HTA Research to support evidence-based healthcare

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.


Proposals should develop new or improved methodological approaches and frameworks, and foster methodological consensus-building, to address all of the following areas:

  1. 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.
  2. 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.
  3. 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].
  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.

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