Forschungs- & Entwicklungsinformationsdienst der Gemeinschaft - CORDIS

FP7

MEDTECHTA Berichtzusammenfassung

Project ID: 305694
Gefördert unter: FP7-HEALTH
Land: Italy

Final Report Summary - MEDTECHTA (Methods for Health Technology Assessment of Medical Devices: a European Perspective)

Executive Summary:
It has been claimed that special characteristics of medical devices raise additional challenges which require the HTA community to reflect on whether the current methods are adequate. Three major features of devices deserve special attention: (i) the device-operator interaction can generate learning curve effects and thus risk biases in estimating the size of the benefits; (ii) the incremental nature of innovation (e.g., longer battery life, miniaturisation) needs to be addressed by careful identification of the alternatives for comparative and incremental cost-effectiveness analysis) (iii) the broader organizational impact in terms of training and infrastructure, coupled with dynamic pricing, requires a more flexible approach to costing. Whether these differences between medical devices and pharmaceuticals require a different framework for HTA needs to be investigated.
The objective of MedtecHTA project was to investigate improvements in HTA methods to allow for more comprehensive economic evaluation of medical devices. It consisted of several work packages (WPs). WP 1 considered the available evidence on the currently adopted approaches for the HTA of medical devices and on international regulatory guidance on the licensing of medical devices. WP2 considered the geographical variation in access to medical devices in EU countries by estimating the rate of adoption of selected medical technologies in the field of electrophysiology. The core part of the project sought to develop an improved methodological framework for conducting HTA of medical devices by acknowledging the complexities that arise from their integration into clinical practice. The new methodological approaches were tested on medical devices at different stages of development and diffusion within the health care system. WP 4 explored different methods for economic evaluation of medical devices currently adopted in EU countries in order to make suggestions about the development of new methods and offer guidance on future directions in the use of economic evaluation for medical devices. WP5 focused on the uncertainty in the economic evaluation of medical devices, as compared with pharmaceuticals, arising from the less demanding requirements to obtain a CE mark and the device-user interface (ie learning curve). The final methodological issue, investigated in WP6, was the organizational impact of medical devices. In this part of the project the aim was to propose a methodology that will allow for incorporating organizational issues in a broader HTA framework.
Recommendations (WP7) stemming from the overall project were grouped under 3 main directions. First, to improve the process of HTA the regulatory processes for MDs should be more closely aligned, that the HTA evaluative framework for MDs should be harmonized and processes for conditional coverage and evidence development should be used. Secondly, the methods for HTA should consider MDs as complex interventions, require the establishment of high quality registries, consider an iterative approach to the evaluation of MDs over time, recognize and allow for the particular characteristics of devices and use appropriate approaches for confounder adjustment in comparative effectiveness and safety studies. Thirdly, to optimize the diffusion of MDs a common classification should be developed across countries in order to facilitate international comparisons, factors driving diffusion should be explored in HTA reports and physicians’ personal goals and motivation should be better understood. Taken together, the key recommendations of the MedtecHTA project should improve the conduct and use of HTA for MDs.

Project Context and Objectives:
Health technology assessment (HTA) has become increasingly important in health care decision-making in Europe. Although in principle HTA can be applied to all health technologies, its major use in a decision-making context has been in the pricing and reimbursement of pharmaceuticals. However, there are over 200,000 medical devices on the European market (Fraser et al, 2011). These represent a very heterogeneous family of technologies that needs to be better classified for the purpose of HTA. “Medical device”, according to the EU Directive 2007/47/EC, is defined as “any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination.… to be used for human beings for the purpose of diagnosis, prevention, treatment, monitoring or alleviation of disease”.

While some devices require very simplified assessment, others need to be assessed through a full evaluation of safety, efficacy, effectiveness and economic impact. A thorough HTA would require consideration of final outcomes in terms of life expectancy and health-related quality of life, going far beyond the assessment that devices undergo to obtain a CE (European Conformity) mark, to enable them to be marketed in the European Union. This is particularly true for implantable devices used in cardiology (Boriani et al., 2009; Boriani, Maniadakis, Auricchio, & Vardas, 2010; R. Tarricone & Drummond, 2011), which represent the main focus of the MedtecHTA project.

The current EU legal framework already requires all high-risk devices (class III) to have safety and performance testing for decisions on market authorization. Essentially, manufacturers must accomplish a conformity assessment and undergo an inspection and certification procedure by one of the Notified Bodies within the EU. In addition, there is stringent post-marketing surveillance, requiring manufacturers of devices to implement a “medical device vigilance system” to monitor their products once they are on the market (Cohen & Billingsley, 2011). Conversely, in the United States, a much greater importance is given to pre-market approval (PMA), requiring clinical testing to inform the market about safety and effectiveness. Nevertheless a much lighter ex-post conformity assessment is in place.

