Supporting the Uptake of Innovative Health Technology Assessment (HTA) Methodology and Advancing HTA Expertise Across EU

This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 6 “Maintaining an innovative, sustainable and globally competitive health industry”. To that end, proposals under this topic should aim to deliver results that are directed, tailored towards and contributing to all of the following expected outcomes:

• Identification of the most innovative HTA methods developed by EU-funded projects, which respond to the needs of HTA bodies and are ready to be used in real-life settings. Endorsement by HTA bodies of such innovative methods would allow for advancing HTA methodology and improve evidence-based decision making, and patient access to novel health technologies
• Dissemination among EU HTA bodies of robust innovative HTA methods and tools developed by EU-funded projects.
• Harmonisation of HTA expertise across EU though the development of a training programme developed in collaboration with academia. The training should address HTA expertise in general, as wells as expertise in joint HTA to be carried out at EU level in accordance with Regulation (EU) 2021/2282, based on the methodological guidelines elaborated by the Coordination Group on HTA.
• Contribution to a successful implementation of the HTA Regulation as well as to building an EU methodological HTA framework fit for purpose and fit for the future.

HTA bodies have the responsibility to assess the added value of new health technologies and advise on its reimbursement and use within a healthcare system. Due to the rapid pace at which technology advance and in order to support decision making in an appropriate manner, HTA experts have to adapt/revise regularly their methodology. Whilst EU-funded projects in the field of HTA have addressed some of the research needs of the HTA bodies (e.g. methods of analysis, use of real-world data, use of patient reported outcomes), translation of their results/recommendations into HTA work remains limited.

Advancing HTA methodology and expertise could benefit from a more systematic dialogue between HTA bodies and academia. Therefore, this action could represent an excellent opportunity for both those generating and those using the evidence to come together and discuss the key HTA methodological issues.

Under the newly adopted Regulation (EU) 2021/2282, the Coordination Group on HTA will have to adopt methodological guidelines for joint HTA work (e.g. joint clinical assessments, joint scientific consultation), to regularly review, and where necessary update them. The project could provide input to issues identified by the Coordination Group as important for future updates/revisions of HTA methodology for joint HTA work.

The topic is divided into two strands of activities, with applicants tackling both in their proposals:

• Implementation of innovative HTA methods: EU-funded research projects (e.g. COMED, IMPACT-HTA, HTx, GetReal, EHDEN) developed innovative methods aiming at addressing HTA bodies’ needs. Identifying which of these methods are ready to be used in real-life settings is a first crucial step towards broader uptake and dissemination. Successful implementation of innovative methods in actual HTA practices will contribute to provide a timely response to HTA challenges (e.g. use of real-world data in HTA) also providing a sound scientific resource for updates of methodological guidelines by the Coordination Group on HTA for joint activities as requested by the Regulation (EU) 2021/2282. HTA bodies/agencies participating in such activities will gain expertise in those methods that could be later transferred to other bodies/agencies using the training framework developed in the second strand of work.
• Advancing HTA expertise across the EU and Associated Countries should be carried out through a training programme tailored to the needs of HTA bodies, which may include twinning activities between HTA bodies/agencies to develop expertise and facilitate knowledge sharing among HTA bodies/agencies in the EU. The training programme is expected to contribute to the harmonisation of HTA practices in the EU that will in turn contribute to a greater consistency of health technology assessments across the EU and Associated Countries. Thus, the training programme should also support the engagement of HTA experts from Member States and EEA countries in carrying out joint HTA work starting January 2025 (i.e. implementation date of the Regulation on HTA), with the aim to produce high-quality and robust joint clinical assessments. The training programme should include all the necessary elements for carrying out robust assessments at national and EU level. Regarding the latter, the training programme should also promote the dissemination of the methodological guidelines to be adopted by the Coordination Group on HTA (based on the methodology developed and fine-tuned by EUnetHTA joint actions and EUnetHTA21 service contract).

The proposals should address all of the following activities:

• Identification of innovative methods and tools, in particular those developed in EU-funded projects able to address HTA bodies' needs (in different areas: relative effectiveness assessment, cost-effectiveness assessment, etc.).
• Identifications of barriers to the uptake of these methods (and potential associated tools, e.g. open-source software to run cost-effectiveness analyses).
• Use cases (based on the needs identified by HTA bodies) to facilitate the endorsement by HTA bodies of innovative methods.
• Development of an implementation plan including supporting tools and training modules (by researchers, alone or in collaboration with HTA bodies, to be delivered to HTA bodies/agencies).
• Recommendations for broader dissemination.