Cost-effectiveness included as part of the assessment of new hospital-only medicinal products
Fimea has published an updated description of the assessment process of new hospital-only medicinal products. The update was made in order to enhance stakeholder cooperation and to further improve the value and usability of the assessments. The most important change is that the assessment of cost-effectiveness has been added as an optional part of the assessment.
The assessment of cost-effectiveness will be included as part of the assessment if the marketing authorisation holder submits a cost-effectiveness analysis and a related model and documentation to Fimea. In such a case, the time needed for responding to the request for information will be longer than usual.
- Vesa Kiviniemi, Head of Assessment, tel. +358 29 522 3516
- Ulla Härkönen, Research Physician, tel. +358 29 522 3530
- E-mail address format: firstname.lastname@example.org