EUnetHTA Assembly May 2018

https://www.polleverywhere.com/multiple_choice_polls/WW4ChbtMteqOiXh

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

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

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

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)

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.

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

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

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

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

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

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

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

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

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

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)

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

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

Timely output

Timely output