Nevertheless, medical devices have traditionally been less regulated than pharmaceuticals and the amount of evidence collected for licensing medical devices is generally lower (Fattore, Maniadakis, Mantovani, & Boriani, 2011; Schreyögg, Bäumler, & Busse, 2009; Taylor & Iglesias, 2009). The EU directive in 2007 made some significant changes in this respect by recognizing that it is necessary to enhance the provisions on clinical evaluation, including clarification that clinical data are generally required for all devices (2007/47/EC). Consequently, medical devices placed on the EU market or put into service after March 21st 2010 must be in conformity with these new requirements. However, in contrast to the requirements for pharmaceuticals, the studies can be small clinical trials or even nonrandomized clinical investigations, and long-term efficacy data are not required, thus reducing the knowledge base for subsequent HTA activities.

A full HTA, such as that applied to pharmaceuticals in many EU member states, would require a thorough examination of the clinical and cost-effectiveness of devices. However, medical devices differ from other health technologies in a number of respects: i) they often change rapidly; ii) clinical outcomes often depend on the training, competence and experience of the end-user (Ramsay et al., 2001); iii) pricing is typically more dynamic than that of pharmaceuticals; iv) costs often comprise both procurement costs (including the associated infrastructure) and running costs (including maintenance and consumables).

It has been claimed that these special characteristics of devices raise additional challenges which require the HTA community to reflect on whether the current methods are adequate (Drummond, Griffin, & Tarricone, 2009). Three major features of devices deserve special attention: (i) the device-operator interaction can generate learning curve effects and thus risk biases in estimating the size of the benefits; (ii) the incremental nature of innovation (e.g., longer battery life, improvement of the software systems, miniaturisation) needs to be addressed by careful identification of the alternatives for comparative and incremental cost-effectiveness analysis (Fattore et al., 2011; Sorenson, Tarricone, Siebert, & Drummond, 2011; R. Tarricone & Drummond, 2011; Taylor & Iglesias, 2009) (iii) the broader organizational impact in terms of training and infrastructure, coupled with dynamic pricing, requires a more flexible approach to costing. Whether these differences between medical devices and pharmaceuticals require a different framework for HTA needs to be investigated.
The objective of MedtecHTA project was to investigate improvements in HTA methods to allow for more comprehensive economic evaluation of medical devices. The project aimed at filling the gap on the current research debate on the challenges to the available methodological framework for HTA when applied to medical devices. The MedtecHTA also explored current differences in methods used for HTA of medical devices in EU countries and the resulting consequences of these differences in terms of within- and between country variations in access to innovative medical devices that have important implications on equity.
The project consisted of seven work packages (WPs), organized in three interrelated parts.
Part I: Cross-country analysis of HTA practices and utilization of medical devices
Part II: Methodological issues in HTA of medical devices
Part III: Conclusions, synthesis and recommendations

