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ustekinumab

Last Updated: September 14, 2020
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 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.

Submission Type: New

Project Status: Complete

Companion Diagnostics: No

Date Recommendation Issued: July 16, 2020

Recommendation Type: Reimburse with clinical criteria and/or conditions

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 acceptedAugust 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 29, 2020
Embargo period endedMarch 12, 2020
Clarification:

- Request for extension to embargo period received from the sponsor

- Embargo extension request granted

- Reconsideration requested

Sponsor's request for reconsideration placed on CDEC agendaJune 17, 2020
CDEC recommendation sent to sponsor and drug plansJune 24, 2020
Embargo period endedJuly 09, 2020
CDEC Final Recommendation & CADTH review report(s) issued to sponsor and drug plansJuly 16, 2020
CDEC Final Recommendation postedJuly 20, 2020
Redaction requests from sponsor on draft CADTH review report(s) receivedJuly 30, 2020
Redacted CADTH review report(s) sent to sponsor and drug plansAugust 12, 2020
Validation of redacted CADTH review report(s) receivedAugust 19, 2020
Final CADTH review report(s) postedSeptember 14, 2020