1. technology and computing

EUnetHTA Plenary
Assembly
April 10-11, 2014
Madrid, Spain
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
Agenda - I
April 10, 2014
09:00 – 09:15
Opening remarks
09:15 – 10:15
First half of EUnetHTA JA2 – Report from the Coordinator
10:15 - 10:45
EUnetHTA Elections 2014
• Presentation of candidates and procedure
10:45 – 11:15
Coffee break – and elections
11:15 – 12:00
Approval of amended EUnetHTA Conflict of Interest Policy
and SOP
12:00 – 12:30
Short –(2014-15), mid- (2016-20) and long-term (post-2020)
strategic development of EUnetHTA
• Introduction by EUnetHTA and HTA Network
12:30 – 13:30
Lunch
13:30 – 13:40
Results of the elections
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
2
Agenda - II
April 10, 2014
13:40 – 14:45
Short-term (2014-15) strategic development of EUnetHTA
14:45 – 15:15
Coffee break
15:15 – 17:30
Mid-term (2016-20) strategic development of EUnetHTA – I
• Introduction and Group work
18:30 – 20:15
20:30 – ca.
23:00
Social event: Guided bus tour from hotel Melia Galgos through
Madrid
Dinner at Café de Oriente, Plaza de Oriente, 3
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
3
Agenda - III
April 11, 2014
09:00 – 10:15
Reports from Group discussion
10:15 – 10:45
Coffee break
10:45 – 12:00
Mid-term (2016) strategic development of EUnetHTA – II
• Plenary discussion
12:00 – 13:00
Lunch
13:00 – 14:00
Long-term (post-2020) strategic development of EUnetHTA
14:00 – 14:30
HTA 2.0 Europe – teaming up for value, Rome Oct. 30-31,
2014
14:30 – 15:00
Other issues and Conclusion
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
4
Opening remarks
• Mirjana Huic, PA Chair
• Antonio Sarria-Santamera, Director HTA
Department, ISCIII
• Finn Børlum Kristensen, EUnetHTA Executive
Committee Chair
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
5
Meeting objectives:
To provide a networking opportunity and strengthen
work relationships among the EUnetHTA participants
To discuss and decide an outline for developing
recommendations on the implementation of a
sustainable European network for HTA (Deliverable 1 of
EUnetHTA JA2)
• To discuss and promote national uptake and implementation of
EUnetHTA outputs
• To identify main prerequisites for the optimal conditions for
sustainability, design and management of the future EUnetHTA
cooperation as the scientific and technical mechanism of the
European cooperation on HTA
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
6
First half JA2 – report from
the Coordinator
EUnetHTA Secretariat, DHMA (Denmark)
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
First half JA2: report from the Coordinator (I)
Scientific Output:
-
1st Core HTA completed and 2nd started (WP4)
-
-
First drafts of the MSPs (Methodological Standard and Procedures);
4 rapid Core HTAs (2-pharma, 2- non-pharma) completed; 3 more started (WP5)
-
Procedure manuals , templates for assessments and evaluation surveys developed for both
strands of rapid pilots
-
6 pilot Early Dialogues finalised on medicinal products (WP7SG1)
-
Template for a disease specific guideline produced, concept paper delivered, first draft being
developed (WP7SG1)
-
Literature review on the AEG (Additional Evidence Generation) performed (WP7SG2)
-
The first 3 guidelines are being drafted and work on the next 3 has started (WP7SG3)
-
Guideline elaboration process, templates for guideline concept and working manual
-
1st draft of the submission template for pharmaceuticals developed and work on the submission
template for the medical devices commenced (WP7SG4)
-
Local (national/regional) HTA adaptations of the Core HTAs and rapid HTAs : see next 3 slides
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
8
National Adaptation JA2 - I
EUnetHTA output
Past uptake
Planned and Potential National
Reports
1st Pilot, Zostavax for
the prevention of
herpes zoster and
post herpetic
neuralgia
-Used by LBI-HTA (Austria) for
the production of a national
report (Published 2013)
• CVZ (Netherlands) (ongoing)
• AAZ (Croatia) plan to use the Zostavax
report (1st quarter 2015)
• MoH Spain (no date indicated)
• HAS (France) and MoH Slovakia have
expressed interest in national/local
production (no date indicated)
-
•
•
•
•
•
•
JA2, WP5 Strand A
2nd pilot on
canagliflozin for the
treatment of type II
diabetes mellitus
JA2, WP5 Strand A
CVZ (Netherlands) (planned 2014)
FIMEA (Finland) (planned Q2 2014)
AAZ (Croatia) (planned Q3 2014)
NCPE (Ireland) (no date indicated)
CAHIAQ (Spain) (no date indicated)
MoH, Slovakia (no date indicated)
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
9
National Adaptation JA2 - II
EUnetHTA output
Past uptake
Planned and Potential National
Reports
1st pilot on
Duodenal-jejunal
bypass sleeve
(EndoBarrier®)
•
CVZ (Netherlands), AAZ (Croatia),
MoH Czech Republic, NOKC
(Norway), and HIQA (Ireland) have
expressed interest in national/local
production (no date indicated)
JA2, WP5 Strand
B
2nd pilot on Renal
denervation
systems
JA2, WP5 Strand
B
•
Used by LBI-HTA (Austria) for the
production of a national report.
