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tofacitinib

Last Updated: December 4, 2018
Result type: Reports
Project Number: SR0572-000
Product Line: Common Drug Review

Generic Name: tofacitinib

Brand Name: Xeljanz

Manufacturer: Pfizer Canada Inc.

Indications: Ulcerative colitis

Manufacturer Requested Reimbursement Criteria1: Indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) with an inadequate response, loss of response or intolerance to either conventional UC therapy or a TNFa inhibitor.

Submission Type: New Indication

Project Status: Active

Biosimilar: No

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 postedMay 22, 2018
Patient group input closedJuly 11, 2018
Clarification:

- Patient input submission received from the Gastrointestinal Society

Patient input summary sent for review to patient input groupsJuly 17, 2018
Patient group comments on input summary closedJuly 24, 2018
Clarification:

- Patient input summary feedback received

Submission receivedJune 27, 2018
Submission accepted for reviewJuly 12, 2018
Review initiatedJuly 13, 2018
Draft CDR review report(s) sent to applicantOctober 10, 2018
Comments from applicant on draft CDR review report(s) receivedOctober 19, 2018
Redaction requests from applicant on draft CDR review report(s) receivedOctober 26, 2018
CDR review team's comments on draft CDR review report(s) sent to applicantNovember 09, 2018
Canadian Drug Expert Committee (CDEC) meetingNovember 21, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plansDecember 04, 2018
Embargo period ended and validation of redacted CDR review report(s) receivedDecember 18, 2018

Tags

digestive system, gastrointestinal tract