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European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
Cross-Border Collaboration
Can the Lessons Be Learned From the Development and Piloting of the EUnetHTA Rapid Relative Effectiveness Model Serve to Support HTA of Medical Devices Throughout Canada?
CADTH Symposium,Saskatoon, Canada 12-14 April 2015
Simone Warren MScProject Coordinator WP5 EUnetHTA
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
Brief Introduction EUnetHTA
The HTA Core Model
Work Package 5
Application in HTA of Medical Devices/other medical technologies
Overview
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European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
Scope of EUnetHTA’s work
to create an effective and sustainable network for HTA across Europe to help developing reliable, timely, transparent and transferable information
support collaboration between European HTA organisations that brings added value at the European, national and regional level through facilitating efficient use of resources available for HTA
creating a sustainable system of HTA knowledge sharing
promoting good practice in HTA methods and processes.
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European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
Participants in EUnetHTA
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EUnetHTA Partners and Associates in JA2.
44 Partner organisations designated by Member States
Large number of regional agencies and non-for-profit organisations that produce or contribute to HTA
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
EUnetHTA Joint Action 2 (2012-2015)Objectives
To achieve a better understanding for the European Commission and Member States of ways to establish a sustainable structure for HTA work in the EU
To produce recommendations regarding the design and management of the future EU HTA cooperation
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Total budget: € 9,428,550
To strengthen the practical application of tools and approaches to cross-border HTA collaboration
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.euEuropean network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
The HTA Core Model
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European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
The Domains of the HTA Core Model®
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
Rel
iab
le,
tim
ely,
tra
nsp
aren
t,
tran
sfer
able
HTA
in
form
atio
n
Val
ue
??
?
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
Within each domains – several issues
HTA Core Model DOMAINS
1. Health problem and current use of technology
A0001: For which health conditions, and for what purposes is the technology used?
A0002: What is the disease or health condition in the scope of this assessment?
A0003: What are the known risk factors for the disease or health condition?
4. Clinical effectiveness
D0001:What is the expected beneficial effect of the intervention on mortality?
D0020: Does use of the test lead to improved detection of the condition?
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.euEuropean network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu 9
Joint Rapid Assessments (WP5)
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European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
Two definitions are commonly used in the context of a relative effectiveness assessment :
•Relative efficacy can be defined as the extent to which an intervention does more good than harm, under ideal circumstances, compared with one or more alternative interventions.
•Relative effectiveness can be defined as the extent to which an intervention does more good than harm compared with one or more alternative interventions for achieving the desired results when provided under the usual circumstances of health care practice
Definition of Relative Effectiveness Assessment (REA)
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European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
Tools for Strand B
Procedure manual that describes Strand B process
Assessment template provides
guidance for reporting
Guidelines provide
methodo-logical
guidance
provides working
framework through a
set of research
questions*
*+ checklist for ethical, organisational, social and legal issues
Submission File template
that is submitted by manufacturer
(s)
+ consideration of other Core Model
applications
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European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
Rapid HTA Core Model
Rapid timeframe as assessment characteristics are adapted to national reimbursement context – timely information
Similar set of information within the four domains and European
countries – shareable/ transferable information
A compact and easy-to-read format – useful information
Cross-border collaboration, quality assurance – reliable and transparent information
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European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
Main output- Rapid REA
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No Recommendations!
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/methodological-guideline-rea-pharmaceuticals-clinical-endpoints
9 Methodological Guidelines for Rapid REA
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Pilot team:
•1 – 3 (co)authors
•3 – 6 dedicated reviewing agencies
•Coordination Team
•EUnetHTA members
Stakeholders:
•Manufacturers: evidence, reimbursement status, project plan, assessment, submission file
•Patient/Consumer representatives: project plan, assessment
•Medical experts: project plan, assessment
•Stakeholder Advisory Group/Stakeholder Forum: project plan
•Public: project plan
Production of assessments
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European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
1 authoring agency: responsible for the overall quality of the assments, usually for Effectiveness and Safety Domain and for the Summary
1 – 3 co-authors: assist authoring agency in selection of relevant assessment elements of HTA Core Model for Rapid REA; quality of assurance of work of author; usually responsible for authoring 1 – 2 other domains
Dedicated reviewers: 3 – 6; read first draft of assessment – quality assurance
Coordination Team: LBI-HTA for managing contact with manufacturers/Stakeholder Forum(Stakeoholder Advisory Group), overseeing communication/work-flow within pilot team
Team Building and Topic selection
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Relevance of topic assessed will determine participation by other members AND uptake of assessment in local/national context,
No technology specific assessments – class assessments
2 options:
1. Call for collaboration: Authoring agency selects 2 topics out of their own work programme – WP5 members are asked to indicate their preference – choice of final topic
Also members are asked if they want to contribute: co-authors, dedicated reviewers
2. POP- Database: overlap in topics indicate potential partners for collaboration and also relevance for other countries. Authors can approach agencies directly and ask if collaboration would be feasible
Team Building and Topic selection
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Modes of collaboration
agency X
Agency A: author of all domains
Agency B: co-author checks work of author
agency 4
agency 1
agency 3
agency X
agency X
agency Xagency X
agency 5
agency 2
agency X
agency Xagency X
agency Xagency X
Agency C:1-? domains
Agency B: 1- ? domains
Agency A: 1 - ? domains
Agency D: 1 - ? domains
agency 3
agency 1 agency 2
agency 5agency 4