(Published end of July 2013).
Used in Strand A in the Rapid REA
on Canagliflozin (not national
uptake per se but usage); parts of
the text, mostly for the 1st domain,
were used.
(Published February 28, 2014)
• NOKC (Norway) and HIS
(Scotland, UK) have expressed
interest in using parts of the
assessment in national/local
production (no date indicated)
• CR.DK (Denmark) (ongoing, as of
March 2014)
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
10
National Adaptation JA1
EUnetHTA output
Past uptake
Planned and Potential National
Reports
Core HTAs on
Abdominal Aortic
Aneurysm (AAA)
Screening
• Used by HVB (Austria) for the
production of a national report
(published 2013)
-
• Used by NOKC (Norway) for
the production of a national
report
(published 2014)
JA1
Core HTA information
on “Fecal
Immunochemical Test
(FIT ) versus guaiacbased fecal occult
blood test (FOBT) for
colorectal cancer
screening”
JA1
-
• IER (Slovenia) and NIPH (Slovenia),
(March 2014)
• AAZ (Croatia), (2nd half of 2014)
• GÖG (Austria) and HVB (Austria), (2nd
half of 2014)
• THL (Finland),(no date indicated)
• NSPH MPD (Romania), SBU
(Sweden), INFARMED (Portugal) and
NCPHA (Bulgaria) have expressed an
interest in national/local production. (no
date indicated)
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
11
First half JA2: report from the Coordinator (II)
Scientific Output - TOOLS:
-
2nd release of EVIDENT Database (+maintenance) (WP6)
-
POP Database further development (+maintenance) (WP6) – see next slide for contents
-
IMIS (Information Management Infrastructure and Services) development (new intranet, public
website, re-design of the centralized authentication system, upgrade of EUnetHTA Aggregator,
Toolbar, identification of technical options for e-learning platform, review of evolution needs for the
Common Standards, evaluation of interoperability options; various support activities for JA2
operations management (financial/tech reporting; stakeholder involvement supporting tools, etc)
(WP6)
-
Updated contents and applications of the HTA Core Model® (WP8)
-
Updated Policy and License (commercial license) (WP8)
-
Upgrading of the HTA Core Model Online Service (WP8)
-
-
All done with feedback from the ongoing pilots
Development and delivery of the tailored trainings and learning material for the EUnetHTA
members and stakeholders (WP2)
THE FIRST HALF YEAR OF JA2 OVERLAPPED WITH FINALISING AND REPORTING JA1……….
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
12
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
(Jan/March 2014) POP Request
Out of 63 EUnetHTA JA partners:
Out of 68 EUnetHTA JA partners:
•
•
28 responded and entered/updated
projects in the database
•
11 responded but DID NOT feed
35 responded and entered/updated projects
in the database
•
8 responded but DID NOT feed the database
(no current changes in the projects)
the database
•
24 did not respond at all (38%)
•
25 did not respond at all (37 %)
•
Total number of projects: 1,219
•
Total number of projects: 1,216
•
Alert (SAME) topics: 101 (8%)
•
Alert (SAME) topics: 103 (8 %)
•
Similar projects (within alert topics): 249
•
Similar projects (within alert topics): 247
•
Access-rights: 41 partners
•
Access-rights: 46 partners
13
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
First half JA2 : report from the Coordinator (III)
Output: SERVICE – OPERATIONS AND Project MANAGEMENT (tools and
support):
- EUnetHTA JA2 3-year Work Plan, Consortium agreement, SOP, various
templates (WP1, Secretariat)
- Established and functioning Stakeholder Forum and Stakeholder Advisory
Groups (SAGS), public consultations structure and function (SI PROCESS
SUPPORT) (WP1, Secretariat)
- Electronic timesheets (for the purpose of the financial reporting AND for
calculation of efficiency gains) (WP1,WP3, Secretariat)
- Surveys and interviews to audit the progress and to capture specifics of the
cross-border collaboration activities (WP3)
- Internal and external communications support (eg, newsletters, coordination
and facilitation of presentations at various events, news service, social
media presence (Secretariat, WP1)
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
14
First half JA2: report from the Coordinator (IV)
External collaborations:
Policy developed to govern involvement with external parties
- EMA: 3 year Work Plan; 2 joint meetings per year; input in a number of
workshops; coordinated EUnetHTA input to one of EMA’s public
consultations; presence in ENCePP
- PARENT JA: participation in the workshops, review/input to their
deliverables; regular updates on developments
- 4 FP7 projects: coordinating meeting held; contacts established between
relevant EUnetHTA WPs/activity lines and FP7 projects
- EUPATI: EUnetHTA participates in the Advisory Board
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
15
First half JA2: report from the Coordinator (V)
New developments:
- EUnetHTA Position (process & procedure; 1 EUnetHTA Position developed)
- Framework for collaboration with EFPIA
- ToR and project with Roche on exploring the application of the HTA Core
Model in the internal company’s processes
- Clarifying synergistic co-existence and cooperation with the HTA Network
(input to the Rules of procedure, Multiannual work plan and Strategy paper
on long-term provisions) – EUnetHTA is the scientific and technical
cooperation mechanism of the HTA Network
- Co-Chair function in the Stakeholder Forum
- EUnetHTA partners cooperation to form SEED
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
16
First half JA2: report from the Coordinator (VI)
Finances:
Total expenditure Y1: 2.107.215 € (i.e. 22 %* of the total budget)
Grant spent Y1:1.417.963 € (72.1 % of the pre-finance received)
•
77,6% spent on staff (budgeted figure: 75,7%)
•
6,8% spent on travel/subsistence (budgeted figure: 9,3%)
•
24 partners spent >50% of the distributed grant (13 of them spent 100%)
•
12 partners spent <50% and 2 did not declare any expenditure at all
•
A budget revision is planned 1-2Qs of Year 3
* THE FIRST HALF YEAR OF JA2 OVERLAPPED WITH FINALISING AND REPORTING
JA1.
