- The European Medicines Agency (EMA) and EUnetHTA have published a new joint document work plan for 2021-2023, outlining the main areas of activity and expected outcomes through the upcoming joint EU HTA initiative.
- The document is a product of the European Commission inviting the two organizations to establish a joint work plan for delivering on previously identified priorities. According to the plan, deliverables on the HTA side will be actioned either by EUnetHTA21 if related to their service contract delivery or alternatively through individual HTA bodies from the consortium or beyond who are from a European (EU/EEA) Member State and express interest to participate.
- The two groups recognize that the implementation of the activities needs to be flexible, so that “such collaborative work can transition into a legislative framework on European HTA cooperation, once adopted”.
BRUSSELS, Belgium—The European Medicines Agency (EMA) and EUnetHTA have published a new joint document work plan for 2021-2023, outlining the main areas of activity and expected outcomes through the upcoming joint EU HTA initiative.
The document is a product of the European Commission inviting the two organizations to establish a joint work plan for delivering on previously identified priorities. According to the plan, deliverables on the HTA side will be actioned either by EUnetHTA21 if related to their service contract delivery or alternatively through individual HTA bodies from the consortium or beyond who are from a European (EU/EEA) Member State and express interest to participate.
However deliverables occur, the EMA and the EUnetHTA21 secretariat will keep oversight of all activities.
Before delving into the logistics of the priorities, the two groups recognize that the implementation of the activities needs to be flexible so that “such collaborative work can transition into a legislative framework on European HTA cooperation, once adopted”.
EU Joint HTA
The European Commission recently adopted the Regulation on HTA, paving the way for new rules that will allow health technologies — such as innovative medicines, certain medical devices, medical equipment and prevention and treatment methods — to be assessed under a joint European HTA system.
Following the adoption of the Regulation, it is slated to begin in January 2025, but implementation efforts will begin immediately. The Commission is working on setting up the necessary governance structure and preparatory documents to ensure effective application from this date.
According to the Commission, the Regulation will ensure the “efficient use of resources, strengthen the quality of HTA across the EU, save national HTA bodies and industry from duplicating their efforts, reassure business and ensure the long-term sustainability of EU HTA cooperation”.
Priority areas in the joint work plan include joint scientific consultation for robust evidence generation, generation of patient-relevant data and information to support decision-making, and methodologies to engage patients and healthcare professionals.
Among the key activities listed in the document, the initiative plans to focus on the following:
Joint scientific consultation (JSC) for robust evidence generation, including post-licensing/launch evidence generation
- Relaunch of a European procedure for Joint Scientific Consultation involving HTA bodies and EMA (previously known as parallel scientific advice/parallel consultation/Early Dialogue)
- Optimizing utilization of registries for post-licensing/launch evidence generation to support decision-making
Exchange of information on the respective assessments of medicinal products by regulators and HTA bodies
- Fostering opportunities for information exchange between regulatory assessors and HTA authors on identified products of mutual interest, including ATMPs
Generation of patient-relevant data and information to support decision-making
- Fostering development of methodologies in order to enable stronger reliance on patient-relevant data in the context of decision-making
Methodologies for engagement of patients and healthcare professionals
- Deepening the mutual experience/exchange on the involvement of patients and healthcare professionals in activities, with a focus on challenges of mutual interest
- Supporting targeted consultations in the context of assessment activities
Horizon scanning and preparedness of HTA and regulatory systems
- Sharing horizon scanning activities and outcomes
- Joint discussion of challenges stemming from high-impact, innovative medicines that address an unmet medical need
Continuous optimization of regulatory outputs as reference for downstream decision-making
- Further optimization of the regulatory assessment report to facilitate uptake of regulatory consideration in the context of HTA
- Continue sharing experience on labelling and EPARs information, e.g., regarding information on subpopulations
- Optimizing the published information on orphan medicinal products
Developing study methods and guidelines for real-world evidence, including for registries
- Collaborative work on registry methodologies
- Collaborating on establishing the evidentiary value of real-world evidence
- Supporting access to and analysis of real-world data
Extrapolation and evidence transfer as a tool to support assessment in smaller populations
- Joint methodological work on the concept of extrapolation/evidence transfer to better understand each other’s reasoning for accepting extrapolation
Practices in the context of assessment work related to companion diagnostics
- Share practices and experiences with companion diagnostics
The working document specifies which of the priorities will be actioned as part of EUnetHTA21 deliverables and which will be undertaken as a voluntary activity by individual HTA bodies.
Assessor Selection Criteria
The European Health and Digital Executive Agency (HaDEA) awarded the EUnetHTA consortium the service contract for the provision of joint health technology assessment (HTA) work supporting the continuation of EU cooperation on HTA, which will run for 24 months up to September 2023.
In February, EUnetHTA 21 launched a public consultation on the selection criteria for assessor and co-assessor of Joint Clinical Assessments (JCA). The consultation ran between March 7 and April 5, 2022, until 23:59 CET on the March date, and general principles for public consultation can be found here.
The EUnetHTA 21 joint consortium is led by ZIN (The Netherlands) and includes the following HTA agencies: AEMPS (Spain), AIFA (Italy), AIHTA (Austria), GBA (Germany), HAS (France), INFARMED (Portugal), IQWIG (Germany), KCE (Belgium), NCPE (Ireland), NIPN (Hungary) and NOMA (Norway).
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