Introduction of the HTACG and HAG
Two Health Technology Assessment (HTA) organisations have been set up in recent years to try and establish a coordinated HTA network to oversee the EUnetHTA process, and implementation of the HTA regulation within national settings.
In 2021, the Heads of HTA Agencies Group (HAG) launched, as an independent body, with the aim of collaborating 20 HTA agencies across Europe to facilitate ‘high level strategic exchange and discussion’ in favour of EUnetHTA. As of April 2023, the group now has 32 members from across Europe.
The Coordination Group on Health Technology Assessment (HTACG) was established in June 2022 by the Regulation on Health Technology Assessment (HTAR) tasked primarily to coordinate and adopt methodological and procedural guidelines of EUnetHTA.
Although there is a shared membership of many HTA agencies in both the HTACG and HAG, the HAG’s focus is committed towards complementing the processes and developments of the HTACG and supporting relevant EU institutions and national HTA bodies.
The HTACG adopts and coordinates the procedural and methodological guidelines developed by its subgroups on the Joint Clinical Assessment (JCA) and Joint Scientific Consultations (JSC). These subgroups were established in the HTACG’s second meeting. During the transitional phase all subgroups will be established in one configuration covering both medicinal products and medical devices .
What progress has been made with the planned deliverables?
To date, all deliverables for methodological components planned under the EUnetHTA have been published. In the table below a progress update is indicated for the other deliverables.
|4.3||Practical and Methodological Guideline on Direct and indirect comparisons||Finalised|
|4.5||Applicability of evidence||Finalised|
|4.6||Validity of clinical studies||Finalised|
|4.7||Assessment of high-risk medical devices/EUDAMED data reporting template/Guidance for EUDAMED-based TISP process||Finalised|
|Joint Clinical Assessment (JCA) / Collaborative Assessment (CA)|
|5.1||JCA/CA Submission Dossier Template||Finalised|
|5.2||JCA/CA Assessment Report Template||Finalised|
|5.3||Procedural guidelines for appointing assessors and co-assessors/HTAb technical expert working groups||Finalised|
|5.4||Production of JCA/CA on medicinal products and medical devices||Project plan will be published once the compound/medical device is known|
|Joint Scientific Consultations (JSC)|
|6.1||Production JSC||Nothing will be made public due to confidentiality procedures|
|6.2/3||Template briefing book and JSC report||Expected September 2023|
|6.4||Procedural Guideline JSC||Expected September 2023|
|7.1||Guidance for the interaction between HTD and HTA (for JCA and JSC)||Finalised|
|7.2/3||Guidance and template for the interaction with patient representative, healthcare professional and other experts||Finalised|
|7.4||Guidance for identifying and handling conflict of interest (COI) and declaration of interest (DOI) – and EUnetHTA confidentiality agreement (ECA) forms||Finalised|
What do recent publications mean at national level?
Notably, the deliverable D4.4, Practical Guideline on Endpoints was produced in January which aimed to provide guidance to Member States through two key objectives. The first by defining relevant outcomes during the scoping process (guideline D4.2) , and secondly how assessors and co-assessors can report all elements needed Member States to carry out national appraisal of the clinical value of a health technology. The intention of the guideline was to combat the heterogeneity that exists between relevance and interpretation of clinical outcomes between Member States. Key takeaways from the published guideline include:
- EUnetHTA guidelines recommend that outcomes should be long-term or final where possible and considered in collaboration with patients and healthcare professionals. The final decision remains up to the individual Member State. Surrogate outcomes should only replace a final patient-centred outcome of interest if necessary and must be validated. Association between the surrogate and patient-centred outcome should be demonstrated in the JCA reporting.
- Use of Core Outcome Set (COS) as a standardised set of outcomes defined at an international level is preferable for specified therapeutic areas, and recommendations from well-established COS should be considered in the assessment scoping process. Involvement of stakeholders from patients, caregivers and healthcare professionals will ensure that patient-centred outcomes will be identified and can complement the use of COS.
- In terms of safety, any need for a specific adverse event must be requested, and the JCA must report these. The guideline outlines the safety terminology that will be used in JCA reporting.
- The last section to the document focuses on validity, reliability and interpretability of outcome measurement instruments. The guideline outlines the requirements for JCA reporting such as specifying the main source of information for a given outcome, and references.
In general, the practical guideline produced by the HTACG does not endorse any criteria, but encourages standardising relevant outcomes, through wording templates, to mitigate the heterogeneity between Member States. It demonstrates how the HTAR will encourage adoption of the JCA at the national level. Further, the guideline provides safety criteria and a framework for outcomes measurement instruments between Member States.
What can we expect next?
In December 2022, the Coordination Group initiated a call for applications to select members for the Health Technology Assessment Stakeholder Network. The HTACG are looking to establish a network with stakeholder’s from organisations such as: patient associations, consumer organisations, health technology developer associations, health professional organisations and other relevant non-governmental organisations in the field of health . The European Commission has evaluated the applications and the list of successful organisations will be published in April 2023 HTACG .
Recently, the HTACG produced an implementation rolling plan HTACG  to provide national authorities and stakeholders with the most updated information for progress on the HTAR. Key milestones of the plan are as follows:
- The first meetings of the subgroups established by the HTACG will take place in April
- The act for Joint Clinical Assessments for medicinal products is in preparation to be adopted in Q4 2023
- The first meeting of the newly formed Stakeholder Network (to be announced in April) is planned to take place in June
- Development of the HTA IT platform is ongoing; the next milestone is the fifth meeting of the working group happening in May
- In March 2023, two projects: HTA4Patients and EUCAPA, as part of EU4Health Work Programme 2022 kicked off, the aim to build capacity of patients and clinical experts contributing to joint health technology activities
- Work is also in preparation for dissemination activities in Member States to raise awareness about the HTAR, with first information day being held in May in Stockholm
The HTACG continues to develop and publish methodological and procedural guidance documents. At a national level, Member States are starting to have a clearer idea of how the JCA will be implemented and begin familiarising themselves with the process. For the pharmaceutical industry, this provides appropriate material to support the forecasting of required market access activities for products expected to go through the JCA. The HAG, as an independent agency, can support industry and HTA bodies in building frameworks and writing legislation to support the implementation of the HTAR when it comes into effect in 2025.
Other articles in this series:
EU HTA and what it means for manufacturers
What are Joint Scientific Consultations and why they are important for manufacturers to consider?
What is the joint clinical assessment and what does it entail?
- European Commission. Flash Report. https://health.ec.europa.eu/system/files/2022-11/hta_20221128_flash_en.pdf, 2022.
- EUnetHTA. D4.4 Outcomes Endpoints, 2023.
- European Commission. Call for applications for the selection of members of the Health Technology Assessment Stakeholder Network. Secondary Call for applications for the selection of members of the Health Technology Assessment Stakeholder Network 2022.
- HTACG. Implementation Rolling Plan. https://health.ec.europa.eu/system/files/2023-04/hta_htar_rolling-plan_en.pdf: European Commission, 2023.