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
17
Achievements to support cooperation
practice (by WP)
WP2: successfully delivered first training courses to EUnetHTA members (91%
- expectations met) and stakeholders (63% - ”very useful”)
WP3: calculation concept, specific database and a tool (timesheet) for easy
data extraction from the timesheets and for assurance of data quality for
calculations of cost-efficiency
WP4: both process of actual collaboration on delivering Core HTA and
methods/procedures for supporting collaboration developed timely
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
18
Achievements to support cooperation
practice (by WP)
WP5: Strand A
Inside WP: The successful completion of 2 joint pilot rapid relative effectiveness assessments with partners
from across Europe which has resulted in national uptake of these reports by a number of reimbursement
authorities across Europe. The lessons learned from the pilots have resulted in improved procedures
and templates.
Across WPs:
• Collaborating in the creation of a pilot European manufacturer's submission template in cooperation with
NICE for the WP7 SG4 working group.
• Ongoing discussion and cooperation with WP4 and WP8 on the development of the HTA Core Model®
and the model for rapid REA. This communication ensures that the rapid model and the HTA core model
are synchronized and all relevant partners are aware of the updates occurring in the refinement process
of the model for rapid REA.
• Dissemination of information on the model for rapid REA and the process of the joint pilot rapid REAs
occurring throughout WP5 JA2 for the WP2 EUnetHTA partners training and education meetings.
External cooperation: Collaboration with EMA to improve the awareness and process of the pilot joint rapid
REAs and to discuss future opportunities for collaboration and parallel, complimentary procedures.
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
19
Achievements to support cooperation
practice (by WP)
WP5: Strand B
Inside WP:
• Development and continuous improvement of the Procedure Manual and templates to facilitate/ support the
cooperation of the pilot team members. The update of the templates is based on lessons learned during the
production of the first 2 pilot rapid assessments.
• The successful completion of 2 joint pilot rapid assessments being positive practice examples of the feasibility of
international cooperation, leading to increased motivation to participate.
• The definition of clear tasks and responsibilities according to the role of pilot participants (strengthening of project
management, 1st authors’ responsibility for quality assurance), sharpened focus to support the joint assessment
production on a high quality level.
Accross WPs:
• Cooperation with WP7 SG4 on the development of a pilot manufacturer’s submission file template for medical
devices.
• Dissemination of information on the process of the joint rapid pilot production for medical devices throughout WP5
JA2 for the WP2 EUnetHTA partners training and education meetings.
External parties: Continuous improvement of supporting processes (e.g. communication within the team and with
external experts/ stakeholders: e-meetings, new consultation process, CT manages communication with manufacturers)
to ensure a high quality process management and output production.
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
20
Achievements to support cooperation
practice (by WP)
WP7:
SG1: Conduct of 8 ED pilots (instead of 3 planned) as a result of an overwhelming interest expressed
by industry and continued partner commitment.
Improvement of the ED procedure as a result of repeat testing via the increased number of ED pilots
and the feedback obtained by surveying the EUnetHTA partners and Industry.
Face to face interactions between HTA bodies provides an opportunity to strengthen relationships and
give feedback on the evolving ED process.
Early Dialogues with EMA as an observer
SG2: Survey on Additional Evidence Generation successfully conducted (90% response rate) allowing
the identification of partners able to actively contribute to the development of this activity.
Collaboration with partners underway (6 active partners/4 collaborating).
Capacity building with regard to the conduct of studies for additional evidence generation that should
meet both the requirements of regulators and HTA bodies. Collaboration with ENCePP and EMA.
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
21
Achievements to support cooperation
practice (by WP)
WP7:
SG3: 22 partners actively support the elaboration of six methodological guidelines in a newly designed
process and two production waves. A working manual has been written and consented.
