The clinical and non-clinical domains of Health Technology Assessment (HTA)

By Prof. Dr. Lieven Annemans, expert-trainer of the courses 
Health Economics for Non-Health-Economists and Critical New HTA Developments in Europe: Challenges & Solutions.
 

The EU’s co-funded joint actions on HTA (EUnetHTA Joint Actions) have identified nine domains by reference to which health technologies are assessed.

Of these nine domains, four are clinical and five are non-clinical.
 

➡ The four clinical domains of assessment concern:

1. the identification of a health problem and current health technology, in other words, what is the condition that is treated or prevented, and what are the current treatment and prevention options and their effectiveness
2. the examination of the technical characteristics of the health technology under assessment, for instance, the mode of administration, the duration of dose of the treatment, …
3. its relative safety, and
4. its relative clinical effectiveness. The latter 2 are key criteria in order to assess whether the new technology (such as a medicine or a medtech solution) is offering added therapeutical value for patients or for other stakeholders

➡ The five non-clinical assessment domains concern:

1. cost and economic evaluation of a health technology, whereby the focus is on cost-effectiveness, and its
2. ethical (for instance who can benefit from this technology), 
3. organisational (for instance do hospitals have to take measures to make the use of the technology possible),
4. social (for instance impact on certain population groups) and
5. legal aspects

The joint clinical assessment (JCA) will focus on the clinical domains only.
 

Successfully planning for HTAs in Europe is an ever more complex undertaking, considering the detailed analyses required for each of the above 9 domains and especially the varying approaches adopted by different countries.
To navigate these complexities, everyone involved in the process must develop a thorough understanding of the expected changes and issues related to both the clinical and the non-clinical domains.