A Review of the Economic Tools for Assessing New Medical Devices (original) (raw)
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Frontiers in Medicine
Background: Health-technology assessment (HTA) is a recognized mechanism to determine the relative benefits of innovative medical technologies. One aspect is their health-economic impact. While the process and methodology for pharmaceuticals is well-established, guidance for medical devices is sparse. Aim: To provide an overview of the health-economic aspect in current European HTA guidelines concerning medical devices and identifying issues raised and potential improvements proposed in recent literature. Methodology: Available guidelines by European agencies were each reviewed and summarized. To complement this, a full systematic review of current literature concerning potential improvements to existing HTA practices for medical devices, from PubMed and EMBASE, was conducted; the focus was on health economics. Authors could only review documents in English, French, or German. The systematic review yielded 518 unique articles concerning HTA for medical devices, 32 of which were considered for full-text review after screening of all abstracts. Results: There is very limited consensus in-and mostly a complete lack of-guidance specific to medical devices in official HTA guidelines, for both clinical and economic analyses. Twenty two of 41 European countries had published official HTA guidance in English, French, or German. Among these only 4 (England, France, the Netherlands, and Sweden) dedicated a chapter or separate document to medical devices. In the literature, there is sufficient evidence to suggest medical devices need to be addressed separately from pharmaceuticals. However, mostly challenges are discussed rather than implementable solutions offered. We present the following set of frequently discussed issues and summarize any solutions that pertain to them: a weak evidence base, learning-curve effects, organizational impact, incremental innovation, diversity of devices, dynamic pricing, and transferability. We further combine reviewed information to suggest a set of possible best practices for health-economic assessment of medical devices. Blüher et al. Medical-Device HTA Guidelines Review Conclusion: For greater efficiency in medical-device innovation, European agencies should look to (re-)address the specific requirements of medical devices in their HTA guidelines. When both the health-economic and data requirements for the HTA of medical devices are defined, the development of practical solutions will likely follow.
Economic methods used in health technology assessment
E+M Ekonomie a Management
Early decision-making process about the development of a new product is essential for any company in order to gain relevant fi nancial returns and thus prosper. Therefore, managers need to have at their disposal appropriate assessment tools which assist them in their decisions about the development of the new product and guarantee that their product will generate a desirable profi t. The purpose of this review focuses on the exploration of the methodology, commonly used in the economic evaluation as part of health technology assessment for medical devices. On the basis of the selected original studies, the authors summarize the main methods used in the decision-making processes about the development of new medical devices and discuss their benefi ts and limitations. The methods employed in this study include a method of literature search in the databases Web of Science, MEDLINE, and Embase, and a method of comparison and evaluation of the results. The fi ndings of this study indicate that the most preferred methods used in the economic evaluations of medical device development are cost-utility analysis and cost-effectiveness analysis. In addition, the Headroom Method is recommended to be used in the early assessment of the medical device development since it uses broader estimates of potential by determining the maximum reimbursable price of the new device. Selection of each method then depends on the research question, the condition of interest, and the availability of data on outcomes. There is an urgent need to conduct the early assessment of the medical device development in order to avoid negatively high costs and prevent a failure rate at each stage of the development process.
Cureus
Background and objectives Value-based pricing (VBP) is used quite frequently for medicines, but its application to medical devices is very limited. The objective of the present study was to conduct a pilot experience of systematic estimation of the value-based price of medical devices from the perspective of our national health system. Our experience was focused on high-technology devices (class IIb/III and active implantable). The objective was to evaluate the applicability of VBP in a real-world setting and to estimate the value-based price of devices in all cases where this estimation was feasible. Methods The dataset analysed in this work consists of 24 new devices approved consecutively in the Tuscany region over the period from January 2020 to December 2021. Since the calculation of value-based price requires the availability of a cost-effectiveness analysis, we searched for this information for each of these devices. The Cost-Effectiveness Analysis (CEA) Registry of Tufts Medical Center (US) and the health technology assessment (HTA) reports of our region were considered adequate sources of these data. Standard equations of cost-effectiveness were applied to determine the value-based price for these devices, and these prices were compared with the corresponding real prices charged in our region. Results We found adequate information for five devices (21%) out of the total of 24. In three of these cases, the published analysis taken as a reference was based on Markov modelling. The comparison between valuebased prices and real prices generally showed an acceptable concordance, though with a couple of outliers. An important finding is that, in a large proportion of cases (79%), the information needed for this calculation was lacking. Conclusion To our knowledge, this is the first experience in which an institution of the healthcare system has tried a systematic application of VBP in the field of high-technology devices. Our results are encouraging and suggest a wider application of cost-effectiveness in this field.
