEEMD) carried out by RedETS.Methods:The FEEMD were identified through the RedETS website publications database. Assessments about screening technologies were not included. The characteristics of FEEMD were analyzed using a formal RedETS HTA quality checklist. The characteristics extracted were analyzed through a descriptive univariate analysis.Results : Twenty-six FEEMD were found. The publication years were distributed quite uniformly over time (approximately 2/year), although 7 were published in 2008 and 7 in 2013. Thirteen studies analyzed cost-utility, ten cost-effectiveness but not utility, and three both. The most frequent medical devices (MD) class analyzed were “In vitro diagnosis MD” (n = 8) and Class III products (8). The most frequent sources to analyze effectiveness were literature (22) and data collected through ad hoc studies (6). The main sources of unit costs were official public tariffs (14), manufacturers direct values (10) analytical accounting of one/more centers or regions (11) and DRGs (7). In relation to the modelling used, 14 evaluations performed Markov models and 7 decision trees. The perspective of 23 studies was that of the National Health System (NHS), and the rest corresponded to the perspective of a specific region (2) or social perspective (1). All studies analyzing time horizons greater than 1.5 years, except for 1, applied discount rates in the modelling. All studies included a sensitivity analysis.Conclusions:The economic evaluations of MD published by the RedETS accomplish most of the quality checklist aspects and are therefore exhaustive. These FEEMD have been used in the framework of decision making for an efficient management of the NHS basic portfolio.

Challenges in the Assessment of Medical Devices: The MedtecHTA Project.

Assessing medical devices (MDs) raises challenges which require us to reflect on whether current methods are adequate. Major features of devices are: (i) device-operator interaction can generate learning curve effects; (ii) incremental nature of innovation needs to be addressed by careful identification of the alternatives for comparative and incremental cost-effectiveness analysis; and (iii) broader organizational impact in terms of training and infrastructure, coupled with dynamic pricing, requires a more flexible approach to costing. The objective of the MedtecHTA project was to investigate improvements in HTA methods to allow for more comprehensive evaluation of MDs. It consisted of several work packages concerning (i) the available evidence on the currently adopted approaches for regulation and HTA of medical devices; (ii) the geographical variation in access to MDs; (iii) the development of methodological frameworks for conducting comparative effectiveness research and economic evaluation of MDs; and (iv) the organizational impact of MDs. This introductory paper summarizes the main results of the project and draws out the main overarching themes. This supplement represents a comprehensive report of all the main findings of the MedtecHTA project, and it is intended to be the main source for researchers and policy makers wanting information on the project. © 2017 The Authors. Health Economics published by John Wiley & Sons, Ltd.

Improving the Methods for the Economic Evaluation of Medical Devices

Medical devices (MDs) have distinctive features, such as incremental innovation, dynamic pricing, the learning curve and organisational impact, that need to be considered when they are evaluated. This paper investigates how MDs have been assessed in practice, in order to identify methodological gaps that need to be addressed to improve the decision-making process for their adoption. We used the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklist supplemented by some additional categories to assess the quality of reporting and consideration of the distinctive features of MDs. Two case studies were considered: transcatheter aortic valve implantation (TAVI) representing an emerging technology and implantable cardioverter defibrillators (ICDs) representing a mature technology. Economic evaluation studies published as journal articles or within Health Technology Assessment reports were identified through a systematic literature review. A total of 19 studies on TAVI and 41 studies on ICDs were analysed. Learning curve was considered in only 16% of studies on TAVI. Incremental innovation was more frequently mentioned in the studies of ICDs, but its impact was considered in only 34% of the cases. Dynamic pricing was the most recognised feature but was empirically tested in less than half of studies of TAVI and only 32% of studies on ICDs. Finally, organisational impact was considered in only one study of ICDs and in almost all studies on TAVI, but none of them estimated its impact. By their very nature, most of the distinctive features of MDs cannot be fully assessed at market entry. However, their potential impact could be modelled, based on the experience with previous MDs, in order to make a preliminary recommendation. Then, well-designed post-market studies could help in reducing uncertainties and make policymakers more confident to achieve conclusive recommendations. © 2017 The Authors. Health Economics published by John Wiley & Sons, Ltd.

