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Last Updated: August 13, 2019
Result type: Reports
Project Number: SR0627-000
Product Line: Common Drug Review

Generic Name: ustekinumab

Brand Name: Stelara

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: Received

Companion Diagnostics: No

Fee Schedule: Pending

  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
Patient input summary sent for review to patient input groups-
Patient group comments on input summary closed-
Submission receivedAugust 12, 2019
Submission accepted for reviewAugust 26, 2019
Review initiated-
Draft CADTH review report(s) sent to applicant-
Comments from applicant on draft CADTH review report(s) received-
CADTH review team's comments on draft CADTH review report(s) sent to applicant-
Canadian Drug Expert Committee (CDEC) meeting-
CDEC recommendation sent to applicant and drug plans-
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