eunethta interim technical report year 2010 · from the european union, in the framework of the...

The EUnetHTA JA (2010-2012) has received funding from the European Union, in the framework of the Health Programme

E U R O P E A N N E T W O R K F O R H E A L T H T E C H N O L O G Y A S S E S S M E N T

EUnetHTA

INTERIM TECHNICAL REPORT

YEAR 2010



EUnetHTA

INTERIM TECHNICAL REPORT – WP1

YEAR 2010

EUnetHTA JA on HTA – WP 1 1/14

2011-02-28

Joint Action on HTA 2010-2012

Work Package 1 Coordination

Interim Technical Report

2010


2011-02-28

Contents 1. Overview ................................................................................................................................................ 3 2. Activities performed in 2010................................................................................................................... 7

Development of the 3-year work plan and SOP; preparation of the consortium agreement; preparation of the 1st interim financial and technical reports......................................................................................................... 7 1st Plenary Assembly meeting and elections ................................................................................................... 7 Communication (information management system, public website, promotional material (cooperation with WP6 and WP2); communication with EAHC and DG SANCO; presentation at external (to the EUnetHTA JA) meetings and conferences) ............................................................................................................................. 7 Meetings .......................................................................................................................................................... 9 Adherence to the Work Plan in 2010............................................................................................................. 10 Additional activities ........................................................................................................................................ 10

3. Work Plan for the next period (2011) ................................................................................................... 10 Preparation of the 2nd Plenary Assembly meeting (May 2011, London, UK)............................................... 10 Preparation of the 2nd Interim Technical (and Financial) report; financial management.............................. 11 Development of the content of the WP activities for the information management system .......................... 11 Assistance with preparations for the EUnetHTA Conference, December 8-9, 2011, Gdansk, Poland......... 12 Meetings ........................................................................................................................................................ 12 Stakeholder and external expert involvement ............................................................................................... 13 Cooperation with other WPs / LPs................................................................................................................. 13 Gantt chart ..................................................................................................................................................... 14

4. Appendices .......................................................................................................................................... 14


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1. Overview

Technical Fact Sheet – EUnetHTA Joint Action

Joint Action European network for Health Technology Assessment (EUnetHTA JA)

Grant Agreement No. 2009 23 02 – EUnetHTA Joint Action

Programme Second Programme of Community Action in the field of Health (2008-2013)

Unit of DG Sanco Health Strategy (Unit C5)

Start Date of Project January 1, 2010

Duration 36 months

General Objective The overarching objective of the Joint Action (JA) on Health Technology Assessment (HTA) including work on relative effectiveness of pharmaceuticals is to put into practice an effective and sustainable HTA collaboration in Europe that brings added value at the European, national and regional level.

Tasks/Work packages WP1 Coordination

WP2 Dissemination

WP3 Evaluation

WP4 Core HTA

WP5 Relative Effectiveness Assessment (REA) of Pharmaceuticals

WP6 Information Management System

WP7 New Technologies. Facilitating evidence generation and collaboration on (pre-coverage) assessment

WP8 Strategy and business model development

EAHC Representative Mr. Guy Dargeant

DG Sanco Representatives Mr. Jerome Boehm, Mr. Anders Lamark-Tysse

EUnetHTA JA Leader Prof. Finn Børlum Kristensen

Coordinator National Board of Health of Denmark, Danish Centre for HTA (DACEHTA)

Associated Beneficiaries / Partners

• LBI-HTA, Ludwig Boltzman Institute, HTA, Austria

• HVB, Hauptverband der Österreichischen Sozialversicherungsträger (Association of Austrian Social Insurance Institutions), Austria

• GÖG-Gesundheit Österreich GmbH/Geschäftsbereich BIQG-Bundesinstitut für Qualität im Gesundheitswesen, Austria

• KCE, Belgian Health Care Knowledge Centre, Belgium

• National Center of Public Health Protection, Bulgaria

• Agency for Quality and Accreditation in Health Care, Department for Development, Research and Health Technology Assessment* , Croatia (*Nominated in 2010)

• Ministry of Health, Czech Republic

• NBoH, National Board of Health, Denmark

• SDU, Centre for Applied Health Services Research and Technology Assessment, University of Southern Denmark (CAST), Denmark

• UTA, Department of Public Health, University of Tartu, Estonia

• THL, National Institute for Health and Welfare, Finland


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• HAS, Haute Autorité de Santé, France

• DIMDI, Deutsches Institut für Medizinische Dokumentation und Information, Germany

• IQWIG, Institute for Quality and Efficiency in Health Care, Germany

• NSPH, National School of Public Health, Greece

• ESKI, National Institute for Strategic Health Research, Hungary

• EMKI, Institute for Healthcare Quality Improvement and Hospital Engineering, Hungary

• HIQA, Health Information and Quality Authority, Ireland

• AGE.NA.S, Agenzia Nazionale per i Servizi Sanitari Regionali, Italy

• AIFA, Italian Medicines Agency, Italy

• Regione del Veneto, Italy

• Centre of Health Economics, Latvia

• VASPVT, State Health Care Accreditation Agency, Lithuania

• SSD/MSOC, Ministry for Social Policy, Strategy and Sustainability Division, Malta

• CVZ, Health Care Insurance Board, The Netherlands

• NOKC, Norwegian Knowledge Center for the Health Services, Norway

• AHTAPol, Agency for Health Technology Assessment, Poland

• INFARMED, National Authority of Medicines and Health Products, Portugal

• SLOVAHTA, Slovakian Agency for HTA , Slovakia (Nominated in 2010)

• IPH-RS, Institute of Public Health of the Republic of Slovenia

• Ministry of Health, Spain

• ISCIII, Instituto De Salud Carlos III, Spain

• SBU, Swedish Council on Technology Assessment in Health Care, Sweden

• NETSCC, NIHR Evaluation, Trials and Studies Coordinating Centre, UK

• NICE, National Institute for Health and Clinical Excellence, UK

Collaborating Partners • University for Health Sciences, Medical Informatics and Technology, Austria

• RIZIV, National Institute for Health and Disability Insurance NIHDI, Belgium

• IRF, Institute for Rational Pharmacotherapy, Denmark

• Dept of Health Services Research and HTA, Centre for Public Health, Central Denmark Region, Denmark

• DSI, Danish Institute for Health Services Research, Denmark

• National Centre for Pharmacoeconomics, St James's Hospital, Ireland

• ARESS, Agenzia Regionale per i Servizi Sanitari (Piedmont Health Care Agency), Italy

• ASSR, Agenzia Sanitaria e Sociale Regionale Regione Emilia Romagna, Italy

• Laziosanità – Agenzia di Sanità Pubblica, Regine Lazio, Italy

• REGLOM-DGSAN - Regione Lombardia, Direzione Generale Sanita, Italy


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• University Hospital “A.Gemelli”, Itlay

• Quality unit, Ministry of Health of Serbia

• Agency for Medicinal Products and Medical Devices, Slovenia

• AETSA, Andalusian HTA Agency, Spain

• CAHTAR, Catalan Agency for HTA and Research, Spain

• UETS, HTA Unit, Agencia, Laín Entralgo, Spain

• AVALIA-t, Galician Agency for HTA, Spain

• OSTEBA, Basque Agency for HTA, Spain

• Dental and Pharmaceutical Benefits Agency (TLV), Sweden

• SNHTA, Swiss Network for HTA, Switzerland

• KDTD Turkish Evidence-Based Medicine Association, Turkey

• CMTP, The Center for Medical Technology Policy, USA (joined in 2010)

EUnetHTA Joint Action Technical Report – general information This report (in 8 parts according to eight Work packages) is the first Interim Technical Report on Implementation of the European network for Health Technology Assessment Joint Action (EUnetHTA JA), delivered by the Coordinator National Board of Health of Denmark to the Executive Agency for Health and Consumers (EAHC). The Interim Technical Report of EUnetHTA JA covers the period from January 1, 2010 (start of the project) to December 31, 2010.

The project is co-funded by the National Board of Health of Denmark and thirty-two Associated beneficiaries of the project.

As stipulated in the Reporting Requirements (Annex III of the Grant Agreement 2009 23 02 the Interim Implementation Report

• provides information on the results obtained to date and an indication of any deviation from the initial work programme set out in annex I to the grant agreement that has occurred or is likely to occur

• the work programme planned for the following period; • copies of any publications, products or other relevant outputs or deliverables of the project to date

The Interim Technical Report on Implementation of the EUnetHTA JA was prepared by the Coordinator in collaboration with the Lead Partners of the Work Packages (WPs) where the Coordinator is not leading the work :

• WP2 (NIPH, Slovenia and SBU, Sweden), • WP3 (NETSCC, UK), • WP4 (THL, Finland and AGENAS, Italy), • WP5 (CVZ, Netherlands, and HAS, France), • WP7 (HAS, France and LBI@HTA, Austria),

In WP8 NBoH was assisted by AHTAPol, Poland and ISCIII, Spain in preparing the report on the WP8 special lines of activities dedicated to the HTA strategies and EUnetHTA tools training.

According to Article II.5.2 of the Grant Agreement, the beneficiaries authorise the Commission to disseminate, communicate or publish the report concerning the action. The annexes indicated as having a restricted confidentiality level due to planned future publication and postponed public presentation of the preliminary results should not be made public until the end of the action (December 2012).

Additionally, the Coordinator has submitted a consolidated financial statement on the first period (January 1, 2010 – December 31, 2010).


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Technical Fact Sheet – WP1

Work Package 1 Coordination

Lead Partner National Board of Health of Denmark

Organisations Involved 1. AGENAS, Italy 2. AHTAPol, Poland 3. CVZ, Netherlands 4. DIMDI, Germany 5. HAS, France 6. ISCIII, Spain 7. KCE, Belgium 8. LBI, Austria 9. NETSCC, UK 10. NIPH-RS, Slovenia 11. SBU, Sweden 12. THL, Finland

WP Objectives WP1 objective of an effective coordination and management of the EUnetHTA JA facilitates the achievement of the EUnetHTA JA general objective to put into practice an effective and sustainable HTA collaboration in Europe that brings added value at the European, national and regional level.

No Specific Objective as per the Grant Agreement is connected to this WP.

Activities Performed in 2010

• Development of 3-year work plan • Preparation of the consortium agreement • Preparation of the technical and financial reports • Plenary Assembly meeting and EUnetHTA elections • Communication

o Cooperation with WP6 on development of the information management system

o Cooperation with WP2 on public website development and promotion material/activities

o Cooperation with EAHC and DG SANCO o Presentations at external meetings, conferences, etc

Current Status on Milestones and Deliverables

MILESTONES M3 – First draft of SOP and 3-year EUnetHTA JA Work Plan circulated to the EUnetHTA JA partners – achieved M5 – SOP and 3-year EUnetHTA JA Work Plan approved by the Plenary Assembly – achieved M14 – First EUnetHTA JA interim report to the EAHC (potential delay of 2 weeks) DELIVERABLES M14 - EUnetHTA JA Interim Technical and Financial Report (including evaluation results), D11 –potential delay of 2 weeks

Additional Outcomes / Activities in 2010

• Cooperation with EMA • Contribution to the development of the complimentary joint action

on HTA • Assistance in starting preparations for the EUnetHTA Conference

to be held in December 2011 in Gdansk, Poland (CVZ and AHTAPol are main organisers)


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2. Activities performed in 2010

Development of the 3-year work plan and SOP; preparation of the consortium agreement; preparation of the 1st interim financial and technical reports The Lead and Co-Lead Partners (LPs and Co-LPs) of the Work Packages (WPs) developed detailed 3-year work plans for their respective work package. The National Board of Health of Denmark as the Coordinator of the EUnetHTA JA (Secretariat) facilitated this work through preparation of the Work Plan structure, coordination of timing (to avoid duplication or overlapping) of activities between the Work Packages, ensuring the streamlined communication between the LPs and Co-LPs and compiling the individual WP work plans into one overall EUnetHTA JA 3-year Work Plan. The EUnetHTA Work Plan was reviewed and endorsed by the EUnetHTA Plenary Assembly at its meeting on May 20-21, 2010 in Ljubljana, Slovenia.

Based on the WP technical reports 2010, the plans for years 2011 and 2012 will be adjusted to reflect the current state of development in the Joint Action.

The Standard Operating Procedures (SOP) Manual was developed by the Secretariat in the first two months of 2010. The SOP Manual was reviewed by the EUnetHTA JA APs and adopted at the Plenary Assembly meeting in Ljubljana. The purpose of the manual is to describe and make transparent procedures for governing and implementing EUnetHTA JA activities including financial management and reporting.

The templates of the financial and technical reports were developed and provided several months in advance (four and two months respectively) to the technical/financial reporting deadline (January 15, 2011) for each participating organization along with the individualized instructions on how to prepare a technical/financial report. The Secretariat continuously provided advice (via e-mail and telephone) regarding technical and financial reporting.

The EU pre-financing funds (40% of total EU-grant) were distributed to the APs according to the grant agreement.

The draft consortium agreement was developed by the Secretariat and made available for the first round of the Associated Partners’ (APs) review in September 2010. The comments will be taken into account in production of the next version of the agreement which is to be available for partners approval and signature in spring 2011 (delay of 3 months from original planning due to heavy workload with other coordinating activities). The purpose of the consortium agreement is to facilitate the fulfillment of the research work and related services and activities allocated to Partners under the Grant Agreement by setting forth the terms and conditions for the proper performance of the action.

1st Plenary Assembly meeting and elections The 1st Plenary Assembly meeting was held on May 20-21, 2010 in Ljubljana, Slovenia. The meeting was jointly organized by the EUnetHTA Secretariat and the National Institute of Public Health of Slovenia. The nomination process of the Plenary Assembly Chair and Co-Chair as well as 3 electable members of the EUnetHTA Executive Committee took place during the preparatory months prior to the meeting with elections taking place at the meeting in Ljubljana. Thirty three organisations (28 APs and 5 CPs) participated in the meeting where the 3 year Work Plan was endorsed and the SOP manual adopted, the composition of the EUnetHTA JA Stakeholder Forum and general principles of stakeholder involvement agreed. The Plenary Assembly meeting participants discussed the EUnetHTA long-term strategy approaches which provided initial input into the development of the business model for European cooperation on HTA. Representatives from the Executive Agency for Health and Consumers (EAHC) and DG SANCO participated in the meeting.

Communication (information management system, public website, promotional material (cooperation with WP6 and WP2); communication with EAHC and DG SANCO; presentation at external (to the EUnetHTA JA) meetings and conferences) The Secretariat assisted the WP6 in developing the structure of the Members Only area of the EUnetHTA website, collected and fed information into the online contact database of the individuals working in EUnetHTA JA, created organisational profiles on the public website of each organisation participating in the EUnetHTA JA. It further created the access rights database through collecting and entering of information on each individual working in EUnetHTA JA. Individual consent forms to the EUnetHTA information


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dissemination policy were collected; the Secretariat assisted WP6 in developing the information dissemination policy (via involvement of the EUnetHTA Executive Committee).

The Secretariat worked with the WP2 LP and Co-LP in developing the content of the promotional material for the EUnetHTA JA (leaflet; standard slide presentation; presence in the social networks and Wikipedia) and the structure and content of the public website. The design of the website was ready in M6 according to schedule, however, the public launch of the fully updated/restructured website was postponed to M8 due to a heavy workload and summer vacation across Europe (July and August).

The Secretariat issued a quarterly EUnetHTA Members Update (an electronic newsletter) which is distributed to all individuals working in the EUnetHTA JA participating organisations. Public news were also published regularly on the EUnetHTA website on the developments in the network.

A regular communication was established to inform the C5 Unit (Health Strategy) of DG SANCO. The contact persons at C5 Unit in charge of the cooperation with EUnetHTA JA are regularly invited and participate in the WP1 / Executive Committee e-/meetings and in the Plenary Assembly meetings and are provided with a full access to the Members Only area of the EUnetHTA website. On a number of occasions the Secretariat and C5 contact persons collaborated to present EUnetHTA JA and the European Commission’s position with regards to HTA cooperation in Europe (eg, Networking Meeting of the Competent Authorities for Pricing and Reimbursement of Pharmaceuticals (Prague, Czech Republic; April 2010), An increasing number of invitations to speak at the European and international conferences were received by the EUnetHTA Secretariat and EUnetHTA JA partners. Table 1.1 gives an overview of the EUnetHTA Joint Action presentations held during 2011 Most of these presentations were held at the expense of the receiving institution or the presenting organisation. Individual APs held presentations in their local institutions and held briefings at their respective ministries. Table 1.1: Presentations of EUnetHTA in 2011

Date Place Audience Content of the presentation

Presenting Institution

01/2010 Zagreb, Croatia

National audience from ministry, public health, healthcare, and academia

European HTA collaboration, EUnetHTA JA

Secretariat

01/2010 London, UK Tapestry Network meeting EUnetHTA JA Secretariat

01/2010 Brussels, Belgium

European Cervical Cancer Association, European Parliament workshop

Value of HTA, EUnetHTA JA

KCE

02/2010 Milan, Italy HTA workshop, Direzione Generale Sanita' Regione Lombardia

HTA concept. EUnetHTA JA

Secretariat

03/2010 Washington, USA

CMR International Institute Workshop on Review and Reimbursement

EUnetHTA JA; HTA in Europe; HTA and regulation

Secretariat


European Patients Forum, HTA Seminar

EUnetHTA JA; patients involvement in HTA

THL

05/2010 Atlanta, USA ISPOR 15th Annual International meeting

EUnetHTA Joint Action; HTA

Secretariat

05/2010 Krakow, Poland

5th European Conference on Rare Diseases

EUnetHTA working group on Monitoring emerging/new technology development and prioritisation of HTA

LBI

06/2010 Dublin, Ireland

HTAi Annual Conference HTA and benchmarking, EUnetHTA JA; REA of Pharmaceuticals, etc (several posters and oral presentations)

KCE, Secretariat, CVZ, HAS

09/2010 Barcelona, Spain

EURORDIS Summer School in Regulatory Affairs and

EUnetHTA JA HAS


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Health Technology Assessment for Advanced Patient Advocates


Innovation and solidarity on Pharmaceuticals Ministerial Conference, EU Belgian Presidency

EUnetHTA JA Secretariat

09/2010 London, United Kingdom

London Scholl of Economics Patient Academy – HTA course

EUnetHTA JA; HTA concept

Secretariat


2nd Croatian Congress on preventive medicine and health promotion with international participation, in

EUnetHTA JA Croatian Agency for Quality and Accreditation in Health

10/2010 Washington, USA

Pharmaceutical Market Access World Conference

HTA panel discussion; European coolaboration on HTA / EUnetHTA JA; early advice

Secretariat

11/2010 Prague, Czech Republic

13th Annual European Congress EUnetHTA JA update (incl. WP4,5 and 7 details)

Secretariat THL CVZ HAS


EDMA workshop Reimbursement of Innovative Technologies

EUnetHTA JA; HTA concept

KCE

12/2010 London, United Kingdom

Health Technology Assessment World Europe Congress

European HTA collaboration; REA of Pharmaceuticals

Secretariat, CVZ


DG Enlargement - Workshop on Health Technology Assessment

EUnetHTA JA Secretariat

The following publication was made known to the Secretariat and discussed the EUnetHTA approaches/tools/activities: Health technology assessments: what do differing conclusions tell us? British Medical Journal, BMJ 2010; 341:c5236

Meetings Time Location Duration

(nights) Participants Purpose

M2 2010-02-25/26

Copenhagen (DK)

1 WP1 partners and Executive Committee members; DG SANCO

Coordination of details in the EUnetHTA JA 3-year Work Plan, SOP manual, Stakeholder involvement Policy.

M4

2010-04-07

e-meeting 0 WP1 partners and Executive Committee members; DG SANCO

Regular coordination issues (preparation of the EUnetHTA presence at HTAi in Dublin)

M5

2010-05-05


Preparation for the Plenary Assembly meeting

Regular coordination issues


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M5

2010-05-20/21

Ljubljana, Slovenia

1 EUnetHTA Partners, DG SANCO, EAHC

Plenary Assembly meeting

M6

2010-06-30


Half-year activities review


M9

2010-09-08

e-meeting 0 WP1 partners and Executive Committee members, DG SANCO

Preparation for the EUnetHTA educational symposium at ISPOR (Nov 7) in Prague; agenda of the Brussels WP1 meeting

Regular coordination issues (preparation for the 1st Interim report)

M10

2010-10-14/15

Brussels (BE)

1 WP1 partners and Executive Committee members, DG SANCO

Regular coordination issues; Educational Symposium in Prague; discussion of the 1st draft of the business model – agreement on fundamental components

M12

2010-12-09


1st Interim report to EAHC


Adherence to the Work Plan in 2010 All milestones were achieved on time.

The delivery of the first interim technical and financial report is delayed 18 days due to delays in receiving supporting financial documentation and individual financial reports from the APs. Delayed submission of the report to the EAHC was agreed with the EAHC.

Additional activities 1. Cooperation with the European Medicines Agency (EMA). The Secretariat with support and

involvement of the EUnetHTA Executive Committee facilitated the development of the cooperation between the EUnetHTA JA and EMA. The focus of activities were on providing advice in EMA’s adaptation of a European public assessment report (EPAR) – the Lead Partners of WP5, CVZ and HAS, lead the scientific work and participants of WP5 were consulted and provided comments.

2. Cooperation with DG SANCO on preparation of the complementary joint action on HTA. The Secretariat with support and involvement of the EUnetHTA Executive Committee facilitated involvement and comments from the EUnetHTA JA partnership in development of the initial considerations on the content for the complementary joint action.

3. Assistance in starting preparations for the EUnetHTA Conference to be held in December 2011 in Gdansk, Poland (CVZ and AHTAPol are main organisers). The secretariat provided advice and organizational assistance (planning, budgeting and e-meeting facilitation) as well as involvement of WP1 and Executive Committee members for development of the content and programme for the conference.

3. Work Plan for the next period (2011)

Preparation of the 2nd Plenary Assembly meeting (May 2011, London, UK)

Planning

M13-M14 – EUnetHTA Secretariat (in cooperation with NICE): logistics of the meeting – venue, catering, social programme, transportation, registration for the meeting, etc


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M13-M15 – agenda and material preparation;

M15 – launching of the relevant election process (3 elected members of the Executive Committee);

M17 – final agenda and material distributed to the partners (target - 2 weeks in advance)

M18 – report from the meeting

Target group

All EUnetHTA partners

Parties involved

WP1 LP, NICE, Executive Committee

Preparation of the 2nd Interim Technical (and Financial) report; financial management

Planning

M 15– EUnetHTA secretariat delivers 1st Interim Report to EAHC, request for next pre-financing instalment (depending on expenditure in 2010)

M15-M16 – EUnetHTA Secretariat clarifies if necessary the details of the 1st interim report with the EAHC;

M17-18 - if the next pre-financing approved by and received from the EAHC – distributes the grant to the APs

M22-M24 – preparing the content of the interim report

M25 (deadline – January 15, 2012) – delivery of the reports to the EUnetHTA Secretariat

Target group

All EUnetHTA partners (specific EU-reporting requirements applicable to JA APs); EAHC

Parties involved

All WP LPs partners - preparation and delivery of the WP technical interim reports

EUnetHTA JA Associated Partners – preparation and delivery of financial reports for their respective organisation’s financial involvement in EUnetHTA

EUnetHTA Secretariat – preparation and delivery of the EUnetHTA JA Technical and Financial report to EAHC

Development of the content of the WP activities for the information management system

Planning

M13-M24 – update of the structure and content of the general sections of the public and MO sites regarding the EUnetHTA JA activities (including specifics for each WP);

M15, M18, M21, M24 – regular updates (compilation of the available news) to the EUneHTA partners on the progress and results of the EUnetHTA JA

Target group


External parties

Parties involved

WP1 LP, WP2 LP and CO-LP, WP6 LP – regarding the structure and process organisation; WP1 LP – delivery of regular updates to the partners

All WP LPs – relevant WP content provision for the IMS and regular updates


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Assistance with preparations for the EUnetHTA Conference, December 8-9, 2011, Gdansk, Poland

Planning

M13-M23 – Secretariat’s assistance with promotion and, when appropriate, with organisational and logistical preparations for the conference. WP1 and Executive Committee involvement with the programme development.

M24 – Conference takes place in Gdansk, Poland (December 8-9, 2011)

Target group


External parties (European Commission, stakeholders, HTA doers, academics, policy makers)

Parties involved

Secretariat, WP1 members, Executive Committee. AHTAPol and CVZ – main organisers of the event; DG SANCO, EAHC representatives will be invited

Meetings

Time Location Duration (nights)

Participants Purpose

M13

2011-01-26



M15

2011-03-21/22

Paris (FR) 1 WP1 partners and Executive Committee members, DG SANCO

Business Model draft preparation for the review by the EUnetHTA JA partners and public consultation; preparation for the complimentary joint action on HTA


M16

2011-04-13



M17

2011-05-25/26

London, UK

1 EUnetHTA Partners, DG SANCO, EAHC

Plenary Assembly meeting

M18

2011-06-15



M21

2011-09-07




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M22

2011-10-05

Warsaw (PL)

1 WP1 partners and Executive Committee members, DG SANCO

Final preparations of the Business model launch

Preparation of plans for 2012 aiming at securing sustainability beyond 2012

M23

2011-11-16


Preparation for the EUnetHTA Conference


Preparation for the 2nd interim report

Stakeholder and external expert involvement No stakeholder involvement is foreseen in the activities of WP1. Coordination of the stakeholder involvement is performed through the mechanism of the EUnetHTA Executive Committee.

Cooperation with other WPs / LPs WP2 LP and Co-LP

Close cooperation on development of the content of the dissemination/communication material and establishing contacts with external parties.

WP3

Close cooperation with WP3 to be ensured for the best use of the evaluation process and results. Coordination with the Secretariat in preparation of the Plenary Assembly meetings should be planned to facilitate completion of the WP3 surveys (eg, non-responders list should be made available to the Secretariat in due time prior to the PA meetings).

WP6

EUnetHTA Members Only site support (information to partners) and support in developing any other sub-sites (eg, Stakeholder Forum site).


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Gantt chart

4. Appendices WP1.1 EUnetHTA JA 3-year Work Plan (version of August 2010)

WP1.2 EUnetHTA JA Standard Operating (SOP) Procedures Manual (version of June 2010)

WP1.3 EUnetHTA Plenary Assembly meeting (May 20-21, 2010, Ljubljana, Slovenia) summary of discussions

WP1.4 WP1/Executive Committee meeting summary of discussions, February 22-26, 2010, Copenhagen, Denmark

WP1.5 WP1/Executive Committee e-meeting summary of discussions, April 7, 2010

WP1.6 WP1/Executive Committee e-meeting summary of discussions, May 5, 2010

WP1.7 WP1/Executive Committee e-meeting summary of discussions, June 30, 2010

WP1.8 WP1/Executive Committee e-meeting summary of discussions, September 8, 2010

WP1.9 WP1/Executive Committee meeting summary of discussions, October 14-15, 2010, Brussels, Belgium

WP1.10 WP1/Executive Committee e-meeting summary of discussions, December 9, 2010



EUnetHTA


YEAR 2010


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Work Package 2 – Dissemination


2010


2011-02-28

Contents 1. Overview ................................................................................................................................................ 3

2. Activities performed in 2010................................................................................................................... 4

EUnetHTA newsletters and PowerPoint slides................................................................................................ 4

EUnetHTA public web site ............................................................................................................................... 4

Work Package 2 meetings............................................................................................................................... 4

EUnetHTA leaflet ............................................................................................................................................. 4

Pilot creation of Groups for Social Networks (LinkedIn and Facebook) and Wikipedia text .......................... 4

Adherence to the Work Plan in 2010............................................................................................................... 4

3. Work Plan for the next period (2011) ..................................................................................................... 5

Deliverables ..................................................................................................................................................... 5

Milestones 2011............................................................................................................................................... 5

Informational video........................................................................................................................................... 5

Dissemination Plan .......................................................................................................................................... 5

Dissemination plan for the Joint Action will be built around 3-year Work Plans to be developed by each Work Package.................................................................................................................................................. 5

Meetings .......................................................................................................................................................... 5

Stakeholder and external expert involvement ................................................................................................. 5

Cooperation with other WPs / LPs................................................................................................................... 5

Gantt chart ....................................................................................................................................................... 6

4. Appendices ............................................................................................................................................ 6


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1. Overview

Work Package 2 Dissemination Lead Partner

Co-Lead Partner • National Institute of Public Health (NIPH), Slovenia

• Swedish Council on Technology Assessment in Health Care (SBU)

Organisations Involved • NBoH, Denmark

• Hauptverband der Österreichischen Sozialversicherungsträger (HVB), Austria

• National School of Public Health, Greece

• National Center of Public Health Protection, Bulgaria

• MoH, Spain

• SLOVAHTA, Slovak Republic

• SNHTA, Switzerland

• OSTEBA, Spain

WP Objectives To facilitate coherent, effective and sustainable external communication of the JA EUnetHTA, where its aims, objectives, work in progress, results and final products are known to all partners, identified stakeholders and target groups in the EU and national/regional levels.


