H. Vondeling Centre for Applied Health Services Research (CAST) University of Southern Denmark

1. In search of a robust, cheap and fast methodology to assess outcomes of integrated care programs and systems in Denmark: the potential contribution of two recent developments in Health Technology Assessment H. Vondeling Centre for Applied Health Services Research (CAST) University of Southern Denmark Berlin, April 2013

2. Outline • Health Technology Assessment • European Network in HTA (EUnetHTA) Two recent developments 1) HTA Core Model 2) 13 Methodological Guidelines for Rapid Relative EffectivenessAssessment of Pharmaceuticals Applicability to Integrated Care programs and systems?

3. Health technology • Definition • ‘The drugs, devices and medical and surgical procedures used in health care, and the organizational and supportive systems within which care is provided’(Source: Office of Technology Assessment, 1978) • Examples of organizational systems • Primary care, secondary care • Transmural care, intensive care • Examples of supportive systems • The electronic patient record • Hotel service in hospitals

4. Medical purpose Diagnostic Preventive Therapeutic Rehabilitative Palliative Organizational or administrative Supportive Physical nature Drug Device Procedure Classification Health technology

5. Relatively small and discrete E.g. in comparison with military technology, air and space technology, and environmental technology Highly pervasive Refers to the impossibility to lead out lives without, sooner or later, being confronted with health care technology in matters of life and death Characteristics Health technology

6. Associated with health benefits Increase of life-expectancy Increase of healthy life-year expectancy Reduction of human suffering Positive aspects Health technology

7. Technologization of health care E.g. applying a technology where it would have been more appropriate to e.g. provide reassurance by talking to a patient Medicalization of society Inappropriate translation of societal problems to healthcare problems Technologies that do not work DES in prevention of complications during pregnancy Gastric freezing in treatment of peptic ulcers Controversial aspects Health technology

8. Overuse of technologies Diagnostic technologies Related to defensive medicine Ethical aspects of the use of technology E.g. at the beginning and at the end of life High costs of technology Equality and equity in access to technology Evaluation, planning and control of technology Controversial aspects Health technology

9. HTA is the systematic evaluation of the properties and effects of health care technology. The primary purpose of HTA is to provide objective, reliable, and valid information to support health care decisions and policy-making at the local, regional, national and international level (…). (Source: ISTAHC leaflet, 1995) HTA is a multidisciplinary activity which uses analytic frameworks from a variety of methods. (Source: ISTAHC leaflet, 1995) Definition Health technology assessment

10. HTA is the systematic evaluation of properties, effects or impacts of health technology. It may address the direct, intended consequences of technologies as well as their indirect, unintended consequences. Its main purpose is to inform technology-related policy making in health care. (Source: HTA Glossary, 2006) HTA is conducted by interdisciplinary groups using explicit analytic frameworks from a variety of methods. (Source: HTA Glossary, 2006) Definition Health technology assessment

11. United States 1972 U.S. Congress Office of Technology Assessment (OTA) 1975 – 1991 Health program at OTA International 1985-2003 International Society for Technology Assessment in Health Care (ISTAHC) 2003 – present Health Technology Assessment international 1993 – present International Network of Agencies for Health Technology Assessment (INAHTA) 2013: 53 member agencies in 29 countries Establishment Health technology assessment

12. Aspects Safety Efficacy/effectiveness Economic Legal Organizational Ethical Educational Accreditation and certification Diffusion Adoption Use Scope Health technology assessment

13. Future technology Technology not yet developed Emerging technology Technology prior to adoption New technology Technology in the phase of adoption Accepted technology Technology in widespread use Obsolete technology Technology that should be taken out of use To serve as an aid to decision-making, hta should be done in phase with the life-cycle of a technology HTA and decision-making

14. Industry Marketing and promotion Policy-makers Regulation, legislation, evaluation Hospitals and providers Purchase and use Patients Individual healthcare decisions Insurers Payment New technology HTA and decision-making

15. Identification Monitoring technologies Priority setting Selecting those technologies most in need of assessment Testing Conducting the appropriate data collection and analysis Six steps: 1-3 A process or system of HTA

