HORIZON EUROPE
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Specific Challenge:Health technology assessment (HTA) is gaining increasing importance across Europe and the world as a tool to support evidence-based decision-making in healthcare. HTA aims to assess the added clinical/therapeutic value of a new health technology compared to the existing standard of care, under the usual circumstances of healthcare practice (relative effectiveness assessment). HTA can also assess additional aspects of added value (e.g. economic or organisational), depending on the specific context in which it is used.
European collaboration on HTA has increased in recent years, notably in the context of EU-funded projects[1], including work towards shared methodologies and the joint production of relative effective assessments. Despite recent progress, a number of methodological challenges remain in the field of HTA. This includes a need for methodologies that address the specificities of particular types of health technologies[2] and their increasingly combined use in healthcare. Better methodological agreement is also needed in particular therapeutic areas, including on important aspects of relative effectiveness assessment such as health outcome me...
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Specific Challenge:Health technology assessment (HTA) is gaining increasing importance across Europe and the world as a tool to support evidence-based decision-making in healthcare. HTA aims to assess the added clinical/therapeutic value of a new health technology compared to the existing standard of care, under the usual circumstances of healthcare practice (relative effectiveness assessment). HTA can also assess additional aspects of added value (e.g. economic or organisational), depending on the specific context in which it is used.
European collaboration on HTA has increased in recent years, notably in the context of EU-funded projects[1], including work towards shared methodologies and the joint production of relative effective assessments. Despite recent progress, a number of methodological challenges remain in the field of HTA. This includes a need for methodologies that address the specificities of particular types of health technologies[2] and their increasingly combined use in healthcare. Better methodological agreement is also needed in particular therapeutic areas, including on important aspects of relative effectiveness assessment such as health outcome measures. Moreover, there is a need to resolve methodological issues related to the use of "real-world" data, to inform the assessment of effectiveness under the usual circumstances of healthcare practice.
Thus the challenge is to address these complex issues and needs, by bringing together methodological expertise from across the various relevant research communities. Such a collaborative effort should draw on the best available expertise and latest evidence, in order to develop methodological approaches that are scientifically sound, fit for purpose and fit for the future.
Scope:Proposals should develop new or improved methodological approaches and frameworks, and foster methodological consensus-building, to address all of the following areas:
Specific types or groups of health technologies: Help adapt existing HTA frameworks to reflect the specificities of particular types of health technologies97 for which HTA is currently less established but gaining importance. Particular consideration should be given to the increasing role of combinations of technologies, co-dependent technologies (e.g. companion diagnostics) and personalised medicine[3] in healthcare.Selected therapeutic areas: The focus should be on therapeutic/disease areas where new products frequently face challenges in HTA, but a high unmet medical need persists. Methodological work and consensus-building should be aimed at key issues for relative effectiveness assessment, such as patient-relevant health outcomes, appropriate outcome measures, clinically relevant patient subgroups, and the current evidence-based standard of care. With regard to patient-relevant health outcomes, patient preferences and patient-reported outcome measures (PROMs) should be taken into account. Particular consideration should be given to strengthening synergies between HTA and clinical guideline development, with a view to more consistent reporting on the clinical/therapeutic value of health technologies.Use of real-world data: Methodological work should address current concerns and uncertainties around the quality and suitability of real-world data (e.g. from diseases-specific registries and routine healthcare databases) for relative effectiveness assessment in HTA. It should also contribute to broader efforts for improving the collection, comparability and analysis of real-world data across Europe[4].Implementation: In all of the above areas, part of the efforts should be directed at implementation of methodological work, using e.g. case studies or pilots. Involvement of HTA bodies in all of the above areas should ensure that the needs of HTA practitioners are addressed and uptake in HTA practice is facilitated. The proposed consortium should bring together partners with relevant expertise from e.g. academia, HTA bodies, regulators, centres of expertise for clinical research and care[5], scientific and medical learned societies, and organisations involved in developing evidence-based clinical guidelines and systematic reviews in healthcare. The consortium should also seek input from relevant stakeholders such as patients, technology developers, healthcare providers and payers. The composition of the consortium should ensure a broad geographical representation of European countries. Gender equality aspects should be taken into account in carrying out the relevant research objectives and activities.