2 guideline draft versions are under internal review (Meta-analysis of diagnostic accuracy, Economic
Evaluation)
Carrying out of fruitful internal consultation to reach consensus on the objectives for challenging topics
(i.e. Economic Evaluation)
SG4: Development of a draft submission template that reflects the range of evidence requested from
manufacturers by 27 European countries that use evidence submissions from manufacturers to inform
national decisions about reimbursement of pharmaceuticals.
Any future jointly produced HTA information would be facilitated by a manufacturer’s submission
template that contains the evidence requirements of all countries that decide to participate.
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
22
Achievements to support cooperation
practice (by WP)
WP6:
• Implementation of the new Intranet with a general group to share information with all partners and
associates; restricted group areas (one for each WP, and for each WP sub group) + provision of
training to the group owners
• Managing the Planned and Ongoing Projects database and regular provision of alerts for potential
collaborations
WP8:
• Up-to-date, improved contents of the HTA Core Model, including a new application to support
production of core HTAs on pharmaceuticals
• Improved electronic support tools: the HTA Core Model Online to work with the new Model version
• Updated the Policy for the HTA Core Model and core HTA information
• Updated the Terms of Use for the HTA Core Model, including the inclusion of a commercial license
• Constant improvement of the skills and expanding the user base of the Model: several occasions of
providing training on the HTA Core Model
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
23
First half JA2: report from the Coordinator (VII)
While implementing JA2 and managing the EUnetHTA operations…
-
Conflict of Interest and confidentiality handling need to be standardised across WPs
-
Cross-WP coordination takes more time and resources than initially allocated
-
Stakeholder involvement – need to plan better, structure better, manage consistently and
know what is the purpose of the input we are seeking
-
practice and process details of the stakeholder involvement in EUnetHTA need to be
refined to be efficient and value-generating, not an exercise in comforting
-
possibly having yearly meetings to discuss challenges and experience
-
develop appropriate involvement mechanism for SHs from all 4 groups to contribute in
scoping meetings
-
Challenges with “volunteering” or “interest-driven” approach to assigning partner
organisations to WPs that all have detailed plans for the action – more efficient and effective
models need to be in place (after JA2)
-
Good planning and management (process and project management) skills are scarce (or
attention to these is lacking) – detrimental to sustainability of a network focusing on the
“production of HTA information” and providing services around it
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
24
First half JA2: report from the Coordinator (VIII)
-
Complexity and sheer amount of activities are very high – efforts to reduce both are needed
-
Diverse IT systems and varying access to the latest applications – will continue to be a
problem-causing issue as EUnetHTA (also when it comes to support systems) is a network of
independent legal entities (neither a “corporation” nor an agency) with diverse IT
systems
-
New (and mostly young) staff members join the agencies – need for regular training to bring
the newcomers up-to-speed in a complex project
-
As long as the EUnetHTA activities (or any “cross-border cooperation on HTA” in whatever
framework) remain being perceived as a “project” or “ad hoc “ or “extra-curricular” to the daily
activities of national/regional agencies – there will be difficulties with implementation and
progress…
-
A minimum requirement of having a “EUnetHTA liaison” person in each partner organisation
(who indeed knows “ins and outs” in the organisation vis-à-vis EUnetHTA) must be
implemented
-
Transparency is vital to success: in external collaborations as well as in planning the national report
production with the use of the EUnetHTA information
-
Defining boundaries of remits of the strategic (HTA Network) and scientific and technical mechanism
(EUnetHTA) of the European cooperation on HTA will be helpful
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
25
Reflections from first half of
EUnetHTA JA2 - DISCUSSION
• Factors that facilitate collaboration and/or receiving greatest value
by your organisation from EUnetHTA
• Main barriers to collaboration and/or to receiving greater value for
your organisation from EUnetHTA (including reflections on the
formal/budget conditions of the Join Action as per the grant
agreement as well as internal organisational barriers in your
organisation)
• Feasibility of incorporating/applying current EUnetHTA tools and
processes into your own organisation’s processes and routines
• Most useful of the current external collaborations of EUnetHTA
• Stakeholder involvement in EUnetHTA and relevance/lessons
learned for the national stakeholder involvement practices
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
26
EUnetHTA Elections 2014
Presentation of candidates and procedure
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
27
EUnetHTA PA Chair and Deputy Chair –
Candidates (term 2014-2016)
Candidate for the position of the Chair:
• Luciana Ballini, Head of Research Unit - "Regional Observatory for
Health Innovation", Agenzia Sanitaria e Sociale Regionale (ASSR), Italy.
Candidate for the position of the Deputy Chair:
•
Dr. Mairin Ryan, Director HTA, Health Information and Quality Authority
(HIQA), Ireland.
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
28
Elections 2014 – Executive Committee
Candidates (term 2014-2015)
1. Galician Agency for Health Technology Assessment (Avalia-T), Spain
(Represented by Marisa López García)
1. National Institute for Health and Care Excellence (NICE), UK
(Represented by Elisabeth George)
2. State Health Care Accreditation Agency (VASPVT), Lithuania
(Represented by Gintarė Mikšienė)
3. Swiss Network for Health Technology Assessment (SNHTA),
Switzerland
(Represented by Christoph Künzli)
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
29
EUnetHTA PA Chair and Dep. Chair
Governance Guiding Principles:
The Plenary Assembly shall elect a Chair and a Deputy Chair from among its
members on the basis of individual merits, and not as representatives of their
respective organisations for the period of 2 years, not to serve for more than
two terms in the same function.