Review of Economic Submissions to NICE Medical Technologies Evaluation Programme.

The economic evaluation of medical devices is increasingly used to inform decision making on adopting new or novel technologies; however, challenges are inevitable due to the unique characteristics of devices. Cost-consequence analyses are recommended and employed by the English National Institute for Health and Care Excellence (NICE) Medical Technologies Evaluation Programme (MTEP) to help address these challenges. The aim of this work was to review the critiques raised for previous MTEP submissions and explore if there were common problems across submissions. We reviewed a sample of 12 economic submissions to MTEP representing 50% of 24 sets of guidance issued to July 2015. For each submission, we reviewed the External Assessment Centre's (EAC) report and the guidance document produced by NICE. We identified the main problems raised by the EAC's assessments and the committee's considerations for each submission, and explored strategies for improvement. We found that the identification and measurement of costs and consequences are the main shortcomings within economic submissions to MTEP. Together, these shortcomings accounted for 42% of criticisms by the EACs among the reviewed submissions. In certain circumstances problems with these shortcomings may be unavoidable, for example, if there is a limited evidence base for the device being appraised. Nevertheless, strategies can often be adopted to improve submissions, including the use of more appropriate time horizons, whilst cost and resource use information should be taken, where possible, from nationally representative sources.

A Systematic Review of the Level of Evidence in Economic Evaluations of Medical Devices: The Example of Vertebroplasty and Kyphoplasty.

ContextEconomic evaluations are far less frequently reported for medical devices than for drugs. In addition, little is known about the quality of existing economic evaluations, particularly for innovative devices, such as those used in vertebroplasty and kyphoplasty.ObjectiveTo assess the level of evidence provided by the available economic evaluations for vertebroplasty and kyphoplasty.Data SourcesA systematic review of articles in English or French listed in the MEDLINE, PASCAL, COCHRANE and National Health Service Economic Evaluation databases, with limits on publication date (up to the date of the review, March 2014).Study SelectionWe included only economic evaluations of vertebroplasty or kyphoplasty. Editorial and methodological articles were excluded.Data ExtractionData were extracted from articles by two authors working independently and using two analysis grids to measure the quality of economic evaluations.Data SynthesisTwenty-one studies met our inclusion criteria. All were published between 2008 and 2014. Eighteen (86%) were full economic evaluations. Cost-effectiveness analysis (CEA) was the most frequent type of economic evaluation, and was present in 11 (52%) studies. Only three CEAs complied fully with the British Medical Journal checklist. The quality of the data sources used in the 21 studies was high, but the CEAs conforming to methodological guidelines did not use high-quality data sources for all components of the analysis.ConclusionsThis systematic review shows that the level of evidence in economic evaluations of vertebroplasty and kyphoplasty is low, despite the recent publication of a large number of studies. This finding highlights the challenges to be faced to improve the quality of economic evaluations of medical devices.

Health economic evaluations of medical devices in the People's Republic of China: A systematic literature review

BackgroundThe objective of this study is to identify and review the methodological quality of health economic evaluations of medical devices performed in the People’s Republic of China. To our knowledge, no such investigations have been performed to date.MethodsA systematic literature review involving searches of Medline, Medline In-Process, the National Health Service Economic Evaluation Database, the Cost-Effectiveness Analysis Registry of the Tufts Medical Center, and the Wanfang Database was performed. The search spanned the period from 1990 to 2013. Studies on health economic evaluations of medical devices, in-vitro diagnostics, procedures, and the use of medical devices in Chinese health care settings were included. Full-text articles and conference abstracts in English and Chinese were included.ResultsFifty-seven publications were included, 26 (46%) of which were in English and 31 (54%) of which were in Chinese. The included publications covered a wide range of clinical areas, such as surgery (n=23, 40%), screening (n=9, 16%), imaging use (n=6, 11%), kidney intervention (n=4, 7%), and nine other technological areas. Most of the studies (n=31, 54%) were cost analyses. Among the others, 13 (50%) studies used modeling, and another 13 (50%) were within-trial evaluations. Among studies that used modeling, eleven (85%) conducted sensitivity analyses, six of which had one-way sensitivity analysis, whereas one conducted both one-way and two-way sensitivity analyses; four of these eleven modeling-based analyses included probabilistic sensitivity analyses. The incremental cost-effectiveness ratio was reported in ten (18%) studies, eight of which were screening studies. The remaining two modeling studies were in areas of imaging and oncology.ConclusionThis study indicates that there are major limitations and deficiencies in the health economic evaluations on medical devices performed in the People’s Republic of China. Further efforts are required from different stakeholders – academic, governmental, and privatized – to improve health economic research capacity and to put it to use when informative decisions are made in the health care setting.

