Summary
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In summary the Regulation (Eu) 2021/2282 Of the European Parliament and of the Council of 15 December 2021 on health technology assessment (HTAR) establishes:
- a support framework and procedures for cooperation of Member States on health technologies at Union level;
- a mechanism by which any information for the JCA is to be submitted by the health technology developer only once at Union level;
- common rules and methodologies for the JCA of health technologies.
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- 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
The main parties and key procedures under the HTAR are shown in the following figure:
Figure 9: High Level Graph of main parties and key procedures under the HTAR. Adapted from: EU HTAR 2021/2282 – What the Harmonized HTA Will Bring, Johner Institute (2022)https://www.johner-institute.com/articles/health-care/and-more/eu-hta-regulation-2021/2282-what-the-harmonized-health-technology-assessment-will-bring/
Procedures
- 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.