The HTA Core Model

HTA assessments are comparative analyses of the existing standard of care with the new technology to see what value would be added by introducing and using the new technology, the so called “added value”. HTAs will consider the health problem in their local context and then assess the treatment for the indication that the regulators have agreed for the medicine.

Within that indication, HTA bodies examine available data to evaluate how well the treatment can work in comparison with the standard of care (in terms of safety and clinical effectiveness). Some also assess the costs and cost effectiveness of a medicine, and while some do formal assessments of the ethical, organisational, social, and legal aspects, others simply consider these issues implicitly in their assessment.

The ‘added value’ of a new medicine is determined by each HTA body in a different, multifaceted way. Conclusions about the ‘added value’ may differ between HTA bodies. The European network for HTA (EUnetHTA) has developed a framework by which the ‘added value’ can be assessed, called the HTA Core Model®.

There are nine domains in the HTA Core Model®:

  1. Health problem.
  2. Technical description of technology.
  3. Safety.
  4. Clinical effectiveness.
  5. Costs and economic evaluation (cost effectiveness).
  6. Ethical analysis.
  7. Organisational aspects.
  8. Social aspects.
  9. Legal aspects.

EUnetHTA has defined the assessment of the first four domains as a ‘relative effectiveness assessment’, i.e. compared to the existing treatment(s). It has sought to coordinate HTA agencies across Europe to develop a relative effectiveness assessment report format for a particular health technology, which can then be used for decision-making in local contexts.