Voting:
absolute majority of the Plenary Assembly voting members present and by
secret ballot. Several rounds of election take place in case when 2 or more
candidates are nominated for the same position and receive equal number of
the majority votes for the same position in the first round of election.
1 vote per 1 candidate
The Deputy Chair shall be elected following a procedure identical to that
of the Chair.
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
30
EUnetHTA Executive Committee
Governance Guiding Principles:
The electable members of the Executive Committee are elected for the period
of 1 year, not to serve for more than 2 consecutive terms in the same function.
The Executive Committee shall not contain more than 2 partners from one
country.
Voting:
a simple majority of the Plenary Assembly voting members present at an
annual meeting and by secret ballot. Several rounds of election take place in
case when 2 or more candidates are nominated for the same position and
receive equal number of the majority votes for the same position in the first
round of election.
1 vote per 1 running organisation
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
31
Election procedure Madrid
1.
Nomination of 2 tellers amongst the Plenary Assembly
participants
2.
Vote casting during the coffee break 10:45-11:15
3.
Vote counting 11:15 -13:30 (lunch)
4.
Results of the election 13:30
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
32
Approval of amended
EUnetHTA CoI Policy and SOP
Presentation, discussion and endorsement
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
33
Conflict of Interest and Confidentiality
handling - proposal
Background:
-
Necessity to standardise across JA2 WPs managing pilots on specific technologies
-
No information on the presence of formal policies and procedures in a substantial
number of EUnetHTA organisations
-
-
Diversity of the extent, thoroughness and specific practice of implementation in
various organisations – need for a standard policy and procedures for a European
level activity
Concrete experience in JA2 pilots indicate the necessity to have a standard EUnetHTA
CoI and Confidentiality handling procedures
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
34
Conflict of Interest and Confidentiality
handling - proposal
Specific procedures proposal:
-
Obligation to inform on the availability of the CoI and confidentiality policies and procedures in the
partner/associate institutions once they apply for joining EUnetHTA
-
LPs and Co-LPs informed on the availability
-
Status of availability publicly announced on the EUnetHTA website
-
DOICU form to be completed by each individual participating in JA2 prior to commencing any work
in WP4 and 5 pilots
-
DOICU form to be provided to the individuals by the WP4 and 5
-
Completed form to be returned to the respective WP LPs/Co-LPs AND the EUnetHTA
Secretariat
-
Info valid for 1 year – after 1 year a new form/update of the old one is requested
-
EUnetHTA secretariat sets up a database for the DOICU issues. LPs and Co-LPs are to consult
the database prior to requesting completion of the form by individuals (to avoid multiple
declarations)
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
35
CoI and Confidentiality – proposal (ii)
-
EUnetHTA member organisations are to explicitly indicate the confidential nature of the shared
documents. Patient data or commercially sensitive/proprietary information is confidential “by
default”.
-
Liability for breaches in handling of the confidential information lies with those who are actually the
“breaching” party – neither the Secretariat nor the coordinating agencies are to be held liable
-
In case of no clear instructions of how to specifically handle the confidential information, if the info
is indicated to be confidential it is NOT TO BE DISTRUBUTED FURTHER without asking for
permission.
-
In case of publication of any articles or providing any training to the third parties on the subject
where an individual had access to the confidential information through participation in the
EUnetHTA activities, s/he needs to inform the EUnetHTA Secretariat and the organisation that led
such activity. Confidential information cannot be published in national assessment before the
EUnetHTA pilot report has been published.
-
DOICU Form changes (tracked changes visible):
- Confidentiality undertaking clause (based on EMA form)
- EUnetHTA Secretariat role
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
36
Comments received so far
No explicitly stated rejection of proposed approach
Additional concern:
- Explicit criteria to assess the presence of CoI in relation to a specific
project/pilot?
Currently:
- DOICU form content guiding to possible areas of concern
- LPs and Co-LPs (when relevant) assessing and making decisions
- Work to develop such criteria should start
- A Task Force to be set up to develop such criteria (also possibly serving as
a ”sounding board” for the LPs in concrete CoI situations; no responsibility
to decide on the outcome of the specific cases)
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
37
Amended SOP
Based of the concrete experience of JA2 implmentation
Changes developed in coopreation with the project managers of WP LPs and
Co-LPs
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
38
Short- (2014-15), mid- (2016-20)
and long-term (post-2020)
strategic development of
EUnetHTA
Introduction by EUnetHTA and HTA Network
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
39
The timeline of reaching a sustainable
and permanent HTA network in Europe
Health
Programme
2005
2009
2011
Call for
project
proposals
Call for joint
action
Call for
joint
action
2015-2020
Financial support
JA3
2006-2008
2009
2010-2012
2012-2015
EUnetHTA
Project
EUnetHTA
Collaboration
EUnetHTA
JA
EUnetHTA
JA2
2016-2020
S
/
T
EUnetHTA
Scientific and
A
technical cooperation R
M
Legislation
2008-2011
2011-12
2013
2013+
Draft Cross Border
Healthcare Directive.
