Summary

• supports the work of the Coordination Group and acts as its secretariat
• decides on conflict of interest
• requests the dossier from the health technology developer
• supervises the procedures for joint clinical assessments
• provides administrative, technical and IT support
• publishes information and documents
• facilitates the cooperation, through the exchange of information, with the European Medicines Agency, and with expert panels and the Medical Device Coordination Group on the joint work 
• establishes a stakeholder network

• Member States designate their members of the CG (Each MS has one vote)
• The members of the CG designate their national or regional authorities and bodies as members of subgroups of the CG, which will include HTA experts
• The CG establishes subgroups, for the following:
  
  • Joint Clinical Assessments;
  • Joint Scientific Consultations;
  • Identification of emerging health technologies;
  • Development of methodological and procedural guidance
• Main duties of the CG include:
  
  • Working closely with the EU Commission.
  • Coordination of the subgroups
  • Identifying emerging health technologies
  • Creating strategic and methodological guidance documents for subgroup work
  • Specification of procedural steps and timeframes for JCA, updates of JCAs and JSCs 
  • Involving stakeholder organisations

• Consist of patient associations, consumer organisations, non-governmental organisations in the field of health, health technology developers and health professionals 
• Cupports the work of the Coordination Group and its subgroups upon request
• Shall meet with the Coordination Group at least once each year

• Occurs before JCA for technologies likely to undergo JCA
• Requested by the developer
• Aims to guide evidence generation for later JCA
• Includes a meeting and ends with a scientific recommendation document

• limited to the description of the health technology and factual review of its technical and clinical characteristics (the clinical domains)
• MS are still responsible for the assessment of all non-clinical aspects (non-clinical domains) and the ensuing conclusions, such as added value, pricing and reimbursement

Process:

• Initiation by the subgroup by appointing a suitable assessor and co-assessor from different MS.
• Subgroup establishes the scope of the JCA must include all relevant parameters regarding: 
  
  • The patient population
  • The intervention or interventions
  • The comparator or comparators
  • The health outcomes
  • Information provided by the health technology developer
  • Inputs received from patients, clinical experts and other relevant experts
  • MS interests
• Health technology developer submits a dossier containing all the necessary information on the technology on request from the Commission. A company may not submit evidence at a national level that is already available at EU level.
• Performance of the assessment by assessor and co-assessor based on the dossier and the defined assessment scope.
• They may also consult databases and other sources of clinical information, such as patient registries.
• Preparation of the report The assessor and co-assessor create an analytical assessment report and a summary report draft. 
• Comments from subgroup members, the health technology developer and others, including patients, are incorporated
  The revised draft is sent to the Coordination Group.
• Review of the report by the CG and endorsement
• The report is published on the IT platform established by the Commission for finalisation.