M2 – Project launch (making the project known to relevant target groups and stakeholders; website and press release)

M2 – Design and production of templates for e-newsletters and PowerPoint slides

M3 – 3-year work plan for EUnetHTA Dissemination

M5 – Promotional leaflet for the project issued

M4 – Pilot input for Wikipedia and translation into WP2 languages, updating and monitoring the content

M6 – Workshop/session at HTAi Conference in Dublin

M6 – Public Web Site Launch. New structure and design, including some new functionality

M5 – Pilot creation of Groups for Social Networks (LinkedIn and Facebook) as a marketing tool, with prior agreement with the Executive Committee, Secretariat and WP6 LP on the issues of security, maintenance, moderation and content of such pages, and animation of the community

M11 – Educational Symposium at ISPOR Europe in Prague. This was a launch event for EUnetHTA with LPs of WP4, 5 and 7 and the Secretariat presenting first intermediate results and plans for the next 2 years.


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Milestones achieved


Nomination for the European Health Award at The European Health Forum Gastein (EHFG); shortlisted


EUnetHTA newsletters and PowerPoint slides

A new design and production of templates for the public e-newsletter (EUnetHTA News) and the member’s e-newsletter (Members Update).

Upgraded PowerPoint templates with a new design and a variety of slides have been put together using the EUnetHTA graphic profile. Intended for external and internal presentations, they incorporate the logos of both EUnetHTA and the EU.

EUnetHTA public web site A new structure and design was developed, including some new functionality, eg RSS feed, interactive timeline, print optimized page, share on Facebook and twitter, etc. The design includes a slideshow in the top frame with pictures from the EU member states represented in EUnetHTA.

Work Package 2 meetings In 2010 WP2 held the first face-to-face meeting March 11–12th in Vienna, and an e-meeting on November 29th. The minutes of the meetings are in the appendix.

EUnetHTA leaflet A EUnetHTA promotional leaflet was created and presented at the Plenary Assembly meeting, May 20–21 in Ljubljana. The leaflet was used for promotional activities at the 2010 HTAi, EHFG and ISPOR meetings.

Pilot creation of Groups for Social Networks (LinkedIn and Facebook) and Wikipedia text

Pilot creation of Groups for Social Networks (LinkedIn and Facebook) as a marketing tool, with prior agreement with the Executive Committee, Secretariat and WP6 LP on the issues of security, maintenance, moderation and content of such pages, and creation of the community. The initial experience with both groups indicated that further focus of efforts regarding social networks will be put on LinkedIn while Facebook presence will be discontinued.

EUnetHTA description was put in Wikipedia, and translated into the languages of the WP2 members.

In addition to the activities performed according to the work plan, WP2, on behalf of NIPH, Slovenia, HVB, Austria and SBU, Sweden nominated EUnetHTA for the European Health Award, where EUnetHTA was among the finalists for the award at the EHFG, European Health Forum Gastein.

Adherence to the Work Plan in 2010 According to plan with slight deviations in timing: WP 2 developed the new version of the website and it was available in M6, however, the structure was not in place until M8. The structure suggested in M6 needed additional amendments in order to meet the needs and developments within the overall Joint Action (the overview of which is with the Secretariat) and required further work on it by the Secretariat. Due to other urgent tasks and the vacation season that stretches over 2 months in Europe, the full launch of the website - ie with the new design, structure and updated content - was postponed till M8.


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Deliverables M18- Dissemination plan

Milestones 2011 M24 – Informational Video to be put on EUnetHTA public website; Launch of the video at the EUnetHTA Conference, December 8-9, 2011 - Gdansk, Poland

M22 – Session/workshop at ISPOR and EHFG conferences in Europe

M22–M24 – EUnetHTA event in support of the launch of the business model for a sustainable collaboration (preparation in cooperation with Secretariat, AHTAPol and CVZ)

M24 – 2nd WP2 Interim Technical Report Deviations from the initial 3-year work plan

The informational video will be postponed from M21to M24, in order to launch it at the EUnetHTA conference.

Informational video In order to foster the usage of EUnetHTA JA results and to inform the wider public of the project itself, WP2 will produce an informational video for distribution through the EUnetHTA website, and possibly though DG Sanco website and YouTube. The video will explain the aims and objectives of EUnetHTA JA and include Questions and Answers in a dialogue between main stakeholders, including patients, HTA institutions and policy makers from EU MS etc., and the EUnetHTA JA Partners regarding eg, the purpose of EUnetHTA and what can be achieved with the network.

Dissemination Plan

Dissemination plan for the Joint Action will be built around 3-year Work Plans to be developed by each Work Package.

Meetings



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Madrid, ES

1 15 Informational video, dissemination plan

Stakeholder and external expert involvement Stakeholder involvement is foreseen as collaboration on stakeholders input into the content of the informational video. The members/participants of the EUnetHTA JA Stakeholder Forum will be approached for possible content contributions to the video.

Cooperation with other WPs / LPs Outcomes of other WPs are expected to be put on public website. Moreover, certain individuals from other WPs will be invited to participate in the production of the informational video.


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Gantt chart 2011 M13 M14 M15 M16 M17 M18 M19 M20 M21 M22 M23 M24

Meetings (Face-to-face)

MadridSpain ,March 28-29

Informational Video Dissemination Plan Session/workshop at EHFG Session/workshop at ISPOR EUnetHTA event in support of the launch of the business model for a sustainable collaboration (preparation in cooperation with Secretariat, AHTAPol and CVZ) 2nd WP2 interim technical report Pilot creation of Groups for Social Networks (LinkedIn and Facebook), maintenance, monitoring Pilot input for Wikipedia, updating and monitoring 2012 M25 M26 M27 M28 M29 M30 M31 M32 M33 M34 M35 M36Pilot creation of Groups for Social Networks (LinkedIn and Facebook), maintenance, monitoring Pilot input for Wikipedia, updating and monitoring

Meetings (Face-to-face) 3rd

Final report

4. Appendices Wikipedia text European network for health technology assessment (EUnetHTA) is a network, established to create an

effective and sustainable network for health technology assessment (HTA) across Europe that could develop

and implement practical tools to provide reliable, timely, transparent and transferable information to contribute

to HTAs in members states.

The overall strategic objective of the network is to connect public national/regional HTA agencies, research

institutions and health ministries, enabling an effective exchange of information and support to policy


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decisions by the Member States.

EUnetHTA Joint Action consists of a total of 34 government appointed organisations from 23 EU member

states, Norway, Croatia and a large number of relevant non-for-profit organisations that produce or contribute

to HTA.

Work packages

• Core HTA including adaptation

• Relative effectiveness assessment (REA) of pharmaceuticals

• Information management system

• New technologies. Facilitating evidence generation and collaboration on (pre-coverage) assessments

• Strategy development (business model for sustainability including capacity building to do HTA)

• Coordination

• Communication

• Evaluation

Health technology can be defined as any intervention that may be used to promote health, to prevent,

diagnose or treat disease or for rehabilitation or long-term care. This includes the pharmaceuticals, devices,

procedures and organizational systems used in health care.

Examples of health technology: diagnostic and treatment methods, medical equipment, pharmaceuticals,

rehabilitation and prevention methods, organisational and supportive systems within which health care is

provided.

Health technology assessment (HTA) is a multidisciplinary process that summarizes information about the

medical, social, economic, and ethical issues related to the use of health technology in a systematic,

transparent, unbiased, robust manner. Its aim is to inform the formulation of safe, effective, health policies

that are patient focused and seek to achieve best value. Despite its policy goals, HTA must always be firmly

rooted in research and the scientific method.

Sources

http://www.eunethta.eu

http://www.htaglossary.net

Kristensen FB, Mäkelä M, Allgurin Neikter S, et al. European network for Health Technology Assessment,

EUnetHTA: Planning, development, and implementation of a sustainable European network for

Health Technology Assessment. Int J TechnolAssess Health Care. 2009;25 (Suppl 2):107-116.

http://www.sbu.se/sv/Om-SBU/Internationellt/Eunethta/

http://ec.europa.eu/geninfo/query/resultaction.jsp?page=1

http://journals.cambridge.org/action/displayIssue?jid=THC&decade=2000&volumeId=25&issueId=S2&iid=6


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894084

MINUTES FROM THE MEETINGS: EUnetHTA

1st Work Package 2 Meeting | Dissemination

Vienna 2010, March 11–12

Minutes from the Meeting

Present: Eva Turk, Urška Kaloper (both NIPH, Slovenia), Susanna Allgurin Neikter

(SBU, Sweden), Gottfried Endel, Dagmar Bernardis, Nina Pfeffer (all HVB, Austria),

Plamen Dimitrov (NCPHP, Bulgaria), Julia Chamova (EUnetHTA Secretariat, NBoH,

Denmark), Isabel Saiz, Isabel Peña-Rey (both Ministry of Health and Social Affairs, Spain),

Eleftheria Karampli (NSPH, Greece), Christoph Künzli (SNHTA, Switzerland).

Apologizes: Rosa Rico (OSTEBA, Spain).

1. Welcome and Introduction

Mr. Probst, Managing Director of HVB welcomed the participants. Afterwards Eva Turk opened the meeting and welcomed all participants to the 1st Work Package 2 Meeting of the EUnetHTA Joint Action. She expressed her appreciation to HVB for hosting the meeting in Vienna. Susanna Allgurin Neikter welcomed the members and stated that the aim of the meeting was to get to know each other better and to exchange ideas. The work should build on what was previously achieved during the EUnetHTA project 2006–2008, but we are now taking it to the next level. All members of Work Package 2 presented themselves. Eva presented the meeting agenda and some practical information.

2. Work Package 2, Dissemination (all relevant presentations from the 1st face to face meeting in Vienna are available in Workroom 2)

Eva Turk presented Work Package 2.

• Work Package 2 Work Plan 2010

• Partners

• Objectives

• Stakeholders and target audiences

• Deliverable: Dissemination Plan (built on the Communication Strategy developed 2007)

• Milestones

• Promotion:

– Promotional leaflet

– Web-based encyclopedias

– Social media

– Promotional video

• Collaboration with other Work Packages.


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3. Social Media – Discussion

Eva Turk presented the idea of setting EUnetHTA profiles on Facebook, LinkedIn, and Xing.

Susanna Allgurin Neikter supported the strategy to include social media among possible communication channels. Urška Kaloper pointed out that social media are gaining their power in creating public opinion and that they will quickly develop and become an even more important part of communication.

Julia Chamova argued that the representation of EUnetHTA in social media should not compete with the communication tools for networking that already exists within EUnetHTA Members-only or on the public website.

Christoph Künzli doubted the necessity of creating the profiles in social media and suggested to discuss the target groups first and then the tools of communication.

Eva Turk defined the main purpose of engaging the social media in the communication effort was to raise awareness about EUnetHTA.

Isabel Saiz pointed out that she is not allowed to join Facebook on behalf of the ministry of health and social affairs or be a part of such a network as a representative of the ministry.

Christoph Künzli asked who would update the profile and what would the editing policy be.

Julia replied that the Secretariat cannot be responsible for the content in the social media and does not have resources to monitor it.

The safety issue was raised and discussed. It was agreed that the risks involved have to be thoroughly assessed, eg, to avoid confidential information to leak. Susanna Allgurin Neikter suggested that creation of a Facebook-group for HTA could be an alternative, as a first step.

Gottfried Endel suggested that we should create a standard operating procedure that would define work with the social media. An important thing to be defined is the response to bad publishing. It was suggested that currently the use of the social media will be limited to the individuals and not for official (“on-behalf-of-EUnetHTA”) communication.

Another alternative was discussed, that the members of EUnetHTA adds a link to the official EUnetHTA webpage and become “fans” of EUnetHTA on their personal Facebook profiles.

Eva Turk suggested that the social media should become a “side channel” and that everyone seeking official information would be redirected to the official website.

Nina Pfeffer argued that we should – regarding the communication and dissemination of the results of Work Packages – first define “what, who, why – and then how”, ie the purpose of using the specific communication channel and its benefit in comparison to other existing and already used ones.

Isabel Saiz suggested focusing on dissemination of the Work Packages’ results in more traditional ways. She believes that more people from the EUnetHTA target groups would be reached that way.

CONCLUSIONS:

• The issue of social media was raised and discussed, but requires further deliberation. The decision about social media will continue.

• Eva Turk and Urška Kaloper should prepare a review of similar organizations engaged in online social networks and a document about pros and cons and possible consequences of such engagement.

4. The Secretariat and Financial Issues

Julia Chamova presented the role of the Secretariat and financial issues.

• Members of the EUnetHTA Secretariat at the NBoH in Denmark

• EUnetHTA Joint Action General Objectives

• Secretariat’s general tasks


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• Coordination of EUnetHTA Joint Action

• Coordination between the Secretariat and Work Package 2

• Financial issues

Christoph Künzli asked why the EUnetHTA Joint Action budget would be reviewed only after the 2nd interim report to EAHC (M26–M28). Julia Chamova replies that the decision was made based on the experience from the EUnetHTA Project. Since most activities happen in the 2nd year,budget review after the 1st year would be too soon to provide any useful results.

Julia Chamova informed that Partners could consult the SOP Manual for details of financial management or to contact Staffan Stilven at [email protected] or +45 7222 7739.

5. New EUnetHTA Public Website

Susanna Allgurin Neikter presented the new designs of EUnetHTA’s PowerPoint template, the EUnetHTA e-newsletter and the Members Update. Susanna presented a first draft of the new public website. She described what had been previously done in Work Package 2. She started with a brief overview of the Milestones and Deliverables during the EUnetHTA Project 2006–2008, as well as during 2009. She explained the development process from the launch of the public website, Members-only site and 8 extranets in 2006 and the development of the Clearinghouse prototype in 2007. During the last months of the EUnetHTA-project 2009 SBU developed a new information system for Members-only, including several new functions and tools, eg personalized functions, virtual work rooms, interactive note board, check-in/check-out files, a short message system, etc.

From July 1, 2009 KCE is responsible for the information system on the Members-only site and SBU is only responsible for the Public website. The new Members-only site was later adjusted to the Joint Action, eg, with a new front page, and launched in September 2008. The Members-only site will be further developed in Work Package 6.

• The new public webpage will be launched in June 2010.

• A draft of a new web design was presented, including some new functionality, eg Bookmark, “Share the page on Facebook and Twitter” RSS-feed, Todays date, etc. For example latest news will be published as an RSS-feed.

• It has been a request from members to have at least slightly different designs on the EUnetHTA public website and Members-only to avoid confusion.

• Proposal: to include a slideshow of pictures from different countries in the top frame. Another idea was to have a “most popular pages” function.

• The top menu will include different headings, ie, Home, About EUnetHTA, EUnetHTA Tools, Activities, HTA, Partners and Contact.

• There should also be a line of boxes with direct links from the first page, some fixed, eg, EUnetHTA Project 2006–2008, and some open, eg, EUnetHTA at the HTAi Meeting in Dublin.

• Google Analytics has been installed, which will allow us to have reliable statistics, eg, about the number of visitors and the most popular pages.

Susanna Allgurin Neikter asked the members of the Work Package 2 to suggest functions, information, and features for the new public website and to think about how to attract more visitors to the site. The members proposed different ideas that were discussed. Several members suggested that FAQ should be added. Urška Kaloper suggested that the line of boxes should be an interactive timeline of events. Julia Chamova suggested that different events are marked with different colours depending on their relevance within the EUnetHTA work plan. Susanna supported those ideas.

Urška Kaloper and Susanna Allgurin Neikter proposed that some general texts on the webpage should be reviewed and simplified to be more user-friendly.

Elefteria Karabli suggested a page in the website under the heading Media (Downloads could be an alternative or any other suitable heading) where all the materials related to the EUnetHTA electronic promotional material would be available to the public and could be uploaded. It could include:

- Promotional leaflet


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- Fact sheet

- Informational video

- URL with source code so that anyone interested in posting the link on their website would be facilitated to do so

- Link to the wikipedia post

- Any other promotional material developed

It would actually be the equivalent to the Library (Under Resources) in the Members Only website. E. Karabli believed that it would be useful for all those interested in the EUnetHTA promotional activities to know that there is an easy way to find all the material needed. They will also know where to look for new material when it is available.

She also suggested to Susanna Algurin Neikter to provide the members of WP2 with credentials to be able to access the website before it is officially “on air” so that the members could act as “testers”.

Further on E. Karabli suggested a feature called Share This tool, which can be used on the EUnetHTA as it makes it easy for users to send an interesting article/news feed/anything worth sharing to their contacts. More information at http://sharethis.com/.

CONCLUSIONS:

• Susanna Allgurin Neikter will prepare a new design of the new public website and check if it is possible to develop an interactive timeline within the budget.

• Susanna Allgurin Neikter will disseminate the statistic for the public website from Google Analytics.

• Partners of Work Package 2 will provide questions for FAQ by May 10, 2010

• The text on the public website will be updated by the Secretariat. Urška Kaloper and Susanna Allgurin Neikter in collaboration with the Secretariat will revise the general EUnetHTA information. The new texts should be available before 20th June 2010.

6. Target Groups for the Dissemination of EUnetHTA Results

Eva Turk revised the target groups for the dissemination of the results of the EUnetHTA.

• All target groups are on the European level. The national representatives are responsible for the dissemination of the EUnetHTA results on the national level.

• What should be communicated: What is done in the other Work Packages? What is EUnetHTA?

• Objectives of the Work Package 2 should be relevant to the general objectives.

• Primary target: HTA agencies/professionals to work more efficiently.

Christoph Künzli asked why the Health Ministries were not included among the stakeholders.

Susanna Allgurin Neikter mentioned that EUnetHTA is responsible for the European level, but each HTA agency is responsible for communicating the EUnetHTA results on the national level, including to the Ministries of Health – this was agreed in the EUnetHTA project and included in the developed EUnetHTA Communication Strategy. Julia Chamova explained that the stakeholder definition and list of the stakeholder groups have been agreed upon during the EUnetHTA project and confirmed by the Executive Committee; Ministries of Health and health policy makers are important target audiences, however, they are not defined as stakeholders for the EUnetHTA stakeholder involvement process and communication with the Ministries of Health is the responsibility of national/regional HTA organisations/agencies.

CONCLUSION:

• EUnetHTA can offer support when it comes to messages on the nation level. The action/implementation of


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communication on national level must be the responsibility of the Partners.

7. Promotional Leaflet

Eva Turk asked for opinions about the promotional leaflet: should it be based on the fact sheet that was developed during the EUnetHTA-project 2006–2008 or should a completely new content/layout be prepared?

Gottfried Endel suggested a leaflet based on the fact sheet and that the content changes once a year.

Susanna Allgurin Neikter proposed that the general fact sheet is available online as before where it can be updated and printed by each Partner when needed. She suggested that the leaflet should be more promotional than fact-based and printed in advance. The focus should be why EUnetHTA is important to the target groups. She also suggested to be open to non- traditional format of the leaflet, eg the form of a business card. Another idea from Eva Turk was a leaflet in form of a circle.

Isabel Paiz asked if the leaflets and fact sheets could be translated into national languages, which was confirmed. It is up to the Partners to decide if they want to translate the information to their own language.

Gottfried Endel pointed out that the aim of the EUnetHTA leaflet should also be “branding”: not only to disseminate the messages, but also to promote the EUnetHTA and build trust in its work.

Nina Pfeffer suggested that the promotional leaflet should offer less information and should direct to the website as the main source of the detailed and updated information about EUnetHTA.

Isabel Paiz suggested that not only promotion, but also key information about EUnetHTA should be published in the leaflet.

CONCLUSIONS:

• The promotional leaflet should consist of information about EUnetHTA as well as more targeted texts.

• Eva Turk and Urška Kaloper will in the coming weeks prepare a draft of the contents and send it to other partners in Work Package 2 for comments.

• Eva Turk and Urška Kaloper will check the costs for different formats of the leaflet (and whether it is possible to produce, for instance, a “credit card” and circle at the same printing).

• The leaflet will be published in electronic form on the website, in print it will be handed out at meetings and conferences.

• The date of issuing the promotional leaflet is postponed to the beginning of the summer.

8. EUnetHTA Information in Web-based Encyclopedias

Eva Turk presented the idea of publishing information about EUnetHTA in web-based encyclopedias. Content of the EUnetHTA information: Aims, Objectives, Mission, Vision, and EUnetHTA Partners

Susanna Allgurin Neikter suggested that the presentation should also include a description of the HTA concept. For that purpose the EUnetHTA’s HTA definition should be used.

Nina Pfeffer pointed out that we should define who is responsible for the content in web- based encyclopedias (who can publish it, who and how shall we react if another content is published etc).

The fear that EUnetHTA will not have any control of the texts in the wikis was raised and discussed. Susanna Allgurin Neikter mentioned that a certain level of safety is provided by Wikipedia and Medpedia as administrators are notified when new content is added and can react.

Isabel Paiz asked if Partners could translate the content for their national versions of the web- based encyclopedias, which was confirmed.

CONCLUSIONS:


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• Publishing on Wikipedia and Medpedia should start as pilot project by Work Package 2.

• Eva Turk and Urška Kaloper will prepare the draft of the original text in English (basic core information is on the website – should be cited “original is found on www.…”) before 6th April 2010.

• The text should explain: What is EUnetHTA? What are the products? Where do we find it? What is HTA? What is the purpose of the Joint Action?

• The draft will be circulating between the Partners of Work Package 2. Comments should be made before 12th April 2010.

• The accepted and confirmed version will be translated into national languages by the partners in the Work Package 2 before 14th May.

• The pilot project will be presented at the Plenary Assembly Meeting .

• If the pilot proves to be successful, the text could be translated into other European languages by the Partners and published in other local web-based encyclopedias.

• Eva Turk and Urška Kaloper will prepare the instruction for publishing and use of the web-based encyclopedias by September 2010.

9. Informational Video

Urška Kaloper presented the planning of the promotional video.

• Primary target audience: health professionals, but the video should relate to everyone

• Aim EUnetHTA and its advantages (presenting real-life situations)

• Length should be approx. 2,5 min, it should consist of combination of narration and statements of eg, the stakeholders + European Commision + European Medicine Agency.

• It should be rich with graphics, modern, similar to “news story” (in montage, narration etc)

• Proposal: The film could open with a “problem”: lines in the hospitals, pharmacies …And continue with “solutions”: how can EUnetHTA/HTA help to solve the “problem” .

Nina Pfeffer expressed the need to redefine the target audience – do we need to make a video to reach them or would other tools be more effective?

Isabel Saiz suggested that we should use actors instead of real individuals in order to overcome the difficulty of choosing the right individuals for the statements. Christoph Künzli supported the idea. Susanna Allgurin Neikter and Urška Kaloper argued to instead use real HTA experts and real people acting as themselves, which can facilitate EUnetHTA in building trust and credibility.

Susanna Allgurin Neikter suggested to aim for reaching audiences on the emotional level with the film – to “sell” HTA as a concept to do good and to contribute to a better health care for people in Europe.

Susanna Allgurin Neikter stressed that the preparation phase of the film was very important but time consuming and that we should set aside time for it. The idea behind the film, the concept, the message, who it should target etc, must be thoroughly worked out and analytic and creative work has to be done before we can go into the technical film production phase.

CONCLUSIONS:

• The decision when to produce the informational video was postponed. A proposal was to schedule the production to autumn 2011 (M21).

• Eva Turk and Urška Kaloper will prepare a draft of the scenario by autumn 2010 (M11).

Eva Turk concluded the meeting. Eva Turk and Susanna Allgurin Neikter thanked all the members for a successful meeting, with active contribution, many ideas and open discussions.

Eva Turk gave a special thanks to HVB for hosting the meeting.

MEETINGS:


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The Partners of Work Package 2 will be invited to three scheduled e-meetings during 2010– 2012: October 26th, 2010 and November 29th, 2010.

The 2nd face-to-face meeting will take place in Madrid in March 2011 (M 15).

The 3rd face-to-face meeting will be in Ljubljana in June 2012 (M30).

ADDITION AFTER THE MEETING:

After the meeting Elefteria Karabli suggested to alter the promotional material in the shape of circle (i.e the leaflet, and maybe a coaster or a mouse pad if the budget allows it) into a shape of multiple co-centric circles. In her opinion the patient should be at the center (emphasizing the patient-centered approach of HTA). Moving from the center to the outer circles could represent a level of decision-making (she believed that it is important to illustrate that HTA is a tool in the decision-making process not the solution), e.g. patient→ physician→ hospital → insurance organization/national health service→ national health systems→ EU level cooperation through EUnetHTA).

WP2 E-meeting minutes, 29.11.2010, 13.00–14.05 Attendees:

Eva Turk, NIPH

Julia Chamova, NOBH, EUnetHTA Secretariat

Christoph Kuenzli, SNHTA

Eleftheria Karampli, NSPH

Nina Pfeffer, HVB

Susanne Eksell, SBU

Susanna Allgurin Neikter, SBU

Patrice Chalon, KCE

AGENDA 1. Wikipedia 2. Social networks: LinkedIn, Facebook, Twitter 3. Modification of EUnetHTA PowerPoint slides 4. Informational video and Stakeholder Involvement 5. Other

Ad1: WIKIPEDIA

National translations of the Wikipedia text will be put on national Wikipedia site by WP2 members. All WP2 members agree to upload the national versions to national Wikipedia website. Maintenance will be provided by WP2 members. Comment CH: As being part of MoH, it needs to be seen how the maintenance can be assured.

The text in the English version will not be modified, except the number of EUnetHTA Agencies and number of EU countries. In case of modification of the English version, the WP2 members will be informed by email and they can update the text.

For common languages (eg. German), there will be one common site. Nina Pfeffer and Christoph Kuenzli will discuss this matter internally.

Ad.2: SOCIAL NETWORKS

LINKEDIN

Pilot Phase of LinkedIn:


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Due to requests of people from outside EUnetHTA circle, there is a proposal for opening the LinkedIn group for broader use and to create a group called “HTA in Europe” on LinkedIn. EUnetHTA will be the one who will establish and maintain the group, the focus of discussions and membership will be broader than just EUnetHTA.

After the discussion about how to use the logo, and the importance of having a graphical picture in the Group, the decision was made that EunetHTA logo will be removed from the letter O in ”HTA in Europe” and EUnetHTA will be mentioned as the establisher, manager and maintainer of the group in the description of the group. LinkedIn group is established and maintained by EUnetHTA, however EUnetHTA is not responsible for the discussions and that outsiders can have a voice there. Julia volunteers to develop the text of the responsibilities of EUnetHTA.

Susanna Allgurin Neikter will prepare the proposal for the HTA in Europe logo by December 25th. An email for consensus will be sent asap to the WP2 members.

WP2 will propose the LinkedIn group to Executive Committee and get consent of them.

FACEBOOK

The survey carried out by WP3 shows that only 35% of the responders are willing to publish EUnetHTA on their FaceBook profile while 72% are willing to do so on their LinkedIn profile. Facebook group will be abolished, we will continue only with LinkedIn.EUnetHTA on Twitter.

Workload – possibilities from the content management system to automatically take already written news and feed in Twitter. Minimal use- automatically feed official news from public EUnetHTA site. We will not use the news from News Agregator.

Susanna proposed to rewrite the EunetHTA news to feed them into Twitter. This will be discussed among WP2 Lead and Co-lead partner.

Ad.3: MODIFICATION OF POWERPOINT SLIDES

Comments from EUnetHTA partners that there is not enough space for presenting the scientific information and results from the group and scientific details from the reports.

We will get in touch with WP5 to get detailed information on what needs be modified.

AD4: INFORMATIONAL VIDEO AND STAKEHOLDER INVOLVEMENT

The first initial idea was presented. More detail is needed to describe the content of the video, which needs to be interesting and touching for the people of attention, and give purpose of EUnetHTA. Aim and objectives need to be well defined. It is important to get the people who are gaining from EUnetHTA and gender balance is needed. It is suggested that the informational video will be made by a professional team from Slovenia. The idea of contacting the communication department of the European Commission was put on the agenda, where WP2 will still be in charge of the content. Christoph raised the issue that it might get to bureaucratic if we contact the EC too early. The option of involving the EC will be considered.

Before contacting the EC and other people, a more elaborated scenario will be prepared by NIPH (by December 25) for consent in WP2 and consent within the Executive Committee (mid January). In February start contacting external parties.



EUnetHTA


YEAR 2010

EUnetHTA JA on HTA – WP 3 Evaluation 1/8

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Work Package 3 - Evaluation


2010


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Contents 1. Overview ................................................................................................................................................. 2 2. Activities performed in 2010.................................................................................................................... 4

Plenary Assembly Evaluation Survey…………………………………………………………………………………..4 EUnetHTA JA Participants’ 2010 Baseline Survey……………………………………………................................4 EUnetHTA JA Stakeholder Forum 2010 Baseline Survey…………………………………………………………...4

EUnetHTA JA Baseline Survey 2010 for those that applied to join the Stakeholder Forum but were not successful………………………………………………………………………………………………………………….5

Adherence to the Work Plan in 2010............................................................................................................... 5

3. Work Plan for the next period (2011) ...................................................................................................... 5

Interim Participants’ Survey 2011……………………………………………………………………………………….5

Interim Stakeholders' Survey 2011 ..................................................................................................................... 5

Meetings ......................................................................................................................................................... 6

Stakeholder and external expert involvement ................................................................................................. 6

Cooperation with other WPs / LPs................................................................................................................... 6

Gantt chart ....................................................................................................................................................... 6

4. Appendices.............................................................................................................................................. 7

Disclaimer statements; This project was part-funded by the NIHR Health Technology Assessment programme (project number 05/52/03) and will be published in full in Health Technology Assessment in 2013. See the HTA programme website for further project information: http://www.hta.ac.uk/

The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the Department of Health.