Article 15 on HTA network
CBHC Directive
now decided
EU
Cooperation
on HTA
Implementing
Decision
HTA Network
DG R&I
W
i
t
h
2011 FP7-Health
Horizon 2020
2012-Innovation-1
Calls
New methodologies for HTA
Health Care
Other sources
-
Structural Funfs
-
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
IMI
- Other
40
S
E
C
R
E
T
A
R
I
A
T
Please remember to
fill out the Yearly
WP3 Survey!
Enjoy Lunch!
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
Results of the elections
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
42
Short-term (2014-15) strategic
development of EUnetHTA
Discussion in plenary
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
43
Focus on HTA in Europe to
• strengthen the practical
application of tools and
approaches to cross-border
HTA collaboration
• achieve a better understanding
for the European Commission
and Member States of ways to
establish a sustainable
structure for HTA work in the
EU
• produce recommendations
regarding the design and
management of the future EU
HTA cooperation
Three main objectives of
EUnetHTA JA2:
• to increase collaborative
production of timely and fit for
purpose HTA information that is
applicable in national or
regional HTA production and
decision making
• to increase reliability, quality
and relevance of HTA thus
expanding its applicability for
policy making
• to build capacities in HTA
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
44
Your (ie, your organisation’s) expectations and/or
views regarding the remainder of the JA2 (April 2014September 2015)
I. National uptake and implementation of the EUnetHTA
outputs
II. The final product in the form of a report is seen as an
acceptable and desirable output in the production of the rapid
Core HTAs of pharmaceuticals to fit with the Transparency
Directive requirements
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
45
I) National uptake and implementation of the
EUnetHTA outputs
1. Does national legislation directly or indirectly hinder uptake of
international (e.g., EUnetHTA) reports / collections of information in the
national assessments? What can we do about this?
2. As per the EUnetHTA JA2 Grant Agreement, “at least 40 national
HTA reports are to be produced with use of tools and information from
JA2” (p. 44 of the GA).
Would the following minimum requirements for identifying the
“national reports produced with the use of the EUnetHTA tools
and outputs” be acceptable?
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
46
Local (national/regional) HTA report is
produced with usage of one of the full Core HTAs
produced in JA1 or JA2
o The whole Core HTA is used
o Parts of the Core HTA is used
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
47
Local (national/regional)HTA report is produced
with usage of the rapid HTAs produced in JA1 or
JA2
o The whole rapid HTA is used
o Parts of the rapid HTA is used
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
48
• Local (national/regional) HTA
report is produced with
application of the EUnetHTA
Adaptation Toolkit in adapting
of one of the national/regional
reports from a different country
to local settings
• An local (national/regional)
HTA report is the outcome of
collaboration facilitated by the
POP database service
• Local (national/regional) HTA
report is produced with
application and has reference
to one or more of the
EUnetHTA guidelines
• Local (national/regional) HTA
report clearly describes the
development process that
includes usage of or reference
to any of the EUnetHTA tools
(i.e., POP Database, Evident
Database, HTA Core Model
(including Online Service and
Database)
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
49
3. Your organisation’s specific suggestions of
feasible ways to overcome barriers for
collaboration and ensure national uptake of the
EUnetHTA outputs in the remainder of the JA2
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
50
II) “Joint assessment report” = in the form of a
report
Recent discussions in the HTA Core Model Challenges meeting and the WP5
meeting in Vienna (end of November 2014) followed by the discussions and
agreement in the EUnetHTA Executive Committee confirmed that the final
product in the form of a report is seen as an acceptable and desirable output
in the production of the rapid Core HTAs of pharmaceuticals to fit with the
Transparency Directive requirements.
It was agreed at the same time that the final product’s format should not
compromise the goal of transferability/re-usability, transparency and possibility
to assess the quality of the final product as well as respect the Member States’
competences and responsibilities for the organisation and delivery of health
services and medical care.
“Joint assessment report” is one of the currently used formats.
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
51
Issues to consider for 2014-2015 DISCUSSION
Page 3-4 Background Paper
˗ National legislation and international reports / collections of
information – what are the concrete challenges/problems? Anything
can be done about it?
˗ Minimum requirements to identify national reports based on the
EUnetHTA information – acceptable?
Final product of joint assessments in a form of a report – acceptable?