Early economic evaluation of emerging health technologies: protocol of a systematic review
Systematic Reviews, 2014
The concept of early health technology assessment, discussed well over a decade, has now been collaboratively implemented by industry, government, and academia to select and expedite the development of emerging technologies that may address the needs of patients and health systems. Early economic evaluation is essential to assess the value of emerging technologies, but empirical data to inform the current practice of early evaluation is limited. We propose a systematic review of early economic evaluation studies in order to better understand the current practice. This protocol describes a systematic review of economic evaluation studies of regulated health technologies in which the evaluation is conducted prior to regulatory approval and when the technology effectiveness is not well established. Included studies must report an economic evaluation, defined as the comparative analysis of alternatives with respect to their associated costs and health consequences, and must evaluate some regulated health technology such as pharmaceuticals, biologics, high-risk medical devices, or biomarkers. We will conduct the literature search on multiple databases, including MEDLINE, EMBASE, the Centre for Reviews and Dissemination Databases, and EconLit. Additional citations will be identified via scanning reference lists and author searching. We suspect that many early economic evaluation studies are unpublished, especially those conducted for internal use only. Additionally, we use a chain-referral sampling approach to identify authors of unpublished studies who work in technology discovery and development, starting out with our contact lists and authors who published relevant studies. Citation screening and full-text review will be conducted by pairs of reviewers. Abstracted data will include those related to the decision context and decision problem of the early evaluation, evaluation methods (e.g., data sources, methods, and assumptions used to identify, measure, and value the likely effectiveness and the costs and consequences of the new technology, handling of uncertainty), and whether the study results adequately address the main study question or objective. Data will be summarized overall and stratified by publication status. This study is timely to inform early economic evaluation practice, given the international trend in early health technology assessment initiatives.
International Journal of Technology Assessment in Health Care, 2014
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.
2021
In this commentary, we discuss early stage assessments of innovative medical technologies both in terms of methods applied as well as their use in healthcare decision-making. We argue that cost-effectiveness alone may be too reductive if taken as the only decision rule, and it would benefit from being used within a broader evaluation framework. We discuss innovative methods which may contribute to better estimate the potential costs and consequences of a technology in the absence of solid clinical data, as frequently the case in early assessments. Finally, we comment on the potential synergies which may take place should early economic models be used not only by technology developers alone but as a negotiating base during early dialogues with health technology assessment (HTA) bodies.
Medical technology assessment and the role of economic evaluation in health care
Journal of Evaluation in Clinical Practice, 1996
The growth in health care expenditure over the last few decades has necessitated the introduction of priority setting and decision making based on the results of critical evaluation. Medical technology assessment (MTA) is a valuable tool to assist policy makers in controlling existing and new medical technologies. Medical technology assessment and the role of economic evaluation as part of MTA are described, and various techniques of economic evaluation are discussed.
2020
This commentary considers the positive and negative consequences of early economic modelling and explores potential future directions. Early economic modelling offers device manufacturers an opportunity to assess the potential value of an innovation at an early stage of development. Early modelling can direct resources into potentially viable technologies and reduce investment in technologies with limited prospect of value. However, it is unclear whether early modelling is sufficiently specific to identify innovations with low value. It may be that early modelling is more useful for directing data gathering to reduce decision uncertainty. Early modelling is of primary benefit to the manufacturer and may have both positive and negative consequences for reimbursement processes that should be considered.
The U.K. NHS ECONOMIC EVALUATION DATABASE Economic Issues in Evaluations of Health Technology
International Journal of Technology Assessment in Health Care, 2000
Objective: The U.K. NHS Economic Evaluation Database (EED) project is commissioned to identify papers on economic evaluations of health technologies and to disseminate their findings to NHS decision makers by means of structured abstracts that are available through a public database and the Cochrane Library. This paper discusses current issues relating to the economic aspects of producing NHS EED abstracts. Methods: A review of NHS EED was undertaken between 1994 and 1999 to determine the methodologies adopted and issues that influence the usefulness of economic evaluations. Methods adopted to improve the quality of NHS EED abstracts are also reported. Results: Eighty-five percent of NHS EED abstracts are cost-effectiveness analyses (CEAs), 9.3% are cost-utility analyses (CUAs), and only 1.4% are cost-benefit analyses (CBAs). Of the total abstracts, 65.9% are based on single studies, 19.5% on reviews, 3.9% on estimates of effectiveness, and 10.7% on combinations of these sources. Models are utilized in 16.7% of CEAs, 60.2% of CUAs, and 20% of CBAs. Analyses of CBA studies reveal a degree of misuse of well-established definitions. NHS EED internal control mechanisms are reported that provide a means of ensuring that abstracts are based on sound academic principles. Conclusions: Most economic evaluations are conducted by means of CEA, followed by CUA, while CBA accounts for an extreme minority of cases. Single studies form the principal source of effectiveness data, although models are widely used, principally in CUA. The structure of NHS EED abstracts provides decision makers with the principal results and an interpretation of the relative strengths and weaknesses of economic evaluations.