EUnetHTA Joint Action is supported by a grant from the European Commission. The sole responsibility for the content of this report lies with the authors and the European Commission is not responsible for any use that may be made of the information contained therein. www.eunethta.net


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1. Overview

Work Package 3 Evaluation

Lead Partner

Co-Lead Partner (if applicable)

• NETSCC

Organisations Involved NETSCC

WP Objectives WP3 will provide an evaluation, the main purpose of which is to identify to what extent the individual Work Packages enable the JA to meet its objectives. No Specific Objective as per the Grant Agreement is connected to this WP.

Objectives to address the questions; • Will the JA will achieve its overarching objective, and

ultimately did it?

• Will the JA achieve its specific objectives, and ultimately did it?


• Plenary Assembly 2010 survey • EUnetHTA JA Participants’ 2010 Baseline survey • EUnetHTA JA Stakeholder Forum 2010 Baseline survey • EUnetHTA JA Baseline Survey 2010 for those that applied to join

the Stakeholder Forum but were not successful


• M1 Submission of the evaluation plan ED1, which was submitted according to the workplan.

• M2 Submission of the finalised evaluation plan ED2, which was submitted according to the workplan.

• ED3 refers to submission of status updates from WP3 to the Secretariat every 2-months; this has occurred as planned.


Four activities were performed in 2010 which were in addition to the workplan;

• Plenary Assembly evaluation; design, distribution and analysis of paper-based self-completion surveys about the Plenary Assembly 2010. A report about this has been submitted to the Secretariat.

• Incorporation of WP8 questions into the Baseline Participants’ survey – this involved collaboration with WP8 colleagues, piloting of these questions at the WP6 face-to-face meeting in April, reporting at the WP6 face-to-face meeting in October and preparation of a report.

• Preparation of reports from the Baseline Participants’ survey; for workpackage leaders about their questions (WP2, WP6 and WP8) and for tool developers about their tools.

• Preparation of reports from the Baseline Participants’ survey for workpackage leaders about questions about their workpackage (WP1, WP2, WP4, WP5, WP6, WP7, WP8).


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Plenary Assembly Evaluation Survey The first Plenary Assembly of the EUnetHTA JA was held 20th-21st May 2010 in Ljubljana, Slovenia. This was the first time that representatives from the partner organisations had met in the Joint Action. The paper-based survey was given to all meeting participants in their meeting pack, to evaluate the meeting. It contained evaluation questions about the meeting; objectives, satisfaction with the venue & facilities, good factors, poor factors and possible future improvement.

The survey was completed by 74% - 29 out of 39 who were eligible to complete an evaluation form did so. The responses were analysed using Statistical Package for the Social Sciences (version 16) for the quantitative components and NVivo (version 8) for the qualitative responses. The qualitative components were analysed into themes according to iterative grounded theory.

The survey report is included in Appendix 1.

EUnetHTA JA Participants’ 2010 Baseline Survey This baseline survey was sent to all registered individual participants of the EUnetHTA JA from EUnetHTA member organisations in the Summer of 2010. The survey was designed in 7 sections; demographics, specific organisational and HTA information, setting-up process, administration & communication, information technology, EUnetHTA tools and specific workpackages. Work was undertaken by WP3 to incorporate the questions from WP2, WP6 and WP8 into the baseline survey. The survey was designed as a web-based survey and was hosted by surveymonkey.com It was designed by the NETSCC WP3 evaluation team (Dr Eleanor Guegan and Dr Andrew Cook) and piloted by the EUnetHTA JA Executive Committee and a representative from the European Commission DG Sanco.

The survey was completed by 88% - 154 of the 175 recipients surveyed. The responses were analysed using Statistical Package for the Social Sciences (version 16) for the quantitative components and NVivo (version 8) for the qualitative responses. The qualitative components were analysed into themes according to iterative grounded theory. The results of the survey pertaining to WP2, WP6 and WP8 questions were reported at the WP6 face-to-face meeting in October 2010. Individual reports were compiled for the workpackage leads; 2, 6 and 8 and for the developers of the EUnetHTA JA tools.


EUnetHTA JA Stakeholder Forum 2010 Baseline Survey This baseline survey was sent to all registered participants of the EUnetHTA JA Stakeholder Forum in the Summer of 2010. The survey was designed in 4 sections, of views about; role as general stakeholders of the EUnetHTA JA, the SF, the EUnetHTA JA, workpackages of the EUnetHTA JA. The survey was designed as a web-based survey and was hosted by surveymonkey.com. It was designed by the NETSCC WP3 evaluation team (Dr Eleanor Guegan and Dr Andrew Cook) and piloted by the EUnetHTA JA Executive Committee and a representative from the European Commission DG Sanco.

The overall response rate was 83% - 10 of the 12 recipients surveyed. It should be noted that there was an additional respondent who started the survey but did not complete it (despite repeated requests). The responses were analysed using Statistical Package for the Social Sciences (version 16) for the quantitative components and NVivo (version 8) for the qualitative responses. The qualitative components were analysed into themes according to iterative grounded theory


EUnetHTA JA Baseline Survey 2010 for those that applied to join the Stakeholder Forum but were not successful This baseline survey was sent to the 5 stakeholder umbrella organisations who had applied to join the Stakeholder Forum but had been unsuccessful in becoming a member of the Forum (all identified stakeholders are able to participate in the Stakeholder Forum via their representative). The survey was designed in 4 sections, of views about; role as general stakeholders of the EUnetHTA JA, the SF, the EUnetHTA JA, workpackages of the EUnetHTA JA. The survey was designed as a web-based survey and was hosted by surveymonkey.com. It was designed by the NETSCC WP3 evaluation team (Dr Eleanor


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Guegan and Dr Andrew Cook) and piloted by the EUnetHTA JA Executive Committee and a representative from the European Commission DG Sanco.

The overall response rate was 100% - 5 of the 5 recipients surveyed responded. The quantitative responses were analysed using Statistical Package for the Social Sciences (version 16) and the qualitative responses with NVivo (version 8). The qualitative components were analysed into themes according to iterative grounded theory.


Adherence to the Work Plan in 2010 The work has adhered to the workplan in 2010, although the analysis of the EUnetHTA JA Participants’ 2010 Baseline Survey took slightly longer than envisaged (due to the large amount of data it contained).


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2010 (Year 1)

3. Work Plan for the next period (2011) No deviations from the original 3-year Work Plan of WP3 (developed in the beginning of 2010) are envisioned for Year 2 - 2011. An extra activity will occur; liaison with WP8 (training strand) to incorporate their questions into the Interim Participants’ Survey 2011. This interim survey will be sent to all registered individual participants of the EUnetHTA JA from EUnetHTA member organisations in 2011.

Interim Participants’ Survey 2011 This will involve planning the survey questions and structure (M13-M14 Jan-Feb), distributing the survey (within the window of M15-M19 March-July) and analysis (M19-M22 June-Oct). Work will be undertaken to collaborate with WP8 training strand, to incorporate their questions.

Interim Stakeholders’ Survey 2011 This will involve planning the survey questions and structure (M15-M17 March-May), distributing the survey (M17-M19 May-July) and analysis (M20-M23 Aug-Oct).

Meetings One face-to-face meeting is planned with ISC-III in Spring 2011 in Madrid about incorporating the WP8 (training strand) questions into the interim participants’ survey.

Stakeholder and external expert involvement Stakeholder involvement will be through surveying stakeholders’ opinion in the Interim Stakeholders’ Survey of those in the Stakeholder Forum.


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Cooperation with other WPs / LPs WP8 – Strategy and Business Case (Training strand)

Cooperation will be through incorporation of WP8’s questions into the Interim Participant’s Survey 2010. This will involve a meeting with WP8 (training strand). A report of the survey responses will be prepared for the strand leaders.

Gantt charts = Dates of regular progress report issued by WP3 to the Executive Committee

2011 (Year 2)

2012 (Year 3)


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4. Appendices WP3.1 Report of the ‘Plenary Assembly 2010 Survey’

WP3.1 Report of the ‘EUnetHTA JA Participants’ 2010 Baseline Survey’ WP3.3 Report of the ‘EUnetHTA JA Stakeholder Forum 2010 Baseline Survey’ WP3.4 Report of the ‘EUnetHTA JA Baseline Survey 2010 for those that applied to join the Stakeholder Forum but were not successful’ WP3.5 ED3 – copies of the status reports sent every 2 months from WP3 to the Secretariat; Jan-Feb 10, March-April 10, May-June 10, July-August 10, September-October 10.



EUnetHTA


YEAR 2010

EUnetHTA JA on HTA – WP4 1/18

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Work Package 4 – CORE HTA


2010


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Contents

1. Overview ................................................................................................................................................. 3 2. Activities performed in 2010.................................................................................................................... 5

STRAND A....................................................................................................................................................... 5 Development of Online Tool & Service............................................................................................................ 5 First pilot testing of Online Tool & Service....................................................................................................... 6 Development of HTA Core Model Application for Screening Technologies .................................................... 6 Policies for Online Tool & Service ................................................................................................................... 7 STRAND B....................................................................................................................................................... 9 Stakeholder involvement practices .................................................................................................................. 9 Topic selection and priority setting processes............................................................................................... 10 Procedures for topic selection and priority setting and for stakeholder involvement .................................... 11 Collaborative models for producing Core HTAs ............................................................................................ 12 BOTH STRANDS........................................................................................................................................... 12 Meetings ........................................................................................................................................................ 12 Adherence to the Work Plan in 2010............................................................................................................. 13

3. Work Plan for the next period (2011) .................................................................................................... 13 STRAND A..................................................................................................................................................... 13 STRAND B..................................................................................................................................................... 14 STRANDS A + B............................................................................................................................................ 14 Meetings ........................................................................................................................................................ 15 Stakeholder and external expert involvement ............................................................................................... 15 Cooperation with other WPs / LPs................................................................................................................. 16 Gantt chart ..................................................................................................................................................... 17

4. Appendices............................................................................................................................................ 18


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1. Overview

Work Package 4 CORE HTA

Lead Partner (LP)

Co-Lead Partner (Co-LP)

THL, Finland AGENAS, Italy

Organisations Involved Associated Partners (APs, participation in strands in brackets):

1. AGENAS, Italy (A/B) 2. AHTAPol, Poland (A/B) 3. CVZ, Netherlands (A) 4. DIMDI, Germany (A/B) 5. GÖG, Austria (B) 6. HIQA, Ireland (A/B) 7. HVB, Austria (A/B) 8. INFARMED, Portugal (A/B) 9. IPH-RS, Slovenia (A/B) 10. IQWIG, Germany (A/B) 11. ISCIII, Spain (A/B) 12. KCE, Belgium (A/B) 13. LBI-HTA, Austria (B) 14. NBoH, Denmark (A) 15. NICE, UK (A/B) 16. NOKC, Norway (A/B) 17. Regione Veneto, Italy (A/B) 18. SBU, Sweden (A) 19. SDU, Denmark (B) 20. SSD/MSOC, Malta (B) 21. THL, Finland (A/B) 22. UTA, Estonia (A/B)

Collaborating Partners (CPs, participation in strands in brackets):

1. AETSA, Spain (A/B) 2. ARESS, Italy (A) 3. ASSR Emilia Romagna, Italy (A/B) 4. Avalia-t, Spain (A/B) 5. Department of Health Services Research, Denmark (A/B) 6. DSI, Denmark (A/B) 7. KDTD, Turkey (A/B) 8. Lazio Sanità, Italy (A/B) 9. OSTEBA, Spain (A) 10. Quality unit, Ministry of Health of Serbia, Serbia (A/B) 11. Regione Lombardia, Italy (A/B) 12. SNHTA, Switzerland (A/B) 13. University of Health Sciences, Austria (B) 14. University Hospital "A.Gemelli", Italy (A/B) 15. Agency for Quality and Accreditation in Health, Croatia (B)


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WP Objectives Development of HTA tools and methods To develop principles, methodological guidance as well as functional tools and policies for producing, publishing, storing and retrieving structured HTA information and Core HTAs (including a new application of the HTA Core Model on screening). Application and field testing of developed tools and methods To develop two joint Core HTAs and methods for the production of Core HTAs on common topics, including experimenting different methods of collaboration among agencies and agreeing upon methods to select topics and to involve stakeholders in the assessment process.


STRAND A+B • WP4 Workshop 1, Helsinki, 18 March 2010 • WP4 Workshop 2, Rome, 25 November 2010 STRAND A • Development of Online Tool & Service, basic functionalities (1st

pilot ready) • First pilot testing of Online Tool & Service (focus on core HTA

protocol design) • Development of the HTA Core Model and its Application for

Screening Technologies (1st draft ready for review by January 2011)

• Agreement on methods for developing policies for Online Tool & Service

• Online Tool & Service Workshop 1, Helsinki, 19 March 2010 • Screening Application Workshop 1, Helsinki, 19 March 2010 • Online Tool & Service Workshop 2, Rome, 26 November 2010 • Screening Application Workshop 1, Rome, 26 November 2010

STRAND B • Analysis of WP4 participants' topic selection and priority setting

processes • Analysis of WP4 participants' stakeholder involvement practices • Surveys on topic selection/priority setting and stakeholder policies • Agreed upon procedures for topic selection and priority setting and

for stakeholder involvement in WP4/B (To be completed by February 2011)

• Consideration of collaborative models for producing Core HTAs


MILESTONES • M11 Core HTA topics identified (To be completed by M13) • M12 1st WP interim technical reports (This report)

APPLICABLE ONLY IN 2011-2012:

• M15 A new application of the HTA Core Model ready (on screening).

• M15 Start of Core HTA production. • M24 2nd WP interim technical reports • M36 Final versions of the online System and relevant

processes and policies and final validated versions of the Core HTAs.

• M36 Final report on WP4 to contribute to WP 1 deliverable "Final Report"

• M36 (37) – WP final technical report


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DELIVERABLES • D1A: An online Tool & Service for producing, publishing, storing

and retrieving HTA information. First pilot ready. • D1B: Screening application of the HTA Core Model. First draft

ready for review in January 2011. • D2: A set of 2 Core HTAs. Commence in 2011


• WP4 LP representatives have actively followed the work of WP5 and discussed matters of mutual interest with WP5 LP, in order to coordinate the approach between the two WPs, in particular the design of HTA Core Model applications developed within WP5.

• WP4 has followed actively developments within WP6 in order to ensure feasible use of jointly agreed on standards and procedures.

• Second and third surveys to identify the topics for the production of the two HTAs using the HTA Core Model.

• WP4 has actively contributed to discussions about the actual collaboration between HTA agencies, together with WP7 and at the Belgian EU presidency meeting in October 2010, organized by KCE

• WP4 has participated in discussions on the development of the Stakeholder Forum and later in discussions within the Stakeholder Forum.

• Setup of a mailing list for WP4 Stakeholder Advisory Group (closed for group members only).


STRAND A

Development of Online Tool & Service, basic functionalities (1st pilot ready) A first pilot version to support the production of core HTAs of WP4 Strand B was developed primarily during the first half of the year, based on (then paper-based) basic concepts and processes developed within EUnetHTA Joint Action 2006-2008 and EUnetHTA Collaboration 2009.

The focus was on basic functionalities that would allow defining protocols for core HTAs and entering of results.

Current features of the tool

- Online version of the Handbook available for reading

- User account management (to be replaced with the centralised management in co-operation with WP6)

- Instant feedback functionality

- Starting new "projects" and managing existing ones

Defining basic project information like name, technology, scoping and HTA Core Model application to be used

Managing project participants and their roles

Protocol design and entering research results are part of the project

- Protocol design

Evaluating assessment element relevance for the protocol and translating the generic issues into research questions specific for the technology that is being assessed


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Specifying domain framing

Reviewing the resulting protocol as a web page

- Entering research results

- Entering answers for each research question of the protocol

- Writing introduction, methodology, discussion and references chapters for each domain

- Writing general introduction and summary of the whole project

- Reviewing the resulting report as a web page

First pilot testing of Online Tool & Service (focus on core HTA protocol design) A pilot testing phase of the tool was carried out in September - November 2010. All EUnetHTA members and associates where invited to participate. The task was to create at least one core HTA protocol and to provide feedback on the Tool and the Handbook using an online questionnaire. A core HTA protocol defines the contents of the core HTA through identifying relevant issues that are translated into practical research questions. It serves as basis for a more detailed research protocol in which much more detail (typically e.g. on the background and methodology) is included.

A total of 22 responses where acquired from 21 agencies. A clear majority, 85 % of respondents were either clearly or mostly satisfied with the current implementation of the protocol design process. According to 67 % of the respondents both the content and format of the resulting protocol would be useful in steering the design of a more detailed research protocol. Almost all respondents where very satisfied or mostly satisfied with the technical functionality of the system and the Handbook (90 % and 95 % respectively). Other data were also collected, but it is more dependent on individual testing topics and the used model applications that were developed already during the previous project. More detailed report on the pilot testing will be available during first half of 2011.

Through collecting textual comments on the testing experience, many issues and opportunities for improvement were identified in the pilot. We are continuing the development by addressing these needs and then proceeding to adding missing functionality like public search and browsing of the tool's report database.

Development of HTA Core Model Application for Screening Technologies Participants

All together

– 68 individuals from

– 23 partner agencies (15 APs, 8 CPs) from

– 16 countries

Domain team investigators



– 15 countries

Domain team reviewers



– 13 countries

The primary coordinator for the whole project was from Finohta/THL, the Lead Partner of WP4.

A coordination and editing team (CET) was constructed of the primary investigator in each Domain: 9 individuals from 7 partner agencies (6 APs and 1 CPs) from 6 countries.


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Timeline 2010

The work was divided into three parts: Domain description, Assessment Elements, and Methodology. In each of these three phases the task of the investigators was to update and modify the text from the former Model applications (for medical &surgical and diagnostic technologies, prepared during the EUnetHTA project 2006-08). The Domain reviewers commented the work and the feedback was implemented.

– Call for participation and building the Domain teams March 2010

– Workshop at the WP4 meeting in Helsinki March 18-19 2010

– Kick-off, selection of primary investigators, establishing CET April 2010

– Agreeing on and documenting April 2010

o common definition for screening

o communication protocol

– Domain description:

o investigators May 2010

o reviewers June 2010

– Assessment Elements table:

o investigators June-July 2010

o reviewers August 2010

– CET e-meeting Sep 1 2010

– Methodology:

o investigators Sep-Oct 2010

o reviewers Nov 2010

– Workshop at the WP4 meeting in Rome Nov 24-25 2011

Agreement on methods for developing policies for Online Tool & Service The further use and development of the Online Tool & Service requires agreement on several policies that steer the use and utilization of the system.

The process through which policies would be crafted and a list of key policies were both discussed in the two WP4 workshops organized during 2010. After the discussions in Rome workshop (November 2010), at least the following policies will be crafted:

1. Topic selection for Core HTAs (based on work of Stream B)

2. Production of Core HTAs and other information (based on work of Stream B)

– Who is allowed to be involved in production of information (role of e.g. members of EUnetHTA Collaboration, other HTA agencies, other non-commercial organizations, commercial organizations, or stakeholders of a specific technology) ?

– What expertise is required from those who produce information?

– What kind of organizational structure is required from Core HTA producers, is the contribution from one HTA agency enough?

– How should the questions be answered (e.g. national/international view?)

3. Publishing Core HTAs and other structured information in the Service

– What quality assurance mechanisms, including possible peer-review, are required for publishing Core HTAs and other information?

– Authorship


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– Use of other material (e.g. figures or tables from original articles)

4. Use of Core HTAs and other structured information in the Service

– Who should be allowed to browse and utilize Core HTAs and other information?

– At which phase does information become others beyond the project group?

– On what terms can various parties use the information?

5. Updating the HTA Core Model and its applications

6. Updating Core HTAs and other information

7. Terms of use of the HTA Core Model (also elsewhere)

The following crafting process has been agreed on:

1. Agreement on which policies will be developed and on the overall crafting process. M11-12, Confirmed in Rome in November 2010 and over email afterwards

2. Mapping and discussing a) plausible options for each policy, b) results of WP4 Strand B analyses M11-13, Discussions in Rome in November 2010 and online survey among WP4 participants

3. Find out agencies preferences, i.e. which options are best for each policy M14, Online survey among WP4 participants

4. Agreement on policies within WP4 M15, Consideration and proposal by WP4 Coordination work group (to be set up in the near future) Review and comments by WP4 participants

5. Consultation of WP4 Stakeholder Advisory Group (WP4 SAG) (NEW STEP, AFTER SETUP OF SAG) M16, Review and commentary through email

6. Public consultation M17, Online survey

7. Final approval by EUnetHTA Executive Committee M21

8. Final approval by EUnetHTA Plenary Assembly After M21


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STRAND B

Participants


– 19 countries

The primary coordinator for the project strand was from AGENAS, the co-Lead Partner of WP4. The work was divided into four activities:

• Analysis of WP4 participants' stakeholder involvement practices • Analysis of WP4 participants' topic selection and priority setting processes • Agreed upon procedures for topic selection and priority setting and for stakeholder involvement in

WP4/B (To be completed by February 2011) • Consideration of collaborative models for producing Core HTAs

Analysis of WP4 participants' stakeholder involvement practices The production of a comprehensive and multidimensional Core HTA implies an evaluation within each domain (e.g. social, organisational etc.). For this purpose APs and CPs of WP4/B might need to “involve” one or more specific group of stakeholder per domain through “selected” representatives of those groups (e.g. via a sample+ interviews with more or less structured instruments, or via their national associations).

Literature Search The objectives were to:

• improve the knowledge of the stakeholder involvement process based on the available evidence • agree on a common terminology • enhance the development of the questionnaire

The tasks performed were:

Search strategy

We searched for articles dealing with stakeholders or/and single stakeholder groups (and/or industry-producers-manufacturers/patients/public/consumer/health related media, policy makers, health professionals/clinicians) involvement/participation in Health Technology Assessment at macro/meso/micro/national/regional/hospital level (all years and all languages). The literature search has been conducted on PubMed, Embase and Cochrane Library.

January-February 2010

Filtering

We obtained a total of 163 articles, and we read abstracts of all of them. We ended up with a set of 62 potentially relevant articles, and full text copies of 51 of them have been retrieved and screened (11 were found to be duplicates). 17 articles were included.


Analysis January-February 2010


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Survey

The objective was to collect information on how partners handle stakeholder involvement through an ad hoc questionnaire aimed at investigate their practices related to the topic. The tasks performed were:

Questionnaire development March 2010

Questionnaire agreement (WP4 meeting in Helsinki) March 2010

Questionnaire submission April 2010

Data collection April-June 2010

Data analysis July-October 2010

Presentation and sharing of results (WP4 meeting in Rome) November 2010

Analysis of WP4 participants' topic selection and priority setting processes The production of a comprehensive and multidimensional Core HTAs requires the identification of the technologies to be assessed. For this APs and CPs of WP4/B needed to define and share a methodological framework and criteria for the “Topic Selection Process”.

Literature Search The objectives were to:

• improve the knowledge of the topic selection and priority setting process based on the available evidence

• agree on a common terminology • enhance the development of the questionnaire

Search strategy

We performed a search of scientific evidence related to this issue to describe the current “state of the art”. We searched for articles dealing with “Topic selection”, “Technology selection” “Identification of technology” “Proposal of technology”, “Priority setting”, “Prioritisation” in Health Technology Assessment (all years and all languages). The literature search has been conducted on PubMed, Embase and the Cochrane Library.


Filtering

We obtained a total of 311 articles, and we read abstracts of all of them. We ended up with a set of 33 potentially relevant articles, and full text copies of 27 of them have been retrieved (4 were not found and 2 were duplicates). 23 articles were included.


Analysis January-February 2010

Survey The objective was to collect information on how partners handle topic selection and priority setting through an ad hoc questionnaire aimed at investigating their relevant practices. The tasks performed were:

Questionnaire development March 2010

Questionnaire agreement (WP4 meeting in Helsinki) March 2010

Questionnaire submission April 2010

Data collection April-June 2010


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Data analysis July-October 2010

Presentation and sharing of results (WP4 meeting in Rome) November 2010

Agreed upon procedures for topic selection and priority setting and for stakeholder involvement in WP4/B The objective was to define an agreed on procedure for topic selection and priority setting and to use it for the identification of the technologies for the 2 Core HTAs. The work activities evolved in the following phases: Proposal to use Planned and Ongoing Projects (POP) (WP7/B database) as database to select the technologies + procedure agreed to prioritise the technologies

March 2010 (WP4 meeting in Helsinki)

Test of POP database utilization in WP4/B April 2010 Results of test: : POP could not be used directly to identify topics for WP4/B core HTAs, due to the high number of pharmaceuticals and the broad definitions of planned projects recorded while a more detailed description of technology is needed to the topic selection and priority setting process.

April 2010

Proposal of a new procedure to select topics: development of an ad hoc “identification form” with “Criteria Rank” questionnaire

April-May 2010

“Identification form” and “Criteria Rank” questionnaire agreed and send both to all partners

May-June 2010

Collection of filled “Identification form” and “Criteria Rank” questionnaire

July-September 2010

Analysis of results September-October 2010 Results presentation and sharing Meeting conclusions: to refine the proposals of the technologies through a second survey (narrowing those with broad scope)

November 2010 (WP4 meeting in Rome)

Sending the second survey December 2010 Collecting the preferences of all WP4 partners on topics identified (through the 1st and 2nd survey, December 2010) for the prioritization through a third survey

December 2010-January 2011

Stakeholder involvement procedure: The two Core HTAs are subjected to public consultation during which feedback is actively sought on relevant parts of the work from key stakeholder groups identified within the EUnetHTA Joint Action and from the general public. Prior to subjecting these documents to public consultation, members of the EUnetHTA Stakeholder Forum are given a possibility to review and comment on earlier drafts of these documents. WP4 invites representatives of Stakeholder Forum participants to appoint their representatives into a WP4 Stakeholder Advisory Group (SAG).


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Consideration of collaborative models for producing Core HTAs Proposal of Collaborative Models (ColMod) for producing Core HTAs by Agenas and FINOHTA THL

September-November 2010

Presentation of the proposal of ColMod to all WP4 partners Sharing of proposal ColMod

November 2010 (WP4 meeting Rome)

Development of form to “Call for participation” in Core HTA development by partners and related Collaborative Model chosen.

December 2010-February 2011

BOTH STRANDS

Meetings

Purpose Key topics Time Location Duration (nights)

WP4 workshop 1 General coordination, introduction to basics and previous work on HTA Core Model, topic selection, priority setting, collaboration when producing core HTAs, stakeholder involvement, adaption of information

March 18, 2010 Helsinki 1

WP4 workshop 2 General coordination, policies and working groups, stakeholder involvement, topic selection and priority setting, adaptation, collaborative models and methodological issues.

November 25, 2010 Rome 1

Core Model on screening workshop 1

Coordination, common approaches


Core Model on screening workshop 2

Coordination, common approaches


Online tool workshop 1 Functionalities of 1st pilot of online tool & service


Online tool workshop 2 Further agreement of basic concepts and solutions, results of 1st pilot and further refinement needs.


Participant lists of all meetings attached as Appendices A-C. Minutes of workshops in Helsinki and Rome attached as Appendices D and E (both confidential).


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Stakeholder participation In order to ensure adequate contacts with stakeholders in line with overall EUnetHTA practices (defined within WP8), WP4 LP has participated in the activities of the Stakeholder Forum, including its first face-to-face meeting in Dublin. A Stakeholder Advisory Group (SAG) was formed during the second half of 2010 and a mailing list was set up to allow easy communication. Both LP and Co-LP participate in the activities of the SAG.

Adherence to the Work Plan in 2010

STRAND A

Tasks of Strand A have been completed mostly according to the timeline defined in the 3-year plan. Two tasks were postponed: a) Review of the Screening Application was postponed from Nov/Dec until January 2011. This change, however, should not affect the goal of having a functional first version of the application ready by the end of M15, as planned. The primary reason for the delay is the late completion of some of the domain texts, which still require some editing and merging into a single coherent document that is easier to review. b) The second piloting of the Online Tool was postponed from December 2010 until February/March 2011, due to time required to implement the development needs identified within the first piloting.

STRAND B

All the activities were performed according to the work plan. The results of identification of topics for two core HTAs, (M9) have been presented to the partners during the workshop in Rome (M11). The discussion showed the need to narrow down the scope of the identified topics through a second survey which was submitted to the partners that had made a proposal during the first survey (M12). A new survey was carried out in order to collect the preferences of all WP4 partners on topics identified (through the 1st and 2nd survey, December 2010) for the prioritization through a third survey that will be complete in January 2011.

