JA2 Archive (2012 – 2015)

EUnetHTA Joint Action 2 (2012-2015)

General Objectives

See a full list of all JA2 deliverables below on this page

The general objective of the EUnetHTA Joint Action 2 (JA2) on Health Technology Assessment (HTA) was to strengthen the practical application of tools and approaches to cross-border HTA collaboration. The JA2 aimed at bringing collaboration to a higher level resulting in better understanding for the Commission and Member States of the ways to establish a sustainable structure for HTA in the EU. Specifically, the JA2 was to develop a general strategy, principles and an implementation proposal for a sustainable European HTA collaboration according to the requirements of Article 15 of the Directive for cross-border healthcare.

The strategic objectives of the JA2 were:

• To strengthen the practical application of tools and approaches to cross-border HTA collaboration
• To aim at bringing collaboration to a higher level resulting in better understanding for the Commission and Member States (MS) of the ways to establish a sustainable structure for HTA in the EU
• To develop a general strategy, principles and an implementation proposal for a sustainable European HTA collaboration according to the requirements of Article 15 of the Directive for cross-border healthcare.

See the Technical Annex of the JA2 Grant Agreement with the Commission

See the full list of partners

Work Packages

JA2 WP1 – Coordination

JA2 WP2 – Dissemination

JA2 WP3 – Evaluation

JA2 WP4 – Testing collaborative production of HTA information for national adaptation and reporting

JA2 WP5 – Applying the HTA Core Model for Rapid Assessment for national adaptation and reporting

JA2 WP6 – Information Management Infrastructure and Services (IMIS)

JA2 WP7 – Methodology development and evidence generation: Guidelines and pilots production

JA2 WP8 – Maintenance of HTA Core Model infrastructure to support shared production and sharing of HTA information

Stakeholder Involvement

The EUnetHTA JA Stakeholder Involvement Policy developed during EUnetHTA Joint Action 1 continued to apply during the EUnetHTA JA2 (EUnetHTA JA2 Grant Agreement conditions apply where necessary and appropriate).

• EUnetHTA JA Stakeholder Involvement Policy
• EUnetHTA JA Stakeholder Involvement Standard Operating Procedures (SOP)
• EUnetHTA JA Expert Involvement Standard Operating Procedures (SOP)

The following adjustments in the procedures were agreed and approved by the Plenary Assembly to be applicable in the EUnetHTA JA2 stakeholder involvement activities:

• Increase the number of organisations per stakeholder group from 4 to 6 in the EUnetHTA Stakeholder Forum meetings
• All applying organisations found eligible for participation in the EUnetHTA Stakeholder Forum received a status of a Stakeholder Forum member
• The stakeholder group members were responsible to organise themselves for the participation in the Stakeholder Forum meetings (with the maximum number of meeting participants per stakeholder group limited to 6)
• New forms of stakeholder involvement (in addition to the Stakeholder Forum and Stakeholder Advisory Groups (SAGs) eg, expert meetings, was introduced
• Earlier involvement of stakeholder expertise was to be considered
• Adequate time to provide input was to be allowed

Deliverables and Other Outputs

Deliverables

1. Recommendations on the implementation of sustainable European network for HTA
2. Final Technical Report
3. Report on yearly training courses on EUnetHTA tools and methodology
4. Report on evaluation of project completion including assessment of impact on secondary users of HTA information – will be published when available (end of March 2016)
5. Full Core HTAs
6. Pilot rapid assessments
7. Report on Information Management Infrastructure and Services
8. Guidelines and pilots to improve quality and adequacy of initial and additional evidence generation:

• Report on lessons learned on disease-specific guideline development (not delivered)
• Report on 11 Early Dialogues (9 for pharmaceuticals and 2 for medical devices) (not delivered)
• Consolidated procedure for Early Dialogues
• Common Core Protocol on AEG
• Position Paper on Study Design
• Position Paper on research recommendations
• 5 methodological Guidelines, 1 reflection paper, 9 updated JA1 Guidelines

1. Submission template for Pharmaceuticals and Submission template for Medical Devices
2. Upgraded and updated application package of HTA Core Model

 

Other official Outputs

1. Communication Strategy and updated recommendations (internal document)
2. Training Strategy
3. Report on e-learning production
4. Methodological Standards and Procedures for full/comprehensive Core HTAs
5. HTA Core Model for Rapid REA
6. Procedure Manual Strand A: Rapid Relative Assessments of Pharmaceuticals
7. Procedure Manual Strand B: Rapid Assessments of other health technologies such as medical devices, surgical interventions or diagnostics
8. Project Plan Template Strand A (available upon request to the coordination team)
9. Project Plan Template Strand B (available upon request to the coordination team)
10. Assessment Template Strand A (available upon request to the coordination team)
11. Assessment Template Strand B (available upon request to the coordination team)
12. Updated EVIDENT database
13. Report on results of the cooperation with the technology manufacturer in applying the HTA Core Model® in their internal processes
14. Training material on the HTA Core Model