Goals of transferability/re-usability, transparency and possibility to
assess quality not to be compromised
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
52
Mid-term (2016-20) strategic
development of EUnetHTA - I
Introduction and Group work
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
53
Introductory remarks
Aim in establishing EUnetHTA: ”to involve and ensure
HTA interests across Europe to secure an efficient and
sustainable network”
Operational purpose: ” to support the production of HTA
information tailored to the needs of the national/regional HTA
organisations participating in EUnetHTA. A wide range of formats
and solutions are offered to facilitate various steps in the HTA
production process accommodating various types of healthcare
technologies as well as different phases in their life-cycle”
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
54
Introductory remarks
Complexity of the task and relationships with (and
concurrent developments in) the external environment
Need to ”close the gap” between piloting done and
”real life” implementation in daily HTA production of
the HTA agencies
˗ Feasibility of implementation
˗ Already established effectiveness
˗ What remains to be done
Analysis of the wealth of experience, results and achievements in
JA1 and JA2
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
55
Introductory remarks
Formal conditions of JA mechanism need to be
different from JA1 and JA2 if sustainability and
permanency of the European cooperation on HTA
is to be ensured through JA3
Governance structure to be adjusted appropriately
Stakeholder involvement to reflect a new reality
Remits of the scientific and technical cooperation
and the HTA Network to be clarified
JA2 Deliverable 1 – Recommendations – way
forward from now on
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
56
Group work - QUESTIONS
1. What will be the objective of EUnetHTA in the next phase (2016-2020) of its
development (what will EUnetHTA want to achieve in these years?)
2. What will define priorities that will guide identification of the specific activities
to pursue in years 2016-2020?
3. What are the limitations of the current conditions of cooperation (both formal
on the EU level and organisational (EUnetHTA-wise and within your own
organisation’s internal structure and processes) that need to be adjusted?
4. What modes of operation will your organisation see as preferable in JA3?
5. What should the relation be between the HTA Network and the scientific and
technical cooperation to make it attractive to EUnetHTA after JA2?
6. Which specific processes already employed in JA2 should be further improved
and how? Some of the processes: stakeholder involvement; topic
identification, selection and prioritisation for joint work; capacity building and
continuous education for EUnetHTA members and stakeholders; national
adaptation of joint collaborative results.
7. Other issues?
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
57
Group discussions - OBJECTIVES
˗ An explicit, understandable strategic signal from EUnetHTA on the scientific
and technical network cooperation 2016-20
˗ Directions for EUnetHTA’s mid-term scientific and technical network
cooperation and management structure/system and a business model that
can be proposed for implementation
˗ Prioritised and more focused EUnetHTA activities of
˗ implementing/using our tools, raising standards, implementing outputs at national and
regional level, building capacity, involving stakeholders, and connecting with research
and innovation
˗ Upholding a network mode of collaboration enabling each organisation to chose
among three levels of participation
˗ Constructive exploration of hosting of the secretariat function for sustainability by
EMA in open deliberations with all those who have a stake in this
˗ The voices of various (geographically, size, mandate, etc.) individual EUnetHTA
partners must be heard – speak up!
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
58
EUnetHTA Plenary
Assembly
April 11, 2014
Madrid, Spain
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
Agenda
April 11, 2014
09:00 – 10:15
Reports from Group discussion
10:15 – 10:45
Coffee break
10:45 – 12:00
Mid-term (2016) strategic development of EUnetHTA – II
• Plenary discussion
12:00 – 13:00
Lunch
13:00 – 14:00
Long-term (post-2020) strategic development of EUnetHTA
14:00 – 14:30
HTA 2.0 Europe – teaming up for value, Rome Oct. 30-31,
2014
14:30 – 15:00
Other issues and Conclusion
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
60
Reports from Group
discussions
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
61
Mid-term (2016-20) strategic
development of EUnetHTA - II
Plenary discussion
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
62
Next steps (mid-term) – development of
Recommendations (Deliverable 1)
End of April
- summary of discussions PA Madrid
May – August
- first draft of the Recommendations (Deliverable 1), to be developed
by the Coordinator (Secretariat) for discussions in the Executive
Committee
Sept 24-25
- draft finalised for the 1st review round by the PA
Oct 3-20
- 1st review round by the PA
Oct 30-31
- main outline and main points presented at the Rome conference
Nov-Jan
- further refinement of the document (Secretariat and Exec Comm)
Feb
- 2nd review round by the PA; processing the final comments
March 2015
- adoption and delivery of the final Recommendations
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
63
Please remember to
fill out the Yearly
WP3 Survey!
Enjoy Lunch!
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
Long-term (post-2020) strategic
development of EUnetHTA
Discussion in plenary
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
65
EUnetHTA Joint Action 2 (2012-2015)
Objectives
- To strengthen the practical application of tools
and approaches to cross-border HTA collaboration
- 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
Total budget: € 9,428,550
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
66
2014-15
2016-20
2021+
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
Options / Alternatives
???
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
68
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
69
EUnetHTA Joint Action 2 (2012-2015)
Total budget: € 9,428,550
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
70
2012
2013
2014
Euro
Euro
Euro
Fees collected
174,247,820
199,810,000
236,156,000
European Union
38,831,827
39,230,000
39,230,000
GRAND TOTAL
223,527,419
251,560,000
297,169,000
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
71
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
72
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
73
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
74
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
75
2014-15
2016-20
2021+
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
2020
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
77
2021+
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
78
Options / Alternatives
???
