Topic selection

The topics suitable for the HTA assessment of hospital-only medicinal products are selected either through an application-based or official-initiated procedure. In the application-based procedure, the company informs Fimea about the new hospital drug and the anticipated time of submitting the application. In the official-initiated model, Fimea selects the assessment topics monthly from the positive opinions made by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) and sends the company a request for information.

When a therapeutic indication of a hospital-only medicinal product is extended, the network of chief assessment physicians can propose transferring the assessment to the Fimea-COHERE process, if the topic is financially significant or if there is otherwise a need for more extensive assessment. The assessment model related to the extension of the indication is currently being piloted.

Below is a monthly updated Excel file (partly in Finnish), which provides a short summary of the CHMP's positive opinions and information on which subjects Fimea has initiated or will initiate an HTA assessment. New medicinal products and indication extensions are in their own tabs in Excel. In addition, the Excel file has its own tab with information on completed assessment statements for extensions of indications (starting from June 2024). Information about ongoing and completed assessments can be found on the Arviointiraportit page (only in Finnish).