The focus of Fimea's HTA activities is on the assessment of new hospital-only medicinal products. In addition, Fimea may produce other kind of assessments and reviews for different purposes in special cases or upon special request. Fimea does not, however, principally start assessments of vaccines, biosimilars, generic products or medicines used in outpatient care.
Fimea selects topics suitable for the assessment of hospital-only medicinal products by monitoring monthly the positive opinions made by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP). Decisions on launching assessments are made by Fimea. The selection of topics has been done systematically since the beginning of 2017, and Fimea has also started publishing information related to the topic selection process in 2020.
Below is a monthly updated Excel file (partly in Finnish) that provides a brief summary of the CHMP positive opinions, as well as information on which topics Fimea has chosen to launch the assessment. New medicines and extensions of indication can be found in the Excel file on their own tabs. Ongoing and completed assessments can be found on the Arviointiraportit page (only in Finnish).
Topic selection excel
Topic selection sininen sisältölaatikko
Ulla Härkönen, Research Physician, tel. +358 29 522 3530
Vesa Kiviniemi, Head of Assessment, tel. +358 29 522 3516
E-mail addresses take the form email@example.com.