Proposals should complement or build on existing work, including results of EU-funded projects in the field of HTA76. The consortium should closely liaise with EUnetHTA[6] to avoid duplication, build on EUnetHTA existing work and create synergies with ongoing EUnetHTA activities and other relevant EU cooperation efforts.
The Commission considers that a proposal requesting an EU contribution between EUR 5 to 10 million would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amounts. Should more than one proposal be selected, applicants are expected to collaborate and this should be indicated in the proposal.
Expected Impact: New or improved methodological approaches, frameworks and consensus-building mechanisms to address the above-mentioned challenges for particular types and groups of technologies, therapeutic areas and real-world data use in HTA. Strengthened methodological quality of HTA by input of specialist expertise from the broader scientific, clinical research and evidence-based healthcare community. Improved methodological agreement between HTA researchers across Europe, increasing the impact of HTA on evidence generation, clinical guideline development and evidence-based healthcare. Contribute to strengthening EU cooperation on HTA, building on ongoing and planned efforts.
Cross-cutting Priorities:Gender
[1]EUnetHTA Joint Actions 1-3, AdHopHTA, ADVANCE-HTA, INTEGRATE-HTA, MedtecHTA, GetReal, ADAPT-SMART
[2]Health technologies are broadly defined to include e.g. pharmaceuticals, medical devices, in-vitro diagnostics, medical procedures, screening tests, vaccination programmes, eHealth, and other measures used for health promotion, disease prevention, diagnosis or treatment.
[3]Personalised medicine refers to a medical model using characterisation of individuals' phenotypes and genotypes (e.g. molecular profiling, medical imaging, lifestyle data) for tailoring the right therapeutic strategy for the right person at the right time, and/or to determine the predisposition to disease and/or to deliver timely and targeted prevention.
[4]Synergies should be sought with related initiatives, e.g. EUnetHTA Joint Action 3 (Work Package 5), the EMA initiative for patient registries, and JRC activities on registries.
[5]For rare diseases, involvement of European Reference Networks (ERNs, see https://ec.europa.eu/health/ern/policy_en) should be considered.
[6]EUnetHTA Joint Action 3 is a European network of national/regional HTA bodies under the EU Third Health Programme.
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Características del consorcio
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La ayuda es de ámbito europeo, puede aplicar a esta linea cualquier empresa que forme parte de la Comunidad Europea.
Características del Proyecto
Los costes de personal subvencionables cubren las horas de trabajo efectivo de las personas directamente dedicadas a la ejecución de la acción. Los propietarios de pequeñas y medianas empresas que no perciban salario y otras personas físicas que no perciban salario podrán imputar los costes de personal sobre la base de una escala de costes unitarios
Los otros costes directos se dividen en los siguientes apartados: Viajes, amortizaciones, equipamiento y otros bienes y servicios. Se financia la amortización de equipos, permitiendo incluir la amortización de equipos adquiridos antes del proyecto si se registra durante su ejecución. En el apartado de otros bienes y servicios se incluyen los diferentes bienes y servicios comprados por los beneficiarios a proveedores externos para poder llevar a cabo sus tareas
La subcontratación en ayudas europeas no debe tratarse del core de actividades de I+D del proyecto. El contratista debe ser seleccionado por el beneficiario de acuerdo con el principio de mejor relación calidad-precio bajo las condiciones de transparencia e igualdad (en ningún caso consistirá en solicitar menos de 3 ofertas). En el caso de entidades públicas, para la subcontratación se deberán de seguir las leyes que rijan en el país al que pertenezca el contratante
Características de la financiación
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 2020 projects. See the information in the Online Manual.
