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

EUnetHTA Applying the HTA Core Model in producing and reporting assessments – and other joint work in EUnetHTA

European network for

Health Technology Assessment

AdvanceHTA Capacity Building Workshop, AOTM, September 26, 2015

Finn Børlum Kristensen

Adjunct professor, University of Southern Denmark

Secretariat Director, EUnetHTA Secretariat

Danish Health and Medicines Authority (EUnetHTA Coordinator),

Copenhagen, Denmark

Policy making

paradigm

HTA-paradigm

Decision-making domain Research domain

Planning

/policy

question

HTA-

questions

HTA

project

Summary

of the

assessment

Based on Kristensen FB et al. Seminars in Colon and Rectal Surgery, 2002; 13: 96 – 103


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• Germany, IQWIG,DIMDI (+GBA, Medical Valley – EMN) • UK, NICE, NETSCC, (+HIS) • France, HAS • Italy, AGENAS, AIFA, ASSR Emilia Romagna, Veneto Region • Spain, ISCIII, AETSA, OSTEBA, Avalia-T, AQuAS • Poland, AHTAPOL • Austria, LBI, HVB, GÖG • Croatia, AAZ • Netherlands, CVZ • Belgium, KCE • Portugal, INFARMED • Sweden, SBU, TLV • Norway, NOKC • Finland, THL, FIMEA • Denmark, DHMA (Coordinator), CFK Region Midt

Some of the Partner Organisations

in Joint Action 2 (2012-15), e.g.


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Health Technology

Life-cycle



EUnetHTA output and

national HTA work

6


HTA is context specific

Globalize the evidence, localize the decision

J.M. Eisenberg

7



EUnetHTA Tools

8


9

EUnetHTA Tools

EUnetHTA HTA Core Model Online

EUnetHTA HTA Core Model Applications

EUnetHTA Methodological Guidelines for Rapid Relative

Effectiveness Assessment (REA)

EUnetHTA Submission templates for drugs and devices

EUnetHTA Planned and Ongoing Projects Database (POP)

EUnetHTA Evidence database on new technologies (EVIDENT)

EUnetHTA Adaptation Glossary & Toolkit

_______________________________________________________

EUnetHTA Contact Database

EUnetHTA Intranet Groups

EUnetHTA E-meeting facility

EUnetHTA Community of Practice


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The HTA

Core Model®

Description

The HTA Core Model® is a

methodological framework for

shared production and sharing of

HTA information.

Purpose

To enable production of high

quality HTA information in a

structured format to support the

production of local (national or

regional) HTAs and reuse of

existing information.


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The Structure of

the HTA Core Model®

ONTOLOGY

Questions

that an HTA

should answer

METHODOLOGICAL GUIDANCE

How to answer the questions

REPORTING

STRUCTURE

How to present

the answers


The Domains of the HTA Core Model®

- assessing dimensions of value

HTA Core Model DOMAINS

1. Health problem and current use of technology

2. Description and technical characteristics

3. Safety

4. Clinical effectiveness

5. Costs and economic evaluation

6. Ethical analysis

7. Organisational aspects

8. Social aspects

9. Legal aspects

SCOPE

Rap

id

Fu

ll

Reli

ab

le, ti

mely

, tr

an

sp

are

nt,

tran

sfe

rab

le H

TA

in

form

ati

on

Valu

e ?

??


Access to the HTA Core Model®: www.htacoremodel.info

The HTA Core Model Online®

13

http://www.htacoremodel.info/


Core HTA Structure

14

INF

OR

MA

TIO

N

Collections Serve also as project platforms

TO

OL

S

Official EUnetHTA

Other

Pool of structured

HTA Information

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

Core HTA

Rapid HTA

Full domain

Free set (≥ 1)

My collection

Primarily EUnetHTA Primarily national

AUTOMATIC

L HTA L RHTA

L HTA

L HTA

L RHTA

Primarily EUnetHTA Primarily local

L HTA

L RHTA

TAILORED

VOLUNTARY


WP4 Update Activity Due date /

Milestone

Status

1st Core HTA Fecal Immunochemical Test

(FIT) versus guaiac-based fecal

occult blood test (FOBT) for

colorectal cancer screening.

May ‘14 - Core HTA published

2nd Core HTA Intravenous immunoglobulins

for Alzheimer’s disease

including Mild Cognitive

Impairment

Sep ’14 • 1st draft of the text in

finalised

3rd Core HTA Telemonitoring in home care for

patients with chronic

cardiovascular disease

Jul ’15 • Topic notification

procedure in finalised

European network for Health Technology Assessment | JA2 2012-2015 |

www.eunethta.eu

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Current full HTA pilots


Current rapid REA pilots

October 2, 2014 16

Pilot nr. Topic Status/Clarification

Strand A Ongoing:

1. Pilot SA-3 Draft Submission has been submitted

Scoping Meeting 05-09-14 in Rome

2. Pilot SA-4

Letter of Expression of Interest has been received

The Authoring team for the pilot is complete

3. Pilot SA-5

Expected to start in Q4-2014/Q1-2015

Letter of Expression of Interest has been received

Currently looking for volunteers to serve the role as Co-Authors

4.

