2. HTA Core Model


HTA Core Model 

The nine domains shown below set the framework for HTAs. All domains and relevant questions to ask are presented in detail in the EUnetHTA Core Model shown in Figure 1. below.

Figure 1: HTA Core Model®. EUnetHTA [1].

Of the nine assessment domains in the EunetHTA Core Model, four are clinical and five are non-clinical. The four clinical domains concern: 

  • Identification of a health problem and the current technology used (CUR).
  • Examination of the technical characteristics (TEC).
  • Relative safety (SAF).
  • Relative clinical effectiveness (EFF).

The European Commission, in the HTA regulation, defines the joint clinical assessment as: 

    • the scientific compilation and description of a comparative analysis of the available scientific evidence on a health technology,
    • in comparison with one or more other health technologies or existing procedures,
    • in accordance with an assessment scope agreed pursuant to this Regulation,
    • based on the scientific aspects of the clinical domains of HTA of the description of the health problem addressed by the health technology
    • the current use of other health technologies addressing that health problem,
    • the description and technical characterisation of the health technology,
    • the relative clinical effectiveness, and the relative safety of the health technology’ [2].

The five non-clinical assessment domains concern: 

  • Cost and economic evaluation (ECO).
  • Ethical implications (ETH).
  • Organisational aspects (ORG).
  • Social aspects (SOC).
  • Legal aspects (LEG).

In the HTA regulation non-clinical assessment is defined as:   

'Non-clinical assessment' means the part of an HTA based on the non-clinical domains of HTA of the cost and economic evaluation of a health technology, and the ethical, organisational, social, and legal aspects related to its use’.

The clinical assessment domains are therefore more suited for a joint assessment at the EU level on their scientific evidence base, and for which the HTA regulation provides a framework for, even though societal aspects may influence the status of the current technology used, which may differ between Member States. According to HTA regulation, the assessment of non-clinical domains will still be related to national and regional contexts and approaches. 

The above nine domains apply to medicinal products, Medical Devices and IVDs. However, the timing of HTA and the methodologies that are used are based on medicinal products, and because of different development processes, efficacy measures and time points of measuring, there are challenges in applying the exact same criteria for Medical Devices and IVDs.  
The differences are described in chapter 3 Clinical effectiveness and evidence generation for HTA . including how patients can contribute to addressing aspects that are specific for the HTA process of Medical Devices and IVDs.


[1] HTA Core Model. https://www.eunethta.eu/hta-core-model/  

[2] Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32021R2282