Health Technology Assessment for Medical Devices: Making it work for you
Strategic Management
Health Technology Assessment (HTA) covers the careful evaluation of a medical technology for evidence, safety, efficacy, cost and cost effectiveness. This report investigates approaches to developing product value arguments (PVAs) for medical device products and provides a practical, solution-orientated guide to implementing HTA.
Presenting a thorough analysis of economic evaluation techniques, the report will enable readers to understand how the evidence and data is interpreted. Aiming to provide real solutions for problems, the report is supported by interviews and case studies from key industry contacts in the UK, Japan, Germany, the US and France. This report answers the vital questions:
For further information about this report, please contact our Customer Helpdesk on:
Tel: +44 (0)20 8332 8965 / 66
Fax: +44 (0)20 8332 8992
E-mail: [email protected]
TABLE OF CONTENTS
TABLE OF CONTENTS
LIST OF TABLES
EXECUTIVE SUMMARY
ABBREVIATIONS AND ACRONYMS
CHAPTER 1 INTRODUCTION
1.1 Major global trends in healthcare
1.1.1 Variable population trends
1.1.2 Ageing populations
1.1.3 Structure and comparison of major healthcare systems
1.1.4 Attitudes to health
1.2 What is health technology assessment?
1.3 What does health technology assessment entail?
1.4 Timing of health technology assessment
1.5 What role does HTA play in European healthcare systems?
1.5.1 The EUR-ASSESS project (HTA-Europe)
1.5.2 The European Collaboration for Health Technology Assessment (ECHTA/ECAHI) project
1.5.3 Major European activities
1.6 The role of health technology assessment in purchasing decisions
1.7 European and international organisations involved in health technology assessment
1.7.1 International Network of Agencies for Health Technology Assessment
1.7.2 International Society of Technology Assessment in Healthcare
1.7.3 European Technology Assessment Network
1.7.4 European Information Network on New and Changing Health Technologies (Euroscan)
1.7.5 European Healthcare Telematics Observatory
1.7.6 European Medicines Evaluation Agency
1.7.7 ECRI
1.7.8 WHO Health Technology Assessment Programme
1.7.9 Society for Medical Decision-Making
CHAPTER 2 THE IMPACT OF HEALTH TECHNOLOGY ASSESSMENT
2.1 The purpose and use of health technology assessment
2.2 The scope of health technology
2.2.1 Assessment parameters
2.2.1.1 Technical properties and features
2.2.1.2 Safety
2.2.1.3 Efficacy and effectiveness
2.2.1.4 Economic impact and factors
2.2.1.5 Macro level impact
2.2.1.6 Micro level impact
2.2.1.7 Legal, social, ethical and political implications
2.2.1.8 Ex-ante and ex-post studies
2.3 Evidence-based medicine
2.4 The organisation and use of health technology assessment in individual countries
2.4.1 Government
2.4.2 Industry
2.4.3 Policy and decision-makers
2.4.4 End-users
2.5 UK
2.5.1 The UK healthcare system
2.5.2 Structure and organisation
2.5.3 Healthcare provision
2.5.3.1 NHS Purchasing and Supply Agency
2.5.3.2 Private healthcare in the UK
2.5.4 Healthcare funding
2.5.5 Health technology assessment in the UK
2.5.5.1 National Institute for Clinical Excellence
2.5.5.2 National Co-ordinating Centre for Health Technology Assessment and the HTA programme
2.5.5.3 National Horizon Scanning Centre
2.5.5.4 The NHS Centre for Reviews and Dissemination
2.5.5.5 Centre for Health Economics
2.5.5.6 Health Technology Board for Scotland
2.5.5.7 InterTasc, Technology Assessment Services Collaboration
2.5.5.8 Other organisations
2.6 Germany
2.6.1 The German healthcare system
2.6.2 Healthcare funding and reimbursement
2.6.3 Health technology assessment in Germany
2.6.3.1 The German Agency for Health Technology Assessment
2.6.3.2 The German Working Group for Health Technology Assessment in Health Care
