Improving patient access to novel medical technologies in Europe (original) (raw)
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Journal of Interventional Cardiology, 2010
Objectives: This study aims to analyze mechanisms for facilitating the uptake of new medical devices in the German system of hospital reimbursement, focusing on the example of coronary stents, including (1) trends in their coding, (2) associated diagnosis-related group (DRG) payments, (3) their integration in the German DRG (G-DRG) system, and their diffusion within the inpatient sector. Methods: Published and gray literature provide the basis for analyzing the system of hospital reimbursement. Data on coronary stents were obtained from various regulatory and government bodies and examined in a longitudinal fashion. Results: Although German Procedure Classification (Operationen-und Prozedurenschlüssel; OPS) codes were created for a range of stent technologies between 2004 and 2009, the regular system of G-DRG reimbursement does not distinguish between different stents by means of unique DRGs. Instead, supplementary payments or extrabudgetary payments are used to ensure that newer technologies are reimbursed adequately. The limitations of extrabudgetary payments restrict the use of some devices to a small proportion of patients. Data on the diffusion of different stents show that factors other than the reimbursement regime likely also play a role in the frequency with which certain technologies are used. Bare metal stents currently account for most stent implantation procedures in Germany, followed by drug-eluting stents. Conclusion: The current system of G-DRG reimbursement and of extrabudgetary payments ensures that even the most recently developed technologies can be used in the German inpatient sector. Nevertheless, certain technologies may not be reaching the broad patient population. (J Interven Cardiol 2010;23:546-553) Disclosures: Cornelia Henschke, Michael Baeumler and Matthew Gaskins are research fellows; Reinhard Busse is professor of health care management. All are based at
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.
2006
The TECH research network collected patient-level data on three procedures for treatment of heart attack patients, (catheterization, coronary artery by-pass grafts and percutaneous transluminal coronary angioplasty), for seventeen countries over an eighteen year period to examine the impact of economic and institutional factors on technology adoption. Specific institutional factors are shown to be important to the uptake of these technologies. Health care systems characterized as public contract systems and reimbursement systems have higher adoption rates than public integrated health care systems. Central funding of investments was negatively associated with adoption rates. GDP per capita also has a strong role in initial adoption. The impact of income and institutional characteristics on the utilization rates of these procedures diminishes over time.
Europace, 2011
As in other settings, in the field of clinical use of cardiac implantable electrical devices (CIEDs), the implementation, in various ways, of diagnosis-related groups (DRGs) has created new scenarios in most European healthcare systems. A DRG system is primarily a financial tool with the aim of promoting efficiency and improving utilization of resources. However, there are a variety of ways in which this system is used for funding the activity of centres implanting CIEDs. It is possible that the specific type and method of reimbursement may influence the implementation of CIEDs in the 'real world' through a variable spectrum of practices. These may range from the situation where reimbursement may, together with other factors, constitute a true barrier to the implementation of guidelines, to scenarios where reimbursement is adequate, and/or to situations where reimbursement may be adequate for standard devices but not for prompt implementation of effective technological innovations. The variety in reimbursement also affects how in-office checks of CIEDs are covered and, above all, the possibility to pay for remote follow-up of CIEDs. In the field of medical devices, refinement of DRG systems and adoption of new strategies and policies are needed to sustain and enhance those effective technological innovations that may be beneficial for specific patient populations. It is also important that physicians are deeply involved in the development and deployment of DRGs, and that each country DRGs agency has a transparent approach to engagement with stakeholders, along with robust and transparent mechanisms for updating these systems.
Health technology assessment process of a cardiovascular medical device in four different settings
Journal of comparative effectiveness research, 2017
Health technology assessment (HTA) is a tool to help the decision-making process. The aim is to describe methods and processes used in the reimbursement decision making for drug-eluting stents (DES) in four different settings. DES as a technology under study was selected according to different criteria, all of them agreed by a working group. A survey of key informants was designed. DES was evaluated following well-structured HTA processes. Nonetheless, scope for improvement was observed in relation to the data considered for the final decision, the transparency and inclusiveness of the process as well as in the methods employed. An attempt to describe the HTA processes of a well-known medical device.
A Review of the Economic Tools for Assessing New Medical Devices
Applied Health Economics and Health Policy, 2014
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 longterm 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.
Scientific evaluation and pricing of medical devices and associated procedures in France
2013
Medical devices are many and various, ranging from tongue spatulas to implantable or invasive devices and imaging machines; their lifetimes are short, between 18 months and 5 years, due to incessant incremental innovation; and they are operator-dependent: in general, the clinical user performs a fitting procedure (hip implant or pacemaker), a therapeutic procedure using a non-implantable invasive device (arrhythmic site ablation probe, angioplasty balloon, extension spondyloplasty system, etc.) or follow-up of an active implanted device (long-term follow-up of an implanted cardiac defibrillator or of a deep brain stimulator in Parkinson's patients). A round-table held during the XXVIII th Giens Workshops meeting focused on the methodology of scientific evaluation of medical devices and the associated procedures with a view to their pricing and financing by the French National Health Insurance system. The working hypothesis was that the available data-set was sufficient for and compatible with scientific evaluation with clinical benefit. Post-registration studies, although contributing to the continuity of assessment, were not dealt with. Moreover, the focus was restricted to devices used in health establishments, where the association between devices and technical medical procedures is optimally representative. An update of the multiple regulatory protocols governing medical devices and procedures is provided. Issues more specifically related to procedures as such, to non-implantable devices and to innovative devices are then dealt with, and the proposals and discussion points raised at the round-table for each of these three areas are presented.
Balancing adoption and affordability of medical devices in Europe
Health Policy, 2009
Dramatic increases in health expenditures have led to a substantial number of regulatory interventions in the markets for devices over the last years. However, little attention has been paid thus far to the regulation of medical devices and its effects. This article explores the policies pursued by European countries to find the right balance between improving access to new medical devices and restricting market forces to contain costs and ensure affordability. We outline the medical device policies of the four European countries with the largest expenditures on devices: Germany, France, Italy, and the UK. Subsequently, we discuss how these policies attempt to balance technological adoption and affordability by illustrating two case studies from Italy and Germany. We find that reference prices, if defined as maximum reimbursement levels, can help to achieve balance, because they are supposed to contain costs effectively, but do not necessarily act as a hurdle for the adoption of innovations. We also find that policy tools that encourage technological adoption should be used carefully since the benefits of a new technology are often difficult to predict. Finally, we draw a number of policy implications based on our observations.