Begin main content

ustekinumab

Last Updated: November 28, 2019
Result type: Reports
Project Number: SR0627-000
Product Line: Common Drug Review

Generic Name: ustekinumab

Brand Name: Stelara/Stelara I.V

Manufacturer: Janssen Inc.

Indications: Ulcerative colitis

Manufacturer Requested Reimbursement Criteria1: For the treatment of adult patients with moderately to severely active ulcerative colitis who have failed or were intolerant to treatment with immunomodulators or corticosteroids, but never failed treatment with a biologic, or have failed or were intolerant to treatment with a biologic.

Submission Type: New Indication

Project Status: Active

Companion Diagnostics: No

Fee Schedule: Schedule B

  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.

Key Milestones2

Call for patient input postedJuly 12, 2019
Patient group input closedSeptember 03, 2019
Clarification:

- Patient input submission received from Crohn's and Colitis Foundation of Canada and Gastrointestinal (GI) Society

Patient input summary sent for review to patient input groupsSeptember 06, 2019
Patient group comments on input summary closedSeptember 13, 2019
Clarification:

- Patient input summary feedback received

Submission receivedAugust 12, 2019
Submission accepted for reviewAugust 26, 2019
Review initiatedAugust 27, 2019
Draft CADTH review report(s) sent to sponsorNovember 18, 2019
Comments from sponsor on draft CADTH review report(s) receivedNovember 27, 2019
CADTH review team's comments on draft CADTH review report(s) sent to sponsorJanuary 03, 2020
Canadian Drug Expert Committee (CDEC) meetingJanuary 15, 2020
CDEC recommendation sent to sponsor and drug plansJanuary 27, 2020
To
January 29, 2020