Project Results:
Cross country analysis of regulation and HTA of medical devices
Part 1 of the project was essentially preparatory and included the necessary groundwork for the subsequent research activities. WP 1 considered the available evidence on the currently adopted approaches for the HTA of medical devices and on international regulatory guidance on the licensing of medical devices. We reviewed regulatory practices in the EU, US and 5 other countries and concluded that a number of actions are required to make the clinical evidence gathered through the regulatory process more relevant to HTA. These include the development of international standards on the types of clinical evidence required for the market approval of medical devices and agreement on the balance of clinical data collection pre- and post-launch. The latter is important because of the possibility that, owing to the learning curve and the organizational impact of devices, data from pre-launch clinical trials may not be ideal for assessing effectiveness and cost-effectiveness.
Within WP1 we conducted a cross-country analysis of HTA guidelines and available HTA reports on medical devices in assigned countries using a standardized template for comparison. In order to analyse the state of the art in the application of guidelines reviewed, a sample of HTA reports was selected from the University of York Centre for Reviews of Dissemination HTA database and systematically reviewed at three levels (i) assessment of the nature of evidence included in the reports (ii) HTA methods applied by reports considering medical devices, and (iii) assessment of approaches and methods used to address uncertainty. They found that although 75% of the agencies surveyed had adopted HTA-specific approaches for medical devices, these were largely organizational or procedural in nature. Only one agency had adopted methodological guidelines specific to medical devices.
In the second phase of our research within WP1, we analysed a sample of HTA reports in the field of cardiovascular disease in order to assess whether there are any key differences in how methods are applied. We found that here were several differences, in the types of clinical studies forming the basis for the HTAs, how the health problem and use of the technology was considered, the description and technical characteristics of the technology and the consideration of the organizational aspects of the use of the technology. Most of these differences arose due to the relative ‘complexities’ in the use of devices, in terms of the number of interacting components. These include the number and difficulty of the actions required by those delivering or receiving the intervention, the number of groups and organizational levels targeted by the intervention, the number and variability of the outcomes and the degree of flexibility or tailoring of the intervention.
Geographical variation in the use of medical devices in the EU
WP 2 considered the geographical variation in the use of medical devices in EU countries by estimating the rate of adoption of selected medical technologies in the field of electrophysiology. This subspecialty of cardiology widely uses implantable medical devices whose efficacy has been demonstrated by a number of randomized clinical trials. In one respect these devices resemble pharmaceuticals as they have a curative and/or a secondary prevention function and can be tested in clinical trials similar to those conducted on drugs. On the other hand, they differ from pharmaceuticals because they are subjected to incremental changes (e.g. dimensions and software), learning curve effects due to device-operator interactions and price dynamics. These overall characteristics make the area of electrophysiology an interesting case to study.
Results obtained in this field also have a higher degree of transferability to other class III medical devices. Through the analysis of national/local guidelines and data from registries and administrative databases, rates of utilization were mapped to provide evidence of different degrees of access within member states, and whether this adoption is in line with the existing evidence on clinical and cost effectiveness. In the first part of WP2, we conducted a systematic review of the literature on implant rates for cardiac implantable electrical devices (CIEDs) in Europe. We found that there had been a recent rise in implant rates, with large geographic differences. For example, the ratio between the regions with the highest and lowest implant rates within the same country ranged from 1.3 and 3.4 for cardiac pacemakers, whereas the ratio between the countries with the highest and lowest implant rates ranged from 2.3 and 87.5. The determinants of these differences were only partly explored and differences in study methodology could be one reason for the reported differences.
Therefore, in a subsequent phase of the research, we undertook a new study of implant rates, the first to use the national hospital discharge datasets available in 5 EU countries. We provide novel evidence on differences in use of medical devices within and between member states, investigate the determinants of differences in access to CIEDs, and assess the potential and limitations of administrative databases for the analysis of utilization rates of medical devices in electrophysiology. It is the first international paper to explore simultaneously differences both between countries and within the regions of those countries, Regional per capita GDP appeared to have a small, but significant, effect on use of CIEDs. In addition, the % of residents having tertiary education, the age of the population and life expectancy were associated with higher implant rates. Increased competition (expressed in terms of the implant rates in each region), fostered the use of technologies. However, even after controlling for clinical, epidemiological and (crude) economic indicators, significant variation in implant rates still exist. We They argue that there should be closer examination of the role of organizational factors and clinical preferences in the adoption of devices. These issues are explored further in WP6 of the MedtecHTA project (discussed below).
Methods for assessing the comparative effectiveness of medical devices
The core part of the project (Part II) sought to develop an improved methodological framework for conducting HTA of medical devices by acknowledging the complexities which arise from their integration into clinical practice. The research conducted in WP3, began by considering the approaches and methodologies used for comparative effectiveness research by conducting a systematic review of the methodological literature. It was found that, although most of the good research practices in the evaluation of all health technologies apply to medical devices, the interventions involving the use of medical devices should be considered as complex interventions, owing to the importance of user and context independence. Therefore, specific randomized controlled trial designs need to be considered, dealing with surgeons’ and patients’ preferences, incremental product development and user dependence. In addition, high quality disease- or device-based registries are needed to assess safety and long-term effectiveness. This preliminary research activity provided the basis for the development of improved methods for evaluating comparative effectiveness of medical devices including recommendations for analytic methods and data collection. The research was an important input to the development of guidelines for the evaluation of Therapeutic Medical Devices under the auspices of the EUnetHTA Joint Action 2 (EUnetHTA, 2015).
The framework and new methodological approaches were then tested on medical devices at different stages of development and diffusion within the health care system. First, the use of a method of evidence synthesis that allows for the meta-analysis of randomized controlled trial and observational data, using bias adjustment based on a formal elicitation exercise involving experts, was explored in the case of total hip replacement. We conclude that combining evidence from randomised controlled trials with observational studies and large national registries in a single synthesis could have a significant benefit in terms of the assessment of clinical effectiveness of devices and the associated decision uncertainty for policy makers. Based on this case study, we can recommend considering the use of expert elicited bias-adjustment methods, as a sensitivity analysis, when combining trial based and observational evidence.
Methods for the economic evaluation of medical devices
WP4 focused on exploring different methods for economic evaluation of medical devices currently adopted in EU countries in order to make suggestions about the development of new methods and offer guidance on future directions in the use of economic evaluation for medical devices. The first part of the research considered how differences in culture and values in EU countries lead to differences in the methodology and use of economic evaluation. For example, in northern Europe, economic evaluation is widely used in decisions about the reimbursement of new health technologies and cost-utility analysis (with the quality-adjusted life-year as the primary measure of benefit) is the predominant approach. In contrast, in central and southern Europe, there is more resistance to the use of economic evaluation in decision making and, where it is used, benefits are more often assessed in terms of clinical added value. This part of the research provided useful insights into the potential for increasing the use of economic evaluation in various EU member states.
The second part of the research used two case studies of implantable cardiac devices in order to demonstrate current, and possible future approaches to the use of economic evaluation. The case studies, implantable converter defibrillators (ICDs) and transcatheter aortic valve implantation (TAVI) were chosen in order to explore a wide range of device characteristics, including the significance of irreversible decisions and the complexity associated with evolving technologies. Most of the published economic evaluations and HTA reports located in the literature review did not take account of the special features of medical devices (ie learning curves, incremental innovation, dynamic pricing and organizational aspects) in the base case analysis, but were sometimes considered in sensitivity analyses. Overall, the conclusion was that the existing economic evaluations did not pay enough attention to the specific characteristics of devices explored in the MedtecHTA project.
Finally, building on the findings of both WP3 and WP4, the impact of the learning curve on effectiveness and cost was estimated for endovascular aneurysm repair (EVAR) and fenestrated EVAR. It was found that, in the case of EVAR there was a moderate, but significant effect of learning on both in-hospital mortality and hospital length of stay. The same impact was not found for fEVAR, one reason for which could be its similarity to EVAR, meaning that much of the learning in EVAR was transferable to the new procedure
Uncertainty in the economic evaluation of medical devices
Work Package 5 focused on characterizing uncertainty in the economic evaluation of medical devices and determining future research needs. This research sets out a number of conceptual issues when dealing with uncertainty and the value of research in the context of some of the specific characteristics of devices such as learning curve effects, incremental device innovation and dynamic pricing. It uses value of information analysis to explore the optimal timing of reimbursement decisions and the suitability of conditional coverage decisions, such as ‘only in research’ and ‘approval with research’. Such conditional reimbursement policies are now becoming popular in a number of countries, given the growing recognition that, for medical devices, there will always be considerable evidence gaps, particularly in evidence on effectiveness. As in the other WPs, a case study is chosen to illustrate the use of methods at different stages of device development and diffusion. The example chosen is enhanced external counterpulsation (EECP), a device used to provide symptomatic relief from chronic refractory angina, where the existence of substantial irrecoverable costs and price changes have a substantial impact on coverage decisions.
Organizational impact of medical devices
The final methodological issue investigated in the MedtecHTA project was the organizational impact of medical devices. In this part of the project the aim was to propose a methodology that will allow for incorporating organizational issues in a broader HTA framework. A systematic review of the literature was conducted, which was used to develop a large, 54 item survey of cardiologists, conducted in collaboration with the European Society of Cardiology. The objective was to explore the role of physicians’ motivation and organizational factors in the adoption and diffusion of medical devices. The survey focused on 7 different catheter-based or implantable cardiovascular devices. Multivariate hierarchical modeling was used to determine the associations between the various motivational and organizational factors and device diffusion and use.
In this study, we used a broad approach to analyse the effects of selected factors on the adoption and utilization of cardiovascular devices. Major findings included that better (perceived) manufacturer support was associated with a higher adoption probability for “new” devices (TAVI, RD, MC, LAA), budget pressure was associated with a higher adoption probability for “old” devices (ICD, CRT), and greater size and urban hospital locations were correlated with a higher adoption probability across both groups of devices. Greater hospital size, greater department size, urban location and higher GDP were also associated with higher device utilization, especially in the group of “old” devices (ICD, CRT, DES). Medical evidence did not play a major role in the adoption of devices, which might be due to the often-reported lack of medical evidence in support of new devices. This argument also supports our finding that the adoption of new devices is driven by manufacturer support rather than medical evidence. Findings for financial criteria, physician motivations and organizational impacts of adoption (i.e., the impact of an expected change on the organization) were scarce. To gain a more thorough understanding of these variables’ relevance with scarce evidence, future researchers should test their influence using additional methods (e.g., new instruments to measure physician motivation) and other target populations (e.g., hospital managers).
Our results help explain which hospitals are more likely to adopt and utilize (certain) medical devices. Furthermore, we found evidence that the role of external stakeholders (i.e., through manufacturer support) is highly important and should be considered with other aspects (e.g., medical evidence). Understanding the adoption decision also enables decision makers to identify the key hospitals that are the likely starting points for the diffusion of medical devices throughout a system. Although evidence of the relevance of other factors was scarce (e.g., financial criteria, physician motivation), these should not be disregarded. Instead, decision makers could use this information to prioritize further research.