2.6.3.3 Office of Technology Assessment at the German Parliament
2.7 Spain
2.7.1 The Spanish healthcare system
2.7.2 Healthcare funding
2.7.3 Health technology assessment in Spain
2.7.3.1 The Spanish Agency for Health Technology Assessment (Agencia de Evaluacion de Tecnologias Sanitarias)
2.7.3.2 Andalusian Agency for Health Technology Assessment (Agencia de Evaluacion de Tecnologias Sanitarias de Andalucia)
2.7.3.3 Catalan Agency for Health Technology Assessment and Research (Agencia d'Avaluacio de Tecnologia i Recerca Mediques)
2.7.3.4 Basque Office for Health Technology Assessment
2.7.3.5 The Catalan Health Institute
2.7.3.6 The Spanish Association for the Evaluation of Health Technologies (Asociacion Espanola de Evaluacion de Tecnologias Sanitarias)
2.8 France
2.8.1 The French healthcare system
2.8.2 Healthcare funding
2.8.3 Health technology assessment in France
2.8.3.1 National Agency for Accreditation and Evaluation in Health (L'Agence Nationale pour l'Accreditation et l'Evaluation en Santé)
2.8.3.2 Committee for the Evaluation and Diffusion of Innovative Technologies
2.9 Italy
2.9.1 The Italian healthcare system
2.9.2 Healthcare funding
2.9.3 Health technology assessment in Italy
2.10 US
2.11 Japan
CHAPTER 3 EVALUATING DATA
3.1 Introduction
3.1.1 Why carry out evaluations?
3.1.2 Economic evaluation techniques
3.1.2.1 Outcomes measurement
3.2 Collecting data
3.2.1 Clinical trials
3.2.1.1 Design of clinical trials
3.2.1.2 Control of bias
3.2.2 Effectiveness studies
3.2.2.1 Health-related quality of life
3.2.2.2 Health status measures
3.2.2.3 Quality-adjusted life years
3.3 Analysis of data
3.3.1 Types of analysis
3.3.1.1 Cost-of-illness analysis
3.3.1.2 Cost-minimisation analysis
3.3.1.3 Cost-effectiveness analysis
3.3.1.4 Cost-benefit analysis
3.3.1.5 Cost-utility analysis
3.3.1.6 Cost-consequences analysis
3.4 Conclusion
CHAPTER 4 THE PROCESS OF HEALTH TECHNOLOGY ASSESSMENT
4.1 Introduction
4.2 The 10 basic steps of health technology assessment
4.2.1 Identification and selection of assessment topics
4.2.2 Determining the assessment objectives and designing appropriate measures and approaches
4.2.3 Location of a sponsor and place to perform the assessment
4.2.4 Collection of relevant evidence
4.2.5 Developing systems and methods for collection of appropriate primary data
4.2.6 Interpretation of the evidence
4.2.7 Analysis and consolidation of the evidence
4.2.8 Assembling findings and recommendations
4.2.9 Degrees of evidence
4.2.10 Dissemination of assessment data and recommendations
4.3 Target audiences
4.4 Assessing and monitoring the impact of the assessment
4.5 Health technology assessment databases
4.5.1 NHS Centre for Reviews and Dissemination (NHSCRD), The HTA database (in collaboration with the secretariat of INAHTA)
4.5.2 The NHS R&D Health Technology Assessment Programme
4.5.3 The Cochrane Collaboration
4.5.4 The Agency for Healthcare Research and Quality
4.5.5 Office of Technology Assessment
4.5.6 Health Services/Technology Assessment Text (HSTAT) � National Library of Medicine
4.5.7 Veterans Health Administration � VA Research and Development
4.5.8 Medical Technology and Practice Patterns Institute
4.5.9 ECRI
4.6 National health technology assessment agencies with full online reports
4.7 National health technology assessment agencies with summary online reports
4.8 General scientific databases
4.9 Development of Clinical Practice Guidelines
4.10 Case studies
4.10.1 Case study 1
4.10.1.1 Technology
4.10.1.2 Background
4.10.1.3 Purpose and objectives
4.10.1.4 Methodology
4.10.1.5 Results
4.10.1.6 Findings and recommendations
4.10.1.7 Dissemination of data
4.10.1.8 The impact of the HTA
4.10.1.9 Further research
4.10.1.10 Other comments
4.10.2 Case study 2
4.10.2.1 Technology