3. Work Plan for the next period (2011) Despite the few deviations described above, work within 2011 should continue largely as planned. The Core HTA Workshop 1 has been moved from March 2011 to April 2011, and the same change applies to the starting time of core HTA production. This change should not have a substantial impact on the overall timeline, as the planned start of validation of the core HTAs is in M30.

STRAND A Development of the online Tool & Service Further development of the system, with focus on testing the basic functions, and development of advanced functionality, such as support for adaptation processes and information search and retrieval.

Public consultation (including stakeholders) on the HTA Core Model application on screening After reviewing the application by EUnetHTA members and Stakeholder Advisory Group, the application will be subject to public consultation in which further feedback and comments are sought.

Refinement of the new HTA Core Model application on screening Comments from review and public consultation will be taken into account while preparing the version that is used for core HTA production within Strand B.


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Policies for HTA Core Model use Policies will be crafted according to the process defined in 2010 (see above).

Survey on relevant policies and adaptation processes Survey will provide data for designing policies and processes that support adaptation of information from core HTAs to local reports.

STRAND B Agreed upon criteria/methods to select topics for the 2 core HTAs The methods and criteria to select topics for the 2 Core HTAs production will be crafted according to the process defined in 2010 (see above).

Agreed upon process/method to involve stakeholders in the assessment process within the Core HTA production according to the SOP The involvement stakeholders procedure for the 2 Core HTAs production will be crafted according to the process defined in 2010 (see above).

Collaborative models for Core HTAs finalised and used in the concrete Core HTA production processes A call for testing the collaborative models agreed will be performed through a form aimed to collect the preferences of each AP and CP in being involved in ColMod1 (for Core HTA 1 production) or/and ColMod2 (for Core HTA 2 production). Using the same form, a call for participation and building the domain teams will be done by collecting the preferences of each AP and CP to assess one or more domains within the two Core HTAs. Meantime the primary investigators and investigators for each domain team will be identified.

Furthermore a call to identify one representative of each Strand B agency to be member of the Editorial Team for each Core HTA.

Core HTA production Defining and agreeing on common coordination procedures to produce the 2 Core HTAs, specifically Definition of protocols, Definition of specific Milestones, Scheduling of Milestones, Reporting channels, Interim outline Reporting format, Feedback loop.

Sharing the common procedures and starting Core HTAs production by e-mails and during the workshop meeting that will be held in Rome 6-7 April, 2011.

Moreover the core HTA protocols will be produced and reviewed by Stakeholder Advisory Group (SAG).

Starting the production of Core HTAs by each domain team in parallel and coordination (via e-mails, e-meeting, etc) of Domain teams by Editorial team (for each Core HTA).

STRANDS A + B Coordination with Relative effectiveness WP and IMS WP Collaboration particularly with WPs 5 (REA) and 6 (IMS) will continue to ensure shared approaches both with regard to conceptual and technical matters.

Scientific articles Results of work so far, whenever feasible, will be presented and published as scientific articles in relevant journals.


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Meetings



6-7 Apr 2011 Rome (Italy) 2 19 researchers of a Core HTA (10 per core HTA) divided among participating APs + 2 strand B leader + 1 from LP

Sharing of results of TS and collaborative models to start up the Core HTAs production

15-16 Sep 2011 Wien (Austria) 2 19 researchers of a Core HTA (10 per core HTA) divided among participating APs + 2 strand B leader + 1 from LP

Updating of activities, and planning the future steps

Working groups coordination.

Stakeholder and external expert involvement WP4 Stakeholder Advisory Group will be actively involved in the work through asking their feedback e.g. in the following tasks:

Timing (preliminary)

Strand Topic Notes

Jan 2011 A HTA Core Model Application for Screening Technologies

Feedback will be used to improve the application, after which it can be used by Strand B for core HTA production, starting March 2011.

Jan/Feb 2011

A HTA Core Model Handbook Feedback will be used to improve the online tool for HTA Core Model, after which it can be used by Strand B for core HTA production, starting March 2011.

Apr 2011 A 1st Draft of Policies on the Core HTA Structure (i.e. HTA Core Model and information produced through using it)

Review and public consultation takes place in May 2011 after which refinements are made and the first policy set is expected to by ready for approval by EUnetHTA in Sep 2012.

April 2011 A Survey on adaptation processes

Advice is sought to survey design so that national and regional features can be captured as well as possible within the survey.

June 2011 B 1st draft of core HTA protocols

Review of protocols by SAG


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External experts may be invited into various working groups, primarily in situations where relevant expertise can not be found within WP4 participating organizations. Ethics, medico-legal issues and information technology / knowledge management are areas where specific needs may arise.

Cooperation with other WPs / LPs WP4 will continue active collaboration with WP5 and WP6, to ensure conceptual integrity and technical interoperability of products of each WP.

Training on the use and utilization of the HTA Core Model and the Online Tool & Service will be considered and organized in collaboration with WP8.


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Meetings face-to-face Core HTA WS 1 Core HTA WS 2

Tasks Stream A

Online Tool & Serv ice Refinement Pilot ready

Application on screening Refinement Application ready

Policies 1st draft ready for rev iew

Rev iew and public consultation

Refinement First policy set ready for approv al of EUnetHTA

Adaptation processes Dev elopment starts Pilot testing

Validation

Tasks Stream B

Collaborativ e models

Stakeholder policies

Topic selection practices

Core HTA production Production starts

Validation

Dev elopment of adv anced functionalities (publishing, information search & retriev al, adaptation) start

Surv ey on adaptation processes

Pilot testing and feedback of adv anced functionalities


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4. Appendices

WP4.1 Participants of WP4 workshop 18 March 2010, Helsinki

WP4.2 Participants of WP4 workshop 19 March 2010, Helsinki

WP4.3 Participants of WP4 workshop 25-26 November 2010, Rome

WP4.4 Minutes of WP4 workshop 19 March 2010, Helsinki (CONFIDENTIAL)

WP4.5 Minutes of WP4 workshop 25-26 November 2010, Rome (CONFIDENTIAL)



EUnetHTA


YEAR 2010


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Work Package 5 - Relative Effectiveness Assessment (REA) of Pharmaceuticals


2010


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Contents 1. Overview................................................................................................................................... 3 2. Activities performed in 2010 ........................................................................................................ 5

Initiation of background review ............................................................................................................. 5 Initiation of rapid model (rapid technology assessment of relative effectiveness of pharmaceuticals).......... 5 Initiation of full model ( full technology assessment of relative effectiveness of pharmaceuticals) ............... 5 Initiation of methodological guidelines................................................................................................... 5 Meetings............................................................................................................................................ 5 Emeetings.......................................................................................................................................... 5 Adherence to the Work Plan in 2010..................................................................................................... 6 Stakeholder and external expert involvement ........................................................................................ 6

3. Work Plan for the next period (2011)............................................................................................ 6 Background review ............................................................................................................................. 7 Rapid model (rapid technology assessment of relative effectiveness of pharmaceuticals) .......................... 7 Full model (full technology assessment of relative effectiveness of pharmaceuticals) ................................ 7 Methodological guidelines ................................................................................................................... 7 Meetings............................................................................................................................................ 7 Stakeholder and external expert involvement ........................................................................................ 7 Cooperation with other WPs / LPs ........................................................................................................ 8 Gantt chart (2010&2011) ..................................................................................................................... 8

4. Appendices ...............................................................................................................................8


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1. Overview Work Package 1 (2, 3…) Coordination (Dissemination,…)

Lead Partner


• College voor zorgverzekeringen (CVZ) – Netherlands • Haute Autorité de santé (HAS) - France

Organisations Involved Associated partners 1. AHTAPOol (Poland) 2. AIFA (Italy) 3. ESKI (Hungary) 4. GOEG (Austria) 5. HIQA (Ireland) 6. HVB (Austria) 7. INFARMED (Portugal) 8. IPH-RS (Slovenia) 9. IQWIG (Germany) 10. KCE (Belgium) 11. MPRA (Latvia) 12. MoH (Czech Republic) 13. MoH (Spain) 14. NICE (UK) 15. NOKC (Norway) 16. SDU (Denmark) 17. SSD/MSOC (Malta) 18. THL (Finland)

Collaborating partners 1. AETSA (Spain) 2. A Gemelli (Italy) 3. AMPM (Slovenia) 4. CAHTAR (Spain) 5. DSI (Denmark) 6. IRF (Denmark) 7. KDTD (Turkey) 8. REGLOM-DSAN (Italy) 9. RIZIV (Belgium) 10. SNHTA (Switzerland) 11. SLOVATHA (Slovakia) 12. TLV (Sweden) 13. UETS (Spain)

WP Objectives The objectives of WP5 (as defined in the EUnetHTA Grant Agreement 2010-2012) are:

• Development of HTA tools and methods: Improved relative effectiveness assessments (REA) by identifying areas where methodological guidance is needed and by providing it, suggesting ways to integrate REA of pharmaceuticals as a special version of the HTA Core Model;

• Application and field testing of developed tools and methods: a REA of (a group) of pharmaceuticals in line with the core HTA development.


• Initiation of background review • Initiation of rapid model (rapid technology assessment of relative

effectiveness of pharmaceuticals)


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• Initiation of full model ( full technology assessment of relative effectiveness of pharmaceuticals)

• Initiation of methodological guidelines


Milestones 2010: • M1: Meeting in Diemen >> Completed, minutes and presence list

submitted to secretariat • M3: Finalisation of work plan for WP5 >> finalised and adapted for

stakeholder involvement in November 2010 • M11: Meeting in Paris >> Completed, minutes and presence list

submitted to secretariat • M12: 1st WP interim technical report >> submitted to secretariat on

January 2011 Milestones 2011: • M14: Release of 1st version of Rapid model and Full model >>

draft versions are ready (except for ethical domain), WP5 consultation is ongoing. Release expected to be according to plan.

• M14-15: Choice of topic for pilot. Topic selection to be initiated at beginning of February 2011. Subscription of AP’s and CP’s to pilot is ongoing. Consultation for topic selection (EMA and SAG) planned for March 2011.

• M16: Start of pilot reports. • M18: Meeting in Oslo >> planned for 9&10 June 2011 • M18: Release of 1st vesion of guidelines • M24: 2nd WP interim technical report >> to be initiated in

December 2011 Deliverables (2010-2012):

• A methodological guidance that will be appropriate for the assessment of RE of pharmaceuticals. It should consist of a tutorial that describes the fundamental principles of REA and a toolbox that can be used in daily practice for REA in standardized fashion >> first versions of model and guidelines are in development and should be ready in 2011. A pilot will be started in 2011 to test the first version of the model and guidelines.


• 2 face to face meetings with EMA in London in 2010 regarding adaptations of the EPAR

• Cooperation with LBI initiative on onco drugs • Poster presentation at ISPOR of preliminary results of background

review • Presentations:

o 2 presentations at HTA international (6-9 june 2010 in Dublin) o Presentation of preliminary SG1 results at initiative on onco

drugs (Vienna, 30 September 2010) o KCE workshop in Brussels (12 October 2010) o Presentation of preliminary SG1 results MEDEV meeting

(Brussels, 15 November 2010) o 3 presentations at ISPOR (Prague, 6-9 November 2010) o Presentation at CEESTHAC, Central and Eastern European

Society of Technology Assessment in Health Care (Krakow, 22-23 November 2010)


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Initiation of background review • Working manual was written and agreed upon

• Data abstraction form was completed

• Data abstraction for 26 out of 31 countries completed

• Report writing initiated

Initiation of rapid model (rapid technology assessment of relative effectiveness of pharmaceuticals)

• Domain teams were established

• Working manual was written and agreed upon

• Adapting of domains of HTA core model to REA of pharmaceuticals was initiated in June 2010

Initiation of full model ( full technology assessment of relative effectiveness of pharmaceuticals)

• Domain teams were established

• Working manual was written and agreed upon

• Adapting of domains of HTA core model to REA of pharmaceuticals was initiated in June 2010

Initiation of methodological guidelines • Working manual was written and agreed upon

• Literature searches and writing of guidelines was initiated in 2010

Meetings Face to face meetings:

• Diemen (NL), 21 & 22 Jan 2010, Finalisation of working plan, initiation of review phase

• Paris (FR), 18 & 19 Nov 2010, Presentation of concept results of background review. Discussion on development of concept text for models.

Emeetings • Nov 30, 2009: General WP5 e-meeting

• March 17, 2010: SG 1 emeeting, initiation of background review

• March 24, 2010: General WP5 e-meeting

• March 31, 2010: coordination/allignment of activities in WP4&WP5

• May 3, 2010: SG4, presentation approach.

• Jun 1, 2010: SG2&3, selection of domains and assessment elements

• Jun 24, 2010: SG1, update

• Oct 28, 2010: SG4, preparation of Paris meeting with focus on guidelines

• Dec 20, 2010: Overlap and consistency between the safety domain and the safety guideline


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Adherence to the Work Plan in 2010 • For the time being SG2&3 are working together on the rapid and full model

• During 2010, no deviation from the initial work programme set out in annex I to the grant agreement occurred.

Stakeholder and external expert involvement WP5 Stakeholder Advisory Group (SAG):

The stakehdoler involvement policy and procedures were developed during 2010 as a part of WP8 activities (see WP8 report). The WP5 LP and Co-LP provided continuous input in the discussions taken place as a part of these activities in WP8 (in consultation with the WP5 members). As a result of these developments, a WP5 Stakeholder Advisory Group (SAG) was formed. The overall coordination of the stakeholder involvement issues in EUnetHTA JA are done through the interaction between the stakeholder forum and the Executive Committee (facilitated by the EUnetHTA Secretariat) based on the agreed EUnetHTA JA stakeholder involvement policy and SOP. WP5 LP is responsible for the coordination of the work with the WP5 SAG (with facilitation of certain administrative tasks (eg, SAG member lists and confidentiality undertakings) by the Secretariat).

Members of the WP5 Stakeholder Advisory Group (SAG) were contacted in November 2010 regarding the timeline and practical details of the WP5 SAG working procedures, eg, the timing and procedure for the first request of feedback in 2011 (contact information, mode of response, concrete deadlines, etc). The following policy was defined:

‘WP5 invites Stakeholder Forum participants to appoint representatives with specific expertise into a WP5 Stakeholder Advisory Group (SAG). Each person participating in this group should have a clear mandate from the Forum participant. The mandate should be agreed between the Forum participant and the Secretariat and communicated to WP5 LP and Co-LP by the Secretariat. To ensure effective communication between the partners of WP5 and the SAG, the following feedback method should be used: if there is more than one representative from any given Forum participant, their feedback should be collated into one response, resulting in one response per Forum participant.

The number of representatives per Forum participant is limited to three; it is however possible to change the representatives during the course of the EUnetHTA Joint Action project (2010-2012) based on the expertise that is needed. This policy applies to situations where major feedback is sought on preliminary WP5 documents and activities.

The exact procedure is that we (contact person at WP5 LP) will send out the documents for comments to all members BY E-MAIL on a pre-specified date. We will also indicate the DEADLINE for feedback in this e-mail. As indicated before, feedback must be collated in one response (BY E-MAIL) per stakeholder forum participant. Due to the tight timelines we can not accept feedback that is sent in after the DEADLINE.

Relevant comments of the SAG members will be systematically listed and addressed in a separate document. This document will be send to all the WP5 SAG members latest on the date of the start of the public consultation.

Additionally, all SAG participants have to sign a confidentiality agreement that will be sent to you before the first question for feedback. A signed agreement is essential for participation in the SAG.’

The exact consultation date for the background review was communicated in December 2010. Expert involvement:

Experts on specific methodological issues were involved in the development of the methodological guidelines.

3. Work Plan for the next period (2011) No deviations from the original 3-year Work Plan are foreseen in 2011.


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Background review • WP5/SAG/EMA consultation will start on 24 January 2011

• Public consultation will start on 7 March 2011

• Report to be completed in May 2011

Rapid model (rapid technology assessment of relative effectiveness of pharmaceuticals)

• WP5 consultation of draft documents started on 7 January 2011

• First version to be ready at end of February 2011

• Topic selection for pilot to be started in 1 February 2011

• SAG/EMA consultation of topic selection to be stated on 1 March 2011

• Searches and writing of pilot reports to be started on 1 April 2011

• WP5/SAG/EMA consultation of pilot reports will start in December 2011

Full model (full technology assessment of relative effectiveness of pharmaceuticals) • WP5 consultation of draft documents started on 7 January 2011

• First version to be ready at end of February 2011

• Topic selection for pilot to be started in 1 February 2011

• SAG/EMA consultation of topic selection to be stated on 1 March 2011

• Searches and writing of pilot reports to be started on 1 April 2011

• WP5/SAG/EMA consultation of pilot reports will start in December 2011

Methodological guidelines • WP5 consultation of 1st version of guidelines will be started on 24 January 2011 and 14 February

2011.

• SAG/EMA consultation will be started in April 2011.

• First version of guidelines should be ready by June 2011

Meetings



June 9-10 2011 (M18)

Oslo (NO), 2 days Leads, APs and CPs

Presentation of final results of background review and concept Rapid model and Full model.

Stakeholder and external expert involvement Consultation of SAG in 2011: • draft background review (M13); • selection of pharmaceuticals for the rapid and full REA model (M14); • concept guidelines (M16). • results of the pilot experiments (M24); Specific product assessments (pilot experiments)


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WP5 will consult the manufacturers of the specific products that will be part of the pilot experiments for the rapid and full model. The consultation of the timing is simultaneously with the feedback of the SAG on the results of the pilot experiments (M24). Expert involvement: Experts on specific methodological issues are involved in the development of the methodological guidelines.

Cooperation with other WPs / LPs There will be close collaboration with WP4 in order to avoid important differences between other core HTA models and the REA model of pharmaceuticals. As REA model will be included in the online tool, it should not deviate too much from the other models.

Gantt chart (2010&2011) Details M1 M2 M3 M4 M5 M6 M7 M8 M9 M10 M11 M12 M13 M14 M15 M16 M17 M18 M19 M20 M21 M22 M23 M24 Meetings (f-t-f)

Communication1

Work plan Literature search (back-ground review) Data abstraction (background review) incl targeted queries Report on background review SAG PC Publication on background review Rapid model Pilot Rapid model 2 SAG2 SAGPublication on Rapid model Full model Pilot Full model 2 SAG2 SAGPublication on Full model Guidelines on methodological issues SAG Symposium Final report

4. Appendices Overview of appendixes:

Appendix 1. Minutes and presence list of face to face meeting in Diemen (NL), 21 & 22 Jan 2010

Appendix 2. Minutes and presence list of face to face meeting in Paris (FR), 18 & 19 Nov 2010

Appendix 3. ISPOR poster of SG1 results

1 including telephone and emeetings 2 Selection of pharmaceutical (s)


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Appendix 1 Minutes and presence list of face to face meeting in Diemen (NL), 21 & 22 Jan 2010

Minutes WP5 meeting: 21 and 22 January in Amsterdam

Present: Bogusława Osińska: AHTAPOol (Poland), Thirstrup, Steffen: IRF (Denmark), Rdzany, Rafal: AHTAPOL (Poland), George, Elisabeth: NICE (UK), Orsolya, Nagy: ESKI (Hungary), Belen Corbach: AETSA (Spain), Blasco, Juan Antonio: UETS (Spain), Folino Gallo, Pietro: AIFA (Italy), Rossi, Bernardette : SSD (Malta), Behmane, Daiga: MPRA (Latvia), Almazán, Cari : CAHTAR (Spain), Casteele, Marc Van de : RIZIV (Belgie), Anna Buscics : HBV (Austria), Iris Pasternack (TLV/FINOHTA), Meyer, François; HAS (France), Rüther, Alric: IQWIG (Germany), De Laet, Chris: KCE (Belgium), Bidino, Rossella Di : A Gemeli (Italy), Paladio, Núria : CAHTAR (Spain), Marianne Klemp: NOKC (Norway), Rosário Trindade: INFARMED (Spain), Flattery, Martin: HIQA (Ireland), Mertens, Raf : KCE (Belgium), Vondeling, Hindrik: CAST (Denmark), Heiner Bucher: SNHTA (Switzerland), Anne Dandon (HAS), Wim Goettsch (CVZ), Sarah Kleijnen (CVZ)

General minutes

Thursday, 21 January 2010

4.30 pm: Introduction, including general introduction on work plan • No comments on work plan • Question raised: The EMEA is now under the authority of DG Sanco (instead of DG Enterprise).

How does this influence WP5? The question has been asked to the EU commission and it seems that at that point there will be no real impact. Connections to DG Sanco existed before the shift from DG Anterprise to DG Sanco.

• Subgroups: all participants indicated their preference for the 4 subgroups (SGs). Based on these preferences the SGs were formed. Involvement in a specific SG during the WP5 January 2010 meeting does not determine involvement in SG after the meeting.

6.00 pm: Diner

Friday, 22 January 2010

9.00 am: introduction • There was some discussion on definitions (which to use) and whether SG 2 & 3 should be

integrated into one SG. Therefore is was agreed that the SG sessions would start with a session of one hour in which the SGs could come up with relevant starting point questions to be discussed in a general session at 10.30 am. This would provide the opportunity to continue the SG sessions at 11.00 am with a clear idea of the definitions to be used. During this first session SG2 and SG3 joined up.

9.30 am: first SG session • See SG specific minutes.

10.30 am: general discussion on starting point ‘issues’ of SGs • See SG specific minutes. • Initially SG 2 and 3 will be fused, if further on needed they will be split. The members of SG2 will

focus on rapid review (speedy evaluation of a single technology) and the members of SG3 will focus in full reviews (actually defined as everything that is not a rapid review).

• It was agreed that the definitions of the pharmaceutical forum are the official definitions to be used in WP5.

11.00 am: second SG session • See SG specific minutes

12.15 am: lunch

1.00 pm: presentation of results of SGs and final general discussion. • For presentation of results see SG specific minutes.

General conclusions of the Diemen meeting

The meeting of the WP5 in Diemen has allowed the following conclusions: • Consensus is reached on precise definitions of STA/MTA, efficacy, effectiveness, relative

effectiveness and remind exclusion of the scope of cost-effectiveness assessment. STA=Single


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and rapid drug assessment, MTA= all other kind of assessment (for one or several drugs in the same indication for a longer time). New names will have to be adopted for STA and MTA as these abbreviations do not capture the definitions agreed upon. For the definitions of efficacy, effectiveness, relative efficacy/effectiveness the definitions of the pharmaceutical forum are adopted.

• Challenges can be expected with extrapolating efficacy data into effectiveness data: at the time of rapid single assessments of drugs, there is only efficacy data. The assessment of effectiveness needs extrapolation from these data to real life.

• Challenges can be expected with regards to what we want and what’s possible to assess. • Coherence within subgroups is required • Main goal of the members: to define tools and guidelines that are feasible to use and are

applicable in our different countries. • On a practical point of view: Initially SG 2 and 3 will be fused, if further on needed they will be

split. The primary focus of SG2&3 will be on STA as the products for these type of assessments have the highest priority.

Stakeholder involvement

Stakeholders should be included in the WP5 in accordance with the rules defined by the stakeholder involvement policy. Furthermore some of them (such as pharmaceutical companies for example) are obviously needed as actor of some parts of the WP5 and others should be included as witnesses of the work in progress. This will be defined according to specificities of the WP5. The suggestion should be approved by the executive committee and then to be suggested to the forum.

Timeline of workplan:

Workplan will be adaptated based on the comments during this meeting, adapted version will be sent to all participants in February, comments to the provided in the beginning of March, final verion of workplan ready before end of March.

>> this timeline has changed: The adapted version will be send to all on 3 March 2010. Comments to be provided by 21 March. Emeeting to discuss comments on 24 March 2010 at 3pm.

In addition, on 3 March the workplan will be send to all EUnetHTA member organisations in a joint document that includes all workplans. Comment to be provided by 30 March 2010.

Finalisation of workplan: begin of April 2010.

SG specific minutes

SG1: Background review

Chair: Sarah Kleijnen

Participants: Elisabeth George (NICE), Orsolya Nagy (ESKI), Boguslawa Osinska (AHTAPOL), Rafal Rdzany (AHTAPOL), Steffen Thirstrup (IRF)

Friday morning session:

During the morning session, the main task was to agree on the definitions to be used to ensure consistency among subgroups.

As for the definition of Relative Effectiveness Assessment (REA), the definition of the Pharmaceutical Forum was accepted, as a practical and appropriate starting point.

After considering the possibilities to narrow down the scope of health technologies to be assessed for the background review, according to their degree of innovativeness (new drug vs generic, biosimilar),


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date of licensing, price or budget impact; it was decided that all of the definitions are problematic, so the focus of the WP5 will be on pharmaceuticals without any further restrictions.

After clarifying the definitions, the list of discussion items were answered.

Discussion items: 1. What is the purpose of the review?

The purpose of the review is to provide data on pharmaceutical technology assessment and REA methodology, with special focus on using REA in reimbursement decisions. SG1 will establish status quo, set the scene for the Subgroups.

2. What information do we need from the background review

a. Overview of available data

See question number 3.

b. Comparison of methodologies

See question number 3.

c. Most appropriate steps for the REA within EUnetHTA and proposition of tools for common process.

It was agreed that the most appropriate steps and the propositions will emerge later from the review based on the above mentioned data.

3. Per country, which data should be gathered?

a. Description of the national assessment systems of REA

I. General introduction to the national health system, including regional-national structures, health insurance, decision making, etc

(Action: Orsi to compile a short list of relevant questions for discussion)

II. REA (this list is just a first start and is not an exhaustive list of items to be determined per country)

• Is REA carried out in your country? • If yes, is it used in clinical decision making, reimbursement decision-making and/or

for pricing? • How is relative effectiveness defined? • What is the comparator (placebo, standard care)? • How is the comparator identified (by experts, consensus and/or guidelines)? • How effectiveness is defined (based on clinical trial data or experience in usual

clinical practice)? • If short term clinical data is used, is it extrapolated to reflect the long-term effects? • How are the endpoints selected? • Is the balance of benefits to harms expressed quantitatively (ratio) • Are benefit and harms integrated into one outcome measure such as the QALY(? • How is the benefit – harm ratio weighted? • If benefits and harms are not integrated, how is a decision made about the balance

of benefits and harms. • What is the primary source of the assessment (for example the manufacturers report,

guidelines or literature sources)? • What other sources of evidence are used? • Is the evidence underpinning the assessment and any relevant reports made public?

b. Identification of advantages and weaknesses per system

It was agreed that instead of identifying the advantages and disadvantages, the overall aim is to provide options, tools and raise awareness about the differences in the assessment systems used. 4. Which European countries should be included in the review?

All EU member states and participants of EUnetHTA should be included in the review. 5. Which non-European countries should be included in the review?

The following countries should be included:


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USA, Canada, Australia, New Zealand

(Action: Elizabeth to look for sources of information)

An additional benefit of including these countries (especially USA) is the opportunity to raise awareness of the activities and achievements in the field of HTA in Europe.

If information is available and it is feasible within the deadlines, Asian countries (e.g. Japan, India) can also be considered for inclusion.

6. Which other international actions should be taken into account?

As listed in the workplan. Vancouver group should be included among stakeholders

7. Primary Sources to be used as presented in the Workplan: • ÖBIG country profiles (http://ppri.oebig.at/index.aspx?Navigation=r|2|1-) • Pharmaceutical Forum questionnaire: contains information on REA. It is not in the public

domain, however. Should be explored if we can use the raw data, to avoid duplication; or we can only use the questionnaire as a checklist.

(Action: Sarah to distribute available material) • PhD on health system - mentioned by Steffen

(Action: Steffen to check if it PhD is available) • ISPOR website: contains short background information on the countries’ health system • WHO reports • Input from the national agencies

(Action: Boguslawa and Rafal to look for further sources to be used)

Methodology 1. Clarify concepts

It can be assumed that not all countries that assess relative effectiveness use the term itself. The local terms need to be interpreted and a list of keywords that capture the concept of REA have to be compiled based on the review of literature. 2. List of issues (questions) to be included in the review (see before) 3. Create a database

Considering the structure of the data, an Access database might be more useful. However, it requires more specific skills than Excel.

The system has to allow for comments (‘Yes, but’ type of answers).

Once the table is created, the members of the SG’ need to pilot the questions on their own countries. 4. Search for information in the available resources for the defined issues for each country

To ensure quality, the work of two independent reviewers may be needed. This may also be a prerequisite for publication in a peer-reviewed journal; however, it doubles the workload. The relevant institutions will have the opportunity to check their country profile, which also adds to the quality of the research.

(Action: Elizabeth to discuss with Finn the need for two researchers) 5. Compliment information from a short, targeted questionnaire from the national agencies. The

questions should be standard, but the number of items will vary according to the institution, depending on the open issues.

6. Compile draft review 7. Circulate among national agencies. The involvement of EUnetHTA representatives should

ensure the timely and detailed response.

Cooperation within WP5:

Among all the SGs, cooperation with SG4 is the most crucial; before sending out the questionnaire, SG4 should let SG1 know their priorities so that they are included in the questionnaire (if not found in the literature). After the review is finalised, the most important emerging issues will be referred to SG4, who can discuss the methodological implication and offer suggestions.