2. Eligibility and admissibility conditions: described in Annex B and Annex C of the Work Programme.
Proposal page limits and layout: please refer to Part B of the proposal template in the submission system below.
3. Evaluation:
Evaluation criteria, scoring and thresholds are described in Annex H of the Work Programme.
Submission and evaluation processes are described in the Online Manual.
The thresholds for each criterion in a single stage process will be 4 (Excellence), 4 (Impact) and 3 (Implementation). The cumulative threshold will be 12.
4. Indicative time for evaluation and grant agreements:
Information on the outcome of evaluation (single-stage call): maximum 5 months from the deadline for submission.
Signature of grant agreements: maximum 8 months from the deadline for submission.
5. Proposal templates, evaluation forms and model grant agreements (MGA):
Research and Innovation Action:
Specific provisions and funding rates
Standard proposal template
Standard evaluation form
General MGA - Multi-Beneficiary
Annotated Grant Agreement
Essential information for clinical studies
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 2020 projects. See the information in the Online Manual.
2. Eligibility and admissibility conditions: described in Annex B and Annex C of the Work Programme.
Proposal page limits and layout: please refer to Part B of the proposal template in the submission system below.
3. Evaluation:
Evaluation criteria, scoring and thresholds are described in Annex H of the Work Programme.
Submission and evaluation processes are described in the Online Manual.
The thresholds for each criterion in a single stage process will be 4 (Excellence), 4 (Impact) and 3 (Implementation). The cumulative threshold will be 12.
4. Indicative time for evaluation and grant agreements:
Information on the outcome of evaluation (single-stage call): maximum 5 months from the deadline for submission.
Signature of grant agreements: maximum 8 months from the deadline for submission.
5. Proposal templates, evaluation forms and model grant agreements (MGA):
Research and Innovation Action:
Specific provisions and funding rates
Standard proposal template
Standard evaluation form
General MGA - Multi-Beneficiary
Annotated Grant Agreement
Essential information for clinical studies
6. Additional provisions:
Horizon 2020 budget flexibility
Classified information
Technology readiness levels (TRL) – where a topic description refers to TRL, these definitions apply.
Members of consortium are required to conclude a consortium agreement, in principle prior to the signature of the grant agreement.
8. Additional documents:
Introduction WP 2018-20
Health, demographic change and well-being WP 2018-20
General annexes to the Work Programme 2018-2020
Legal basis: Horizon 2020 Regulation of Establishment
Legal basis: Horizon 2020 Rules for Participation
Legal basis: Horizon 2020 Specific Programme
7. Open access must be granted to all scientific publications resulting from Horizon 2020 actions.
Where relevant, proposals should also provide information on how the participants will manage the research data generated and/or collected during the project, such as details on what types of data the project will generate, whether and how this data will be exploited or made accessible for verification and re-use, and how it will be curated and preserved.
Open access to research data
The Open Research Data Pilot has been extended to cover all Horizon 2020 topics for which the submission is opened on 26 July 2016 or later. Projects funded under this topic will therefore by default provide open access to the research data they generate, except if they decide to opt-out under the conditions described in Annex L of the Work Programme. Projects can opt-out at any stage, that is both before and after the grant signature.
Note that the evaluation phase proposals will not be evaluated more favourably because they plan to open or share their data, and will not be penalised for opting out.
Open research data sharing applies to the data needed to validate the results presented in scientific publications. Additionally, projects can choose to make other data available open access and need to describe their approach in a Data Management Plan.
Projects need to create a Data Management Plan (DMP), except if they opt-out of making their research data open access. A first version of the DMP must be provided as an early deliverable within six months of the project and should be updated during the project as appropriate. The Commission already provides guidance documents, including a template for DMPs. See the Online Manual.
Eligibility of costs: costs related to data management and data sharing are eligible for reimbursement during the project duration.
The legal requirements for projects participating in this pilot are in the article 29.3 of the Model Grant Agreement.
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