HTA is a multidisciplinary process that summarises information about the medical, social, economic and ethical issues related to the use of a health technology in a systematic, transparent, unbiased, robust manner. A health technology is defined by the WHO as “the application of organized knowledge and skills in the form of medicines, medical devices, vaccines, procedures and systems developed to solve a health problem and improve quality of life”. HTA answers clinical questions of new, potential innovative, healthcare technologies such as: How well does a new technology work compared with existing alternative health technologies? For which population group does it work best? HTA can also answer economic questions like: What costs are entailed for the health system? It is therefore considered a key tool for decision makers to ensure the accessibility, quality and sustainability of healthcare.
What is the HTA Core Model® and what are its nine domains?
EUnetHTA developed the HTA Core Model®, which is a methodological framework for collaborative production and sharing of HTA information.The HTA Core Model® consists of the following nine domains:
What is relative effectiveness and what are EUnetHTA Rapid Relative Effectiveness Assessments (REAs)?
Relative effectiveness can be defined as to the extent an intervention does more good than harm, compared to one or more intervention alternatives for achieving the desired results when provided under the usual circumstances of health care practice.
EUnetHTA Rapid Relative Effectiveness Assessments (REA) are health technology assessments consisting of four domains in the HTA Core Model®.
The EUnetHTA Rapid REAs include the following four domains:
- Health Problem and Current Use of the Technology
- Description and technical characteristics of technology
- Clinical Effectiveness
EUnetHTA decided to focus on these four elements because they are considered both important and transferable, i.e. usable in several countries. Besides these four domains, additional domains (i.e. economic evaluation, ethical, organisational, social and legal aspect of the introducing the technology) can be considered on a national level.
What is the primary difference between a full report and a REA?
If all nine domains are covered in an assessment, it is called a full HTA. The last five domains are considered more likely to be context specific, whereas the first four domains are considered both important and transferable (i.e. usable in several countries). Therefore, in the rapid REAs EUnetHTA only focuses on the first four domains of the HTA Core Model®. At a national level, HTA-bodies may of course complement the Rapid REA with other elements that are needed in their context, for the purpose of (coverage) decision-making.
The Rapid REAs are either conducted as Joint or Collaborative Assessments; however, they both follow the same high standard quality assurance procedures. The difference between them are mainly regarding use of submission file, involvement of stakeholders, scoping meetings with the industry and centralised coordination versus decentralised (Activity Centre Department Leads). Therefore, the production processes are slightly different in the two, to allow flexibility when it is feasible. The Collaborative Assessments are only relevant in the non-pharmaceutical field. The need for the two products is related to the different characteristics of the pharmaceutical field and in the medical devices/diagnostic tests field.
Who manages the production and how is it organised?
The production is managed by WP4 Co-Lead Partners. WP4 stands for ‘work package 4’ of the EUnetHTA Joint Action 3. This work package is one of seven in EUnetHTA JA3 and is concerned with the actual production of assessments. The assessments should be fit for purpose, of high quality, of timely availability, and cover the whole range of health technologies. In addition, the production process is continuously refined and improved in order to best meet the needs of HTA-bodies, decision-makers and stakeholders.
The Lead Partner (LP) of WP4 is the Norwegian Institute of Public Health (NIPHNO) and is responsible for the overall coordination of the activities within the work package. There are two Co-Lead Partners who are responsible for the coordination of activities related to assessment production. These are Zorginstituut Nederland (ZIN), and Ludwig Boltzmann Institute for Health Technology Assessment (LBI-HTA), Austria. ZIN is responsible for production of pharmaceutical assessments and LBI-HTA for assessments in non-pharmaceuticals / other technologies.
WP4 has over 60 partners from all around Europe who work together to produce the assessments through cross-border collaboration. The initiation of an assessment is either done by a EUnetHTA partner that wishes to carry out an assessment on a specific topic (usually a Collaborative Assessment for Other Technologies), or a manufacturer that initiates by contacting one of the Co-Lead Partners showing an interest to have their technology/product assessed by EUnetHTA.
The assessment team consisting of authors, co-authors and dedicated reviewers will be established after a Call for Collaboration, based on a set of criteria. These criteria will ensure among other that the team holds – expertise and knowledge in the disease area; skills and experience from previous EUnetHTA assessments; geographical spread within the team and commitment to use the report in a national setting. These criteria should also ensure a high standard quality report available in a timely manner, in addition to facilitate use in national contexts.
What are the steps and timelines in the production process?
The timelines and procedures are aligned differently for pharmaceutical and non-pharmaceutical processes. For more information about the production process, please contact:
- For pharmaceutical manufacturers: WP4_pharmaceuticals@zinl.nl (ZIN)
- For non-pharmaceutical manufacturers: EUnetHTA@hta.lbg.ac.at (LBI-HTA)
For general information about Joint Production: WP4.LP_EUnetHTA.JA3@fhi.no