Key Recommendations
In the final part we present the key recommendations from the MedtecHTA project, organized under three themes (i) improving the process for HTA of medical devices (ii) developing methods for HTA of medical devices and (iii) optimizing the diffusion of medical devices. In each case we outline the issues that the recommendations seek to address, followed by the recommendations themselves. The research underpinning them is described in the papers emanating from the respective work packages, including the other papers in this supplement. Other organizational- and environmental-level factors were found to be significant and associated with adoption and utilization across several devices, including budget pressure. The organizational impact of adoption (i.e., expected changes in human resources, work-flows, planning activities and organizational structures) did not appear to be relevant to the adoption of devices.
Improving the process for HTA of medical devices (WPs 1, 5)
The major issues identified regarding the process for the HTA of medical devices were that (i) the procedures for granting market access to new devices did not always encourage the generation of the clinical data, prior to product launch, necessary to undertake reliable HTAs, and (ii) that the specific characteristics of medical devices (eg the learning curve) were not explicitly considered in the methods guidelines of those organizations conducting HTAs. Furthermore, since the clinical evidence base is often not mature when devices are granted market access, an approach that encourages the generation of more data after product launch is required.
Against this background, we make the following recommendations.
Recommendations A: Improving the process for HTA of medical devices
A1. Align regulatory and HTA processes for devices with respect to data requirements, through:
- joint scientific advice by regulatory and reimbursement bodies for data collection for the device industry
- designing studies that allow collection of data on effectiveness that jointly fulfil the requirements of regulators and payers

