1. EUnetHTA Assembly May 2018

3. Why an HTA initiative? Background
More than 20 years of cooperation: projects, joint actions
ACHIEVEMENTS
LIMITATIONS
Trust between HTA bodies
Capacity building
Development of joint tools (e.g. EUnetHTA Core Model, POP EVIDENT databases)
Piloting joint work (e.g. early dialogues, joint assessments)
Low uptake of joint work  duplication of work
Differences in the procedural framework and administrative capacities of Member States
Differences in national methodologies
No sustainability of current cooperation model

4. Key milestones Background - Inception impact assessment (IIA)
- Published September 2016
- Consultation
- Online public consultation – Report May 2017
- Meetings with EUnetHTA JA3 and HTA Network
- Discussions with stakeholders
- Studies to support the IA process
- Impact assessment – finalised October 2017
- Commission legal proposal – 31 January 2018

5. OBJECTIVES Operational objectives
• Promote convergence in HTA tools, procedures and methodologies
• Reduce duplication of efforts for HTA bodies and industry
• Ensure the uptake of joint outputs in Member States
• Ensure the long-term sustainability of EU cooperation

6. OUTCOMES Expected outcomes Member States Patients Industry
High quality and timely reports
Pooling of expertise  specialisation of HTA bodies
Better allocation of resources
Savings in the long run, contribution to sustainability of healthcare systems
Patients
Increased transparency
Increased engagement in the HTA process at national and EU level
Potential faster access across EU
Industry
Positive impact on business predictability, competitiveness and innovation
Savings (reduced duplication)

7. PROPOSAL The Regulation establishes:
Article 1
The Regulation establishes:
support framework and procedures for cooperation on health technology assessment at Union level
common rules for clinical assessment of health technologies
The Regulation shall not affect the rights and obligations of Member States with regard to the organisation and delivery of health services and medical care and the allocation of resources assigned to them.

8. Key elements (1) PROPOSAL
Provides support framework and procedures for EU cooperation on HTA
Well defined scope
Article 5
Medicinal products with central marketing authorisation:
New active substances
New therapeutic indications for existing substances
Medical devices classified as class IIb and III for which the relevant expert panels have provided a scientific opinion in the framework of the clinical evaluation consultation procedure
In vitro diagnostic medical devices - class D for which the relevant expert panels have provided their views in the framework of the clinical evaluation consultation procedure
the transition period
Selection during
Selection
permanent

9. Examples of high-risk medical devices
PROPOSAL
Examples of high-risk medical devices
High risk devices
IIb), III and IVD class D subject to opinions of expert panels under the medical devices regulation

10. Key elements (2) PROPOSAL Focus on clinical aspects
Enable synergies between regulatory and HTA issues
Defined areas of join work:
Joint scientific consultations/JSC (early dialogues)
Joint clinical assessments/JCA (REA)
Horizon scanning
Voluntary cooperation
Articles 11, 16
Articles
5-11
Articles 12-17
Article 18
Article 19

11. Areas of joint work Building on the work of EUnetHTA JAs
PROPOSAL
Building on the work of EUnetHTA JAs
Areas of joint work Building on the work of EUnetHTA JAs

12. Key elements (3) PROPOSAL Member States driven approach
National agencies to do scientific work
Annual programme decided by the Coordination group
Approval of joint reports by Coordination Group
EC to provide secretariat (administrative, scientific, IT)
EC to publish the joint reports
Obligations for health technology developers to submit a dossier
Obligations for HTA bodies not to repeat the joint clinical assessments
Articles 6, 13
Articles 3-4
Articles 6, 13
Article 25
Articles 7, 27
Article 5
Article 8

13. Member State-driven approach
PROPOSAL
Article 3
Member State-driven approach
 HTA Coordination Group (CG)
Member State-led  members designated, one or more authority or body
Will manage the overall governance of the joint work
Will meet regularly to provide guidance and steer the cooperation.
Will work based on an annual work programme developed and adopted by the Group

14. Key elements (4) PROPOSAL High quality – Member States experts
Timely output
For medicinal products – by the time of publication of the EC Decision granting marketing authorisation
For medical devices  flexible timeline (at or after market launch)
Transparency and independence
Pragmatic phase-in approach
Recitals
17-18
Article 22.1.
Articles 33, 36

15. Preparation of JCA Report
Article 6
Health technology developer (HTD)
Obligatory submission of documentation (comprehensive evidence)
Coordination Group
Joint clinical assessment (JCA) Sub-group
Verify completeness of documentation: if needed request additional information from HTD
Analyse the documentation submitted
Incorporate input from the other members of the SG in the preparation phase (e.g. comparators, patient populations, endpoints)
Consult and incorporate input from external experts (patients, clinical experts)
Prepare JCA draft report, incorporating comments from the other members of the SG
Submits final JCA report to the CG
Draft
JCA report
Assessor & co-assessor
Coordination Group
Approval
Final JCA report -> Publication by EC

16. PROPOSAL
Article 26
MP = medicinal products, MD = medical devices

17. Assessment vs appraisal
Article 6, 8, and Recital 16
Joint clinical assessment
Conclusions limited to:
(a) an analysis of the relative effects of the health technology being assessed on the patient-relevant health outcomes chosen for the assessment
(b) the degree of certainty on the relative effects based on the available evidence. EU 1
NATIONAL
NATIONAL APPRAISAL
of joint clinical assessment and additional context-specific considerations (e.g. number of patients affected in MS, how patients are currently treated in the healthcare system, costs) +/- economic, ethical organisational, legal
Conclusions on added value (e.g. added therapeutic value, cost-effectiveness…) 28
NATIONAL DECISION MAKING (e.g. P&R)

18. Phase-in approach Timeline Articles 33, 36 + Recitals 29-30
DRAFTING
IMPLEMENTING
AND DELEGATED ACTS
CO-DECISION
PROCEDURE
3 years
3 years
Commission
proposal
Entry
into force
Date of
application
All MS
Transition
period
Member States may delay their participation in the system of JCA and JSC until 3 years after the date of application
Prioritization of health technologies subject to JCA, JSC
+ Recitals 29-30

19. Contact: SANTE-HTA@ec.europa.eu
Thank you!
Contact:

20. Timely output

21. Timely output