EUnetHTA Plenary Assembly...• Presentation of candidates and procedure 10:45 – 11:15 Coffee...

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

EUnetHTA Plenary

Assembly

April 10-11, 2014

Madrid, Spain


2

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


3

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


4

Agenda - III

April 11, 2014

09:00 – 10:15 Reports from Group discussion


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


5

Opening remarks

• Mirjana Huic, PA Chair

• Antonio Sarria-Santamera, Director HTA

Department, ISCIII

• Finn Børlum Kristensen, EUnetHTA Executive

Committee Chair


6

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


First half JA2 – report from

the Coordinator

EUnetHTA Secretariat, DHMA (Denmark)


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

First half JA2: report from the Coordinator (I)

8


9

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

JA2, WP5 Strand A

-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)

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)


10

National Adaptation JA2 - II

EUnetHTA output Past uptake


Reports

1st pilot on

Duodenal-jejunal

bypass sleeve

(EndoBarrier®)

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)

CVZ (Netherlands), AAZ (Croatia),

MoH Czech Republic, NOKC

(Norway), and HIQA (Ireland) have

expressed interest in national/local


2nd pilot on Renal

denervation

systems

JA2, WP5 Strand

B

• NOKC (Norway) and HIS

(Scotland, UK) have expressed

interest in using parts of the

assessment in national/local


• CR.DK (Denmark) (ongoing, as of

March 2014)


11

National Adaptation JA1 EUnetHTA output Past uptake


Reports

Core HTAs on

Abdominal Aortic

Aneurysm (AAA)

Screening

JA1

• 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)

-

Core HTA information

on “Fecal

Immunochemical Test

(FIT ) versus guaiac-

based 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)


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……….

First half JA2: report from the Coordinator (II)

12


13

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


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)

First half JA2 : report from the Coordinator (III)

14


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

First half JA2: report from the Coordinator (IV)

15


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

First half JA2: report from the Coordinator (V)

16


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.

First half JA2: report from the Coordinator (VI)

17


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

Achievements to support cooperation practice (by WP)

18


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.


19


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.


20


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.


21


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.


22


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


23


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

First half JA2: report from the Coordinator (VII)

24


- 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

First half JA2: report from the Coordinator (VIII)

25


• 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

Reflections from first half of EUnetHTA JA2 - DISCUSSION

26

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 Elections 2014

Presentation of candidates and procedure

27


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.

EUnetHTA PA Chair and Deputy Chair – Candidates (term 2014-2016)

28


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)

Elections 2014 – Executive Committee Candidates (term 2014-2015)

29


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.

EUnetHTA PA Chair and Dep. Chair

30


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

EUnetHTA Executive Committee

31


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

Election procedure Madrid

32


Approval of amended

EUnetHTA CoI Policy and SOP

Presentation, discussion and endorsement

33


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

Conflict of Interest and Confidentiality handling - proposal

34


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)

Conflict of Interest and Confidentiality handling - proposal

35


- 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

CoI and Confidentiality – proposal (ii)

36


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)

Comments received so far

37


Based of the concrete experience of JA2 implmentation

Changes developed in coopreation with the project managers of WP LPs and

Co-LPs

Amended SOP

38


Short- (2014-15), mid- (2016-20)

and long-term (post-2020)

strategic development of

EUnetHTA

Introduction by EUnetHTA and HTA Network

39


The timeline of reaching a sustainable and permanent HTA network in Europe

40

2005 Call for

project

proposals

2009 Call for joint

action

2011 Call for

joint

action

2006-2008 EUnetHTA

Project

2009 EUnetHTA

Collaboration

2008-2011 Draft Cross Border

Healthcare Directive.

Article 15 on HTA network

2011-12 CBHC Directive

now decided

2013 EU

Cooperation

on HTA

Implementing

Decision

2015-2020 Financial support

JA3

2011 FP7-Health

2012-Innovation-1

New methodologies for HTA

Legislation

DG R&I

Health

Programme

2010-2012 EUnetHTA

JA

2016-2020 EUnetHTA

Scientific and

technical cooperation

Horizon 2020

Calls

Health Care

2012-2015 EUnetHTA

JA2

Other sources

- IMI

- Structural Funfs

- - Other

S

/

T

A

R

M

W

i

t

h

S

E

C

R

E

T

A

R

I

A

T

2013+ HTA Network


Please remember to fill out the Yearly WP3 Survey! Enjoy Lunch!


Results of the elections

42


Short-term (2014-15) strategic

development of EUnetHTA

Discussion in plenary

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

44


Your (ie, your organisation’s) expectations and/or

views regarding the remainder of the JA2 (April 2014-

September 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

45


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?

I) National uptake and implementation of the EUnetHTA outputs

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

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

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


report is produced with

application and has reference

to one or more of the

EUnetHTA guidelines


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)

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

50


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.

II) “Joint assessment report” = in the form of a report

51


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

Issues to consider for 2014-2015 - DISCUSSION

52


Mid-term (2016-20) strategic

development of EUnetHTA - I

Introduction and Group work

53


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”

Introductory remarks

54


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


55


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


56


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?

Group work - QUESTIONS

57


˗ 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!

Group discussions - OBJECTIVES

58


EUnetHTA Plenary

Assembly

April 11, 2014

Madrid, Spain


60

Agenda

April 11, 2014

09:00 – 10:15 Reports from Group discussion


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


Reports from Group

discussions

61


Mid-term (2016-20) strategic

development of EUnetHTA - II

Plenary discussion

62


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

Next steps (mid-term) – development of Recommendations (Deliverable 1)

63


Please remember to fill out the Yearly WP3 Survey! Enjoy Lunch!


Long-term (post-2020) strategic

development of EUnetHTA

Discussion in plenary

65


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

66

Total budget: € 9,428,550

To strengthen the practical application of tools

and approaches to cross-border HTA collaboration


2014-15

2016-20

2021+

European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu 68

Options / Alternatives

???


EUnetHTA Joint Action 2 (2012-2015)

70

Total budget: € 9,428,550


71

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


72


73


74


75


2014-15

2016-20

2021+


2020


2021+


Options / Alternatives

???


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 ?

Long-term development - QUESTIONS

80


HTA 2.0 Europe – teaming up for

value, Rome Oct. 30-31, 2014

81


Conference, October 2014

82

Under the patronage of the Italian Ministry of Health


• 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 HTA-

relevant fields of research), patients, providers, payers

Programme at a glance

83


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).

Promotion activities before the Conference

84

https://intranet.eunethta.eu/general/node/3440

https://intranet.eunethta.eu/general/node/3440


E-mail signature: Promotion banner: Flyer:

To be distributed mid-April

Promotion material

85


• 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.

Promotion activities at the Conference:

86


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


EUnetHTA JA2 Activity Stations - I

87


4. EUnetHTA Guidelines

• Content: Work on guidelines


5. Evidence Generation/Early Dialogues

• Content: EUnetHTA’s input to Early Dialogue processes, EVIDENT


6. Building Capacity for Cooperation

• Content: Information management infrastructure, Community of Practice, POP

Database, training

• Main responsible: WP2 LP, WP6 LP

EUnetHTA Activity Stations - II

88


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.

Free of charge attendees

89


Other issues and Conclusion

90


Other issues

91


Thank you Have a safe trip home!!

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