16. Synthesis Collecting and interpreting existing information and the result of the testing step and, usually, making recommendations on judgments about appropriate use Dissemination Providing the synthesized information to the appropriate persons who use or make decisions concerning the use of health care technologies Implementation Using methods that are intended to turn changes in knowledge and attitudes of decision-makers into changes in behaviour Six steps: 4-6 A process or system of HTA

17. A scheme for the development and diffusion of health care technologies Source: Office of Technology Assessment, U.S. Congress (1976)

18. EURASSESS11994-1997 HTA EUROPE 1997-1999 ECHTA/ECHAHI 1999-2001 EUnetHTA Project 2006-2008 EUnetHTA Collaboration 2008-2009 EUnetHTA JA1 2010-2012 EUnetHTA JA2 2013-2015 EU co-subsidised projects in HTA

19. HTA is understood, perceived and used differently across Europe The structure of HTA reports varies substantially between countries It is difficult to retrieve standardised information in national HTA-reports Work Package 4 (EUnetHTA): Common Core HTA, tries to define and standardise HTA elements in order to increase the international applicability of assessments Production of a general core of evidence which can be shared internationally EUnetHTA – Background to the development of the HTA Core Model

20. CORE HTA StructureDomain – topic - issue • Core HTA structure consists of: • 9 domains • Ca. 50 topics • Ca. 150 issues • Each issue consists of: • Question • Description of the applied methodology • Answer to the question • References

21. Health problem and current use of technology Domains of HTA Technical characteristics Safety • Identified in previous EU projects, particularlyEUR-ASSESS and ECHTA/ECAHI • Promote the multidisciplinary nature of HTA Clinical effectiveness Costs and economic evaluation Ethical analysis Organisational aspects Social aspects Social aspects Legal aspects

22. Health problem and current use of technology Topics Technical characteristics Safety Clinical effectiveness Topic 1: Mortality Clinical effectiveness Issue 1: What is the effect of the intervention on overall mortality? Costs and economic evaluation Topic 2: Morbidity Ethical analysis Issue 2: What is the effect of the intervention on mortality caused by the target disease? Topic 3 etc… Organisational aspects Social aspects Issue 3: etc… Legal aspects

24. Basic unit of the HTA Core Model Combination of a domain, topic and issue define the context of assessment elements Each element describes an aspect of technology or its use Assessment elements

25. From Core Model to Core HTA • The relevance of each assessment element is considered in the context of the technology at hand. • If an element is relevant, the generic issue is translated into one or more practical research question(s). • Possible non-relevance of elements is also recorded in the report. • Relevant questions are answered in the core HTA using typical research methodologies. • RESULT: a structured report in wich information on a particular issue can be found at a standard location (whether in paper or electronic form)

26. Core HTAs • Serve primarily as a scientific basis for local (national, regional) reports • Do not contain recommendations regarding the use (or non-use) of technologies • Enable distributed production of HTA (e.g. different domains by separate research groups) • Enable and promote international collaboration and transfer of information

27. RecommendationThe HTA Core Model • The development and content of the HTA Core Model, in the context of EUnetHTA JA 1 WP5, warrants furtherstudy of itsapplicabilityrelated to integratedcare

28. Methodological guidance • EUnetHTA WP5 13 Methodological Guidelines for Rapid Relative EffectivenessAssessment of Pharmaceuticals Endpointsused for REAs of pharmaceuticals Clinicalendpoints, Compositeendpoints, Surrogateoutcomes, Safety, Health-relatedquality of life Applicability to Integrated Care?

29. RecommendationMethodological Guidance • Recent developments in HTA, amongothers the development of a number of outcomesorientedmethodological guidelines for rapid relative effectivenessassessment of pharmaceuticals warrant to bestudied in detail to assesstheirapplicability to interventions relating to integratedcare

30. Discussion • Outcome of integrated care – Role of HTA • Robust + • International, not confined to Denmark + • Perhaps labour intensive –