Pilot SA-6

Pilot postponed till Q1-2015

Waiting on letter of intent

Looking for volunteers to comprise the authoring team and for dedicated

reviewers

Strand B

3. Balloon Eustachian tuboplasty

for the treatment of Eustachian

tube dysfunction

Compilation of 1st draft of assessment

Ongoing: Dedicated review

4. Biodegradable stents for

benign refractory esophageal

stenosis

Dedicated review

Pilot postponed (results of completed RCT will be awaited)


Current submission template pilots Activity Due date/

Milestone (Since last e-meeting)

Status/Clarification of delays

Draft submission

template for

pharmaceuticals

M26/Nov’14

• Piloting ongoing in Rapid REA

• Confirmed involvement from two partners to

support updating after piloting

Development of

submission

template for

medical devices

M26/Nov’14

• Piloting ongoing – developing process and

timelines for feeding back from EUnetHTA

Rapid REA pilots and national pilots

• Confirmed involvement from two partners to

support updating after piloting

Analysis of cost

information

M25/Oct’14 • Ongoing – working with one partner on

coding information requested in evidence

requirements


Description

The EUnetHTA Planned and Ongoing Projects

(POP) database allows EUnetHTA Partners

and Associates to share information on

planned, ongoing or recently published projects

of participating agencies and identify similar

projects through a matching system provided

by the online database.

The POP Database

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Purpose

To facilitate

collaboration among

European HTA

agencies and reduce

duplication of work.


Access to the POP Database : http://eunethta.dimdi.de/PopDB/

The POP Database Online

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http://eunethta.dimdi.de/PopDB/


POP Statistics: Quarterly Updates

In Spring 2014, POP Database contained: 1,230 planned, ongoing and recently

published projects from 44 EUnetHTA JA partners and 24 countries

(Oct/Dec 2013) POP Request

Out of 63 EUnetHTA JA partners:

• 28 responded and entered/updated

projects in the database

• 11 responded but DID NOT feed

the database

• 24 did not respond at all (38%)

• Total number of projects: 1,219

• Alert (SAME) topics: 101 (8%)

• Similar projects (within alert topics): 249

• Access-rights: 41 partners

(Jan/March 2014) POP Request

Out of 68 EUnetHTA JA partners:

• 35 responded and entered/updated projects

in the database

• 8 responded but DID NOT feed the database

(no current changes in the projects)

• 25 did not respond at all (37 %)

• Total number of projects: 1,216

• Alert (SAME) topics: 103 (8 %)

• Similar projects (within alert topics): 247

• Access-rights: 46 partners


Description

The EVIDENT Database enables sharing early

information on evidence gaps identified during

the production of HTA reports and consequent

recommendations / requests for additional data

collection.

It also contains information on reimbursement /

coverage and assessment status of promising

technologies in Europe.

The EVIDENT Database

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Purpose

To reduce redundancy,

promote generation

of further evidence

and facilitate European

collaboration in the

domain.


Access to the EVIDENT Database: https://evident.has-sante.fr/has/login.xhtml

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The EVIDENT Database Online

https://evident.has-sante.fr/has/login.xhtml




Additional data collection Activity/Activity steps Due date /



Development of the 1st

draft of position papers

Summer 2014 Position paper on how to decide on the

appropriate study design

• 1st draft delivered in Jul‘14

• currently under review by dedicated

reviewers

• to be sent for stakeholder consultation in

September

Position paper on how to best formulate the

research question

• will be developed simultaneously with the 1st

draft of the appropriate study design

Development of the 1st draft

of the common core

protocol

Nov 2014 • Selected topic: Circulite Synergy System

for chronic heart failure

• Development of the protocol started in

Jul’14


Development

9 Methodological Guidelines for Rapid

REA of Pharmaceuticals developed in

JA1 by WP5.

Content

Guidelines on methodological

challenges that are encountered by

health technology assessors while

performing a rapid relative effective-

ness assessment of pharmaceuticals.

Primary Aim

To help the assessors of evidence

interpret and process the data that are

presented to them as part of a REA

9 Methodological Guidelines for Rapid REA

24


Endpoints used for REA

of pharmaceuticals

1. Clinical endpoints

2. Composite endpoints

3. Surrogate endpoints

4. Safety

5. Health-related quality of life

Comparators and comparisons

6. Criteria for the choice of the most

appropriate comparator(s)

7. Direct and indirect comparison

Levels of evidence

8. Internal validity

9. Applicability of evidence in the

context of a relative effectiveness

assessment

Link to the guidelines

http://www.eunethta.eu/outputs/metho

dological-guideline-rea-

pharmaceuticals-clinical-endpoints

9 Methodological Guidelines for Rapid REA

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http://www.eunethta.eu/outputs/methodological-guideline-rea-pharmaceuticals-clinical-endpoints















Current Methodological Guidelines Activity/Activity

steps

Due date /



Elaboration of new

general

methodological

guidelines

M21/Jun‘14

(scheduled

finalisation

according to the

WP7-SG3 work

plan for the first

batch of

guidelines)

First batch of guidelines

a. GL Internal validity of non-

randomised studies (NRS) on

interventions: Piloting of Cochrane

NRS-RoB-Tool now finalised, ongoing

work on the draft guideline

b. GL Economic evaluations: Internal

consultation finalised, validation of

country specific extracted data ongoing,

preparation of a version for SAG / Public

consultation

c. GL Meta-analysis of diagnostic test

accuracy studies: Preparation of the

final version


Activity/Activity

steps

Due date /



Elaboration of new

general

methodological

guidelines (cont.)

M23-M36

Aug ‘14 – Sep ‘15

Second batch of guidelines

a. Personalised Medicine: IQWiG

prepared a concept for a “Position

Paper”, under internal review in the draft

group (Three Partners)

b. GL Medical Devices: Guideline

concept under development

c. GL Information retrieval in

bibliographic databases and study

registries:

Draft guideline prepared, under review

in the draft group

Current Methodological Guidelines


Thank you Any questions?

This presentation arises from the EUnetHTA

Joint Action 2 which has received funding

from the European Union, in the framework

of the Health Programme


HTA 2.0 Europe

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