Authors and co-authors
Dedicated reviewers
WP5 Members Review
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European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu 20
Duodenal-jejunal bypass sleeve for the treatment of obesity with or without type II Diabetes mellitus
Renal denervation for treatment resistant hypertension
Balloon Eustachian Tuboplasty for the treatment of Eustachian tube dsyfunction
Biodegradable stents for benign refractory esophageal stenosis
Implantable devices for the treatment of mitral valve regurgitation
Duration January 2013 – August 2013
April 2013 – December 2013
April 2014 – February 2015
April 2014 – August 2015
October 2014 – September 2015
Pilot team agencies, n
8 8 5 5 9
(Co-)Authoring HTA bodies
LBI-HTA (Austria)AAZ (Croatia)
NOKC (Norway) Avalia-t (Spain)CFK (Denmark)
FinOHTA/THL HIQA (Ireland)
ISCIII (Spain)SAGEM (Turkey)
Agenas (Italy)AAZ (Croatia)MoH (Slovakia)
Dedicated reviewing HTA bodies
GYMEZSI (Hungary)HIQA (Ireland)HVB (Austria)ISCIII (Spain)NOKC (Norway)Charles University Prague (Czech Republic)
HIS (UK)FinOHTA/THL (Finland)AHTAPol (Poland)GYMEZSI (Hungary)IQWiG (Germany)
GYMEZSI (Hungary)HVB (Austria)AHTAPol (Poland)
VASPVT (Lithuania)Slovak Ministry of Health (Slovakia)LBI-HTA (Austria)
HAS (France)BIQG/GÖG (Austria)AETSA (Spain)AAZ (Croatia)HIQA (Ireland)HIS (Scottland)
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.euEuropean network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
Compiling a Rapid REA - Scoping phase
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Main output: final Project Plan including information on:
1. The team
2. Timelines
3. Methods/Scope:
PICO Table
Planned methodology
Data extraction table
Assessment elements and research questions
Scoping Phase
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European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
PICO Table
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European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
4 Domains:
1. Health Problem and Current Use of the Technology
2. Description and Technical Characteristics of the Technology
3. Clinical Effectiveness
4. Safety
Each domain consists of several issues (=generic research questions)
Authors go through these issues and decide whether it is relevant for their assessment
Ethical, organisational, social and legal issues covered in checklist
Selecting relevant assessment elements
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Selecting Assessment elements – formulating research questions
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After selection of relevant issues:
1. Authors translate generic questions into research question (and they provide answers to these research questions during the production phase)
2. Submission file template with the generic questions selected are send to manufactures which provide answers to these questions
Core Model for Rapid REA
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European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
Submission File TemplateContext – WP7 SG4
• EUnetHTA developed a submission template that includes the evidence requirements from European reimbursement organisations and reflects the HTA Core Model to support the production of core HTA information and rapid assessments
• Data extraction of national evidence requirements
• Categorisation of information according to a framework
April 15, 2023 27
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Submission File template
• The template follows the 4 Core Model domains
• Development of a series of modules for each domain (related to CM topic); each module has a group of questions/headings (related to AE issues, clarifications or HTA methodology)
• Link to WP5 assessments – piloting
• Serves as a tool for national agencies
• Meant to standardise processes across Europe and therefore support manufacturers
• Could be used to support national reimbursement processes in Europe, will ideally be used by all European countries for reimbursement
April 15, 2023 28
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.euEuropean network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
Application in HTA of Medical Devices/other medical technologies
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European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
Challenges & solutions 1
Topic selection: determines relevance for and thus uptake by members
indication-specific, not technology-specific
authors provide a rationale for topic selection
mini-prioritisation: authors suggest two potential topics out, members asked to rank them
Scope: CE mark often broad indication – different than that suggested by manufacturer(s), guidelines,…
- Scoping meetings with manufacturer helpful to better characterise, eg. target population, comparison to “Instructions of Use”
- Public consultation of draft project plan
- Involvement of medical experts early on
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
Challenges & solutions 2
Timing of assessment: at what stage of life-cycle of technology, in absence of a clear point of market entry throughout Europe
CE mark as selection criterion
topic selected out of work-programme of authors
Unsolved:
assessment too early with no comparative evidence; lack of comparative studies as “stopping rule”?
too late and already widely used in practice?
updates of assessments?
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
Challenges & solutions 3
Quality assurance: participation of HTA agencies (in WP5 51 partners) with different backgrounds, expertise, experiences, methods
first authors responsible for overall quality of assessments
several quality assurance mechanisms in place: internal review, external review, involvement of stakeholders
Unsolved:
Selection criteria for different roles?? differentiation between „experienced“ and „less experienced“ agencies/individuals?
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
Challenges & solutions 4
Methods: differences in methods for HTA production between HTA institutes, HTA Core Model for Rapid REA redundant, prone to inconsistencies
10 EUnetHTA Guidelines currently published
more in development (e.g. for literature search, non-randomised trials, etc)
Update of HTA Core Model for Rapid REA (ongoing)
Unsolved:
How to grade the overall strentgh of evidence – GRADE?
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
Challenges & solutions 5
Timelines: „rapid“ ~ 6 months, but so far ~ 8 months were needed, even more time needed with piloting the submission file template for medical devices
Unsolved:
routine use of submission file template in future collaborations? First experiences positive from both sides (authors and manufacturers)
timely identification of ALL relevant manufacturer(s)/CE marked products: inquiry about competitors amongst manufacturers, stakeholder advisory group, medical experts…
logistics of scoping meetings with several manufacturers
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
Conclusion There are a lot of unique challenges to the assessments of MDs, different
from that of pharmaceuticals.
Europe and Canada face some similar challenges, such as scoping and timelines
However, the HTA Core Model and the joint pilot assessments are showing promise in addressing these challenges and we are hopeful for further improvements and developments as we progress beyond the pilot stage and into a more sustainable system of joint rapid HTA.
Challenges addressed by EUnetHTA:
Scope
Standardisation
Collaboration: complex but possible!
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European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
Any questions?