Since 2015, the focus of Fimea’s HTA activities has been on the assessment of new hospital-only medicinal products. The purpose is to produce information about the therapeutic and economic effects of a medicine in support of decision-making.
In addition to a new medicinal products (new active substances), the object of the assessment may be a significant extension of a therapeutic indication. The procedure related to the selection of topics is described in more detail in the process description below. Where possible, the assessments will be carried out in such a way that the assessment report would be available as soon as possible after the granting of a marketing authorisation or extension of a therapeutic indication when the adoption of the medicine is considered.