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Deadline expired

The deadline for this call has expired.

Call key data

Supporting the uptake of innovative Health Technology Assessment (HTA) methodology and advancing HTA expertise across EU

Call number

HORIZON-HLTH-2023-IND-06-01

deadlines

Opening
12.01.2023

Deadline
13.04.2023 17:00

Deadline - 2nd stage

Opening
31.01.2023

Funding rate

100%

Call budget

€ 5,000,000.00

Estimated EU contribution per project

€ 5,000,000.00

Link to the call

ec.europa.eu

Link to the submission

ec.europa.eu

Call content

Call objectives

Health Technology Assessment (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.

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Expected effects and impacts

Expected results

  • 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.

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Eligibility Criteria

Regions / countries for funding

EU Member States, Overseas Countries and Territories (OCT)
Moldova (Moldova), Albania (Shqipëria), Armenia (Հայաստան), Bosnia and Herzegovina (Bosna i Hercegovina / Босна и Херцеговина), Faeroes (Føroyar / Færøerne), Georgia (საქართველო), Iceland (Ísland), Israel (ישראל / إِسْرَائِيل), Kosovo (Kosova/Kosovë / Косово), Montenegro (Црна Гора), Morocco (المغرب), North Macedonia (Северна Македонија), Norway (Norge), Serbia (Srbija/Сpбија), Tunisia (تونس /Tūnis), Türkiye, Ukraine (Україна), United Kingdom

eligible entities

EU Body, Education and training institution, International organization, Natural Person, Non-Profit Organisation (NPO) / Non-Governmental Organisation (NGO), Other, Private institution, incl. private company (private for profit), Public Body (national, regional and local; incl. EGTCs), Research Institution incl. University, Small and medium-sized enterprise (SME)

Mandatory partnership

No

Project Partnership

To be eligible for funding, applicants must be established in one of the following countries:

  • the Member States of the European Union, including their outermost regions
  • the Overseas Countries and Territories (OCTs) linked to the Member States
  • third countries associated to Horizon Europe - see list of particpating countries

Applications may be submitted by one or more legal entities, which may be established in a Member State, Associated Country or, in exceptional cases and if provided for in the specific call conditions, in another third country.

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.

Any legal entity, regardless of its place of establishment, including legal entities from non-associated third countries or international organisations (including international European research organisations) is eligible to participate (whether it is eligible for funding or not), provided that the conditions laid down in the Horizon Europe Regulation have been met, along with any other conditions laid down in the specific call topic.

A ‘legal entity’ means any natural or legal person created and recognised as such under national law, EU law or international law, which has legal personality and which may, acting in its own name, exercise rights and be subject to obligations, or an entity without legal personality.

Specific cases:

  • Affiliated entities — Affiliated entities (i.e. entities with a legal or capital link to a beneficiary which participate in the action with similar rights and obligations to the beneficiaries, but which do not sign the grant agreement and therefore do not become beneficiaries themselves) are allowed, if they are eligible for participation and funding.
  • Associated partners — Associated partners (i.e. entities which participate in the action without signing the grant agreement, and without the right to charge costs or claim contributions) are allowed, subject to any conditions regarding associated partners set out in the specific call conditions.
  • Entities without legal personality — Entities which do not have legal personality under their national law may exceptionally participate, provided that their representatives have the capacity to undertake legal obligations on their behalf, and offer guarantees to protect the EU’s financial interests equivalent to those offered by legal persons.
  • EU bodies — Legal entities created under EU law including decentralised agencies may be part of the consortium, unless provided for otherwise in their basic act.
  • Joint Research Centre (‘JRC’)— Where provided for in the specific call conditions, applicants may include in their proposals the possible contribution of the JRC but the JRC will not participate in the preparation and submission of the proposal. Applicants will indicate the contribution that the JRC could bring to the project based on the scope of the topic text. After the evaluation process, the JRC and the consortium selected for funding may come to an agreement on the specific terms of the participation of the JRC. If an agreement is found, the JRC may accede to the grant agreement as beneficiary requesting zero funding or participate as an associated partner, and would accede to the consortium as a member.
  • Associations and interest groupings — Entities composed of members (e.g. European research infrastructure consortia (ERICs)) may participate as ‘sole beneficiaries’ or ‘beneficiaries without legal personality’. However, if the action is in practice implemented by the individual members, those members should also participate (either as beneficiaries or as affiliated entities, otherwise their costs will NOT be eligible.

Additional information

Topics

Digitalisation, Digital Society, ICT, 
Health, Social Services, Sports

Relevance for EU Macro-Region

EUSAIR - EU Strategy for the Adriatic and Ionian Region, EUSALP - EU Strategy for the Alpine Space, EUSBSR - EU Strategy for the Baltic Sea Region, EUSDR - EU Strategy for the Danube Region

UN Sustainable Development Goals (UN-SDGs)

Additional Information

All proposals must be submitted electronically via the Funders & Tenders Portal electronic submission system (accessible via the topic page in the Search Funding & Tenders section). Paper submissions are NOT possible.

Proposals must be complete and contain all parts and mandatory annexes and supporting documents, e.g. plan for the exploitation and dissemination of the results including communication activities, etc.

The application form will have two parts:

  • Part A (to be filled in directly online) contains administrative information about the applicant organisations (future coordinator and beneficiaries and affiliated entities), the summarised budget for the proposal and call-specific questions;
  • Part B (to be downloaded from the Portal submission system, completed and then assembled and re-uploaded as a PDF in the system) contains the technical description of the project.

Annexes and supporting documents will be directly available in the submission system and must be uploaded as PDF files (or other formats allowed by the system).

The limit for a full application (Part B) is 30  pages.

The award criteria are described in General Annex D. The following exceptions apply: The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 3 (Implementation). The cumulative threshold will be 12.

Call documents

HE-Work Programme 2023-2024, Cluster 1, Destination 6HE-Work Programme 2023-2024, Cluster 1, Destination 6(452kB)

Contact

National Contact Points for Horizon Europe
Website

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