4.10.2.2 Background
4.10.2.3 Purpose and objectives
4.10.2.4 Methodology
4.10.2.5 Results
4.10.2.6 Findings and recommendations
4.10.2.7 Dissemination of data
4.10.2.8 The impact of the HTA
4.10.2.9 Further research
4.10.2.10 Other comments
4.10.3 Case study 3
4.10.3.1 Technology
4.10.3.2 Background
4.10.3.3 Purpose of the assessment
4.10.3.4 Methodology
4.10.3.5 Results
4.10.3.6 Findings and recommendations
4.10.3.7 Dissemination of data
4.10.3.8 Further research
4.10.3.9 Other comments
4.10.4 Case study 4
4.10.4.1 Technology
4.10.4.2 Background
4.10.4.3 Purpose of assessment
4.10.4.4 Methodology
4.10.4.5 Results
4.10.4.6 Findings and recommendations
4.10.4.7 Dissemination of data
4.10.4.8 The impact of the HTA
4.10.4.9 Further research
4.10.4.10 Other comments
4.10.5 Case study 5
4.10.5.1 Technology
4.10.5.2 Background
4.10.5.3 Purpose of the report
4.10.5.4 Methodology
4.10.5.5 Results and conclusions
4.10.5.6 Findings and recommendations
4.10.5.7 Dissemination of data
4.10.5.8 The impact of the HTA
4.10.5.9 Other comments
4.10.6 Case study 6
4.10.6.1 Technology
4.10.6.2 Background
4.10.6.3 Purpose and objectives
4.10.6.4 Methodology
4.10.6.5 Data extraction and synthesis
4.10.6.6 Results
4.10.6.7 Economic and cost analysis
4.10.6.8 Findings and recommendations
4.10.6.9 Dissemination of data
4.10.6.10 The impact of the HTA
CHAPTER 5 HTA AGENCIES AND ORGANISATIONS
5.1 Government agencies and organisations
5.1.1 Agence d'Evaluation des Technologies et des Modes d'Intervention en Sant� (AETMIS)
5.1.2 Agenzia per I Servizi Sanitari Regionale (ASSR)
5.1.3 Agencia de Evaluacion de Tecnologias Sanitarias (AETS)
5.1.4 Agencia de Evaluacion de Tecnologias Sanitarias de Andalucia (AETSA)
5.1.5 Alberta Heritage Foundation for Medical Research (AHFMR)
5.1.6 Agency for Healthcare Research and Quality (AHRQ)
5.1.7 L'Agence Nationale d'Accreditation et d'Evaluation en Santé (ANAES)
5.1.8 Australian Safety and Efficacy Register of New Interventional Procedures (ASERNIP-S)
5.1.9 Basque Office for Health Technology Assessment (OSTEBA)
5.1.10 British Columbia Office of Health Technology Assessment (BCOHTA)
5.1.11 Canadian Coordinating Office for Health Technology Assessment (CCOHTA)
5.1.12 Catalan Agency for Health Technology Assessment (CAHTA)
5.1.13 Comite d'Evaluation et de diffusion des Innovations Technologiques Assistance (CEDIT)
5.1.14 College voor Zorgverzekeringen/Standing (Committee for Health Insurance, CVZ)
5.1.15 German Agency for Health Technology Assessment at the German Institute for Medical Documentation and Information ([email protected])
5.1.16 Danish Institute for Health Technology Assessment (DIHTA)
5.1.17 Unidad de Evaluaci�n Tecnolog�as de Salud (ETSA)
5.1.18 Finnish Office for Health Care Technology Assessment (FinOHTA)
5.1.19 Medical Technology Unit, Federal Social Insurance Office Switzerland (FSIOS)
5.1.20 Health Technology Board for Scotland (HTBS)
5.1.21 Health Council of the Netherlands Gezondheidsraad (GR)
5.1.22 Instituto Nacional de Higene Epidemiologia y Microbiologia (INHEM)
5.1.23 Israel Centre for Technology Assessment in Health Care (ICTAHC)
5.1.24 HTA Unit of the Institute of Technology Assessment (ITA) of the Austrian Academy of Science
5.1.25 Medicare Services Advisory Committee (MSAC)
5.1.26 National Coordinating Centre for Health Technology Assessment (NCCHTA)
5.1.27 National Institute for Clinical Excellence (NICE)
5.1.28 Medical and Health Research Council of the Netherlands (MHRC) � Netherlands Organisation for Scientific Research (MW-NWO)
5.1.29 National Horizon Scanning Centre (NHSC)
5.1.30 Netherlands Organisation for Applied Scientific Research (TNO)
5.1.31 New Zealand Health Technology Assessment (NZHTA)
5.1.32 Norwegian Centre for Health Technology Assessment (SMM)
