What a Health Technology Assessment covers: domains and criteria

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

Often, when preparing a case for an HTA, only economic factors are taken into account. However, HTA bodies also highly value the best scientific evidence on the medical, social, and ethical implications of investments in health care.

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

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

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 domains

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 (for instance, privacy or liability issues)
    

What the Joint Clinical Assessment covers

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

The criteria that influence the decision

The nine domains set out what an assessment covers. A second list matters just as much: the criteria that influence the decision itself. Depending on the country, an HTA can address up to ten of them. Some are obvious, others are not always considered, or are left out for practical reasons. 
 

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.