Supporting the uptake of innovative Health Technology Assessment (HTA) methodology and advancing HTA expertise across EU
HORIZON Coordination and Support Actions
Basic Information
- Identifier
- HORIZON-HLTH-2023-IND-06-01
- Programme
- A competitive health-related industry (Single stage - 2023)
- Programme Period
- 2021 - 2027
- Status
- Closed (31094503)
- Opening Date
- January 12, 2023
- Deadline
- April 13, 2023
- Deadline Model
- single-stage
- Budget
- €8,000,000
- Min Grant Amount
- €3,000,000
- Max Grant Amount
- €5,000,000
- Expected Number of Grants
- 2
- Keywords
- HORIZON-HLTH-2023-IND-06-01HORIZON-HLTH-2023-IND-06Diagnostic technologyHealth technology assessmentPharmaceutical developmentPublic health
Description
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.
Destination & Scope
Calls for proposals under this destination are directed towards the Key Strategic Orientation KSO-A ‘Promoting an open strategic autonomy by leading the development of key digital, enabling and emerging technologies, sectors and value chains’ of Horizon Europe’s Strategic Plan 2021-2024. Research and innovation supported under this destination should contribute to the impact area ‘A competitive and secure data-economy’ and in particular to the following expected impact, set out in the Strategic Plan for the health cluster: ‘EU health industry is innovative, sustainable and globally competitive thanks to improved up-take of breakthrough technologies and innovations, which makes the EU with its Member States more resilient and less dependent from imports with regard to the access to and supply of critical health technologies’. In addition, research and innovation supported under this destination could also contribute to the following impact areas: ‘Industrial leadership in key and emerging technologies that work for people’, ‘High quality digital services for all’, and ‘Good health and high-quality accessible health care’.
The health industry is a key driver for growth and has the capacity to provide health technologies to the benefit of patients and providers of health care services. The relevant value chains involve a broad variety of key players from supply, demand and regulatory sides. In addition, the path of innovation in health is long and complex. The development of novel health technologies is generally associated with uncertainties and market barriers due to expensive and risky development (e.g. high attrition rate in pharmaceutical development), high quality and security requirements (e.g. clinical performance, safety, data privacy and cybersecurity) and market specificities (e.g. strong regulation, pricing and reimbursement issues). In addition, the growing concern about environmental issues is putting more pressure on this industry. Therefore, there is a need for research and innovation integrating various stakeholders to facilitate market access of innovative health technologies (medical technologies, pharmaceuticals, biotechnologies, digital health technologies).
In order to address these challenges, in particular green and digital transitions and proper supply of health technologies and products, destination 6 will focus on research and innovation activities that aim at:
- Facilitating the production of pharmaceuticals in compliance with the objectives of the European Green Deal.
- Developing methodologies, guidelines and standards, assessment studies, and structuring activities adapted to digital solutions and interventions for GDPR compliant translation into health care practice, including inter-operability, cyber-security and data confidentiality.
- Supporting public authorities with better methodologies and interdisciplinary approaches to assess and value new health technologies and interventions.
In view of increasing the impact of EU investments under Horizon Europe, the European Commission welcomes and supports cooperation between EU-funded projects to enable cross-fertilisation and other synergies. This could range from networking to joint activities such as the participation in joint workshops, the exchange of knowledge, the development and adoption of best practices, or joint communication activities. Opportunities for potential synergies exist between projects funded under the same topic but also between other projects funded under another topic, cluster or pillar of Horizon Europe (but also with ongoing projects funded under Horizon 2020). In particular, this could involve projects related to European health research infrastructures (under pillar I of Horizon Europe), the EIC strategic challenges on health and EIT-KIC Health (under pillar III of Horizon Europe), or in areas cutting across the health and other clusters (under pillar II of Horizon Europe). For instance, with cluster 4 “Digital, Industry and Space” such as on industrial research and innovation infrastructures (pilot plants, testing and simulation facilities, open innovation hubs); additive manufacturing and other production technologies (incl. bio manufacturing); safe, smart and sustainable materials.
Expected Impacts:
Proposals for topics under this destination should set out a credible pathway to contributing to maintaining an innovative, sustainable and globally competitive health industry, and more specifically to one or several of the following expected impacts:
- Health industry in the EU is more competitive and sustainable, assuring European leadership in breakthrough health technologies and open strategic autonomy in essential medical supplies and digital technologies, contributing to job creation and economic growth, in particular with small- and medium-sized enterprises (SMEs).
- Health industry is working more efficiently along the value chain from the identification of needs to the scale-up and take-up of solutions at national, regional or local level, including through early engagement with patients, health care providers, health authorities and regulators ensuring suitability and acceptance of solutions.