A2. Harmonize the HTA evaluative framework (collection & synthesis of clinical evidence and economic evaluation) for devices across international HTA agencies, though:
- developing a standardized international risk classification for MDs
- determining appropriate levels of evidential requirements by risk category

A3. Recognize that assessment of expected cost-effectiveness is not sufficient: conditional coverage and evidence development decisions should be assessed
- the value of the device and future value of research needs to be quantified and used to identify the optimal timing of reimbursement decisions in the device’s life cycle
- implementation may commit resources that cannot be recovered

A4. Consider the implications of the learning curve (LC) on policy decisions (and vice versa)
- the LC does not only change the estimate of effectiveness but also affects the uncertainty in the decision
- identify the mechanisms of learning likely to cause change over time and assess the profile of investment risk according to user experience affected by the rate of uptake of the device in practice

A5. Consider the likely prospects of research and who should pay for it
- is it priority for public funding or for manufacturers to undertake?

Developing methods for HTA of medical devices (WPs 3,4,5)
The methods for assessing the clinical and cost-effectiveness of medical devices need to adhere to the general standards for all health technologies, but also take account of the specific characteristics of medical devices. These include the existence of the learning curve, incremental innovation, dynamic pricing and organizational impact. The reviews of the literature conducted for the MedtecHTA project found that, although the general standards were good, more attention needs to be paid to these specific characteristics. In terms of the assessment of comparative effectiveness, it is best to consider procedures involving the use of medical devices to be ‘complex interventions’. In terms of economic evaluation, the changes due to the learning curve, incremental innovation, dynamic pricing and organizational impact need to be modeled adequately.
Other key challenges relate to the relative lack of randomized controlled trials, as compared with pharmaceuticals, and the inherent uncertainty about clinical and cost-effectiveness at the time of product launch. Therefore, efforts may be necessary to collect data on safety and effectiveness post-launch. In addition, because of the likely reliance on observational studies, such as registries, appropriate methods of bias-adjustment need to be applied. Finally, the decision to approve, or not approve, a new device for reimbursement is closely linked to the decision on whether to collect more data and the nature of the data collected.
Against this background, we make the following recommendations.

Recommendations B: Developing methods for HTA of medical devices
B1. Refine existing methods (for collection and synthesis of clinical and economic data) for handling the common ‘complexities’ of devices, including:
- synthesis of observational and trial evidence
- incorporating learning curves into decision analytic models
- recognizing the potential for incremental innovation

B2. Consider the MD-related intervention as a complex intervention; in particular, include the intervention’s components and the relation between intervention, modifying factors and outcome in the formulation of the research question

B3. Consider specific study designs and analysis methods, in addition to general recommendations for RCTs, in order to assess the comparative effectiveness of MDs
- these approaches should address challenges often associated with devices, including rapid incremental development, the device/user interface and effect modification by contextual factors

B4. Establish disease-based or device-based registries of high quality for the long-term study of the effectiveness and safety of MDs.

B5. Design such registries to allow comparative analyses:
- routinely collecting information on possible confounding factors
- collecting information on treatment patterns to facilitate HTA

B6. Use appropriate methods for confounder adjustment in comparative effectiveness or safety analyses and try to address residual confounding. If data from large registries are available for inclusion in the evidence synthesis in HTA, consider bias-adjustment based on expert elicitation as one scenario in the sensitivity analysis.

B7. Document research using suitable existing reporting guidelines.

B8. Consider MD-specific application of guidance on the methods for evidence synthesis from the framework on complex interventions.

B9. Assess the applicability of findings considering the challenges arising from patient eligibility, user dependence, study design, and rapid evolution of the technology

B10. In economic evaluations and HTAs of MDs, pay particular attention to the particular characteristics of MDs and explore their quantitative impact on cost-effectiveness as part of the study.

B11. Consider an iterative process to the evaluation of devices as additional evidence and learning emerges over time

B12. Consider the likelihood of future price changes:
- price influences the benefits of early approval and the benefits of additional research
- it may be useful to identify effective price thresholds for which guidance changes

B13. Determine whether manufacturers should be expected to conduct the research, based on an assessment of:
- the commercial value to manufacturers of early evidence
- the potential for Approval with Research and for improving research timelines

Optimizing the diffusion of medical devices (WPs 2,6)
Optimizing the use of medical devices would involve ensuring that they are used only in situations where they are clinically and cost-effective. The review of the literature conducted in the MedtecHTA project showed that there are wide geographical variations in the use of implantable cardiac devices, but very little understanding of why these variations exist. In order to obtain a better understanding of the use of devices, it is important to have standardized methods of data collection, so that differences between regions and countries can be reliably studied.
Furthermore, it is important to gain a better understanding of the clinical, professional and organizational factors that encourage or discourage the use of the clinical procedures involving the use of devices. Therefore, more study is required of the motivational factors facing patients, physicians and the institutions in which they work. In addition, attention needs to be paid to the relevant demographic factors and the impact of health care financing and organization.
Against this background, we make the following recommendations.
Recommendations C: Optimizing the diffusion of medical devices

