This is the pharmaceutical Joint Assessment PTJA07 – on ustekinumab for the treatment of ulcerative colitis (UC). In September 2019, EMA approved the extension of the indication for ustekinumab to include treatment of adult patients with moderately to severely active UC who have had an inadequate response with, lost response to or were intolerant to either conventional therapy or a biologic, or have medical contraindications to such therapies. This Joint Assessment aims to compare the clinical effectiveness and safety of ustekinumab in the target patient populations with relevant comparators (according to the national requirements of the EUnetHTA partners, the relevant comparators are adalimumab, infliximab, golimumab, vedolizumab, tofacitinib).
Below is the documentation provided by the Joint Assessment authoring team (project plan, assessment report and responses to the factual accuracy check performed by Janssen) and by Janssen, the Market Authorisation Holder of ustekinumab (PTJA07 submission dossier).
For any questions regarding the assessment, please contact WP4_Pharmaceuticals@zinl.nl
PTJA07 – Final Assessment Report
Janssen Core Submission Dossier
External Comments – Factual Accuracy Check Market Authorisation Holder