EUnetHTA Training course for Stakeholders - Introduction to the HTA Core Model® and core HTA information

1. European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu Introduction to the HTA Core Model® and core HTA information EUnetHTA Training Course for Stakeholders Rome, 29 Oct 2014 Kristian Lampe, THL/FINOHTA

2. European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.euEuropean network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu Background and purpose 2

3. European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu • To capture the shareable ”core” of HTA • To enable production of structured HTA information and sharing the acquired knowledge • To support joint HTA production • To support local HTA production Key aims of the HTA Core Model 3

4. European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu How do we perceive HTA, i.e. how to split the onion?

5. European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu What is the Core? - Two options for splitting the onion Technology assessment in health care is a multidisciplinary field of policy analysis. It studies the medical, social, ethical, and economic implications of development, diffusion, and use of health technology. (INAHTA 2005) 5

6. European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu What is TA / HTA? – back to basics “The Congress hereby finds and declares that: (a) As technology continues to change and expand rapidly, its applications are 1. large and growing in scale; and 2. increasingly extensive, pervasive, and critical in their impact, beneficial and adverse, on the natural and social environment. (b) Therefore, it is essential that, to the fullest extent possible, the consequences of technological applications be anticipated, understood, and considered in determination of public policy on existing and emerging national problems.” Office of Technology Assessment Act, 1972 http://www.princeton.edu/~ota/ns20/act_f.html 6

7. European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu E Draborg et al. International comparison of the definition and the practical application of health technology assessment. Int J Technol Assess Health Care. 2005 Winter;21(1):89-95. 433 HTA reports published 1989- 2002 by 11 agencies in 9 countries Great variation in HTA practice 7

8. European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.euEuropean network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu The Model 8

9. European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu 9

10. European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu Health problem and current use of technology Technical characteristics Ethical analysis Organisational aspects Legal aspects Clinical effectiveness Costs and economic evaluation Safety Domains of HTA • Identified in previous EU projects, particularly EUR-ASSESS and ECHTA/ECAHI • Promote the multidisciplinary nature of HTA Social aspects 10

11. European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu Clinical effectiveness Topics Health problem and current use of technology Technical characteristics Ethical analysis Organisational aspects Social aspects Legal aspects Costs and economic evaluation Safety Topic 1: Mortality Topic 2: Morbidity Topic 3 etc… Clinical effectiveness Issue 1: What is the effect of the intervention on overall mortality? Issue 2: What is the effect of the intervention on mortality caused by the target disease? Issue 3: etc… 11

12. European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu Three components of the HTA Core Model HTA QUESTIONS (ONTOLOGY) Questions that an HTA should answer METHODOLOGICAL GUIDANCE How to answer the questions REPORTING STRUCTURE How to present the answers 12

13. European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu ˗ A formal representation of the information contents of an HTA (e.g. ”the effect of technology on reduction of symptoms”) and relationships between various parts of the content ˗ Assessment elements as building blocks (each provides information on certain aspect of technology) ˗ Assessment elements are defined by ˗ 9 domains (wider angle of viewing, e.g. clinical effectiveness), ˗ topics within domains (more specific areas of investigation, and ˗ issues within topics (practical questions) HTA Questions / Ontology 13

14. European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu ˗ Assists in finding answers to questions defined by the ontology ˗ Different levels: domains, assessment elements, whole model / whole HTA ˗ Domain-level guidance mostly as reviews of state-of-the-art methodology and links to detailed guidance ˗ Different strengths of guidance: tips, recommendations, standards Methodological guidance 14

15. European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu ˗ Standardized format for output of HTA information production ˗ In the form of collections containing ˗ General texts, e.g. introduction, summary ˗ Domain-level content, e.g methodology, discussion ˗ Result cards, each containing an answer to question (or answers to questions) defined by one assessment element (=combination domain-topic-issue) ˗ Appendices ˗ Core HTA information = any HTA information produced using the HTA Core Model and published within the HTA Core Model Online ˗ Different types of collections (EUnetHTA/Other) ˗ EUnetHTA Core HTA = Extensive assessment, all domains included ˗ EUnetHTA Rapid HTA = Fast assessment, a selection of domains included ˗ Other = Based on users needs, e.g. single AE, single domain ˗ EUnetHTA collections do not contain recommendations Reporting structure 15

16. European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.euEuropean network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu Core HTA information 16

17. European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu Production process in brief 1. Select the assessment elements to be included in the collection. 2. Translate the included issues each into one or more practical research question(s). 3. Answer the questions using guidance within the Model. 4. Organise and present the answers according to the common reporting structure. 5. RESULT: a structured collection of HTA information in which information on a particular issue can be found at a standard location (whether in paper or electronic form). 17

18. European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu Core HTAs • One type of core hta information collection • Five pilot core HTAs produced until now within EunetHTA, sixth will be ready soon. One further pilot commenced within WP4 of EUnetHTA JA2. • Intentionally built to “not look like a European HTA report” • 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) • Easy sharing of produced information • Easier than before to update only a selection of information 18

19. European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu INFORMATION Collections Serve also as project platforms TOOLS Core HTA Structure 2012 19 Official EUnetHTA Other Pool of structured HTA Information Result cards (RC) based on assessment elements Local products HTA Core Model Online Tool & Service Local Tools RC RC RC RC RC RC RC RC RC RC RC RC RC RC RC RC RC RC RC RC RC RC RC RC RC Core HTA Rapid HTA Core HTA Rapid HTA Full domain Free set (≥ 1) My collection Full domain Free set (≥ 1) My collection Primarily EUnetHTA jurisdiction Primarily local jurisdiction AUTOMATIC L HTA L RHTA L HTA L HTA VOLUNTARY L RHTA Primarily EUnetHTA jurisdiction Primarily local jurisdiction L HTA L RHTA TAILORED

24. European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu • Currently published through the EUnetHTA main site at www.eunethta.eu • Select ”Output” and filter by activity JA2-WP5 for most recent rapid HTAs • Work in progress to include rapid HTAs in the HTA Core Model Online Rapid assessments 24

25. European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu Thank you This presentation arises from the EUnetHTA Joint Action 2 which has received funding from the European Union, in the framework of the Health Programme

EUnetHTA Training course for Stakeholders - Introduction to the HTA Core Model® and core HTA information

EUnetHTA Training course for Stakeholders - Introduction to the HTA Core Model® and core HTA information

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