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SG2: Rapid assessment

Chair: Wim Goettsch

Participants: Belen Corbach, Juan Antonio Blasco, , Pietro Folino Gallo, , Bernardette Rossi, Daiga Behmane, Cari Almazán, Marc Van de Casteele, Anna Buscics.

The particular focus of the subgroup of the rapid assessments was to discuss the questions as were stated during the introduction on Friday morning. Due to the limited timespan of the discussion the subgroup especially discussed the role of the EUnetHTA core HTA in the development of a model for rapid assessments.

Question 1: Do we assess relative effectiveness or relative efficacy in these rapid assessments within a limited period of time? It was discussed in our subgroup that ideally we want to assess relative effectiveness in our rapid assessments. However, at the timepoint of the assessment just after market authorisation, mostly only data from clinical trials are available, which give only information on relative efficacy. Nevertheless, on basis of experience with similar pharmaceuticals in real life, in most countries these relative efficacy data for a new pharmaceutical may be often used to estimate the relative effectiveness for this new pharmaceutical.

Question 2: Which domains of the core-HTA must be used in the STA version of the relative effectiveness assessment of pharmaceuticals? Most important domains are clinical effectiveness and safety, but also health problem and current use of technology are very relevant for this assessment. Costs and economic evaluation are also important, but is currently no part of the EUnetHTA assignment on relative effectiveness assessment of pharmaceuticals. So, this domain will not be taken into account in this assessment. Other domains such as ethical analysis, organisational aspects, social and legal aspects may also be relevant but very context specific. Specific issues and/of topics of these domains may be taken into account in this assessment.

Question 3: Which topics of the included domains of the core-HTA are the most important in this STA assessment? The subgroup discussed the topics within the different domains, criteria that were used in the discussion were importance/relevance; can it be assessed internationally and can it be assessed within 90 days. • Health problem and current use of the technology:

o Target condition is very relevant, can be assessed internationally and within 90 days. Specific comment was made on the inclusion of ATC coding within this topic;

o Utilisation of the pharmaceutical is also very relevant, although it may differ between countries this information should be assessed internationally because a comparison between countries may provide valuable information. It may be assessed within 90 days. Specific comment was made that in a lot of cases the new pharmaceutical is not used yet, but that we are interested in estimations on how much the new pharmaceutical is going to be used.

o Current management of the condition is also very relevant, can be assessed internationally and within 90 days. This relates to the comparative treatment.

o Regulatory status is also very relevant, can be assessed internationally and within 90 days. Although it may differ between countries this information should be assessed internationally because a comparison between countries may provide valuable information.

o Life cycle and other were found to be less relevant for our rapid assessment. • Safety:

o Identification and assessment of harms is very relevant, can be assessed internationally and within 90 days. Specific comment was made that it was very important to analyse the individual harms.

o Summary of impact (outcomes) of harms is also very relevant, can be assessed internationally and within 90 days. This is actually the summary of the first topic, also is the impact of possible side-effects on morbidity, mortality and quality of life assessed.

o Minimisation of harms. Although relevant, this topic relates mostly to precautionary statements. This can be assessed internationally and within 90 days

o Comparison of alternative technologies. We believe that this comparison to alternative


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technologies is not a specific topic but should be a part of the total assessment over all domains.

o Environmental safety seems to be less relevant • Clinical effectiveness

o Mortality is also very relevant, can be assessed internationally and within 90 days. o Morbidity is also very relevant, can be assessed internationally and within 90 days. o Function and HRQL is also very relevant, can be assessed internationally and within 90 days.

Specific comment was made that there were no questions on surrogate endpoints in the specific topics and that it may be useful to add a topic on these endpoints in this domain. Also the assessment of a possible relation between this surrogate endpoints and mortality, morbidity, function and HRQL should be added to this topic

o Patient satisfaction was judged as of less importance. • Costs and Economic evaluation

o We did not discuss this domain in detail because it is not a part of our assignment • Other relevant topics in the other domains

o Is the technology a new, innovative mode (ethical analysis). This is relevant, can be assessed internationally and within 90 days.

o Is the technology used for patients that are especially vulnerable (ethical analysis). This is relevant, can be assessed internationally and within 90 days. This may relate to the subgroup analysis but also valuation of disease severity.

The subgroup indicated that this first assessment of domains, topics and issues is not complete and that we need to do a more detailed analysis of the topics and issues in the domains as part of the work for this rapid assessments.

The other questions were not discussed due to the limited time available for discussion.

SG3: Full assessment

Chair: Iris Pasternack

Participants: Rossella Bidino, Juan Antonio Blasco, Chris de Laet, Franςois Meyer, Núria Paladio, Alric Rüther

During the dinner on Thursday 21st:

Active discussion on precise goals, scope and naming of the models we want to develop and about concepts. What is really included in a STA and an MTA? This issue was finally discussed and agreed upon during the morning discussion (Jan 22nd) with SG 2 and 3 together, and afterwards in the plenary group.

At the meeting on Friday 22nd,

About the other dinner questions that were left untouched by WG 3 because of the previous discussion:

What do we want to achieve • One (full) core drug model + one (full) core drug HTA pilot • Intensive collaboration or even fusion of subgroups 2 and 3 • Intensive collaboration with WP 4 • Proposal to work online on the WP4 system (HTA Core Model online), or through Info

Management System developed by WP 6 • Final achievement: willingness by (x) agencies to use system for drug HTA project

Questions asked on Friday 22nd for the ‘full’ model (formerly known as MTA)

Timeline in lifecycle: this depends upon societal demands and available evidence when revision is considered necessary.

Optimal duration: as short as possible but maximum 1 year.

Questions that correspond to questions for WG 2, but answered from WG3: 1) What do we assess? Both relative efficacy and relative effectiveness


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2) Which domain must be used for this (full) assessment? All, but not necessarily all topics, and

some topics or issues should be added 3) Which topics could be excluded, what is the transferability of topics (items 3-7)? We did not go

into details because these should be assessed at issue level during development of the model. Other topics and issue might need to be added.

Specificities for (full) model? Instead of full model specificities we would like to turn the question around and ask which slimmed down specificities are needed for the rapid model. During the morning session it was agreed that the rapid model should be a subset of the full model, whatever the name.

About names of the drug application of the HTA Core Model

We took some extra time to propose names for both applications • We propose to rename the former STA: either Rapid Assessment of Drugs (RAD), or Rapid

Assessment of Pharmaceuticals (RAP) • We propose to rename the former MTA: either Assessment of Drugs (AD) ), or Assessment of

Pharmaceuticals (AP)

SG4: methodological issues

Chair: Anne d’Andon

Participants: Marianne Klemp, Rosario Trindade, Martin Flattery, Raf Mertens, Hindrik Vondeling, Heiner Bucher and Anne d’Andon, representing respectively Norway, Portugal, Ireland, Belgium, Denmark, Switzerland and France.

1) Questions asked: 1. Methodological issues

i. Is the list of methodological issues comprehensive? ii. What would be the rational for prioritization these methodological issues? iii. On which criteria are we going to chose the most important ones for inclusion in

WP5? iv. How can we get additional data on the other methodological issues? v. Which ones can be described within the limitted period of time of this WP? vi. Are there common steps, method, criteria for the validation of EU concept

guidelines? 2. For each methodological issue

i. Are the scope and the questions appropriate? ii. Is there existing national/international concept guidelines?

a. Question to be included in the survey? iii. What are the specificities of each methodological issue for STA and MTA

2) Conclusions

The list of methodological issue has been reviewed, additional subjects considered and regroupment of the effective issues that the members of the WP5 will effectively work on and define guidelines. The regroupment takes into account prioritization defined according to 2 criteria: needed and feasible at a common level.

Regroupment of methodological topics for which the WP5 will provide guidelines has been done. Even if the different methodological topics have been regrouped, each of it will be the subject of a guideline.

1- Comparator and comparisons • Criteria for choice of the best comparator(s). All kind of comparators will be considered: either

drugs and medical device or other procedures (surgical, dietetic, …) • Methods of comparison • Direct and indirect comparisons


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2- Outcomes • Patient relevant outcomes • Clinical outcomes • Surrogate markers • Quality of life outcomes • Safety • Composite end-points

3- Level of evidence • Internal and external validity • Grading confidence in experts and experience • Extrapolation from efficacy results to real life situation (effectiveness). The difficulties to

extrapolate from efficacy (clinical trial results of a new drug for its first -and probably single and rapid- and early assessment before launch on the market) to effectiveness have been underlined. Hypothesis, sensitivity analysis will have to be performed for effectiveness assessment. Or specific post-marketing studies will have to be required.

Sources of document can come from different countries and contribute to these different guidelines. Question within the survey should include questions about whether countries have studied and written a report on one or more of these methodological topics. Some topics could be subcontracted.

These guidelines will have several transversal dimensions: specificities according to Single and/rapid drug assessment or other kind of drug assessment, Consideration of the drug as a whole with its dose(s) and its mode(s) of administration and Consideration of the value of assessment analysis.

Additional guidelines could be described: • item to be taken into account for identification of costs specific to drugs for cost-effectiveness

assessment, if time is available • social, ethical, legal dimension will not be integrated for feasibility reasons on a common to

Europe point of view.

Calendar: guidelines should start after the European survey and be set up before the pilot assessment, after integration in the core models. Elaboration of guidelines for usual topics such as criteria for the best comparator or surrogate markers can already start.


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Appendix 2. Minutes and presence list of face to face meeting in Paris (FR), 18 & 19 Nov 2010

Minutes WP5 meeting: 18 and 19 November 2010 in Paris, France

Presents:

Belén Corbacho

Mercedes Martínez Vallejo

Rossella Di Bidino

Bogusława Osińska

Rafał Rdzany

Pietro Folino Gallo

Núria Paladio Duran

Hindrik Vondeling

Sarah Kleijnen

Wim Goettsch

Nagy Bence

Finn Børlum Kristensen

Pertti Happonen

Iris Pasternack

Alexander Eisenmanname

Anne d’Andon

Mira Pavlovic

Pauline Vitré

François Meyer

Martin Flattery

Anna Bucsics

Hans Seyfried

Rosário Trindade

Heiner Bucher

Volker Vervölgyi

Chris De Laet

Maïté Le Polain

Christian Léonard

Antra Fogele

Marjetka Jelenc

Elisabeth George

Carole Longson

Marianne Klemp

Jean-Christian Krayenbuehl

Marc Van de Casteeleame


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Bernardette Rossi

Lisa Landerholm General minutes

Thursday 18 November 2010

Welcome

2.00 pm: Introduction, including presentation of the two days agenda • The aim of the meeting is reminded. It is to check whether the WP5 for each if its tasks

(background review, core HTA models and methodological guidelines) is in the right track. • It is not to decide on all matters but more to reorient if necessary our different tasks. • It has been emphasized how much work has already been done and how much we have to thank

all the involved agencies that performed this work

Presentation and discussion of background review results (SG1) (Sarah Kleijnen)

Specific comments/discussion:

Slide 6. By 18 Nov the data abstraction was completed in 21 countries (USA and Denmark have been completed during this week). There are problems with finding contacts for Cyprus, Estonia, Lithuana and Romania.

Slide 9. It was discussed that a positive/negative reimbursement list for pharmaceuticals does not mean that these are based on HTA. Especially for negative lists. These are often a general list of specific types of pharmaceuticals (e.g life style drugs, over the counter drugs). There is no positive or negative list in Spain.

Slide 11. The high percentage of countries who indicate cost-effectiveness as criteria does not correspond with slide 14. It was asked what the difference is between value for money and cost-effectiveness. Indeed there can be an overlap of these criteria as they were not specifically defined. It was asked whether age can be a specific criterion. This has not been mentioned as a criterion so far.

Slide 13. The purpose of the graph on the assessment is a bit confusing. The percentage of countries that perform STA/MTA for reimbursement purpose is 100%. The results surprised some members: as it was a question oriented to HTA agencies that perform reimbursement evaluations, the response is obviously 100%.

Slide 14. Does everybody understand the same things behind the slide 14? Benefit/risk assessment for example has not been defined. So the answer is provided based on the interpretation of the countries. It was noticed that there seems to be quite a bit of difference in how these terms are interpreted. It was remarked that it will be very difficult to value the outcome if we do not have definitions.

Slide 15. It was asked whether a FDA report is considered as a publication. Yes it is: if it is publicly available than it is considered as a publication.

Slide 16. This graph is a good example of the differences seen are about wording and maybe less about content. Whereas the answers seem diverse (best possible, best standard and other) if you look closely at the definitions of the individual countries they mostly define the comparator similar to ‘usual current practice’.

Slide 17. It was asked whether it could be odd that generic QoL instrument are less accepted than disease specific. It was reasoned that this is logical as this is the methodology for the therapeutic value assessment. Methodology for cost-effectiveness have not been researched in this survey as cost-effectiveness is out of the scope of WP5.

General discussion:

It was asked whether the results will be validated as there seems to be confusion about the definitions. The countries will indeed be asked to validate the results during the WP5 consultation.

It was noted that we should look at some inconsistencies in the results and maybe go back to the countries to clarify. If this is possible, this could be an option, however with the timelines this seems to be very difficult. Maybe the WP5 consultation could be accompanied by specific questions to clarify.

It was concluded that the data are raw preliminary data that we have to cross check. The data gathering is country based which mean we are on the right way for implementing the work.


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Background on core HTA model (Iris Pasternack)

It was emphasized that as the purpose of the model is to be shared for different technologies the text should be as generic as possible. Especially if you look at the online tool in development. There is a generic text that applies to all technologies and then specific sections that apply to specific type of technologies (e.g. pharmaceuticals). it was also said that if there is deviation from the generic model, it should be justified how and why it is done.

Presentation of concept I-REAP and C-REAP (Wim Goettsch)

Slide 6. By 18 November the reviewing of the methodology text for the safety domain was also finished as well as partly for the HPCU domain.

General discussion:

It was asked how other Core models have dealt with the benefit/risk assessment. It was indicated that this indeed is/has been a problem in the other models as well. No solution has been proposed yet, so a proposal is very welcome. It was suggested that benefit/risk assessment might be a subject for a guideline however it was felt that this is the role of EMA for MA purpose. In addition there has to be a clear separation of what assessment is and what is weighting. It was suggested that the existing guidelines on outcomes can maybe partly address this topic.

It was asked whether there will be a consultation of WP5 members of the draft models. Within the current timelines this is not foreseen. After the meeting in Paris it was decided that there will be an opportunity in January 2011 for other WP5 members to review the domains.

It was asked to clarify if REA models are about specific elements or if whole domains are selected. It was indicated that all domains are included (except cost-effectiveness) for now but that specific elements are selected.

There was a discussion on the acronyms. Should we use I-REAP and C-REAP? It was agreed that they are not easy terms and that for now it should be preferred to name them the Rapid and Full model for assessment of Pharmaceuticals and that this can be reassessed in a later stage. It was indicated that at ISPOR the word model has not been very well understood (sounds like ec modeling), however as the Core model is even a registered name in Pubmed and more and more known for what it is this can not be changed.

Presentation of guidelines (Anne d’Andon)

This presentation focused on the current conclusions of the 12 subjects of methodological guidelines.

The objective was to see how far we should go with recommendations, to see if the first conclusions of recommendations are fitting with what we await (not too loose, not too precise).

It has been underlined that definitions are very important (proposition of glossary).

Presentations of the subjects:

- Criteria for choice of the best/most appropriate/most pertinent comparator (E. George)

- Methods of comparison (A. d’Andon on behalf of NOCK)

- Direct/Indirect comparisons (R. Dibidino)

Comments: Concerning indirect comparisons, it has been suggested to consult ISPOR guidelines. Question: Do we need to make hierarchy between direct and indirect comparison? This will be discussed and answered during the parallel session of sub-group 4.

- Clinical outcomes (A. d’Andon on behalf of HIQA)

Comments: Are these guidelines for trial makers or for REA? A distinction is needed between what is needed for an appropriate trial elaboration and what is the method for HTA. An ideal list of what we should find/ what is mandatory/a sort of check list has been suggested. Questions: But what to do if there is no ideal data? How to deal with what we have in assessment practice? These guidelines do not aim to be cook books. We also can have different conclusions with the same information. How to critically review? Discussion occurred on the impact of industries on the guidelines. We have to be transparent and coherent, separate generation of evidence and recommendations.

- Surrogate markers (A. d’Andon on behalf of NOCK)


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Comments: The recommendation would be not to use surrogate markers if there is an alternative.

- Composite endpoints (A. d’Andon on behalf of FINOHTA)

Comments: There is a problem when a given patient experiences several of the endpoints of the composite end-point.

- Patient Relevant Outcomes (J.A Blasco)

- Quality of life (M. le Polain)

Comments: The clinical outcome includes QoL, but QoL also belongs to Patient Relevant Outcomes. The scope of the guidelines have to be discussed and definitions have to be given first.

- Safety (P. Folinio)

- Internal validity (H. Vondeling)

- External Validity & Extrapolation from efficacy results to real life situation (effectiveness) (R. Trindade)

- Grading confidence in experts and experience (A. d’Andon on behalf of REGLOM)

Comments: A database of experts and their level of evidence for specific areas of expertise has been suggested. It is answered that this is not the aim of these kind of guideline

General comments: there are relevant articles and guidelines from ISPOR, Cochrane that can be used. Question: Due to time constrains, how far we should go? Do we need more guidelines (harms/benefits)? A discussion about Benefices/Risks occurred; limited measure is judgment: we have to present data in order to support judgment. Overlaps and links between guidelines and domains have also been addressed.

How the guidelines could also be incorporated in the assessment of other technologies? Is it necessary to develop other guidelines for other type of HTA?

Friday 19 November 2010

Wrap-up of day 1

SG1: a last check will be organized. Data looks different but are quite similar.

SG2&3Core model: discussion about the name “core model”.

SG4: We have to keep in mind for who the guidelines are made: clinical trials makers or RE Assessors? The way how to make recommendations have been discussed. The feasibility depends also of our objectives.

Cooperation with EMA (Wim Goettsch)

It was indicated that EMA is willing to adapt its methods however that to a certain extend it is also constrained to European legislation. It was also asked if we could ask EMA for updates results. Again it was mentioned that EMA can only publish the EPAR, other data are confidential.

The idea was suggested to next year evaluate a number of EPARS and write a joint evaluation report with WP5.

Question: whether countries present different for the reimbursement evaluation (data that are not in the EPAR). This indeed seems to be the case. It may be worthwhile to address this in the background review. Members underlined that a drug can be granted MA but not reimbursed in some countries. It may be a good idea to gather real life examples of these.

Presentation of stakeholders and experts involvement (Wim Goettsch)

Slide 3. There was a specific request from industry to be actively involved in WP4, 5 and 7. As a result the SAG was formed which will be involved in the work as some type of experts who will be consulted (probably in parallel with the WP5 internal consultation) before the public consultation. Their comments will be addressed in a joint response which will be formulated to the SAG members regarding their relevant comments. This document should be available before the public consultation. It was questioned whether the response will be discussed within WP5. This will indeed be done, most likely


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Minutes WP5 meeting: 18 and 19 November 2010 in Paris, France through email.

Slide 4. It is considered relevant that experts from the academic world are involved as well. Therefore they are already involved in SG4 where they function as reviewers of the documents.

General discussion:

It was emphasized that it is important to give the WP5 member as well as for the public consultation enough time to review the product so their organizations can also have a look at them. One month sounds short for effective comments. The FDA for example has 1 year of review. It was answered that the products of WP5 have a very different status than docs by FDA or EMA. Secondly, there are several moments in the project to comment on the same product. We need to work with pragmatic solutions. It was suggested that the dates will be communicated very timely so the organizations can anticipate. However, the consultation period can not be stretched within the timelines of this project.

It was asked how the SAG will be referred to in the products (as authors?). It will only be mentioned in general that the SAG has been consulted (no specific names).

Time investment

Before the group splits in parallel sessions there was a discussion regarding the time investment for WP5 by participants. On one hand there is pressure for WP5 to move faster and there are high expectations of the quality of the products on the other, the lead and co-lead have received signals that the time by individuals to be invested in the project is very high. It was asked to all members how they have perceived the workload so far and how they (and their organizations) see their investment in the future. The perception of the workload varies among the members. For some it is a lot whereas for others it is manageable. It was concluded that there is a high willingness to participate but that it is difficult to find the time to be invested besides the day-to-day job. It is not always easy to find the support within the member organizations for the time investment.

The point was also raised that we should think about additional resources so we could hire additional capacity (subcontracting). Finally, it was emphasized that the current relatively intensive period is essential for the follow-up of the rest of the work package.

Pilots experiments (Iris Pastenack)

Based on the presentation provided by Iris on the previous production of reports within EUnetHTA the discussion started. Iris emphasized that scoping is essential for a coordinated coherent outcome considering that different teams are working on different domains. It is essential to have an exact minimum scope that each domain adheres to. Per domain, if this is relevant, it is possible to enlarge the scope but the minimum cope should always be the basis (and should never be shifted to a different scope).

The importance and transferability of assessment elements is not that straight forward to determine. Tough editing is required to have the outcome look like 1 report instead of different peaces with different styles.

Pilot planning (Sarah Kleijnen)

Presentation on the planning of the pilots within WP5 and topic selection has been made. WP5 members were invited to mention their ideas on topic selection. It was suggested that it might be efficient to have the same area for the rapid as well as the full model as you then have the same clinical problem for both reports. In addition it was mentioned that an oncology drug might not be preferable because these products are all included in therapeutic strategies that are complex. A drug for autoimmune diseases might be preferable. It was referred to an article on HTA topic selection in the Journal of clinical epidemiology. It was also mentioned that it might be a possibility to involve a manufacturer and have a dossier provided (fake or real). The WP7 database might be handy for the selection. If already 3 agencies are working on a specific topic these agencies can also provide potential authors. It would also be interesting to pick pharmaceutical shortly after MA as it would then be possible to compare the outcome to one of national agencies. However, this would be work outside of the current WP5 scope. All WP5 members are invited to send suggestions regarding topic selection to Wim and Sarah.

It was concluded that a short list will be provided to the WP5 members on which they can indicate which topic has their preference.


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Parallel sessions

SG1: background review chaired by Sarah Kleijnen and report by Belen Corbacho

During the parallel session for SG1 the SG members have gone into the details of specific questions of the survey to prepare the report writing. Per questions it has been discussed what relevant considerations are that should be described in the report. One of important conclusions will be that there is difference in perception of various concepts and definitions and a recommendation will be that it would be important to clarify this.

It was asked to the other WP5 members if there would be objections to mentioning specific countries in the text (outliers) of the report. This should not be a problems as long as we are certain that the country is quoted correct! In addition it was asked whether it would be a possibility to attach the raw data (tables) in the appendix. The WP5 members answered that this would be useful and transparent.

In addition, based on their own discussion, SG1 started a debate on whether all domains (except cost-effectiveness) should be included in the rapid and full models or maybe only the domains that really focus on relative effectiveness (HPCU, DCT, effectiveness and safety). There was a lively discussion. Some prefer to leave as much of the Core Model intact and give the opportunity during the actual production of a report to make a selection, whereas others are less convinced that elements of for example the legal and ethical domain are part of a relative effectiveness assessment. Some feel that the remit of WP5 is to look at relative effectiveness and if we include other domains that we are going outside of this remit. If we go outside of this remit this should be clearly communicated to the outside world. Others feel that there are certainly aspects in the other domains such as the social domain that should be part of a REA.

SG 2 & 3 chaired by Wim Goettsch and report by Anna Bucsics

General comments: • It might be possible to leave in many elements even for rapid assessment, but make them

optional. The need is often context-specific, so it may be feasible to say information is missing • Use the opportunity for cross-linking, e.g. organisational and safety • Edit text in tables, clarification field needs to be brief and specific, not pose further questions • Use reference field for further information • NOTE: the workroom documents can only be opened with Internet Explorer • Use the EUnetHTA toolbar, it makes access easier; however the toolbar cannot always be

installed, due to security issues

Health problem and current use of technology: • Straightforward • Minor modifications • All elements of the domain are important! • Methodology text just arrived, text was kept generic, further pharma-specific information would

be valuable

Description and technical characteristics of technology: • There are types of information which is often very important, but where to put it? • Further discussion is needed on which information on registries in the context of rapid

assessments • Need for additional evidence (e.g. registries) – put it in

Organisational Aspects – general: • Coordinated with WP 4 • Deleted screening-specific text • Added text about pharmacovigilance • Orphan drugs – relevant information? Context specific! • Aspect related to specific populations (e.g. elderly) not adequately addressed

Organisational Aspects - Companion diagnostics: • Companion diagnostics are becoming an important issue and need to be addressed • E.g. gefitinib is only effective in a subgroup of patients which need to be identified with a test

which is not widely available • link to effectiveness; assessment of diagnostic and therapeutic needs to be coordinated! • To be put into topic „management“ or process“

Legal Domain:


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Minutes WP5 meeting: 18 and 19 November 2010 in Paris, France • Coordination with WP 4 • Comments received will be added • Methodology text is available, but needs to be technically coordinated; • edit length of text – bullet point format • Generic and specific parts will be separated • Identify what is relevant for rapid assessment

Ethical Domain: • Seeking consensus on how to coordinate authorship and editing • This is a general problem, e.g. „wikipedia problem“ • WP 4 will deal with that…

Social Domain:

Wait for WP 4 model and adapt that to pharmaceuticals CVZ is lead

Economic Domain:

Will be left out, because it is not within the remit of JA 1

Safety Domain: • Consolidate text on methodology & guideline • It is extremely important to sufficiently link safety to efficacy, because pharmacodynamic

effects can not be seen as safety OR effectiveness issues only – they are both! • New drugs do not usually have adequate safety data; this means that evaluations need to be

revised

Clinical Effectiveness: • Domain was separated into smaller parts, due to lack of time of authors, so text needs

editorial consolidation • People involved in core model needed less time than expected • Some Methodology items are relevant for other domains too, those should switch to the

general Methodology text • What should be part of Methodology guidelines, the general Methodology-text ore the specific

Methodology text? • Specific Methodology text should be short, mostly links to the others

Pharma-specific Issues in Clinical Effectiveness: • Emphasis on clinical trials, especially for rapid assessment • Observational data and registries can add information about real life • Drug-specific issues need to be emphasized: dosage, compliance, etc. • Ongoing discussion on synthesis of wanted and unwanted effects into a term „added

therapeutic value“

Outlook:

The whole document – all domains – will be sent around and posted in the workroom for comment.

SG4 : Methodological guidelines chaired by Anne d’Andon and report by Hendrick Vondeling

The following topics have been addressed:

Definitions/Glossary

The importance of precise terminology has been underlined including the meaning of “patient relevant outcomes”. The SG4 thought that the term “outcomes relevant for patients” was closer to the definition. This subject is included in clinical outcomes and QoL but also focus on other specific outcomes. It has been reminded that there is a room for definitions in the template of the guidelines.

It has been proposed to elaborate a glossary: terms should be explicitly and clearly defined. (Among others: Biomarkers, surrogate, QoL). In order to elaborate this glossary, firstly previous documents elaborated within EUnetHTA/from EUnetHTA partners should be checked. Secondly, if some definitions are lacking, other sources should be considered, and lastly, if no definition is available, new one should be elaborated. Please send definition you are aware of.

Structure of each guideline

It has been underlined that the recommendations should be developed for REA, not for industry/clinical trials makers.

For each guideline, a general presentation has been proposed for the recommendation with: 1)


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Minutes WP5 meeting: 18 and 19 November 2010 in Paris, France statement of the ideal (formulate what we (assessors) expect to see in clinical trials, i.e. the best trial in the ideal world should be described as the “ideal” toward clinical trials should strive.)

2) comparison to reality/discussion : as we are not in the ideal world with perfect clinical trials, these guidelines should help assessors in answering “how do we deal when we do not have the fulfillment of the perfect clinical trials?”.

A proposition of structure of the recommendation of the guideline was:

o What is the material that should be used? o How to use the materials? o How the results should be presented? o How to interpret the results and critically assessed the evidence?

The group considered that as a pertinent suggestion and HAS will suggest a final structure.

The guidelines are not meant to design an hierarchy in the outcomes but rather to answer the question “how to deal with this (e.g. surrogate) outcomes?”. We need justifications and to be transparent.

The guidelines should be easily transferable; mostly experiences based and represent an aggregation of results.

Suggestion of architecture/ links between guidelines

An architecture has been suggested with an overall vision (“umbrella”).

1) The subject “Method of comparison” could represent a brief description (short umbrella) and then go through the subjects direct and indirect comparisons.

2) The outcomes guidelines could include a short introduction presenting the different type of outcomes and highlighting commonalities/divergences between them and what are the different outcomes expected to demonstrate.

The guidelines and their links would then be the following:

o Comparators and comparisons

Criteria for choice of the most pertinent comparator(s) Methods of comparison

• Direct comparison • Indirect comparison

o Endpoints Introduction

• Clinical endpoints o General o Focus: Surrogate endpoints o Focus: composite endpoints

• Endpoints relevant for patients (should mainly focus on what clinical endpoints and QoL endpoints do not cover)

• QoL • Unintended effects

o Level of evidence Internal validity External validity and extrapolation from efficacy results to real life situation Grading confidence in experts and experience

Discussion guideline per guideline

A discussion guideline per guideline took place.