MEDICAL DEVICE PRICES IN ECONOMIC EVALUATIONS.

Economic evaluations, although not formally used in purchasing decisions for medical devices in Canada, are still being conducted and published. The aim of this study was to examine the way that prices have been included in Canadian economic evaluations of medical devices. We conducted a review of the economic concepts and implications of methods used for economic evaluations of the eleven most implanted medical devices from the Canadian perspective. We found Canadian economic studies for five of the eleven medical devices and identified nineteen Canadian studies. Overall, the device costs were important components of total procedure cost, with an average ratio of 44.1 %. Observational estimates of the device costs were obtained from buyers or sellers in 13 of the 19 studies. Although most of the devices last more than 1 year, standard costing methods for capital equipment was never used. In addition, only eight studies included a sensitivity analysis for the device cost. None of the sensitivity analyses were based on actual price distributions. Economic evaluations are potentially important for policy making, but although they are being conducted, there is no standardized approach for incorporating medical device prices in economic analyses. Our review provides suggestions for improvements in how the prices are incorporated for economic evaluations of medical devices.

A review of the economic tools for assessing new medical devices.

Whereas the economic evaluation of pharmaceuticals is an established practice within international health technology assessment (HTA) and is often produced with the support of comprehensive methodological guidance, the equivalent procedure for medical devices is less developed. Medical devices, including diagnostic products, are a rapidly growing market in healthcare, with over 10,000 medical technology patent applications filed in Europe in 2012-nearly double the number filed for pharmaceuticals. This increase in the market place, in combination with the limited, or constricting, budgets that healthcare decision makers face, has led to a greater level of examination with respect to the economic evaluation of medical devices. However, methodological questions that arise due to the unique characteristics of medical devices have yet to be addressed fully. This review of journal publications and HTA guidance identified these characteristics and the challenges they may subsequently pose from an economic evaluation perspective. These unique features of devices can be grouped into four categories: (1) data quality issues; (2) learning curve; (3) measuring long-term outcomes from diagnostic devices; and (4) wider impact from organisational change. We review the current evaluation toolbox available to researchers and explore potential future approaches to improve the economic evaluation of medical devices.

Health technology assessments in England: an analysis of the NICE Medical Technologies Evaluation Programme

Many countries undertaking health technology assessments (HTAs) to inform decisions on the reimbursement of technologies focus solely on the analysis of pharmaceuticals [1, 2]. In the UK, the responsibility for undertaking HTAs falls mainly to the National Institute for Health and Care Excellence (NICE). NICE is an independent organisation whose role is to provide guidance on health technologies and clinical practice for the National Health Service (NHS) in England and Wales [3], and it is regarded as a world leader in the HTA field. In contrast to HTA bodies in most other countries, NICE has been given a wider remit to assess the full range of technologies (i.e. not just pharmaceuticals) [4]. There are difficulties present when assessing non-pharmaceutical health technologies, which can reduce the applicability of methods routinely used in the assessment of pharmaceuticals. Nevertheless, it is important not to undertake HTAs only on those technologies where the assessment process is straightforward, otherwise the allocation of resources between the different types of technology may be distorted by an imbalance in the information supporting decisions [2]. In order to overcome the aforementioned difficulties and ensure that the assessments of all forms of health technology are useful in decision-making, NICE has developed four appraisal programmes that are each overseen by a separate committee (technology appraisals, medical technologies, diagnostics and public health). At this point a distinction needs to be made between two sections of the NICE decision process: assessment and appraisal. An assessment is the review and analysis of data and other evidence, whereas appraisal is the a priori consideration of the evidence on benefits and costs of different courses of action in order to distinguish which is superior. The assessment of technologies is undertaken by the NICE technical team and an independent review group, with the manufacturer of the technology also having a major role. The evidence generated from this process is then passed onto one of the NICE committees, who have to make a decision regarding the suitability of the technology for the NHS, the appraisal section of the process. There are four NICE committees, each of which is responsible for one of the four programmes discussed previously. The newest of them is the Medical Technologies Advisory Committee (MTAC). The MTAC assesses a specific subset of health technologies, which can loosely be defined as medical devices. A full description of the technologies that are assessed by the MTAC can be found in the Medical Technologies Evaluation Programme (MTEP) methods guide [5], referred to as ‘MTEP guidance’ in the remainder of this paper. This methods guide stipulates the methodology that manufacturers must follow when undertaking economic evaluations of medical devices that are to be assessed by the MTAC. NICE aims for consistency across its four committees. However, a comparison of the methodology outlined in the MTEP guidance with those used by the other NICE decision-making committees shows some significant differences. The possible W. Green (&) York Health Economics Consortium, University of York, Market Square, Heslington, York YO10 5NH, UK e-mail: william.green@york.ac.uk