C1. Leverage routinely collected data (administrative data) to investigate the adoption and diffusion of MDs, provided that coding system allows for valid and reliable identification of the technology

C2. Endorse the use of a common classification for medical devices (unique identification code) across countries to facilitate international comparisons

C3. Include factors driving adoption of medical devices systematically in HTA reports to estimate the impact of the interplay of:
-physician characteristics,
-organizational, regional, and environmental factors
and manufacturers’ actions

C4. Consider divergent effects by stratifying by medical devices type (e.g. “old” and “new” medical devices)

C5. Concentrate on the identification of key opinion leaders in hospital to better understand the adoption and the diffusion process

C6. Focus on developing the understanding of physicians’ personal goals and motivation and their role in the adoption of medical devices

C7. Monitor manufacturers’ actions, as they seem to be very relevant for the adoption of “new” medical devices

C8. Consider regional (e.g. rural vs urban hospital location) and environmental factors (e.g. GDP and out-of-pocket payment) to understand where the diffusion process is likely to take place
- in large hospitals, with relatively large specialist departments
- in high income countries with lower shares of out-of-pocket payments

Potential Impact:
The MedtecHTA project is expected to make a substantial contribution to the development of methodologies and practices of HTA for medical devices for a wide range of key stakeholders and to inform policy making in the European Union, which in turn will impact on public health in the Region. Given this premise, the Communication Objective of MedtecHTA project is to bring the research to the attention of different target audiences interested in methodological developments of health technology assessment: researchers, policy makers, industry, and patients’ associations among others.

The MedtecHTA project is expected to make a substantial contribution to the development of methodologies and practices of HTA for medical devices for a wide range of key stakeholders to make informed decisions concerning the cost-effectiveness and appropriate use of and patients’ access to medical devices.
MedtecHTA will significantly impact on:
1. policy-making process by providing a rational, objective, transparent and evidence-based approach for the assessment of medical devices. It will also allow for more rational allocation of scarce resources for HTA activities.
2. the scientific community and contribution to the development of HTA methodologies for HTA agencies by improving the understanding of the specific characteristics of medical devices, and the implications for HTA, between and among the HTA scientific community (e.g., the medical professions, biomedical engineers, public health specialists, epidemiologists, economists, etc) and HTA agencies.
3. the healthcare delivery process by providing managers of healthcare organizations with a new tool to assess whether particular new medical devices are worth adopting in their own context. The project will consider not only financial impact on the delivery process of new healthcare services and procedures but it will provide a broader impact assessment on re-adaptation of capital equipment, training of professionals, re-organization of ways of delivering services/procedures.
4. the medical devices industry by helping the industry to improve its business and research decision-making processes, thereby allocating resources where they are most needed and to further develop its capacity to make early assessments concerning which products are worth investing in, given current and future populations’ needs and health policy priorities.
5. patients’ access to health technology by exploring disparities in terms of access to medical devices. It will attempt to quantify the impact of these disparities in terms of health outcomes of EU citizens, and will discuss how disparities can be reduced through the application of an improved framework for HTA of medical devices.

In order to achieve aforementioned objectives in reaching a vast and diverse target audiences, MedtecHTA project has employed a series of complementary channels of communication

MEDTECHTA WEBSITE
The MedtecHTA website has been realized at the following link: www.medtechta.eu. The website has two macro-categories of users: i) academic and scientific environments, but also representatives of patients associations, healthcare managers, decision maker, representatives of industries, general public and ii) project partners, in particular using the Intranet for sharing project materials.

MEDTECHTA INTRANET
The Intranet is only for project partners, and ensures equal and easy communication and exchange of information, as well as safe and centralized storage of project-related documents, available to all partners. This will progressively constitute an “online archive” of the project. Every Consortium member has access to the Intranet.

PROJECT BROCHURE AND GRAPHIC MATERIAL
We have realized a general easy-to-read brochure giving an overview of the concept, the objectives, the expected results and the details of MedtecHTA (duration, activities, partners, website). The brochure is available on the MedtecHTA website, under the section “Project”. The MedtecHTA logo has been created by the Bocconi team, and word/power point template too. Additional graphic materials could be created for conferences/events that will be organized.

SCIENTIFIC PUBLICATIONS
In the second project period, the consortium produced and brought to publication the following manuscripts:

1. Valzania C, Torbica A , Tarricone R, Lyve F, Boriani G. Implant rates of cardiac implantable electrical devices in Europe: A systematic literature review. Health Policy 2016 Jan;120(1):1-15
2. Oriana Ciani, Britni Wilcher, Carl Rudolf Blankart, Maximilian Hatz, Valentina Prevolnik Rupel, Renata Slabe Erker,Yauheniya Varabyova, Rod S Taylor. Health technology assessment of Medical devices: a survey of Non-European union agencies . International Journal of Technology Assessment in Health Care. 2015 Jan;31(3):154-65
3. Tarricone R, Torbica A, Ferre F, Drummond M. (2014) Generating Appropriate Clinical Data for Value Assessment of Medical Devices: What Role Does Regulation Play? Expert Review of Pharmacoenomics and Outcome Research 14 (5), 707-718

In addition, the consortium produced a collection of 9 manuscripts to be published as MedtecHTA Project Supplement in a prestigious journal in the field (Health Economics). The Supplement includes the following papers currently under review:
1. Tarricone R, Torbica A, Drummond M. Challenges in the Assessment of Medical Devices: the MedtecHTA project.

