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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
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
• 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.
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
5
Health Technology
Life-cycle
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
EUnetHTA output and
national HTA work
6
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
HTA is context specific
Globalize the evidence, localize the decision
J.M. Eisenberg
7
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
EUnetHTA Tools
8
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
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
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
10
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.
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
11
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
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
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 ?
??
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
Access to the HTA Core Model®: www.htacoremodel.info
The HTA Core Model Online®
13
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
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
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
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
15
Current full HTA pilots
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
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)
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
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
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
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
18
Purpose
To facilitate
collaboration among
European HTA
agencies and reduce
duplication of work.
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
Access to the POP Database : http://eunethta.dimdi.de/PopDB/
The POP Database Online
19
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
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
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
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
21
Purpose
To reduce redundancy,
promote generation
of further evidence
and facilitate European
collaboration in the
domain.
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
Access to the EVIDENT Database: https://evident.has-sante.fr/has/login.xhtml
22
The EVIDENT Database Online
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
Additional data collection Activity/Activity steps Due date /
Milestone (Since last e-meeting)
Status/Clarification of delays
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
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
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
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
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
25
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
Current Methodological Guidelines Activity/Activity
steps
Due date /
Milestone (Since last e-meeting)
Status/Clarification of delays
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
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
Activity/Activity
steps
Due date /
Milestone (Since last e-meeting)
Status/Clarification of delays
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
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
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