5.1.33 Swedish Council of Technology Assessment in Health Care (SBU)
5.1.34 Swiss Science Council/Technology Assessment (Swiss/TA)
5.1.35 Veterans Affairs � Technology Assessment Programme (VA TAP)
5.2 Private companies
5.2.1 Blue Cross Association and Blue Shield Association (Technology Evaluation Centre, TEC)
5.2.2 Caro Research
5.2.3 Corsair Health
5.2.4 Digital Health Assessment Centre (DHAC)
5.2.5 Fourth Hurdle Consulting Ltd
5.2.6 Hayes Inc
5.2.7 Health Care Analytics Inc
5.2.8 IBA Associates
5.2.9 International Health Resources (IHR)
5.2.10 Jacoti
5.2.11 JLN,MD Associates
5.2.12 Katalyst Health Technology Assessments
5.2.13 The Lewin Group
5.2.14 Medical Outcomes Management Inc
5.2.15 MEDTAP International
5.2.16 MetaWorks Inc
5.2.17 PharMerit BV
5.2.18 Quintiles Transnational Corporation
5.2.19 Strategic Health Resources
5.3 Independent organisations, non-profit-making organisations and universities
5.3.1 Centre for Clinical Effectiveness (CCE)
5.3.2 Danish Institute for Health Services Research (DSI)
5.3.3 Duke Center for Clinical Health Policy Research (CCHPR)
5.3.4 ECRI
5.3.5 Institute for Healthcare Improvement (IHI)
5.3.6 Institute for Medical Technology Assessment (iMTA)
5.3.7 Johns Hopkins Evidence-based Practice Center
5.3.8 McMaster University Evidence-based Practice Centre
5.3.9 Medical Technology and Practice Patterns Institute (MTPPI) Inc
5.3.10 NHS Centre for Reviews and Dissemination (NHS CRD)
5.3.11 Oregon Health and Science University Evidence-based Practice Center
5.3.12 The Southern California Evidence-based Practice Center
5.3.13 Research Triangle Institute�University of North Carolina (RTI�UNC)
5.4 HTA societies and associations
5.4.1 International Society of Technology Assessment in Health Care (ISTAHC)
5.4.2 Netherlands Platform Health Technology Assessment
CHAPTER 6 INTERPRETING AND USING HEALTH TECHNOLOGY ASSESSMENTS
6.1 Interpretation of HTA results
6.1.1 Safety
6.1.2 Clinical effectiveness
6.1.3 Outcomes
6.1.4 Cost-effectiveness
6.2 Possible uses for health technology assessment
6.3 Scope of health technology assessment
6.4 Development of clinical practice guidelines
6.5 Health technology assessments � commercial applications
CHAPTER 7 FUTURE AND OUTCOMES
7.1 Key trends
7.2 Future direction of health technology assessment
REFERENCES
LIST OF TABLES
Table 1.1 Population trends in major developed countries (million), 1985�2020
Table 1.2 The elderly populations of selected countries (% of total population), 2000
Table 1.3 Profile and ranking of healthcare systems in various countries, 1997
Table 1.4 Fifth Information Society Technologies Framework Programme of telemedicine projects, 1998�2002
Table 2.1 Breakdown of NHS HTA programmes, 1996�1998
Table 3.1 Selected multi attribute utility scales
Table 4.1 Summary of a cervical screening programme and associated treatment in an average health authority, 1997/1998
Table 4.2 Average annual utilisation of PET scanners according to INAHTA survey, 1997
Table 4.3 Number of reimbursed PET scans per 100,000 population (June 1998�July 1999)
Table 6.1 Scope of health technology assessments � completed agency projects, 2000�2001
Table 7.1 Ongoing and future agency-based health technology assessments
EXECUTIVE SUMMARY
Healthcare systems throughout the developed world are under increasing pressure from a number of factors including ageing populations, increasing expectation and demand. Developments in health technology are constantly widening the scope of healthcare but as a result costs of care have increased dramatically. Governments and healthcare organisations throughout the world are striving to contain these rising costs while maintaining the quality of care and rationalising resources. As a result there is a growing trend in the use of evidence-based medicine and other systematic methods to determine the cost benefits of treatment. Largely as a result of these trends, health technology assessment (HTA) has emerged.