2. Ciani O, Wilcher B, van Giessan Anoukh, Taylor R. Linking the regulatory and reimbursement processes for medical devices: the need for integrated assessments

3. Torbica A, Banks H, Valzania C, Boriani G, Fattore G. Investigating the diffusion cardiovascular medical devices in European healthcare systems: what drives the differences?

4. Schnell-Inderst P, Iglesias CP, Arvandi M, Ciani O, Matteucci Gothe R, Peters J, Blom AW, Taylor RS, Siebert U. Bias modelling in evidence synthesis: a case-study in total hip replacement.

5. Tarricone R, Callea G, Ogorevc M, Prevolnik Rupel V. Improving the methods for the economic evaluation of medical devices

6. Rothery C, Claxton K, Palmera S, Epstein D, Tarricone R, Sculpher M. Characterising uncertainty in the assessment of medical devices and determining future research needs

7. Varabyova Y. Blankart R, Schreyogg J. The role of learning in the health technology assessments of medical devices.

8. Hatz M, Schreyögg J,Torbica A, Boriani G, Blankart R. Adoption Decisions for Medical Devices in the Field of Cardiology: Results from a European Survey

9. Tarricone R, Torbica A, Drummond M. (for the MedtecHTA project group) Key Recommendations from the MedtecHTA Project
SCIENTIFIC CONFERENCES
Throughout the project research outputs from MedtecHTA have been presented in the most important scientific conferences in the field of HTA and health economics:

HTAi 11th Annual Meeting, Washington DC, June 15th to 16th 2014
Panel session: Medical Devices: are different HTA approaches really needed?
The overarching objective of this Panel was to discuss the question of whether different HTA approaches are needed for medical devices. Four panellists presented and discussed the pros and cons of an HTA agency developing specific structures, processes and methods to handle medical devices (compared to drugs).

• Oriana Ciani: Overview of the findings of an EU funded project survey of HTA agencies approaches to handling of medical devices (Methods for HTA of medical devices: a European perspective- MedtecHTA)
• Les Levine: The Health Quality Ontario (MaRS EXCITE) approach to medical device evaluation: field-based evaluation and pre-regulation trials
• Mirella Marlow: The NICE dual approach to medical device evaluation: MTEP and TA programmes
• Markus Seibert: The industry perspective to HTA consideration of medical devices

The panel session was jointly chaired and discussion facilitated by Aleksandra Torbica (MedtecHTA Deputy Project Director) and Rod Taylor (MedtecHTA WP1 Leader).

11th iHEA Conference – 11-15 July 2015, Dublin, Ireland
Organized session: What drives the diffusion and challenges the evaluation of medical devices? Preliminary results from EU project Methods for Health Technology Assessment of Medical Devices (MedtecHTA)
At the recent international conference of health economics in Dublin, MedtecHTA project had an organized session: What drives the diffusion and challenges the evaluation of medical devices? Preliminary results from EU project Methods for Health Technology Assessment of Medical Devices (MedtecHTA). Mike Drummond, MedtecHTA Scientific Supervisor and Aleksandra Torbica (AT), MedtecHTA Deputy Director moderated the session in which colleagues from three universities presented results of their research progress. First, AT informed the audience about the general aims of the MedtecHTA project to identify improvements of HTA methods by making evaluation of medical devices more comprehensive and by acknowledging complexities rising from their integration into clinical practice. In addition, MedtecHTA aims to investigate determinants of geographical variations in diffusion of medical devices in EU countries. Following this premise, Yauheniya Varabyova (University of Hamburg) presented the paper The Determinants of Medical Technology Diffusion and Adoption: A Systematic Literature Review and Best Evidence Synthesis. Giovanni Fattore (University of Bocconi) discussed preliminary findings of the ongoing research Investigating the diffusion and geographical variations of implantable cardiac medical devices in Europe. Finally, Simon Walker from Centre of Health Economics, University of York illustrated the findings from their methodological work on Cost-effectiveness, uncertainty and value of information analysis for medical devices. The session had good attendance and participants engaged in discussion on future steps of MedtecHTA project.
Organizer: Aleksandra Torbica, Centre for Research on Health and Social Care Management, Department of Policy Analysis and Public Management, University Bocconi, Milan, Italy (MedtecHTA Deputy Director)
Presentation 1: The Determinants of Medical Technology Diffusion and Adoption: A Systematic Literature Review and Best Evidence Synthesis
Presenter: Yauheniya Varabyova. Hamburg Centre for Health Economics, University of Hamburg, Germany
Presentation 2: Investigating the diffusion of implantable cardiac medical devices in Europe
Presenter: Giovanni Fattore - Centre for Research on Health and Social Care Management, Department of Policy Analysis and Public Management, University Bocconi, Milan, Italy
Presentation 3: Cost-effectiveness, uncertainty and value of information analysis for medical devices
Presenter: Simon Walker, Centre for Health Economics, University of York
Health Technology Assessment International- 12th Annual Meeting, Oslo, June 11th to 17th 2015
Panel session: European cooperation in HTA … “at-a-glance”: aims, methodologies, results and opportunities to foster HTA collaboration in Europe
Aim of this panel is to offer to the audience a clearer understanding about aims, methodology and preliminary results of 4 HTA-related research projects cofounded by the EU Commission within the 7th Research Framework Programme and of EUnetHTA. In particularly the panel focused on the opportunity of collaboration that could emerge among the four projects, within the broader HTA European scenario. The panel is an unique opportunity of all European and non–european HTA experts to get a full view of the on-going cooperative initiatives in EU, “at-a-glance”.
MedtecHTA Project was presented by Prof. Rod Taylor (University of Exeter).