- European standards, including for operations involving health data, ensure patient safety and quality of healthcare services as well as effectiveness and interoperability of health innovation and productivity of innovators.
- Citizens, health care providers and health systems benefit from a swift uptake of innovative health technologies and services offering significant improvements in health outcomes, while health industry in the EU benefits from decreased time-to-market.
- Health security in the EU benefits from reliable access to key manufacturing capacity, including timely provision of essential medical supplies of particularly complex or critical supply and distribution chains, such as regards vaccines or medical radioisotopes.
Eligibility & Conditions
General conditions
2. Eligible countries: described in Annex B of the Work Programme General Annexes.
A number of non-EU/non-Associated Countries that are not automatically eligible for funding have made specific provisions for making funding available for their participants in Horizon Europe projects. See the information in the Horizon Europe Programme Guide.
In recognition of the opening of the US National Institutes of Health’s programmes to European researchers, legal entities established in the United States of America may exceptionally participate as a beneficiary or affiliated entity, and are eligible to receive Union funding.
Coordinators of projects must be legal entities established in an EU Member State or Associated Country.
3. Other eligibility conditions: described in Annex B of the Work Programme General Annexes.
4. Financial and operational capacity and exclusion: described in Annex C of the Work Programme General Annexes.
Award criteria, scoring and thresholds are described in Annex D of the Work Programme General Annexes.
The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 3 (Implementation). The cumulative threshold will be 12.
Submission and evaluation processes are described in Annex F of the Work Programme General Annexes and the Online Manual.
Indicative timeline for evaluation and grant agreement: described in Annex F of the Work Programme General Annexes.
6. Legal and financial set-up of the grants: described in Annex G of the Work Programme General Annexes.
Specific conditions
7. Specific conditions: described in the specific topic of the Work Programme.
Documents
Call documents:
Standard application form (HE CSA) - call-specific application form is available in the Submission System
Standard evaluation form (HE CSA)
HE General MGA v1.0
Information on clinical studies (HE)
Additional documents:
HE Main Work Programme 2023–2024 – 1. General Introduction
HE Main Work Programme 2023–2024 – 4. Health
HE Main Work Programme 2023–2024 – 13. General Annexes
HE Programme Guide
HE Framework Programme and Rules for Participation Regulation 2021/695
HE Specific Programme Decision 2021/764
EU Financial Regulation
Rules for Legal Entity Validation, LEAR Appointment and Financial Capacity Assessment
EU Grants AGA — Annotated Model Grant Agreement
Funding & Tenders Portal Online Manual
Funding & Tenders Portal Terms and Conditions
Funding & Tenders Portal Privacy Statement
Support & Resources
Online Manual is your guide on the procedures from proposal submission to managing your grant.
Horizon Europe Programme Guide contains the detailed guidance to the structure, budget and political priorities of Horizon Europe.
Funding & Tenders Portal FAQ – find the answers to most frequently asked questions on submission of proposals, evaluation and grant management.
Research Enquiry Service – ask questions about any aspect of European research in general and the EU Research Framework Programmes in particular.
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The European Charter for Researchers and the Code of Conduct for their recruitment – consult the general principles and requirements specifying the roles, responsibilities and entitlements of researchers, employers and funders of researchers.
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Latest Updates
Call HORIZON-HLTH-2023-IND-06
We recently informed the applicants about the evaluation results for their proposals.
The results of the evaluation are as follows:
Number of proposals submitted (including proposals transferred from or to other calls): 17
Number of inadmissible proposals: 0
Number of ineligible proposals: 1
Number of above-threshold proposals: 8
Total budget requested for above-threshold proposals: EUR 50,650,760.
Call HORIZON-HLTH-2023-IND-06
We recently informed the applicants about the evaluation results for their proposals.
The results of the evaluation are as follows:
Number of proposals submitted (including proposals transferred from or to other calls): 17
Number of inadmissible proposals: 0
Number of ineligible proposals: 1
Number of above-threshold proposals: 8
Total budget requested for above-threshold proposals: EUR 50,650,760.
Call HORIZON-HLTH-2023-IND-06 closed on 13 April 2023. 17 proposals were submitted. The breakdown per topic is:
- HORIZON-HLTH-2023-IND-06-01: 1 proposals
- HORIZON-HLTH-2023-IND-06-02: 3 proposals
- HORIZON-HLTH-2023-IND-06-04: 3 proposals
- HORIZON-HLTH-2023-IND-06-05: 2 proposals
- HORIZON-HLTH-2023-IND-06-07: 8 proposals
Evaluation results are expected to be communicated on Friday 04 August 2023 at the earliest.