According to the International Network of Agencies for Health Technology Assessment (INAHTA), HTA in healthcare is defined as 'a multidisciplinary field of policy analysis. It studies the medical, social, ethical and economic implications of development and use of health technology' where healthcare technology is defined as 'prevention and rehabilitation, vaccines, pharmaceuticals and devices, medical and surgical procedures and the systems within which health is protected and maintained'.
Throughout the world, countries are establishing agencies to specialise in the use and promotion of HTA within their respective healthcare systems. In Europe, countries such as the UK, Spain, France, the Netherlands, Germany and a number of Scandinavian countries are active or becoming active. The UK and Spain in particular appear to be the most well organised and active in the field. Health technology assessment is very much an emerging field � most agencies are only recently established and their respective roles are still developing, both in an international and individual country context.
At its best HTA represents an opportunity for all parties involved to form new partnerships, facilitating the development and introduction of new technology as well as its regulation. It contributes to and facilitates appropriated well-informed decision-making in the healthcare system assisting healthcare purchasers, providers and policy-makers to provide cost-effective, optimal treatments of acceptable safety within the cost constraints of the system. At its best, HTA is objective and balanced and can provide information from a variety of different perspectives.
In a market, which is becoming increasingly cost-sensitive and restricted, manufacturers of medical devices and other similar products will only be able to justify higher unit costs for products or even introduce new products, with clear evidence indicating the benefits of use beyond the immediate performance benefits of the product. Products will have to show clear cost-effectiveness with benefits encompassing economic, social and even legal aspects and with clear indications of improvements in outcomes. Moreover, these benefits must be sufficient to justify the efforts required by interested parties in obtaining their approval for use or change of use. Cash-strapped healthcare organisations are unlikely to adopt new technologies (and the expenses involved) without clear evidence of significant benefits.
The use and application of HTA is increasing and will continue to gain in importance and influence, and manufacturers in the healthcare industry will have to increasingly co-operate with HTA agencies in order to compete in the marketplace. Increasingly health technologies will be evaluated on an international basis as agencies increase their co-operation and poll information resources with other agencies.
The process of HTA is still emerging and evolving with the development of new and improved modelling and analytical techniques. The use of the HTAs is also increasing, as healthcare professionals become increasingly educated.
Perhaps the biggest challenge facing the field of HTA is in resolving the conflicting needs of healthcare systems for high quality assessment data to make informed appropriate decisions in an increasingly cost-sensitive environment versus the needs of medical device manufacturers to rapidly maximise profits in an increasingly competitive, technology-driven marketplace, and at the same time considering the needs of patients to receive optimal care without delay.
© PJB Publications Ltd. 2001
All rights reserved.