The Economic Evaluation of Medical Devices

The economic evaluation of medical technology has evolved as a key element in supporting health budget allocation decisions. Among suppliers of innovation, the medical device industry is one of the most dynamic fields of medical progress with thousands of new products marketed every year. Accordingly, the broad variety of technologies covered by the umbrella term 'medical devices' have come under increasing scrutiny regarding their cost effectiveness. In the process, a number of device-specific factors have become apparent, each of which can complicate a thorough economic evaluation and limit its informative value. Some of these factors relate to specific characteristics of device functioning. Examples of such factors include the fact that most technologies require, or form part of, a procedure and that many devices have multiple indications or purposes. Others in turn reflect external conditions and are more general in character, such as the regulatory framework that a medical device manufacturer faces prior to market approval and the structure of the medical device industry. Drawing on the available literature, these complicating factors and their practical implications are discussed and used as a basis to elaborate on the emerging challenges for the economic evaluation of medical devices.

PRM22 The Headroom Method of Early Economic Evaluation of Medical Devices: A Useful Tool for Device Developers?

PRM22 The Headroom Method of Early Economic Evaluation of Medical Devices: A Useful Tool for Device Developers?

Challenges in the clinical and economic evaluation of medical devices: The case of transcatheter aortic valve implantation

Innovation in the Medical Device (MD) sector is developing at a rapid pace, thus enabling healthcare systems to deliver care where it was not possible. Therefore, it is important to assess the value of MDs so that policy-makers can make informed resource allocation decisions and set priorities. The clinical and economic evaluation of MDs poses greater challenges than the evaluation of drugs. First, it is more difficult to conduct randomised controlled trials of devices, because there is a ‘learning curve’ in their use. Also, the implementation of a new therapy involving a device can have wider economic implications for the organisation and financing of healthcare. The difficulties in obtaining clinical evidence on specific MDs may mean that there is a greater tendency to ‘generalise’ experience with similar devices. Finally, whereas the prices of drugs tend to be set until they become generic, the prices of MDs are more likely to change over time. The purpose of this article is to explore these issues fur...

Economic Evaluation of Medical Devices and Drugs—Same or Different?

Economic Evaluation of Medical Devices and Drugs—Same or Different?

Health economics of medical devices: opportunities and challenges

Expenditure on medical devices is substantial and is expected to grow in the future. This Editorial draws attention to health economic issues surrounding medical devices. To this effect, opportunities and challenges involved in the economic analysis of the market structure of medical device sectors and in the economic evaluation of medical devices are identified.Markets for medical devices tend to be fragmented and suffer from a lack of transparency and competition. In response to this, there is extensive government intervention in many developed countries with a view to keeping down prices, restricting public reimbursement and promoting an efficient use of medical devices. Studies are called for that evaluate and compare country approaches towards regulating medical device markets with a view to informing medical-device policies.Whereas economic evaluation of medicines is well established, and is used to inform pricing and reimbursement decisions in many developed countries, this is less the case for medical devices. There is a need for economic evaluations of medical devices with a view to demonstrating their cost effectiveness. In addition, countries need to implement frameworks for the assessment of new and emerging medical devices with a view to taking pricing and reimbursement decisions.