It has been decided to rename “outcomes” by “endpoints”, the guidelines “Clinical outcomes”+“Surrogate markers”+”Composite endpoints” will be merged (cf plan). It has also been decided to rename “safety” by “unintended effets”. It has been discussed whether or not a guideline on “how we can weight benefices and risks” is needed. This subject had been considered on the scope of market authorization assessment and therefore not included in REA. “Patient relevant outcome” has been renamed by “endpoints relevant for patient”. We did not have time to discuss the topic “LoE”.


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Summary of meeting

Warm thanks.

We have learnt a lot and especially about the work already done and the previous experience and productions.

- Special emphasize has been made about integration of precise definitions and starting by the one already developed by EunetHTA.

- We have to stay on the perspective of REA. - Clarifications on consultations have been made (institutions, stakeholders, public). - Question rose: how far we should go? It depends of the choice of domains. - Integrations of guidelines in models has been discussed.


2011-02-28


2011-02-28

Appendix 3. ISPOR poster of SG1 results



EUnetHTA


YEAR 2010


2011-02-28


Work Package 6 – Information Management System


2010


2011-02-28

Contents 1. Overview ................................................................................................................................................. 4 2. Activities performed in 2010.................................................................................................................... 6

Meetings .......................................................................................................................................................... 6 1st Survey ........................................................................................................................................................ 6 Communication ................................................................................................................................................ 6 Members Only site ........................................................................................................................................... 6 Interoperability: Single Sign On, Common vocabulary, Common layout, Common meta data....................... 6 Planned and Ongoing Projects ........................................................................................................................ 6 Workrooms....................................................................................................................................................... 6 Training and support ........................................................................................................................................ 6 Interim technical Report and Financial Statement........................................................................................... 7 Supplemental activities .................................................................................................................................... 7

Site dedicated to Stakeholder forum ............................................................................................................ 7 Public site ..................................................................................................................................................... 7 Templates, procedures and policies............................................................................................................. 7 Social networks............................................................................................................................................. 7 Face to face meeting WP6 LP - CLP............................................................................................................ 7 Interoperability .............................................................................................................................................. 7 Stakeholder involvement .............................................................................................................................. 7 HTAi vortal .................................................................................................................................................... 7 HTA glossary ................................................................................................................................................ 7 INAHTA and CRD......................................................................................................................................... 7 Meta OAI repository...................................................................................................................................... 7 News aggregator .......................................................................................................................................... 8 Toolbar.......................................................................................................................................................... 8 Planned and Ongoing Projects database..................................................................................................... 8

Adherence to the Work Plan in 2010............................................................................................................... 8 3. Work Plan for the next period (2011) ...................................................................................................... 9

Communication ................................................................................................................................................ 9 Members only site............................................................................................................................................ 9 Interoperability ................................................................................................................................................. 9 Planned and Ongoing Project database.......................................................................................................... 9 HTA reports and supplemental material database .......................................................................................... 9 Information about policy decisions................................................................................................................... 9 Tools supporting day to day collaboration ....................................................................................................... 9 Training and support ........................................................................................................................................ 9 Interim technical Report and Financial Statement........................................................................................... 9


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Supplemental tasks........................................................................................................................................ 10 Planned and Ongoing Project database..................................................................................................... 10 Support to other WPs ................................................................................................................................. 10 Collaboration with external networks.......................................................................................................... 10 Supplemental tools ..................................................................................................................................... 10

Meetings ........................................................................................................................................................ 10 Stakeholder and external expert involvement ............................................................................................... 10 Cooperation with other WPs / LPs................................................................................................................. 10 Gantt chart ..................................................................................................................................................... 11

4. Appendices............................................................................................................................................ 12


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1. Overview

Work Package 6 Information Management system

Lead Partner


• KCE (Belgium)

• DIMDI (Germany)

Organisations Involved Associated Partners (AP)

1. CVZ (Netherlands)

2. EMKI (Hungary)

3. ESKI (Hungary)

4. GOG (Austria)

5. HAS (France)

6. HVB (Austria)

7. ISCIII (Spain)

8. LBI-HTA (Austria)

9. NETSCC (United-Kingdom)

10. NIPH (Slovenia)

11. SBU (Sweden)

12. THL (Finland)

Collaborating partners (CP)

13. ARESS (Italy)

14. OSTEBA (Spain)

15. SNHTA (Switzerland)

16. KDTD (Turkey)

WP Objectives Provision of a contemporary information management system which ensures compatibility and interoperability across WPs’ tools to support collaborative HTA work, and ensure rapid dissemination of HTA results within the JA


• Meetings • 1st Survey • Communication • Members Only site • Interoperability: Single Sign On, Common vocabulary,

Common layout, Common meta data • Planned and Ongoing Projects • Workrooms • Training and support • Interim technical Report and Financial Statement


2011-02-28


• M1, Starting date: started • M12 , Members only adapted site : 1st adaptation delivered • M12 , 1st WP interim technical reports: delivered

• M18 , Already existing EUnetHTA tools are accessible through

the members only site with a single login and password • M24 , Processes and tools for rapid dissemination of HTA

studies • M24 , 2nd WP interim technical report • M36 (37), WP final technical report • M36, Ending Date • Information Management System (IMS) and the related

documentation, processes and policies.


• WP1 support for Stakeholder forum specific area • WP1 support for public site • WP1 support for templates , procedures and policies • WP2 support for social networks • WP6 face to face meetings with WP6 CLP • WP6 interoperability: extension to common layout, common

meta data • WP6 Stakeholder involvement • WP6 collaboration with HTAi vortal • WP6 collaboration with HTA glossary • WP6 evaluation of collaboration with INAHTA and CRD • WP6 meta OAI repository • WP6 news aggregator • WP6 toolbar • WP7 face to face meeting • WP7 POP needs assessment


2011-02-28


Meetings

2010-02-08 (M02) face to face meeting (supplemental)

LP – CLP

2010-04-15 > 16 (M04) face to face meeting all partners

2010-06-10 (M06) face to face meeting WP7 (supplemental)

LP

2010-10-12 > 13 (M10) face to face meeting all partners

1st Survey The 1st survey has been designed with – and conducted by WP3. Survey results were presented during the face to face meeting M10; learning from this survey will be used to support the development of tools.

Communication Communication with all partners occurred through the News section of the Members Only site, and through the Newsletter edited by Secretariat.

Communication with WP6 partners occurred through a specific mailing list; documents were shared through a dedicated workroom.

Communication with work groups occurred through the e–meeting facility.

Members Only site Structure of the site has been improved in a stepwise approach.

Contact database is used as source of data and credentials for the central directory.

Interoperability: Single Sign On, Common vocabulary, Common layout, Common meta data A standard (Lightweight Directory Access Protocol - LDAP) has been selected to allow the access of all EUnetHTA tools using the same login and password through a central directory.

A common vocabulary (Medical Subject headings – MeSH) has been selected to describe topics in all EUnetHTA tools requiring such a functionality.

Planned and Ongoing Projects A dedicated Work room has been set up to host the current POP database (in the form of a worksheet).

Support has been provided to WP7b for the current POP database

Workrooms Workrooms have been activated for all Work packages in M2.

Training and support Training sessions using the e-meeting facility has been provided to all administrators of Workrooms (at least one person per work package)

Training material has been created regarding the Work rooms, the e-meeting facility, the contact database, the Members only site (for administrators), the Toolbar.

Support has been provided to Work room administrators, some problems required consultancy to fix technical bugs.


2011-02-28

Interim technical Report and Financial Statement Interim technical report and Financial Statement have been prepared (ended M13).

Supplemental activities

Site dedicated to Stakeholder forum A sub site with limited access has been set up for the stakeholder forum to support WP1

Public site Support has been provided to WP1 regarding structure of the Public site and technical questions

Templates, procedures and policies Support has been provided to WP1 regarding templates, the management of the contact database, and the annual access renewal procedure.

A policy describing the information dissemination has been created in coordination with WP1 and tools developers.

Social networks Support has been provided to WP2 regarding social networks (concepts + application to Twitter, LinkedIn, FaceBook)

Face to face meeting WP6 LP - CLP A supplemental face to face meeting occurred in M2 between WP6 LP and CLP.

Interoperability A common layout has been agreed for all EUnetHTA tools.

A reference set of meta data (Dublin Core – DC) for use with EUnetHTA tools has been selected

Stakeholder involvement Stakeholder involvement has been reconsidered based on a question from the Stakeholder forum; an explanatory document has been provided

HTAi vortal The HTAi vortal lists online resources related to HTA. WP6 LP participates to editorial team in order to avoid duplication of work

HTA glossary The HTA glossary lists and defines terms related to HTA. WP6 LP participates to editorial team in order to avoid duplication of work

INAHTA and CRD CRD has been contacted in order to evaluate interoperability between tools developed by EUnetHTA and the HTA database.

INAHTA has been contacted regarding the release in November 2010 of a tool that is similar to the EUnetHTA POP developed by WP7b and active since 2009.

Meta OAI repository The meta OAI repository is an automatically updated repository of HTA reports based on OAI-PMH. Currently, only 2 partners publish their reports in a compliant repository, limiting the current possibility to employ the


2011-02-28

meta OAI widely in EUnetHTA; WP6 informed partners about this technology and provided a working demonstrator and an explanatory document

News aggregator The news aggregator is an automatically updated news site. Currently, few partners provide RSS on their website; some feeds have thus been created using a third party online service, but this option is not sustainable; WP6 informed partners about this technology and provided a working demonstrator aggregating news from 22 websites and an explanatory document.

Toolbar A toolbar that can be installed on the main web browser has been developed to provide shortcuts to the EUnetHTA websites (public and Members Only), the EUnetHTA tools, the working areas and online resources related to HTA; the toolbar provides access to News from the EUnetHTA website, the News aggregator and other HTA related organisations.

Planned and Ongoing Projects database LP participated to the WP7 face to face meeting (M6, Dublin) to present the roadmap of the POP database.

An e-meeting has occurred in M9 to prepare the development of the next version of the POP (needs assessment).

Adherence to the Work Plan in 2010 Supplemental face to face meeting with WP6 CLP took place in M02

Supplemental face to face meeting with WP7 took place in M06

Supplemental e-meeting with WP7b took place in M09

Selection of a common vocabulary has been delayed from M4 to M10

Release of central directory has been delayed from M12 to M13


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3. Work Plan for the next period (2011) Work plan 2011 presents deviations:

• delivery of the central directory will occur at M13 (was planned at M12);

• supplemental tasks were added to the planning (see below).

Communication Communication with all partners will occur through the News section of the Members Only site, and through the Newsletter edited by Secretariat.

Communication with WP6 partners will occur through a specific mailing list, but also through E-Meetings for work groups.

Members only site Members only site will be updated: structure of the contact database will be reviewed (M18). Structure and content will evolve to fit with new developments (M24).

Interoperability Central directory will be released at M13

Planned and Ongoing Project database POP db will be developed, and released at M18

HTA reports and supplemental material database Based on the 1st survey, developing such a tool for EUnetHTA only would bring added value: 10% of partners could share confidential preliminary reports within EUnetHTA or EUnetHTA sub-groups; 2% of partners could share confidential reports (non publically available) within EUnetHTA or EUnetHTA sub-groups.

Development will occur between M18 and M23, tool will be released on M24

Information about policy decisions Opportunity of such a tool will be evaluated between M18 and M23. If pertinent, development will start at M 24

Tools supporting day to day collaboration Mailing list server will be released on M18

Training and support The training method will be based on the preferences provided by partners in the survey (see chapter 5 “Tools”)

Handouts or webcasts will be updated / created, training sessions supported by the e-meeting facility will be provided.

Interim technical Report and Financial Statement Interim report will be provided


2011-02-28

Supplemental tasks

Planned and Ongoing Project database An online survey is planned on M13 to get feedback from the current information providers regarding their experience with the first release of the POP db (spreadsheet + workroom), and get their advice about the planned development for the second release (online database).

Support to other WPs Support to other WPs will be provided on demand in order to ensure interoperability of developed solutions.

• One already started in M13 is supporting WP4a on providing a tool to share bibliographies for core HTA’s.

• One already planned is support to WP8 business model.

Collaboration with external networks Collaboration with external networks in order to avoid duplication of work will be evaluated and, where possible, supported (e.g. HTA glossary, HTAi vortal, HTA database, INAHTA projects database).

Supplemental tools Toolbar will be maintained; news aggregator and meta OAI will be maintained as demonstrators, contact with partners will continue in order to favor the use of the underlying standards (RSS, OAI-PMH).

Meetings



2011-01-20 Copenhagen (Denmark)

1 day WP6 LP, WP8 LP

brainstorming session on the business model

2011-10-20 Vienna (Austria)

2 days (1 night)

WP6 LP, Co-LP, AP, CP

Evaluation of progress and fine tuning: • Single sign-on and classification • Planned and Ongoing projects • HTA reports and supplemental

materials tool • Tools supporting day-to-day work • Training materials

Preparation of second survey

Stakeholder and external expert involvement This involvement will occurred based on the new description: no involvement foreseen, stakeholder forum interest for WP6 tasks awaited.

Cooperation with other WPs / LPs All WPs / LPs have been invited to be AP in WP6 in order to ensure involvement in decisions, and regular communication; supplemental communication will occur when needed with the best suited tool.

WP6 will work in close collaboration with WP3 regarding the two users surveys that will be conducted during Joint Action.

LP and Co-LP are members of the WP1 Coordination and WP8 Strategy and Business Model Development and will contribute to the work as per the WP1/WP8 work plan and decisions made during the WP1/WP8 course of action.

WP6 will support other WPs for tasks related to interoperability and information management


2011-02-28


Meetings ftf meeting WP8 LP

3rd ftf

Surveys survey for POP

dbCommunicationMembers only site site update site updateSingle sign on

Planned and ongoing studies database

Tool released

HTA reports & supplemental materal

Tool released

Information about policy decisions

Tools supporting day to day collaboration

Mailing list server

releasedTraining and support

Evaluation and f inal report 2nd WP interim

technical report

collaboration w ith existing tool (outside EUnetHTA) is evaluated vs development of specif ic new tool

Development and testing

collaboration w ith existing tool (outside EUnetHTA) is evaluated vs development of specif ic new tool

Development, testing and provision of learning materialUser support

interim report preparation

ftf meeting preparation

Communication on regular basis

Set up of central directorySupport to tools developers

Support to adaptation of Planned and

ongoing studies database

Support to adaptation of HTA reports and

supplemental material tool (WP6)

Procedure elaborationDevelopment of the new database


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4. Appendices

WP6.1 Guegan E. EUnetHTA JA Prticipants’2010 Baseline Survey. Southampton: NETSCC, 2010.

WP6.2 Minutes of the face to face meeting M02



WP6.5 Scanned copy of participants lists face to face meeting M04

WP6.6 Scanned copy of participants lists face to face meeting M10



EUnetHTA


YEAR 2010


2008-02-28

Joint Action on HTA 2010-2012 Work Package 7 – “New Technologies”

Interim Technical Report 2010


2008-02-28

Contents 1. Overview....................................................................................................................... 3 2. Activities performed in 2010 ............................................................................................ 7

WP 7 strand A: Facilitating evidence generation on new health technologies................................ 7 WP 7 strand B: Pre-market/pre-reimbursement assessment of new health technologies ............... 9 Activities strand A + B: 1st face-to-face meeting, Dublin ............................................................ 13 Adherence to the Work Plan in 2010....................................................................................... 15

3. Work Plan for the next period (2011).............................................................................. 16 WP7 strand A: Facilitating evidence generation of new health technologies ............................... 16 WP7 strand B: Pre-market/pre-reimbursement assessment of new health technologies .............. 16 WP 7 Face-to-face Meetings.................................................................................................. 19 Stakeholder and external expert involvement .......................................................................... 19 Cooperation with other WPs / LPs .......................................................................................... 20 Gantt chart (2011)................................................................................................................. 21

4. Appendices ................................................................................................................. 23 Strand A + B (stand-alone documents) ................................................................................... 23 Strand A (stand alone documents):......................................................................................... 23 Strand B (see documents below):........................................................................................... 24 a) Checklist for collaborations ................................................................................................ 24 b) MeSH terms used for indexing the Planned and Ongoing Projects......................................... 25 c) Onco Drugs Workshop – Agenda ....................................................................................... 29 d) Onco Drugs Workshop – Results/redundancies ................................................................... 31 e) Onco drugs workshop – Signed lists of attendees ................................................................ 33 f) LBI-HTA participation in EUnetHTA meetings 2010............................................................... 37


2008-02-28

1. Overview

Work Package 7 New technologies

Lead Partner

Co-Lead Partner

Haute Autorité de Santé (HAS), France

Ludwig Boltzmann Institute for Health Technology Assessment (LBI-HTA), Austria

Organisations Involved

Associated Partners (19): 1. AGE.NA.S - Italy (Strands A and B) 2. AHTAPol - Poland (Strands A and B) 3. AIFA - Italy (Strand A) 4. CVZ - Netherlands (Strand A) 5. EMKI - Hungary (Strand B) 6. HIQA - Ireland (Strands A and B) 7. INFARMED - Portugal (Strands A and B) 8. ISCII - Spain (Strand B) 9. Ministry of Health - Czech Republic (Strands A and B) 10. NETSCC - United Kingdom (Strand A) 11. NICE - United Kingdom (Strands A and B) 12. NOKC - Norway (Strands A and B) 13. Regione Veneto - Italy (Strands A and B) 14. SBU – Sweden (Strand A) 15. SDU - Denmark (Strand B) 16. SLOVAHTA –Slovak Republic (Strand A) 17. SSD/MSOC - Malta (Strand B) 18. THL - Finland (Strands A and B) 19. VASPVT - Lithuania (Strand A)

Collaborating Partners (9): 1. AETSA - Spain - (Strand A) 2. Agency for Medical Products and Medical Devices - Slovenia

(Strand B) 3. ASSR - Italy (Strands A and B) 4. AVALIA-t - Spain (Strands A and B) 5. KDTD - Turkey (Strand A and B) 6. National Centre for Pharmacoeconomics – Ireland (Strand A

and B) 7. OSTEBA - Spain (Strand A) 8. SNHTA - Switzerland (Strand A)

9. CMTP – USA (Strand A)

WP7 Objectives Strand A: Facilitating evidence generation on new health technologies

Development of HTA tools and methods and Application and field testing of developed tools and methods:

• To implement a web-based toolkit (database) on evidence generation on new technologies.

• To define an agreed dataset to facilitate exchange of information on planned prospective data collection including pragmatic trials.

• To develop criteria to select new technologies for which


2008-02-28

additional evidence generation is of utmost importance.

Strand B: Pre-market/pre-reimbursement assessment of new health technologies • To support information flow on new medical interventions

(between market approval and reimbursement decision). • To reduce duplication on the assessment of new medical

interventions by alerting on parallel activities (between market approval and reimbursement decision).

• To facilitate collaboration on new medical interventions (between market approval and reimbursement decision).


Strand A and B: • WP 7 1st face-to-face meeting, June 10, 2010 in Dublin:

Preparation and organisation in cooperation with HIQA as the local host.

Strand A:

Web-based toolkit (database) • Analysis of the use of the web-based toolkit prototype during

EUnetHTA Collaboration (2009) • Definition of area of improvement of the web-based toolkit

prototype (database) • The analysis of the use of the database and areas of

improvement with WP7 partners at face to face meeting in Dublin - Presentation and discussion

• Constructed, circulated and analysed Survey on needs, possibilities and implementation mechanisms for additional studies for new technologies among a subgroup of relevant WP7 partners (for further development of both database and selection criteria)

• Definition of interoperability of EUnetHTA tools (with WP7B and WP6)

Development of a registry for policy relevant studies in development • Developed project plan • Planned out phases for developing first draft of dataset,

identifying Delphi participants, invitation of participants, construction and execution of 2 (possibly 3) Delphi rounds to refine dataset, and efficacy testing of the resulting dataset

• Shared project plan with WP7 partners at face to face meeting in Dublin

• Used a snowballing process to identify Delphi participants • Constructed, circulated and analysed first Delphi round, then

refined dataset in light of information received • Constructed and circulated second Delphi round, closing data for

response is 20th December.

Criteria to select new technologies for Additional evidence generation (AEG) • Review of published selection/prioritisation criteria for new

technologies relevant for AEG • Presentation and discussion of the review with WP7 partners at

the face to face meeting in Dublin • Survey on needs, possibilities and mechanisms of


2008-02-28

selection/prioritization among a subgroup of relevant WP7 partners (common survey for database and selection criteria)

Other tasks • Organisation of WP6 face-to-face meeting in Paris (mostly in

relation with WP7 activities) • Participation in 6 ftf meetings and 7 e-meetings (M1-12) (HAS

participation) • Writing the interim technical and financial report 2010 (M12) • Activities concerning SF/SAG:

- Participation in SF meetings and e-meetings -Definition of the modalities of consultation of Stakeholder involvement, in coordination with WP4, WP5 and the Secretariat - Contribution to the development of Stakeholder policy - Contribution to the WP7 SAG

Strand B: • A checklist for collaboration was developed and distributed. • 4 POP requests and reminders (email requests for planned and

ongoing projects) were carried out. • 3 POP updates (synthesis of information) including alert lists of

redundancies and similar projects were published in the POP workroom.

• 3 POP communication protocols were written (not public). • New: POP database development, preparation activities already

started in late 2010 (in cooperation with WP 6). • A common classification system for indexing all planned and

ongoing projects (first by using a self-made indexing system, afterwards by using MeSH terms) was piloted and introduced.

• Continuous POP workroom administration, communication and information provision (POP workroom, EUnetHTA members only news area, EUnetHTA members updates…).

• Coordination of collaboration on new health technologies: - New: 2-days workshop on collaboration on oncological drugs in

Vienna hosted by LBI-HTA in Sept/Oct 2010. - New: Active brokering of collaboration on two oncological

drugs - call for joint assessments (M12). - New: Preparation of the active brokering of collaboration on

new high technology interventions in hospitals (preparation in M12, first call for collaboration in M13).

• Participation in 9 ftf meetings and 9 e-meetings (M1-12) (LBI participation)

• Writing the interim technical and financial report 2010 (M12)


Strand A:

Milestones • Review of published selection/prioritisation criteria for new

technologies relevant for AEG: performed • Survey on dataset on prospective data collection: first Delphi

round performed (analysis on the 2nd Delphi round is ongoing) • Training to use toolkit prototype: cancelled (see reasons in


2008-02-28

section 2) • Survey on needs, possibilities and implementation mechanisms

for additional studies for AEG and selection/prioritization criteria: performed

• Delphi rounds to define a first draft set of selection/prioritization criteria: slightly delayed.

Deliverables • No deliverables were planned for 2010 according to the initial

work plan.

Strand B:

Milestones • Checklist for collaboration: published in M3. • Quarterly POP requests: performed in M1/M4/M8/M12, to be

continued in 2011, 2012. • Quarterly POP updates: performed in M3/M6/M9/M13, to be

continued in 2011, 2012. • Quarterly POP communication protocols: 3 finished in

M6/M9/M12, 1 ongoing, to be continued in 2011, 2012. • POP database development in cooperation with WP 6: already

ongoing, database launch planned for M18. • Common classification system (MeSH): introduced and used

since M4. • Coordination of collaboration on new health technologies (1 per

year): - 2010: Onco drugs workshop (performed in M9/10) and first

call for collaboration two on onco drugs (call performed in M12, collaboration ongoing).

- 2011: Call for collaboration on new high technology interventions in hospitals: in preparation, ongoing.

- 2012: To be announced. • Interim WP 7B technical and financial report 2010: finished in

M13.

Deliverables • Checklist for collaboration: published in M3 • Quarterly POP communication protocols: 3 finished in

M6/M9/M12, 1 ongoing, to be continued in 2011, 2012 • POP database development (in cooperation with WP 6): already

ongoing, electronic POP database (version 1) launch planned for M18.


Strand A:

• Administration of WP 7 workroom • Definition of stakeholders involvement for WP 7 • Update of WP 7 work plan

Strand B:

• POP database development: Preparation activities and communication with WP 6 already started in the 2nd half of 2010.

• Active brokering for collaboration:


2008-02-28

- Workshop on oncological drugs organised and hosted - Collaboration on the assessment of two oncological drugs

initiated - Call for collaboration on two new high technology interventions

in hospitals prepared in Dec 2010, first call in performed in Jan 2011

• Administration of POP workroom • Administration of POP admin workroom


WP 7 strand A: Facilitating evidence generation on new health technologies

Web-based toolkit (database)

• A web based toolkit prototype (EIFFEL) was available at the end of the EUnetHTA project (2006-2008). Its interest and use by the EUnetHTA partners during the EUnetHTA Collaboration (2009) was analyzed. This led to the conclusion of a limited use of EIFFEL by EUnetHTA partners, due to poorly accessible information, non efficient queryable abilities and redundancy of items.

• Based on these conclusions, three areas of improvement were identified: set of items (more focused items, avoidance of redundancies), user-friendliness of IT functionalities and a faster access to the relevant information within the database.

• This work was presented and discussed by WP7 partners during the first WP7 face-to-face meeting in Dublin (June 10th 2010). Partners agreed on areas of improvement and necessity to upgrade the database. However, in order to characterize the most relevant items of the database, an investigation of the activities related to the requirement and implementation of additional studies among WP7 partners was required.

• A survey on needs, possibilities and implementation mechanisms for additional studies was performed among a subgroup of relevant WP7 partners (for further development of both database and selection criteria, see main results in Appendix).

• In addition, in order to fulfil an interoperability of EUnetHTA tools, discussions on integration of standards and definition of a common classification/indexation system were carried out in collaboration with WP7B and WP6.

Development of a registry for policy relevant studies in development

• Developed project plan

• Planned out phases for developing first draft of dataset, identifying Delphi participants, invitation of participants, construction and execution of 2 (possibly 3) Delphi rounds to refine dataset, and efficacy testing of the resulting dataset

• Shared project plan with WP7 at the first WP7 partners face-to-face meeting in Dublin

• Used a snowballing process to identify Delphi participants

• Constructed, circulated and analysed first Delphi round, then refined dataset in light of information received

• Constructed and circulated second Delphi round, closing data for response is 20th December.

Criteria to select new technologies for Additional Evidence Generation (AEG)


2008-02-28

• Based on previous work during the EUnetHTA project, a literature review focused on established AEG systems in 7 countries (Ontario, Australia, USA, Spain, England/Wales, France and Italy) was performed to identify the most relevant and practiced process of selection/prioritization. This led to the identification of four domains of selection/prioritization criteria (See Appendix)

• The results of this review was presented and discussed by WP7 partners during the first WP7 face-to-face meeting in Dublin. Partners agreed on the results of the review, on the relevance of developing selection/prioritization criteria within EUnetHTA, and have considered that three of the four identified domains are relevant for the development of selection/prioritization criteria.

• A survey on AEG mechanisms and selection/prioritization criteria was subsequently performed, in order to investigate more precisely the needs and the current selection/prioritisation process applied among EUnetHTA partners (common survey for database and selection criteria, see main results in Appendix).

Activities concerning SF/SAG:

• Participation in SF meetings and e-meetings • Definition of the modalities of consultation of Stakeholder involvement, in coordination with

WP4, WP5 and the Secretariat • Contribution to the development of Stakeholder policy • Contribution to the WP7 SAG


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WP 7 strand B: Pre-market/pre-reimbursement assessment of new health technologies

Checklist for possible collaborations

• A checklist for collaboration was developed (M2), distributed via email to EUnetHTA JA partners and published in the WP 7 workroom (M3). The checklist includes possibilities for exchange among EUnetHTA partners to facilitate ways of collaboration (Please find the checklist in the Appendices - Strand B).

POP requests

• In 2010, 4 POP requests (personalized email requests for planned and ongoing projects) were sent out to all 54 (later 55) EUnetHTA Joint Action partners. Response rates in the range of 70-75% and a total number of more than 1.000 planned and ongoing projects each request, both indicate a quite good echo from partners regarding a continuous POP collection, supervision and update.

