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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

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Page 1: Training SF2014 hta core model - MAKEMEWEBIntroduction to the HTA Core Model ... Production process in brief 1. Select the assessment elements to be included in the collection. 2

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

Introduction tothe HTA Core Model® and coreHTA information

EUnetHTA Training Course for Stakeholders

Rome, 29 Oct 2014

Kristian Lampe, THL/FINOHTA

Page 2: Training SF2014 hta core model - MAKEMEWEBIntroduction to the HTA Core Model ... Production process in brief 1. Select the assessment elements to be included in the collection. 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

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

• To capture the shareable ”core” of HTA

• To enable production of structured HTAinformation and sharing the acquired knowledge

• To support joint HTA production

• To support local HTA production

Key aims of the HTA Core Model

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

How do we perceive HTA,i.e. how to split the onion?

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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 amultidisciplinary field of policy analysis. It studies the

medical, social, ethical, and economic implications ofdevelopment, diffusion, and use of health technology.

(INAHTA 2005)

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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, itsapplications are1. large and growing in scale; and2. 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, theconsequences of technological applications be anticipated,understood, and considered in determination of public policy onexisting and emerging national problems.”

Office of Technology Assessment Act, 1972http://www.princeton.edu/~ota/ns20/act_f.html

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

E Draborg et al. Internationalcomparison of the definition and thepractical application of healthtechnology assessment. Int JTechnol Assess Health Care. 2005Winter;21(1):89-95.

433 HTA reports published 1989-2002 by 11 agencies in 9 countries

Great variation inHTA practice

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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

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Health problem and current use oftechnology

Technical characteristics

Ethical analysis

Organisational aspects

Legal aspects

Clinical effectiveness

Costs and economic evaluation

Safety

Domains of HTA

• Identified in previous EU projects,particularlyEUR-ASSESS and ECHTA/ECAHI

• Promote the multidisciplinary natureof HTA

Social aspects

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

Clinical effectiveness

Topics

Health problem and current use oftechnology

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 theintervention on overallmortality?

Issue 2: What is the effect of theintervention on mortality causedby the target disease?

Issue 3: etc…

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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 HTAshould answer

METHODOLOGICALGUIDANCE

How to answerthe questions

REPORTINGSTRUCTURE

How to presentthe answers

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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”) andrelationships 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

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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 / wholeHTA

˗ 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

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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 Modeland 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

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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

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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 researchquestion(s).

3. Answer the questions using guidance within the Model.

4. Organise and present the answers according to the common reportingstructure.

5. RESULT: a structured collection of HTA information in whichinformation on a particular issue can be found at a standard location(whether in paper or electronic form).

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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, sixthwill be ready soon. One further pilot commenced within WP4 ofEUnetHTA 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 byseparate research groups)

• Easy sharing of produced information

• Easier than before to update only a selection of information

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INF

OR

MA

TIO

N

CollectionsServe also as project platforms

TO

OL

SCore HTA Structure 2012

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Official EUnetHTA

Other

Pool of structured HTAInformationResult cards (RC) based onassessment elements

Local products

HTA Core ModelOnline 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 EUnetHTAjurisdiction

Primarily localjurisdiction

AUTOMATIC

L HTA

L RHTA

L HTA

L HTA

VOLUNTARY

LRHTA

Primarily EUnetHTAjurisdiction

Primarily localjurisdiction

L HTA

L RHTA

TAILORED

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• 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

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Thank you

This presentation arises from the EUnetHTA

Joint Action 2 which has received fundingfrom the European Union, in the framework ofthe Health Programme