International Health Economics Association – Milan, July 12-15, 2015

Organized Session: Advancing methods of Health Technology Assessment for medical devices: key recommendations from the EU MedTecHTA project
Chair: Rosanna Tarricone, Centre for Research on Health and Social Care Management, Department of Policy Analysis and Public Management, University Bocconi, Milan, Italy (MedtecHTA Director)
Organizer: Aleksandra Torbica, Centre for Research on Health and Social Care Management, Department of Policy Analysis and Public Management, University Bocconi, Milan, Italy (MedtecHTA Deputy Director)
Presentation 1: Do we need new methods for comparative effectiveness research of medical devices? (UMIT)
Presentation 2: Challenges and proposals for uncertainty evaluation of medical devices: a case study (YORK)
Presentation 3: Adoption decisions and organisational impact of medical devices: results from a European survey (HCHE)
ADDITIONAL MEETINGS
In addition, MedtecHTA project has participated in the two meetings organized by other EU projects with the final aim to disseminate project results and facilitate coordination between different research initiatives funded by EU. More specifically, MedtecHTA took part in the following meetings:
1. Eunethta Joint Action 2: Meeting with coordinators of FP7 research projects (MedtecHTA, Advance_HTA, Intergrate_HTA & Adhophta) – Vienna , 12 june 2013
2. European Clinical Infrastructures Network/ECRIN - WP5 Medical Devices. Connecting with other EU-initiatives ECRIN meets MedTecHTA, ITECH & Advance-HTA Cologne, 8th July 2014.
3. EunetHTA Conference “HTA 2.0 Europe - Teaming Up for Value conference documents (Rome, October, 2014)
The EUnetHTA Conference "HTA 2.0 - Teaming up for Value" took place on 30-31 October 2014 in Rome, Italy and gathered around 450 participants from all over the world to discuss the latest developments in the interface between science and policy in European healthcare – on HTA, regulation, reimbursement, health policy, and contributing fields of research.
At the HTA 2.0 Europe conference's networking area the attendees had a unique opportunity to meet and discuss with the representatives of EUnetHTA, through the six activity stations, as well as the HTA projects of the 7th Framework Research Programme (FP7), among which MedtecHTA was present.
4. Forum HAS Health Technology Assessment sans frontières - Paris - 30 October 2015
• For its 10th anniversary, the Haute Autorité de Santé was organizing, in collaboration with the European Commission. It was dedicated to assessment in health technology (HTA) and the benefits of European cooperation in this field. It allowed participants to discuss and exchange on key questions:
o How can European cooperation on HTA support the uptake of innovative technologies for more sustainable healthcare systems?
o Engaging stakeholders in health technology development: who to involve in early dialogues and how?
o What are the challenges to assess the value of innovative technologies in current practices?
o How to better inform decision-making on complex health care interventions?
o How can we support hospital decision-makers (managers and clinicians) in making sound decisions on new health technologies for their hospitals?

MedtecHTA Director Rosanna Tarricone, Deputy Director Aleksandra Torbica and WP leader Mark Sculpher took part in the Panel 2 – Towards innovative methodologies & practices, where they presented the salient results of the MedtecHTA project.

MEDTECHTA FINAL CONFERENCE
MedtecHTA Final Conference was held on November 13th in Bocconi University, Milan, Italy. It attracted more than 250 attendees from HTA agencies, policy makers, industry representatives, healthcare professionals and scholars. The program of the conference was designed in a way to foster discussion and exchange among MedtecHTA researchers, panellists and the audience.

List of Websites:
www.medtechta.eu
webmaster: Chiara Peverelli (chiara.peverelli@unibocconi.it)

Verwandte Informationen

Dokumente und Veröffentlichungen

Kontakt

Luigi Pellegrino, (Manager)
Tel.: +390258362242
Fax: +390258362187
E-Mail-Adresse

Fachgebiete

Scientific Research
Datensatznummer: 183976 / Zuletzt geändert am: 2016-06-03
Informationsquelle: SESAM