POP request statistics

2010 Non-

responder Responder

without providing a POP

list

Responder with providing a POP

list

Total responder

Response rate

Total number of Projects listed

Number of alert

topics

Number of similar

projects

1st request: Jan 11 published: March 11 19 3 32 35 (of 54) 64,8% 1.022 28 277

2nd request: April 29 published: June 18 15 3 36 39 (of 54) 72,2% 896 95 312

3rd request: Aug 20 published: Sept 22 13 7 34 41 (of 54) 75,9% 1.070 101 316

4th request: Dec 3 published: Jan 2011 13 6 36 42 (of 55) 76,4% 1.099 129 419


2008-02-28

POP (projects) statistics 2010

1.022

896

1.0991.070

12910128

95

419

277 316312

0

200

400

600

800

1.000

1.200

01-2010 02-2010 03-2010 04-2010

POP request number

Cou

nts

Total projects Alert topics Similar projects (within alert topics)

Response rates - POP requests 2010

72,2%

75,9% 76,4%

64,8%

58,0%

60,0%

62,0%

64,0%

66,0%

68,0%

70,0%

72,0%

74,0%

76,0%

78,0%

01-2010 02-2010 03-2010 04-2010

POP request number

%

POP request number 01-2010 02-2010 03-2010 04-2010 Response rate in % 64,8% 72,2% 75,9% 76,4% Total projects 1.022 896 1.070 1.099 Alert topics 28 95 101 129

Similar projects (within alert topics) 277 312 316 419 Date of request Jan 11, 2010 April 29, 2010 Aug 20, 2010 Dec 3, 2010

Pop list published March, 11, 2010 June 18, 2010Sept 22, 2010 Jan 17, 2010


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POP updates and alert lists

• The synthesis of all POP request information ended up in three POP updates in 2010 (M3/M6/M9) and one in 2011 (M13). The updated POP excel lists also included an alert list of redundancies, which is supposed to be a point-of time support of information flow on new technologies prompting those, where identical assessments of same technologies are detected and where opportunities for information sharing and closer collaboration might be given.

• The quarterly updated POP excel list is available at the EUnetHTA Members Only website in a separate “POP workroom”. Access to this workroom is given only to those partners who provided information on their planned and ongoing projects (who responded to the email requests). Currently 119 persons can access the POP workroom by using the following direct link and : http://www.eunethta.eu/Workrooms/Planned-and-Ongoing-Projects-workroom-POP-WR/

• FAQs and information regarding access to the POP workroom have been published at the EUnetHTA Members Only tools description: http://www.eunethta.eu/Members_only/Resources/EUnetHTA-Tools/Planned-and-ongoing-projects-database

POP communication protocols

• In 2010 three POP communication protocols were written (not public), which contain POP request statistics and an overview of the email communication between WP 7 Co-LP and the EUnetHTA JA partners during the respective POP request period (M6/M9/M12, 1 ongoing).

• To facilitate the investigation of hindrances and chances for collaboration on specific topics as well as the impact of the WP 7B work, an analysis of all communication protocols is planned to be done by an external consultant, Karla Douw (University of Twente at Enschede/Netherlands), in M34-36.

POP classification system

• In collaboration with WP 6, a common classification system to index all planned and ongoing projects (POP) was elaborated and introduced in 2010:

• A WP 7B self-made category system (80 categories) was used for indexing the projects in the 1st POP request (M3).

• Discussion on common classification during the WP 6 ftf meeting on April 15/16 in Paris, presenting MeSH term as the most adequate option for WP 7B (M4).

• A presentation of MeSH as the used classification system for the 2nd POP request followed during the 1st WP 7 ftf meeting in Dublin (M6).

• The final agreement on MeSH as the general classification system within the EUnetHTA Joint Action was made during the 2nd WP 6 ftf meeting on October 12/13 in Brussels (M10).

• Since April 2010 MeSH has been used by WP 7B to categorize planned and ongoing projects in the POP excel file list (by using 114 main/overall MeSH terms). Firstly (in the 1st and 2nd POP request), the project categorization was done by WP 7B only, in the following POP requests (3rd and 4th), partners were asked to choose the appropriate MeSH terms by themselves first with a final review and - if it was necessary – with re-categorization by LBI-HTA afterwards. (Please find the list of MeSH terms in the Appendices - Strand B).

New: POP database development

• The preparation activities (e-meetings, email communication with WP 6) concerning the needs assessment for the POP database development already started in the 2nd half of 2010 (instead of as originally planned for the beginning of 2011). For further details on the POP database development please see chapter “Work plan for the next period – 2011”.


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Communication & administration

• Continuous communication, information provision and administration is necessary for a successful information flow within the work of WP 7B (e.g. concerning POP requests, POP workroom access rights, EUnetHTA members only news area, EUnetHTA members updates, WP 7 reporting).

New: Coordination of 3 collaborations (one per year) on new health technologies (Formerly: Coordinating of 3 collaborations on non-pharmaceutical health technologies)

• As it was originally written in the work plan, WP 7B initially planned to coordinate the collaboration of “new non-pharmaceutical health technologies” – one per year, three in total. In the course of the year 2010, and after analyzing the first two POP lists, enormous redundancies in the assessment of technologies were detected – especially in the field of (oncological) drugs. Therefore we extended the planned task from formerly “new non-pharmaceutical technologies” to pharmaceutical technologies also (onco drugs).

New, concrete ideas for an active coordination of possible collaborations within EUnetHTA followed:

• Organising and hosting an international, 2-days workshop on oncological drugs:

Date September 30 – October 1, 2010 12:00 – 18:00 (30th) and 9:00 – 13:30 (1st)

Venue LBI-HTA office, Garnisongasse 7/20, 1090 Vienna

Objectives • To compile methods and structures of assessments for oncologic drugs of all attending agencies

• To elicit possibilities for & barriers to further cooperation • To define actions for future collaboration amongst all

participating agencies and between individual agencies respectively.

Agenda (main points)

• Round of introduction • CVZ-survey on countries activities • Presentation of profiles/methods (~ 15 mins each) – Part 1:

LBI-HTA, AkdÄ, AHTAPol, CVZ, HAS • Presentation of profiles/methods (~ 15 mins each) – Part 2:

Institut für Pharmakologie am Klinikum Bremen, IQWiG, NCPE, NOKC, Reg Veneto – UVEF, Reg Veneto – Ulss20

Participants

20 persons from 12 European HTA institutions attended the onco drugs workshop.

(lists of attendees in the Appendices – Strand B).

Results

Within the participating agencies many redundancies in the production of onco drugs assessments were detected. Compiled methods and structures of assessments could help to work on joint assessments and to exchange information. Actions for future collaboration amongst all participating agencies and between individual agencies were fixed, e.g. setting up a mailing list to exchange assessment topics before the production of the assessment started in order to ask for possible ways to cooperate between individual agencies/EUnetHTA partners.

(overview of redundancies and the workshop minutes in the Appendices – Strand B).


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• Active brokering of collaboration - Oncological drugs

The intention of “active brokering activities” is to bring HTA agencies together that are planning to assess singular (pharmaceutical and non-pharmaceutical) interventions at a stage before the agencies have already started their own national activities. Coordinator and project manager is WP 7 Co-LP, who aims at producing (1-2) assessment reports together with another interested EUnetHTA partner per year.

In mid December 2010, WP 7 Co-LP sent out a first "Call for Collaboration” (email request) to participating agencies of the Onco Drugs Workshop (which was performed in autumn 2010). The overall aim of this call was to initiate and implement collaboration by joint assessments on the following two oncological drugs:

- Cabazitaxel for the second-line therapy of patients with metastatic castration-resistant prostate cancer, and

- Dasatinib for the first-line therapy of patients with newly diagnosed chronic phase philadelphia chromosome positive chronic myeloid leukaemia.

• Active brokering of collaboration – New high technology interventions in hospitals

In December 2010, WP 7 Co-LP prepared and planned another call for collaboration – this time on “new high technology interventions in hospitals” (the topics for the joint assessments on two interventions will be selected in M13). After the selection process the email call will be sent to interested EUnetHTA partners. For this purpose those interested partners signed in to a separate Google group mailing list beforehand. Again, the aim of this active brokering activity is to initiate joint assessments on two new high technology interventions in hospitals – as being a point-of-time pilot. Furthermore it is planned to feed the gained information of the joint assessments into a EUnetHTA Core Model afterwards (M4), and to produce the fluent text of the assessment report first (keeping the core model as a checklist in mind).

Participation in meetings 2010

• In 2010, Co-LP team members (Claudia Wild, Gerda Hinterreiter, Marisa Warmuth, Anna Nachtnebel and Stefan Mathis) attended 9 EUnetHTA JA face-to-face meetings and 9 e-meetings. (Please find a detailed list of attended meetings in the Appendices – Strand B).

1st interim technical and financial report

• Preparation of the WP 7 technical (in close cooperation with WP 7 LP) and financial report 2010 (M12) and provision of both reports to WP1 “Communication” (M13).

Activities strand A + B: 1st face-to-face meeting, Dublin

Date June 10, 2010 / 9:00 – 16:00

(Strand A: 9:00 -13:00; Strand B: 14:00 – 16:00)

Venue: Health Information and Quality Authority (HIQA) offices at George’s Court, George’s Lane Dublin 7, Ireland

Purpose & objectives:

Strand A:

Eiffel Database • Presentation of the new proposals/improvements for Eiffel web based

tool-kit for 2010-2012 ; • Obtain feedback from meeting participants about these new

orientations.


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Data Set • Obtain feedback from meeting participants about the proposed

dataset • Identify participants interested in being involved in the project,

including nomination of appropriate organisations from their countries • Gain feedback from participants about studies appropriate for testing

the dataset (eg breast cancer)

Criteria Selection • Present the context of the selection/prioritization criteria; • Obtain feedback from meeting participants about orientations; • Define the scope of the development of selection criteria by

EUnetHTA WP7.

Strand B:

Reduction of Duplication • Providing information about the work of WP 7B • Bring people together: identifying concrete fields and projects for

collaboration • Training to use the Planned and Ongoing Projects (POP) workroom

Agenda (main points)

Strand A:

Database for additional evidence generation on new and select technologies • Presentation : “Feedback from Eiffel prototype ; exploring areas of

need and improvement” by Laura Zanetti (HAS, France): • Working groups discussions • Working groups feedback and general discussion

Exploring a dataset for trials in development

• Presentation by Andrew Cook (NETSCC, United Kingdom) • Discussion about the dataset & accessing trial funders

Criteria to select new technologies for additional evidence generation • Presentation: “Criteria to select new technologies for additional

evidence generation” by Cédric Carbonneil (HAS, France) • Working groups discussions • Working groups feedback and general discussion

Strand B:

Part 1: • Work plan 2010-2012,POP results, classification & alert system, POP

workroom training presented by Gerda Hinterreiter, Marisa Warmuth (LBI-HTA, Austria)

• POP database development, needs and functions presented by Patrice Chalon (KCE, Belgium)

Part 2: • Special new techs with high potential for collaboration presented by

Claudia Wild (LBI-HTA, Austria) • Fields and ways to collaborate: working groups discussions • Working groups feedback and general discussion

Participants 31 persons from 23 EUnetHTA JA partner organisations participated in the 1st WP 7 face-to-face meeting. Please find the signature list of all attendees in the Appendices.


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Adherence to the Work Plan in 2010 Strand A:

Overall, the initial work plan was respected, except on four points:

• No training session on the use of EIFFEL toolkit prototype was performed during the first WP7 face to face meeting, as major improvements of EIFFEL were considered to be necessary. Indeed, it would have been useless to train WP7 partners to the use of an obsolete version of EIFFEL. Instead of a training session, the analysis of the use of EIFFEL and areas of improvement were presented and discussed by WP7 partners.

• Instead of two individual surveys, a single survey was performed, aiming to further develop both the database and the selection/prioritization criteria.

• The dates of the 2011 WP7 face-to-face meetings initially provided on the first version of WP7 workplan have been modified. Indeed, it appeared to be more relevant to plan the first 2011 WP7 meeting in March and the second in September in order to have a longer period of working time between the two meetings (7 months instead of 4 months).

• Complete answers from 11 WP7 partners to the survey on “Additional Evidence Generation (AEG) process and selection criteria” were collected in 3 months instead of 1 month, in spite of multiple reminds. Therefore, the subsequent first Delphi round to define a draft set of selection/prioritization criteria have been slightly delayed to 2011.

These elements result in a 3 months delay at the end of 2010, leading to an adjustment of the WP7 work plan in December 2010 (See Appendix). Strand B:

Overall, the initial work plan was respected, excepted on the following (additional or early initiated) tasks:

• POP database development: Preparation activities and communication with WP 6 already started in the 2nd half of 2010 (instead of starting in M13).

• Coordination of three collaborations of new technologies: As it was originally written in the work plan, WP 7B has planned to coordinate the collaboration of “new non-pharmaceutical health technologies” – one per year, three in total. In the course of the year 2010 the field for collaboration has been extended from formerly “new non-pharmaceutical” to new technologies (including pharmaceuticals, respectively oncological drugs also). New initiatives of WP 7 Co-LP for actively coordinating collaboration within EUnetHTA members were/are:

- Organising and hosting the 2-days workshop on oncological drugs (performed) - Initiating collaboration on the joint assessment on two oncological drugs (ongoing) - Initiating collaboration on the joint assessment on two new high technology

interventions in hospitals (in preparation, ongoing)


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WP7 strand A: Facilitating evidence generation of new health technologies

Database • Definition of new fields of information for the database • Presentation of survey results and new fields of information (FTF meeting : Malta) • Database pilot test phase (though XL files) • Upgrading database : conceptual phase of IT implementation • Survey on data processing and functionalities • Presentation of survey and tests results (FTF meeting: Rome) • Stakeholders consultation • Upgrading database : choice of IT subcontractor phase of IT implementation

Development of a registry for policy relevant studies in development • Complete analysis of second Delphi round. • Conduct 3rd Delphi round if required • Refine dataset in light of 2nd (and 3rd) Delphi rounds • Conduct efficacy testing of dataset by using it to attempt to match, by hand, projects suggested

by participants • Refine dataset in light of efficacy testing • Discuss with HAS implications and learning from dataset development probably around the

WP1 meeting in Paris in March 2011 • Hand over final dataset to HAS by end of June 2011.

Criteria to select new technologies for AEG • Presentation of survey results and of Delphi rounds process (FTF meeting : Malta) • Delphi rounds to commonly define a set of selection criteria (first draft) • WP7 SAG consultation • Testing of selection criteria by WP7 partners to select 3 new health technologies for which

additional evidence generation is of importance • Information on the test phase of selection criteria (FTF meeting: Rome)

WP7 strand B: Pre-market/pre-reimbursement assessment of new health technologies POP requests, updates and alerts • M13-M18+: WP 7 Co-LP will continue the current process of collecting information (quarterly

POP email requests + reminders, synthesis of all excel sheets into one updated total POP list, including an alert list on similar projects, followed by the publication of the list in the POP workroom, with access for POP list providers only). WP 7 Co-LP will continue in making use of the workroom facility until the web based POP database will be online (M18).

POP communication protocols • M13-M36: WP 7 Co-LP will continue writing communication protocols after every POP request

period.


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POP database development

Background

The collection of information for the POP database started in 2009 as a part of the WP 7B activities to find practical ways of reducing duplication of activities and facilitating an active information flow on planned and ongoing projects between the European HTA agencies. In early 2010, WP 7 Co-LP joined efforts with WP 6A (KCE), to first provide an online repository (POP workroom) allowing to store and share the collected information (currently stored in an Excel worksheet) as part of the EUnetHTA Information Management System. The regular (quarterly) updates of the database which currently includes 1.031 project listings are facilitated by an active service and management by the WP 7 Co-LP team. Regular calls (POP requests) soliciting input into the database have been issued. Access to the database is limited to those organisations only, who actively and regularly provide contribution to the “database”.

In late 2010, WP 7B and WP 6 started the development of an online solution that will be more user-friendly, fit into the EUnetHTA Information Management System and allow interoperability with the other relevant (non-duplicating) existing databases.

Further steps 2011:

• M13-M17: Continuing the collaboration and communication with WP 6 for information on necessities of the database (needs assessment based on the experience gained with the current process and through a survey (M13) within POP workroom/tool users carried out by WP 6, in cooperation with WP 7B for reviews/inputs).

• M13-M17: Continuing POP database development: procedure elaboration, developing, piloting and testing the database.

• M15: Activity update of the POP database development and discussions with APs and CPs during the WP 7 FTF meeting in Malta.

• M18: Implementation and first launch of the POP database version 1.

• M21: Request for feedback from APs and CPs on the web interface and usability of the POP database during the WP 7 FTF meeting in Rome.

• M36: Database is routine, regularly used and updated by EUnetHTA partners.

Coordination and active brokering of collaboration

WP 7 Co-LP will continue with active brokering calls to bring HTA agencies together, which are planning to assess singular (pharmaceutical and non-pharmaceutical) interventions at a stage before the agencies have already started their own national activities. Aim is to produce (1-2) assessment reports together with another interested EUnetHTA partner in the field of:

• Oncological drugs: Two joint assessments are already ongoing: Dasatinib & Cabazitaxel (M12-M15) Please see chapter “Activities 2010 -strand B” for further details.

• New high technology interventions in hospitals: Two joint assessments are planned to start in early January 2011 (M13-M15) Please see further details in the following table:

Topic selection:

WP 7 Co-LP will receive several topics from the Austrian MoH on January 13, 2011. Afterwards 1-2 topics will be selected for a Call for Collaboration within interested partners. Those partners then should react within a short timeframe (one week), if they want to collaborate on that specific topic.

Aim of this call for collaboration:

To conduct an assessment in cooperation between the LBI-HTA and another agency, and to publish the report jointly.

Language of the joint assessments:

English


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Tasks for the collaborating partners:

• Study selection • Checking the data extraction • Quality assurance of the whole report (= proof-reading of the

whole report, contributing to the discussion section, commenting on the reports if relevant information has been missed, etc.)

Project leader, publication:

• WP 7 Co-LP will be the project leader and first author • The report will be a joint report between two agencies • The evidence synthesis will have around 25 pages in total

Timeframe

(M13-M15):

• Jan 12 to 19: decision on collaboration • Jan 19 to 22: PICO question fixed • then: Literature search by WP 7 Co-LP • End Jan/beginning Feb: study selection by WP 7 Co-LP and

the collaborating partner • End Jan/beginning Feb: literature retrieval by WP 7 Co-LP • Beginning of Feb: data extraction by WP 7 Co-LP • Mid Feb: controlling of data extraction • Feb to beginning March: report writing • Beginning of March to mid March: proof-reading of and

commenting on evidence analysis • Mid March: external peer review (1 week) • End March: the report is completed

Estimated workload for the collaborating partner

5 -7 days

Communication & administration

• Continuous communication and information exchange (above all) with WP 1, WP 7 LP & WP 6.

Participation in meetings 2011

• Co-LP staff members (Claudia Wild, Gerda Hinterreiter, Marisa Warmuth and Stefan Mathis) are planning to attended several EUnetHTA JA face-to-face meetings (WP 1, WP 4, WP 6, WP 7) and e-meetings (WP 1/EC, WP 6+WP 7B) in 2011.

2nd interim technical and financial report

• Preparation of the WP 7 technical (in close cooperation with LP) and financial report 2011 in M24 and provision of both reports to WP1 “Communication” in M25.


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WP 7 Face-to-face Meetings



2011, March 3rd-4th

Valetta

Malta, MA

1 WP 7

LP + CLP APs + CPs

Strand A: To present and discuss surveys results on selection criteria, database items and on common dataset for prospective data collection

Strand B: Activity updates and discussions on - Outcomes of the onco drugs workshop - POP database development - 5th POP request: results and alerts - Active brokering for collaboration: results of

the 1st call for collaboration on new high technology interventions in hospitals

2011, Sept 29th-30th

Rome Italy, IT

1 WP 7

LP + CLP APs + CPs

Strand A: To present and discuss first draft of selection criteria, database functionalities, first draft of dataset for planned studies

Strand B: Activity update and discussions on - POP database: feedback of APs and CPs

(e.g. on the web interface, usability of the database..)

- 6th POP request: results and alerts - Active brokering: experiences and new fields

to collaborate

Stakeholder and external expert involvement The involvement of stakeholders in WP7 will be restricted to WP7A, as no rationale of stakeholders participation was identified for WP7B. Strand B is concerned with collecting information on the agencies ongoing and planned working program in order to identify similar tasks.

Stakeholders will be involved in WP7A in two different ways:

1. Stakeholder advisory groups (SAG)

2. Public consultation

1. Stakeholder advisory groups (SAG)

The feedback of the SAG will be foreseen for the following activities (including timing):

• Review of the first draft of relevant items to be included in the database for additional evidence generation on new technologies (M21-M22);

• Review of the first draft of criteria to select and prioritize new technologies for additional evidence generation before the testing of these criteria (M15-M18);

• Review of the draft of the dataset, following completion of the Delphi activity, on prospective data collection in development (M15-M17).

2. Public consultation (including the timing)

• Comments on the final version of relevant items to be included in the database for additional evidence generation on new technologies before IT upgrading (M23-M24)


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• Comments on the final version of the dataset on prospective data collection in development before IT implementation (M22-M24).

• Comments on the final version of the criteria to select and prioritize new technologies (M24-M26).

Cooperation with other WPs / LPs LP and Co-LP are members of the WP1 Coordination and WP8 Strategy and Business Model Development and will contribute to the work as per the WP1/WP8 work plan and decisions made during the WP1/WP8 course of action. Within WP 7, LP and Co-LP especially act jointly when preparing the WP 7 face-to-face meetings. Strand A:

WP6 “Information Management System”, which is led by KCE (Belgium) and Co-led by DIMDI (Germany) will continue to provide the support to database development for:

• integration of standards

• common classification / indexation system Strand B:

WP7 Strand B has been (and will continue) working in close collaboration with WP 6 “Information Management System”, which is led by KCE (Belgium) and co-led by DIMDI (Germany) within the following topics and deliverables:

• Work room facilities at the Members Only website (access rights, information provision..)

• Common classification system (IT development, testing, piloting, implementation of MeSH terms into the electronic POP database)

• POP database development (IT development, interface, data flow management, single sign on, access rights, testing, piloting..)


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Gantt chart (2011) Strand A: [M (Malta); R (Rome): face to face meetings]

Details M13 M14 M15 M16 M17 M18 M19 M20 M21 M22 M23 M24

Operational web–based toolkit

Definition of new fields of information

Presentation of survey results and

new fields of information M

Database pilot test phase

(XL files) Stakeholders consultation

Survey on data processing and

functionality R Operational toolkit IT implementation

Upgrading the toolkit


Selection criteria

Delphi rounds to identify a set of selection criteria

Presentation of survey results on selection

criteria M

Consultations on new fields (WP7A SAG)

Testing of selection to select 3 new technologies R


Dataset Analysis of 2nd

Delphi Test of dataset

for 3 technologies M

Analysis of test and validation

Key milestone


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Strand B:

2011 M13 M14 M15 M16 M17 M18 M19 M20 M21 M22 M23 M24 FTF Meetings 2nd ftf

Malta 3rd ftf

Rome

POP database development (in coop with WP 6)

needs assessment (survey/WP 6, procedure elaboration, development of the POP database

database release , version 1

db feed-back: ftf meeting

implementing feedback into database version 2

POP requests 5th request

6th request

7th request

8th request

POP updates 4th update 5th update

6th update

7th update

8th update

POP communication protocols

4th protocol

5th protocol

6th protocol

7th protocol

Coordination of collaborations on new high technologies (active brokering)

joint assessment reports on - 2 oncological drugs - 2 new high tech interventions in hospitals

Interim financial and technical report 2011

preparation of financial & technical report


17 March 2011

4. Appendices

Strand A + B (stand-alone documents) WP7.1_AB_1st WP 7 face-to-face meeting, Dublin - Minutes WP7.2_AB_1st WP 7 face-to-face meeting, Dublin - Signed lists of attendees

Strand A (stand alone documents): WP7.3_A_Review of criteria used to select and prioritize new health technologies requiring additional study (July 2010) WP7.4_A_ Presentation of EIFFEL during the WP7 face to face meeting in Dublin (June 2010) WP7.5_A_ WP7A survey on AEG and selection criteria (Sept 2010) WP7.6_A_ WP7A survey on AEG and selection criteria: main results (Dec 2010) WP7.7_A_Survey on Dataset for trials in development: first Delphi round (Oct 2010) WP7.8_A_Survey on Dataset for trials in development: report of first Delphi round (Nov 2010) WP7.9_A_Survey on Dataset for trials in development: second Delphi round (Dec 2010)


17 March 2011

Strand B (see documents below):

a) Checklist for collaborations


17 March 2011

b) MeSH terms used for indexing the Planned and Ongoing Projects

[A] Anatomy: Body Regions [A01]

[A] Anatomy: Musculoskeletal System [A02]

[A] Anatomy: Digestive System [A03]

[A] Anatomy: Respiratory System [A04]

[A] Anatomy: Urogenital System [A05]

[A] Anatomy: Endocrine System [A06]

[A] Anatomy: Cardiovascular System [A07]

[A] Anatomy: Nervous System [A08]

[A] Anatomy: Sense Organs [A09]

[A] Anatomy: Tissues [A10]

[A] Anatomy: Cells [A11]

[A] Anatomy: Fluids and Secretions [A12]

[A] Anatomy: Animal Structures [A13]

[A] Anatomy: Stomatognathic System [A14]

[A] Anatomy: Hemic and Immune Systems [A15]

[A] Anatomy: Embryonic Structures [A16]

[A] Anatomy: Integumentary System [A17]

[A] Anatomy: Plant Structures [A18]

[A] Anatomy: Fungal Structures [A19]

[A] Anatomy: Bacterial Structures [A20]

[A] Anatomy: Viral Structures [A21]

[B] Organisms: Eukaryota [B01]

[B] Organisms: Archaea [B02]

[B] Organisms: Bacteria [B03]

[B] Organisms: Viruses {B04]

[B] Organisms: Organism Forms [B05]

[C] Diseases: Bacterial Infections and Mycoses [C01]

[C] Diseases: Virus Diseases [C02]

[C] Diseases: Parasitic Diseases [C03]

[C] Diseases: Neoplasms [C04]

[C] Diseases: Musculoskeletal Diseases [C05]

[C] Diseases: Digestive System Diseases [C06]

[C] Diseases: Stomatognathic Diseases [C07]

[C] Diseases: Respiratory Tract Diseases [C08]

[C] Diseases: Otorhinolaryngologic Diseases [C09]

[C] Diseases: Nervous System Diseases [C10]

[C] Diseases: Eye Diseases [C11]

[C] Diseases: Male Urogenital Diseases [C12]

[C] Diseases: Female Urogenital Diseases and Pregnancy Complications [C13]

[C] Diseases: Cardiovascular Diseases [C14]


17 March 2011

[C] Diseases: Hemic and Lymphatic Diseases [C15]

[C] Diseases: Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

[C] Diseases: Skin and Connective Tissue Diseases [C17]

[C] Diseases: Nutritional and Metabolic Diseases [C18]

[C] Diseases: Endocrine System Diseases [C19]

[C] Diseases: Immune System Diseases [C20]

[C] Diseases: Disorders of Environmental Origin [C21]

[C] Diseases: Animal Diseases [C22]

[C] Diseases: Pathological Conditions, Signs and Symptoms [C23]

[D] Chemicals and Drugs: Inorganic Chemicals [D01]

[D] Chemicals and Drugs: Organic Chemicals [D02]

[D] Chemicals and Drugs: Heterocyclic Compounds [D03]

[D] Chemicals and Drugs: Polycyclic Compounds [D04]

[D] Chemicals and Drugs: Macromolecular Substances [D05]

[D] Chemicals and Drugs: Hormones, Hormone Substitutes, and Hormone Antagonists [D06]

[D] Chemicals and Drugs: Enzymes and Coenzymes [D08]

[D] Chemicals and Drugs: Carbohydrates [D09]

[D] Chemicals and Drugs: Lipids [D10]

[D] Chemicals and Drugs: Amino Acids, Peptides, and Proteins [D12]

[D] Chemicals and Drugs: Nucleic Acids, Nucleotides, and Nucleosides [D13]

[D] Chemicals and Drugs: Complex Mixtures [D20]

[D] Chemicals and Drugs: Biological Factors [D23]

[D] Chemicals and Drugs: Biomedical and Dental Materials [D25]

[D] Chemicals and Drugs: Pharmaceutical Preparations [D26]

[D] Chemicals and Drugs: Chemical Actions and Uses [D27]

[E] Analytical, Diagnostic and Therapeutic Techniques and Equipment: Diagnosis [E01]

[E] Analytical, Diagnostic and Therapeutic Techniques and Equipment: Therapeutics [E02]

[E] Analytical, Diagnostic and Therapeutic Techniques and Equipment: Anesthesia and Analgesia [E03]

[E] Analytical, Diagnostic and Therapeutic Techniques and Equipment: Surgical Procedures, Operative [E04]

[E] Analytical, Diagnostic and Therapeutic Techniques and Equipment: Investigative Techniques [E05]

[E] Analytical, Diagnostic and Therapeutic Techniques and Equipment: Dentistry [E06]

[E] Analytical, Diagnostic and Therapeutic Techniques and Equipment: Equipment and Supplies [E07]

[F] Psychiatry and Psychology: Behavior and Behavior Mechanisms [F01]

[F] Psychiatry and Psychology: Psychological Phenomena and Processes [F02]

[F] Psychiatry and Psychology: Mental Disorders [F03]

[F] Psychiatry and Psychology: Behavioral Disciplines and Activities [F04]

[G] Phenomena and Processes: Physical Phenomena [G01]

[G] Phenomena and Processes: Chemical Phenomena [G02]

[G] Phenomena and Processes: Metabolic Phenomena [G03]

[G] Phenomena and Processes: Cell Physiological Phenomena [G04]

[G] Phenomena and Processes: Genetic Phenomena [G05]

[G] Phenomena and Processes: Microbiological Phenomena [G06]


17 March 2011

[G] Phenomena and Processes: Physiological Phenomena [G07]

[G] Phenomena and Processes: Reproductive and Urinary Physiological Phenomena [G08]

[G] Phenomena and Processes: Circulatory and Respiratory Physiological Phenomena [G09]

[G] Phenomena and Processes: Digestive System and Oral Physiological Phenomena [G10]

[G] Phenomena and Processes: Musculoskeletal and Neural Physiological Phenomena [G11]

[G] Phenomena and Processes: Immune System Phenomena [G12]

[G] Phenomena and Processes: Integumentary System Physiological Phenomena [G13]

[G] Phenomena and Processes: Ocular Physiological Phenomena [G14]

[G] Phenomena and Processes: Plant Physiological Phenomena [G15]

[G] Phenomena and Processes: Biological Phenomena [G16]

[G] Phenomena and Processes: Mathematical Concepts [G17]

[H] Disciplines and Occupations: Natural Science Disciplines [H01]

[H] Disciplines and Occupations: Health Occupations [H02]

[I] Anthropology, Education, Sociology and Social Phenomena: Social Sciences [I01]

[I] Anthropology, Education, Sociology and Social Phenomena: Education [I02]

[I] Anthropology, Education, Sociology and Social Phenomena: Human Activities [I03]

[J] Technology, Industry, Agriculture: Technology, Industry, and Agriculture [J01]

[J] Technology, Industry, Agriculture: Food and Beverages [J02]

[K] Humanities: Humanities [K01]

[L] Information Science: Information Science [L01]

[M] Named Groups: Persons [M01]

[N] Health Care: Population Characteristics [N01]

[N] Health Care: Health Care Facilities, Manpower, and Services [N02]

[N] Health Care: Health Care Economics and Organizations [N03]

[N] Health Care: Health Services Administration [N04]

[N] Health Care: Health Care Quality, Access, and Evaluation [N05]

[N] Health Care: Environment and Public Health [N06]

[V] Publication Characteristics: Publication Components [V01]

[V] Publication Characteristics: Publication Formats [V02]

[V] Publication Characteristics: Study Characteristics [V03]

[V] Publication Characteristics: Support of Research [V04]

[Z] Geographicals: Geographic Locations [Z01]


17 March 2011


17 March 2011

c) Onco Drugs Workshop – Agenda

Onco drugs workshop ~ aims & agenda~

September 2010

Date: 30th September – 1st October 2010

Time: 12:00 – 18:00 (30th) and 9:00 – 13:30 (1st)

Meeting venue: Ludwig Boltzmann Institute for HTA, Garnisongasse 7/20

1090 Vienna, Austria, Tel.: +43(0)1-2368119-0

Contact: Dr. Anna Nachtnebel, LBI-HTA ([email protected])

12 participating agencies from 9 countries: 1. AkdÄ/ Germany 2. AHTAPol/ Poland 3. CVZ/ The Netherlands 4. HAS/ France 5. Institut für Pharmakologie am Klinikum Bremen/ Germany 6. IQWiG/Germany 7. LBI-HTA/ Austria 8. NCPE/ Ireland 9. NOKC/ Norway 10. Reg. Veneto - UVEF/ Italy 11. Reg. Veneto – Ulss20/ Italy 12. THL/ Finland

Workshop aims: 1. To compile methods and structures of assessments for oncologic drugs of all

attending agencies 2. To elicit possibilities for & barriers to further cooperation 3. To define actions for future collaboration amongst all participating agencies and

between individual agencies respectively.

