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, 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 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:
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, 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 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:
EUnetHTA Joint Actions 1-3, AdHopHTA, ADVANCE-HTA, INTEGRATE-HTA, MedtecHTA, GetReal, ADAPT-SMART
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.
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.
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.
For rare diseases, involvement of European Reference Networks (ERNs, see https://ec.europa.eu/health/ern/policy_en) should be considered.
EUnetHTA Joint Action 3 is a European network of national/regional HTA bodies under the EU Third Health Programme.