This is the pharmaceutical Joint Assessment PTJA08 – on siponimod for the treatment of active SPMS. In January 2020, the European Commission granted marketing authorisation for Mayzent® (siponimod) for the treatment of adult patients with secondary progressive multiple sclerosis (SPMS) with active disease evidenced by relapses or imaging features of inflammatory activity. This Joint Assessment aims to compare the clinical effectiveness and safety of siponimod in the target patient populations with relevant comparators according to the national requirements of EUnetHTA partners.
Below is the documentation provided by the Joint Assessment authoring team (project plan, assessment report and responses to the factual accuracy check performed by Novartis) and by Novartis, the Marketing Authorisation Holder of siponimod (PTJA08 submission dossier).
A revised version of the assessment report originally posted on 13/02/2020 was published on 03/03/2020. An error was identified on 25/02/2020 by the MAH regarding the half-life of siponimod versus fingolimod. In addition, authors corrected the subgroup numbers in the report. For further details please see the version history table in the assessment report.
For any questions regarding the assessment, please contact WP4_Pharmaceuticals@zinl.nl
PTJA08 – Final Assessment report
PTJA08 – MAH Core Submission Dossier