Day 1

12:00 - 13:00 Lunch

13:00 - 13:10 Welcome & introduction to workshop aims

13:10 - 13:30 Round of introduction

13:30 - 14:00 CVZ-survey on countries activities

14:30 - 16:00 Presentation of profiles/methods (~ 15 mins each) 1. LBI-HTA 2. AkdÄ 3. AHTAPol 4. CVZ 5. HAS


17 March 2011

16:00 Coffee break

16:30 - 18:00 Presentation of profiles/methods (~ 15 mins each) 1. Institut für Pharmakologie am Klinikum Bremen 2. IQWiG 3. NCPE 4. NOKC 5. Reg Veneto – UVEF 6. Reg Veneto – Ulss20

18:00 End of day 1

19:30 Dinner

Day 2

8:30 - 9:00 Coffee reception

9:00 - 9:30 Overview: similarities of & differences between methods

9:30 - 10:30 Subgroup work: identification & prioritisation of areas most important for collaboration, barriers to collaboration

10:30 Coffee break

11:00 - 12:00 Subgroup discussions: Ways to overcome barriers and to implement collaboration

12:00 - 13:00 Summary of discussions and defining actions for future collaboration (amongst all members, individual agencies)

13:00 - 13:30 Feedback round

13:30 End of the workshop &

Lunch


17 March 2011

d) Onco Drugs Workshop – Results/redundancies

Legend:

planned ongoing in review finished published (language other than English

published in English

Drug (Generic Name) Indication Institution/s Azacitidine (Vidaza) myelodysplastic syndrome UVEF HAS LBI HTA

Cetuximab (Erbitux) EGFR-expressing non-small cell lung cancer

LBI HTA

Everolimus (Afinitor) adv/metastatic kidney cancer UVEF LBI HTA NOKC

Rituximab (Rituxan/MabThera)

1st and 2nd-line treatment of chronic lymphocytic leukaemia

CVZ LBI HTA HAS

Ibritumomab tiuxetan (Zevalin)

consolidation therapy after first remission in follicular lymphoma

LBI HTA

Gefintinib (Iressa) 1st-line treatment of non-small cell lung cancer

NCPE LBI HTA UVEF

Trabectedin (Yondelis) 2nd-line recurrent platinum-sensitive ovarian cancer

LBI HTA

Plerixafor (Mozobil) autologous stem cell transplantation in patients with lymphoma and multiple myeloma

LBI HTA

Lapatinib ditosylate (Tyverb/Tykerb)

1-st line for adv/metastatic breast cancer

CVZ NOKC LBI HTA UVEF

Bendamustine (Ribomustin/ Treanda/ Levact)

for indolent non-Hodgkin's lymphoma, chronic lymphocytic leukaemia, multiple myeloma

LBI HTA

Panitumumab (Vectibix)

1st-line metastatic colorectal cancer LBI HTA

Trastuzumab (Herceptin)

1st-line advanced HER2+ gastric cancer

CVZ LBI HTA

Pazopanib (Votrient) adv/metastatic renal cell carcinoma UVEV HAS LBI HTA CVZ NOKC

Sunitinib/ Sorafenib/ interferon alpha

renal cell carcinoma UVEF AHTAPol

HAS

Bevacizumab/erlotinib lung cancer AHTAPol ULSS20 HAS

Imatinib gastrointestinal stromal tumours AHTAPol UVEF

Pemetrexed lung cancer AHTAPol UVEF

Bevacizumab breast cancer AHTAPol NOKC

Aromatase inhibitors breast cancer IQWiG Klinikum Bremen

Imatinib CML, CLL, MDS AHTAPol Ipilimumab 1st-line adv melanoma LBI HTA Nilotinib 1st-line CML LBI HTA

Ofatumumab CLL UVEF NCPE ULSS20 Trabectedin (Yondelis) soft tissue sarcoma UVEF NOKC

Lenalidomide Newly diagnosed multiple myeloma ULSS20

Denosumab for patient with advanced cancer and bone metastases

ULSS20


17 March 2011


17 March 2011

e) Onco drugs workshop – Signed lists of attendees


17 March 2011


17 March 2011

f) LBI-HTA participation in EUnetHTA meetings 2010 9 Face-to-face meetings

• WP 1 face-to-face meeting, Copenhagen/Denmark, 25.-26.02.2010 (Claudia Wild)

• WP 4 face-to-face meeting, Helsinki/Finland, 18.03.2010 (Stefan Mathis)

• WP 6 face-to-face meeting, Paris/France, 15. -16.04.2010 (Gerda Hinterreiter, Marisa Warmuth)

• Plenary Assembly face-to-face meeting, Ljubljana/Slovenia, 20.-21.05.2010 (Claudia Wild)

• WP 7 face-to-face meeting, Dublin/Ireland, 10.06.2010 (Claudia Wild, Gerda Hinterreiter, Marisa Warmuth)

• WP 7B Onco drugs Workshop, LBI-HTA Vienna/Austria, 30.09.-01.10.2010 (Claudia Wild, Anna Nachtnebel, Katharina Hintringer)

• WP 6 face-to-face meeting, Brussels/Belgium, 12. -13.10.2010 (Gerda Hinterreiter)

• WP 1 & Executive Committee face-to-face meeting, Brussels/Belgium, 14. -15.10.2010 (Claudia Wild)

• WP 4 face-to-face meeting, Rome/Italy, 25.11.2010 (Stefan Mathis)

9 E-meetings 2010

• WP 1 & Executive Committee e-meeting, 03.02.2010, 13:00–14:30 (Gerda Hinterreiter, Marisa Warmuth)

• WP 6A & WP 7B e-meeting, Training for Workroom administrators, 11.03.2010, 12:00-13:00 (Gerda Hinterreiter)

• WP 1 & Executive Committee e-meeting, 07.04.2010, 13:00–14:30 (Claudia Wild, Gerda Hinterreiter)


• WP 1 & Executive Committee e-meeting, 30.06.2010, 13:00–15:00 (Gerda Hinterreiter)



• WP 6 & WP 7B e-meeting, POP database preparation, 22.09.2010, 11:00-12:30 (Claudia Wild, Gerda Hinterreiter)




EUnetHTA


YEAR 2010


2011-02-28


Work Package 8

Strategy and Business Model Development


2010


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Contents 1.Overview .......................................................................................................................................................... 3 2.Activities performed in 2010............................................................................................................................. 4

Development of the EUnetHTA JA Stakeholder Policy ................................................................................... 4 International seminar/workshop on “How to practically implement an effective collaboration between agencies from different countries” co-organised with KCE during Belgian EU presidency............................. 5 Business model development.......................................................................................................................... 5 Survey on use, barriers and training needs of EUnetHTA tools...................................................................... 5 Preparation and execution of the Survey on national strategies for continuous development and sustainability of HTA ........................................................................................................................................ 6 Meetings .......................................................................................................................................................... 8 Adherence to the Work Plan in 2010............................................................................................................... 8

3.Work Plan for the next period (2011) ............................................................................................................... 8 Meetings ........................................................................................................................................................ 10 Stakeholder and external expert involvement ............................................................................................... 10 Cooperation with other WPs / LPs................................................................................................................. 10 Gantt chart ..................................................................................................................................................... 10

4. Appendices .......................................................................................................................................... 10


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1. Overview

Work Package 8 Business Model Development

Lead Partner

• Lead Partner: National Board of Health of Denmark

AHTAPol (Poland) coordinates the component on facilitation of national strategies for continuous development and sustainability of HTA ISCIII (Spain) coordinates the component on HTA training and capacity building

Organisations Involved Associated Partners: 1. AGENAS, Italy 2. AHTAPol, Poland 3. CVZ, Netherlands 4. DIMDI, Germany 5. HAS, France 6. IPH-RS, Slovenia 7. ISCIII, Spain 8. KCE, Belgium 9. LBI, Austria 10. NETSCC, UK 11. SBU, Sweden 12. THL, Finland

WP8 Special line of Activity

Partners listed under a-l are only involved in the line of WP8 activities associated with the development of the following business model component “facilitation of national strategies for continuous development and sustainability of HTA and HTA training and capacity building”

a. Agency for Quality and Accreditation in Health Care, Croatia b. AIFA, Italy c. GÖG, Austria d. MoH, Czech Republic e. MoH, Spain f. NOKC, Norway g. NSPH, Greece h. Regione del Veneto, Italy i. SDU, Denmark j. SSD/MSOC, Malta k. UTA, Estonia l. VASPVT, Lithuania

Collaborating Partners:

1. Medical Informatics and Technology 2. ASSR, Agenzia Sanitaria e Sociale Regionale Regione

Emilia Romagna, Italy 3. Laziosanità (Agenzia di Sanità Pubblica, Regine Lazio,

Italy 4. University Hospital “A.Gemelli”, Italy 5. Quality unit, Ministry of Health of Serbia 6. CAHTAR, Spain 7. UETS, Spain 8. SNHTA, Switzerland


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9. KDTD Turkish Evidence-Based Medicine Association, Turkey

WP Objectives • Development of a general strategy and a business model for

sustainable European collaboration on HTA. • Construction of a detailed business model for collaboration

addressing the sustainability of the HTA collaboration within EU.


• Development of the stakeholder involvement policy and SOP • International workshop/seminar under the Belgian EU presidency • Business model development • Survey on use, barriers and training needs of EUnetHTA tools • Preparation and execution of the survey on national HTA

strategies


M6 Governance and management structure in place - achieved

M6 Stakeholder Forum established - achieved

M14 Workshop on the facilitation of the national HTA strategies development - achieved

M16 First drafts of the training and facilitation of the national HTA strategies development documents – on time

M18 First draft of the Business model ready for public consultation – on time

Deliverables

M10 Stakeholder Policy – delivered

M24 Business model for sustainability


• Preparatory work on organisation of the EUnetHTA Conference 2011 in Gdańsk, Poland, 8-9 December 2011


Development of the EUnetHTA JA Stakeholder Policy The Executive Committee with facilitation from the Secretariat and in consultation with DG SANCO developed the first draft and principles of the stakeholder involvement policy in the beginning of 2010. Two documents have been drafted to guide the stakeholder involvement process – a Policy document and a standard operating procedures document (SOP). The development of the policy for the whole of the EUnetHTA JA had to take into account varying tasks and specific activities and processes in each of the eight Work Packages as well as a focus on balanced representation of stakeholder interests in a stakeholder involvement mechanism. The complexity of and great number of the parties involved in the task to ensure representation of interests in the process and its outcome required an extended involvement and resource dedication, especially on the part of the Secretariat and WP Lead Partners.

The stakeholder policy development process included an open call for expression of interest by the stakeholder umbrella organisations to participate in the EUnetHTA JA Stakeholder Forum. The call was published on the EUnetHTA public website (see EUnetHTA public website News Archive). In addition, information about an opportunity to be involved in the EUnetHTA JA Stakeholder Forum was sent directly to a number of a European umbrella organisations that previously had indicated interest in the EUnetHTA JA stakeholder involvement activities. The call resulted in 18 applications. The Executive Committee found 17 eligible for further consideration by the Plenary Assembly.

The EUnetHTA Plenary Assembly reviewed the draft documents (stakeholder policy and SOP) and the proposed composition of the Stakeholder Forum. The composition of the Forum was endorsed by the Plenary Assembly and resulted in representation of each of the four identified stakeholder groups in the Forum (up to


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4 organisations in each stakeholder group), with additional 4 eligible organisations from the industry stakeholder group and 1 organisation from patient stakeholder group having an opportunity to participate in the activities of the EUnetHTA JA Stakeholder Forum without a seat.

The EUnetHTA JA Stakeholder Forum members and participants reviewed the drafts of the stakeholder policy and SOP. The Executive Committee adjusted the drafts prior the draft EUnetHTA Stakeholder Policy underwent a pubic consultation in July – August 2010 (see EUnetHTA public website News Archive and webpages dedicated to the EUnetHTA JA stakeholder involvement).

In autumn 2010, the EUnetHTA Executive Committee worked with the EUnetHTA JA Stakeholder Forum to finalise the stakeholder involvement policy and SOP. As a part of the process, the specifics on the involvement of stakeholders and external experts in the work of Work Packages were developed and three WP Stakeholder Advisory Groups (WP SAGs) were defined and formed. The preparation of WP SAG activities (including clarification of confidentiality handling issues) took place at the end of 2010, with actual activities of the WP SAGs commencing in 2011.

International seminar/workshop on “How to practically implement an effective collaboration between agencies from different countries” co-organised with KCE during Belgian EU presidency The workshop was organized by KCE under the auspices of the Belgian presidency of EU and was held on October 13-14, 2010 in Brussels, Belgium. The Minister of Health of Belgium opened the workshop. It was attended by 31 from the EUnetHTA partner and other organisations. The EUnetHTA Secretariat provided support in promoting the workshop and developing the workshop content. Representatives of the EUnetHTA Executive Committee made presentations during the meeting. The workshop resulted in a number of practical suggestions that are taken into account in the development of the EUnetHTA business model.

Business model development Initial understanding of the concept of a business model and prerequisites for its successful development and implementation was required before the start of actual work on its development. The Secretariat took an initiative to develop a first presentation of the concept of a business model in the discussions of the EUnetHTA Executive Committee. The concept of a business model was further presented during the Plenary Assembly meeting in Ljubljana on May 21-22, where the first discussions of the approaches to developing the EUnetHTA business model were discussed. During the face-to-face meeting of the WP1 / Executive Committee and representatives from DG SANCO further clarification of the value and products to be offered by EUnetHTA were discussed as well as better understanding of the potential EUnetHTA customers. It was clarified with the Executive Committee that the upcoming complementary joint action on HTA should be considered when developing the business model further.

The review by the EUnetHTA partners and associates will take place in spring 2011 prior to public consultation in June 2011, after further clarifications and agreement on the main components of the EUnetHTA business model.

Survey on use, barriers and training needs of EUnetHTA tools A survey of use, barriers and training needs of EUnetHTA tools (M1-M4) was designed, including a session to discuss the design in a WP8 face to face meeting that took place in Warsaw in April. The positive cooperation between WP2, WP3, WP6 and WP8 lead to including questions from WP8 in the WP3 baseline survey, which is the main internal evaluation tool during project.

The survey included the following five questions about the following EUnetHTA tools: Adaptation Glossary; Adaptation Toolkit; Contact Database; Core HTA Model; EIFFEL; E-meetings; EUnetHTA toolbar; Mailing list; MO website; MO workrooms; News Aggregator; POP Workroom; Workroom Bulletin Boards.

The survey was launched on May 3rd to the 175 project participants, and closed on June 15th. The response rate was 88% (154 of the 175 recipients replied). The survey results were analysed in order to identify the perceptions that participants in EUnetHTA JA have of training possibilities, barriers and suggestions they made to overcome those problems (please see the WP3 report).


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Preparation and execution of the Survey on national strategies for continuous development and sustainability of HTA Objective WP8 special line of activities “Facilitation of national strategies” has as its objective the preparation of a document on short and long-term national strategies which will constitute a part of the Business Model for sustainability of HTA delivered by WP8. In order to do it, the broad research on the current situation of HTA within EU countries was required. The objective of the survey was to investigate the current experience, stage of development, needs, scopes, outcomes with emphasis put on factors limiting HTA capacity in HTA institutions, organisations or units all over the Europe. The results of the survey will enable reaching the consensus in defining the general strategy for continuous development as well as give practical support for overcoming common barriers, improving structures and processes in established and non-established HTA, regarding cultural, socio-economic, political and organisational differences between the countries. This required active participation of the EUnetHTA JA partners as well as involvement of identified third parties in producing the deliverable: A set of recommendations on national specific strategic plans for the establishment and improvement of HTA. Methodology The methods used to reach the objectives were based on the literature review and work done in previous projects (EUnetHTA 2006-2008 WP8, EUnetHTA Collaboration 2009), as well as EUnetHTA JA WP8 partners consultation. A cross-sectional study by means of a semi-structured questionnaire of HTA organisations was carried out. The selection of questions to be included, questionnaire dissemination strategy and target group of HTA organisations were discussed during e-meetings and a workshop in Warsaw with HTA experts associated with WP8. In order to ensure the study feasibility, a pilot questionnaire among (14) respondents was conducted in May 2010. As comments on clarity of questions and technical issues due to questionnaire form (Excel file) were received, further modifications were made after discussion and reaching consensus. Subsequently, in the period from 31th May till (4th October) the final version of questionnaire was administered via e-mail. Reminders were carried out between 1st July and 31th August 2010 by means of e-mails and phone-calls. Additionally, organisations with uncertainties concerning the e-mail address were contacted by phone. It was assumed that the survey should be completed by one person from each organisation. The designated person should fill the survey on behalf of the entire organisation, if necessary in consultation with other people from the organisation. Completing of the questionnaire took about 30 minutes. Participants were informed that their individual responses would not be disclosed to any other organisations or individual person without the consent. The questionnaire has three sets of questions: one for organisations that already perform HTA activities, the second for those who plan to start their HTA activities and the third for all the respondents. The questionnaire for organisations performing HTA activities consisted of 22 questions whereas the questionnaire for organisations which declared being interested in performing HTA activities in the future comprised from 16 questions. There were 47 questions for both groups. All the questions were incorporated in seven different sections: general information, HTA products, finances, legal aspects, management, human resources and technical resources. There was also additional “summary” question. The survey included a total number of 68 questions from which 27 were multiple-choice questions, 29 were single-choice questions, and 10 were open-ended. Two more questions evaluating the barriers against the process of HTA organisation establishment and performance of ordinary HTA activities were rated using 0-5 Likert scale. Participants The list of HTA-related organisations consisting the target group for questionnaire dissemination was compiled by merging the information from various sources: e.g. directory of EUnetHTA, INAHTA members, websites of existing HTA units directories, agencies or programs and information from EUnetHTA partners. The Internet was searched for the organisations’ homepages and further contact data. Any identified organisation regardless of its location, financial profile or HTA involvement status mentioned within one of these sources was included. The questionnaire was eventually sent to 102 target organisations from 33 countries. The deadline for response was set for the 5th October 2010. Response rate


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Out of 102 questionnaires distributed among identified target group of organisations, a total of 35 responses were received, representing a 36.3% response rate. From thirty five answered questionnaires, thirty were obtained from organisations that already have established HTA and perform HTA – related activities, while five came from organisations planning to get involved into HTA. Respondents originated form 20 European countries, with the distribution of study participants within each country as follows: Austria (3), Czech Republic (1), Croatia (1), Denmark (2), Estonia (1), Finland (1), France (1), Greece (1), Hungary (1), Italy (10), Lithuania (1), Malta (1), Netherlands (1), Poland (1), Romania (1), Slovakia (1), Slovenia (1), Spain (4), Sweden (1), United Kingdom (1). Measurements All the questions were incorporated in seven sections, varying according to information to be obtained: General Information: aimed to obtain information concerning the profile, experience and background of the respondent’s organisation as well as the contact details. The section consisted of 12 questions; HTA products: 7 questions (six multiple-choice questions and one single-choice question) concerning HTA products were included in this section. The questions aimed to obtain information about organisations’ HTA products. Finances: 9 “yes or no” questions and 2 multiple choice questions were included in this part of the questionnaire. These questions aimed to obtain information about funding sources of the organisation’s current and/or future HTA activities and methods of financial management used to support sustainable realization of projects in field of HTA in respondent’s organisation; Legal aspects: questions in this part of questionnaire aimed to obtain information about regulatory framework and legislative environment of respondent’s HTA organisation. The section consisted of 8 single-choice questions and one multiple choice question. Management: the section consisted of 11 questions aimed to obtain information about management environment of the HTA organisation, ongoing activities in the area of HTA and stakeholders’ policy in respondent’s country; Human resources: the section consisted of 10 questions aimed to obtain information about human resources in respondent’s HTA organisation; Technical resources: three questions in this section aimed to obtain information about technical resources in respondent’s organisation. In the summary part of the questionnaire 5 questions concerning the rating of common barriers in the process of HTA organisation establishment and HTA performance as well as problem solving strategies employed were asked. Data analysis Standard descriptive analyses were conducted to characterise the respondents’ organisations and response rate. The content of open-ended questions was analyzed for each question separately. For other kinds of questions, distribution of responses as numerical and percentage rates was calculated. The MS Office Excel program was used to perform statistical analysis of data. The institutions were divided according to their commitment to HTA activities: those who declared being already involved in formalized HTA activities (called “HTA Doers”) and those who stated that were planning to perform HTA activities (called “HTA non-doers”). Results for each group were analyzed separately. Based on the Summary section of questionnaire the barriers against the process of HTA organisation establishment and performing the ordinary HTA activities were identified and rated. Subsequently four main barriers were chosen for further analysis. The respondents were further divided into 3 groups according to estimated strength of each barrier, which was graded 6 point scale (where 0 corresponded to “no barrier”, 1-2 to “moderate barrier” and 3-4-5 to “strong barrier”). The relationship between these barriers and corresponding questions has been investigated.

For full analysis of the survey – see enclosed “Document on the survey results”.


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Meetings No separate WP8 meetings was organised - except for the WP8 meetings scheduled for the “HTA capacity and facilitation of national strategies for HTA sustainability” line of activities – please see below:



M4 2010-05- 11/12

Warsaw (PL)

1 WP8 partners a-k

The objective of the meeting was to discuss and agree on proposed thematic areas and target groups and furthermore on specific questions for the planned survey.

There were 22 participants from 10 countries.

Adherence to the Work Plan in 2010 The review of the draft business model by the EUnetHTA partners and associates was postponed to spring 2011. This does not affect the achievement of the official milestones and deliverables on time as originally planned. All other activities of WP8 were performed on time as initially planned.

3. Work Plan for the next period (2011) Business model development - II Planning

M13-M18 – development of the 1st draft of the Business Model for the public consultation; involvement of the business model consultancy to run an interactive session with the Executive Committee / WP1 to specify the components of the EUnetHTA business model (WP1 / Executive Committee meeting on March 21-22, 2011 in Paris).

M18 – public consultation

M19-M22 – review of public consultation and adjustment of the model

M23-24 – final preparations and launch of the model (including the EUnetHTA Conference in Gdansk to support the launch of the model)

Target group

Healthcare decision makers, politicians, MoH representatives, EU Institutions, identified stakeholder groups, general public, EUnetHTA Executive

Parties involved

EUnetHTA Executive, Secretariat, all EUnetHTA partners

HTA capacity and facilitation of national strategies for HTA sustainability – special component of the business model development

Planning

AHTAPol:

M13 – February 2-4, Warsaw: The survey identified 4 main barriers in HTA development, namely :Funding, Shortage of trained staff, Political interest and Agreement with Stakeholders.

The next (2nd) f-t-f meeting in Warsaw planned for 2-4 February 2011 is aimed at analysis of these four barriers with WP8 involved partners. The results of the discussion of the working groups will be the basis for a future document on the National Strategies. The participation of external experts (whose role will be facilitation of the working groups) is planned.

M13-M16 – working on the 1st draft of the “Facilitation of the national HTA strategies development document’


2011-02-28

M14-M16 - regular e-meetings to finalize the document and to prepare the Ljubljana meeting

M16 - 1st draft of the Facilitation of the national HTA strategies development document ready

M16 – consensus meeting in Ljubljana: the consensus meeting in Ljubljana will focus on discussion on the draft document on the National Strategies. The objective of the meeting is to agree and endorse the final content of the document.

M16-M23 – development of the Facilitation of the national HTA strategies development document final version.

M23 - final document ready

ISCIII:

Survey on use, barriers and training needs of EUnetHTA tools

M13-16 Work on the analysis of survey results

M14 Discussion about survey results in a face to face meeting in Warsaw

Document about requirements, opportunities and risks of the process of training applied to EUnetHTA tools

M13-16 Work on the document

M16 Document submitted to the EUnetHTA Secretariat

Training programme

M13- M16 Elaborate a curriculum for a training programme on EUnetHTA tools

M17-M23 Work on the design of a training programme

M24 Delivery of the course

Target group

AHTAPol: identified survey participants, healthcare decision makers, politicians, MoH representatives, Executive Com

ISCIII: EUnetHTA partners

Parties involved

AHTAPol: EUnetHTA WP8 partners (AP+CP)

ISCIII: EUnetHTA partners (AP+CP)

EUnetHTA Stakeholder involvement Planning

M13-M16 – regular communication with Stakeholder Forum, planning of the Stakeholder 2nd meeting, support to stakeholder involvement activities in WPs,

M17 – Stakeholder Forum meeting (May 3, Brussels)

M18-M24 - support to stakeholder involvement activities in WPs, public consultation (if any planned)

Target group

Identified stakeholder groups, EU institutions, EUnetHTA partners

Parties involved

EUnetHTA Executive, Secretariat, EUnetHTA Partners; Stakeholder Forum members


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Meetings



2011-02-02 Warsaw (PL)

2,5 days (2 nights)

All WP8 special line of activities

Group working on 4 main barriers identified by the survey

2011-06-?? Ljubljana (SLO)

2 days All WP8 special line of activities

Consensus meeting – presentation of the draft document on the National strategies, revision, endorsement of the document by the partners

Stakeholder and external expert involvement The participation of external experts is planned in the 2nd Warsaw meeting in February and also in consensus meeting in Ljubljana in June.

Facilitation of the stakeholder involvement activities through the mechanism of the Stakeholder Forum and Executive Committee cooperation.

Cooperation with other WPs / LPs Co-operation with CVZ, Holland on the organisation of the EUnetHTA Conference 2011 in Gdańsk

Gantt chart

4. Appendices WP8.1 Stakeholder Involvement Policy

WP8.2 Stakeholder Involvement SOP

WP8.3 Agenda, May 11-12, 2010 meeting

WP8.4 Survey on the national HTA strategies

WP8.5 Document on the survey results

eunethta interim technical report year 2010 · from the european union, in the framework of the...

Documents