Key Functions of HTA in Decision-Making

An HTA body’s role within a healthcare system is context-specific, and the nature of an HTA body’s output is likely to reflect societal values. Once a technology has been assessed, a (social) process follows in which decisions about resource allocation and access to technology have to be made.

These are often contentious issues such as in the use of an abortion pill, or cannabis-based medicines.

Assessment vs. Appraisal in HTA

HTA can be split into two components. In some countries, the assessment and appraisal/decision functions of an HTA may be carried out by separate bodies:

📚 Assessment

Collection and synthesis of evidence (e.g., systematic reviews, cost-effectiveness studies).

⚖️ Appraisal / Decision-Making

Considers assessments alongside local policies, ethics, and stakeholder perspectives.

🏢 Assessment Body

One body may be dedicated to an assessment function – collecting and synthesising evidence or reviewing submissions. (Learn more in Course 3 Lesson 1.)

🧑‍⚖️ Appraisal Body

Another body (e.g. a commission) may perform the appraisal and decision function – considering the assessment in light of broader local factors.

An abbreviated excerpt adapted from the European Commission study might give an impression of the role of HTA in decision-making in the EU:

Role of HTA in decision-making in EU Member States (MS) and Norway

The organisation of the HTA process informing reimbursement decisions differs substantially from country to country.
HTA is indicated to be used:

  • ✔️ by a majority of EU member States (MS) and Norway to inform decision-making on reimbursement of pharmaceuticals (24 EU MS) and medical devices (19 EU MS),
  • ✔️ by only 12 EU MS and Norway to inform reimbursement of other technologies.
  • ✔️ by a majority of EU MS (20) and Norway to inform decision-making on pricing of pharmaceuticals and by a minority on medical devices (9 EU MS) and other technologies (7 EU MS).

There is a prevalence of advisory weight of HTA (20 EU MS and Norway) over obligatory weight (16 EU MS and Norway) in relation to the decision-making processes.

The HTA weight as “obligatory” was defined as associated with the HTA process that is formally established and legally mandated, i.e., an HTA must be performed to inform decision-making, e.g., reimbursement, or pricing, or any other type of decision-making on provision of a specific health technology (pharmaceutical/medical device/other technology) in the country. In other words, HTA has an obligatory character if an HTA must be performed in order for a technology to be considered for, e.g., reimbursement, and this requirement has a legal character through a specific legislative act and/or formal procedural document that introduces such a requirement. The results of an HTA may - but do not necessarily have to - be legally binding for an HTA to be considered “obligatory”. Thirteen EU MS indicated more than one kind of HTA influence on decision-making (informative, advisory, obligatory).

Country-Specific HTA Models

  • Germany: The Institute for Quality and Efficiency in Healthcare (IQWiG) conducts evaluations, while the Federal Joint Committee (GBA) handles appraisals and decision-making.
  • Some countries separate HTA for medicines from other interventions, while others cover all health technologies, such as devices, surgical procedures and (in some cases) public health interventions under a single HTA body.

📌Interactive activity

Time to test your knowledge! Answer the following True/False statements about HTA systems in the EU. 

This is not the final assessment, it is just an interactive activity to help you with your learning.