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
79
Long-term development - QUESTIONS
1. What concerns does your organisation have with regards to the
period post 2020?
2. What will be important to clarify and achieve in the mid-term in order
to lay-down a foundation for a sustainable development post 2020?
3. What constitutes your organisation’s considerations of ensured
sustainability – besides access to the finances to fund the activities?
4. What would in your view ensure that EUnetHTA will have higher
chances to have access to sufficient financial resources to continue
its work?
5. Given the expectations that the HTA Network will facilitate “quick
access of patients to new technologies”, how could relationships
between HTA agencies, regulators and manufacturers be further
developed and qualified (in format, content and objectives) in order to
speed the process from proof of concept to reimbursability ?
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
80
HTA 2.0 Europe – teaming up for
value, Rome Oct. 30-31, 2014
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
81
Conference, October 2014
Under the patronage of the Italian Ministry of Health
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
82
Programme at a glance
• Programme 2 days; plenary, panel and round table discussions, direct
interaction with EUnetHTA tools and methodology development teams
• Latest in scientific cross-border cooperation on HTA in Europe
• Challenges, opportunities and potential benefits in alignment and synergistic
interaction between technology developers, regulators and health technology
assessors
• Key messages, insights and perspectives of national healthcare systems,
EU Presidency, European Commission, regulators, reimbursement
authorities
• Concrete examples of advantages for the healthcare system realised
through networking across partnerships and alliances
Target audience:
Policy makers, technology assessors and producers, researchers (from HTArelevant fields of research), patients, providers, payers
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
83
Promotion activities before the Conference
EUnetHTA APs and CPs:
•
Indicating the date of the Conference, 30-31 October, 2014, on your agency’s website
calendars
•
Uploading the Conference promotion banner on their websites
•
Including the Conference promotion banner as part of e-mail signatures (if possible)
•
Distributing the electronic (pdf) Conference announcement flyer internally and in own
networks and/or place it on your agency websites (the flyer will distributed by the
Secretariat in mid-April)
•
Distributing the “paper-version” of the Conference announcement flyer internally and
in own networks (the flyer will distributed by the Secretariat in mid-April)
•
Include the EUnetHTA Conference promotion slide in ppt presentations on EUnetHTA
The slide is available here: https://intranet.eunethta.eu/general/node/3440
Stakeholder Forum:
•
Flyer, banner and promotion slide are also shared with SF for their promotion of the
EUnetHTA Conference (this week).
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
84
Promotion material
E-mail signature:
Promotion banner:
Flyer:
To be distributed mid-April
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
85
Promotion activities at the Conference:
• EUnetHTA JA2 Activity Stations (see next slide)
• The Stakeholder Forum and external collaborating partners (e.g. FP7
projects, HTAi, INAHTA etc.) can display 1 piece of promotional material in
print (e.g. leaflet, brochure etc.) at the Conference.
• AGENAS, as the Conference hosting agency, will also have an exhibition
stand at the Conference.
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
86
EUnetHTA JA2 Activity Stations - I
1. Core HTAs
•
Content: Full core HTAs, national adaptation information
•
Main responsible: WP4 LP
2. Rapid HTAs
•
Content: Work on submission templates???, pilots, rapid model for relative
effectiveness of pharmaceuticals and rapid model for non-pharmaceutical
interventions
•
Main responsible: WP5 LP & Co-LP
3. HTA Core Model and Service
•
Content: Models, tools, and online service/facilities to support collaborative
production of core HTA information
•
Main responsible: WP8 LP
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
87
EUnetHTA Activity Stations - II
4. EUnetHTA Guidelines
•
Content: Work on guidelines
•
Main responsible: WP7 LP
5. Evidence Generation/Early Dialogues
•
Content: EUnetHTA’s input to Early Dialogue processes, EVIDENT
•
Main responsible: WP7 LP
6. Building Capacity for Cooperation
•
Content: Information management infrastructure, Community of Practice, POP
Database, training
•
Main responsible: WP2 LP, WP6 LP
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
88
Free of charge attendees
1 person per EUnetHTA organisation (APs and CPs) can participate in the
EUnetHTA Conference free of charge:
•
For APs and CPs representative: Conference fee to be waived
•
For APs (only): travel and accommodation costs has been allocated in the EUnetHTA
budget.
The Secretariat will kindly request contact information of the free of charge attendees (internal
decision) by 6 June, 2014.
Specially Invited Guests (SIGs) to be identified (1, max 2, from each
Member State): conference fee to be waived, individual invitations, etc
•
Priority group 1: High level official representative of the Ministry of Health (or
equivalent to the MoH)
•
Priority group 2: The CEO/CMO or Chair of the Board (high level management official
of the national authority) having responsibility for the HTA matters in the country.
The Secretariat will kindly request suggestions/recommendation on SIGs including contact information
and potentially contact approach for them by 10 May, 2014.
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
89
Other issues and Conclusion
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
90
Other issues
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
91
Thank you
Have a safe trip home!!
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu