Generic Name: tofacitinib
Brand Name: Xeljanz
Manufacturer: Pfizer Canada Inc.
Therapeutic Area: Ulcerative colitis
Indications: 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.
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: Initial
NOC Status at Filing: Pre NOC
Project Status: Complete
Biosimilar: No
Companion Diagnostics: No
Date Recommendation Issued: February 27, 2019
Recommendation Type: Reimburse with clinical criteria and/or conditions
Fee Schedule: Schedule B
- 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 posted | May 22, 2018 |
| Patient group input closed | July 11, 2018 |
| Clarification: - Patient input submission received from the Gastrointestinal Society | |
| Patient input summary sent for review to patient input groups | July 17, 2018 |
| Patient group comments on input summary closed | July 24, 2018 |
| Clarification: - Patient input summary feedback received | |
| Submission received | June 27, 2018 |
| Submission accepted | July 12, 2018 |
| Review initiated | July 13, 2018 |
| Draft CADTH review report(s) sent to sponsor | October 10, 2018 |
| Comments from sponsor on draft CADTH review report(s) received | October 19, 2018 |
| Redaction requests from sponsor on draft CADTH review report(s) received | October 26, 2018 |
| CADTH review team's comments on draft CADTH review report(s) sent to sponsor | November 09, 2018 |
| Canadian Drug Expert Committee (CDEC) meeting | November 21, 2018 |
| CDEC recommendation & redacted CADTH review report(s) sent to sponsor and drug plans | December 04, 2018 |
| Embargo period ended and validation of redacted CADTH review report(s) received | December 18, 2018 |
| Clarification: - Reconsideration requested | |
| Sponsor's request for reconsideration placed on CDEC agenda | February 20, 2019 |
| CDEC Final Recommendation issued to sponsor and drug plans | February 27, 2019 |
| CDEC Final Recommendation posted | March 01, 2019 |
| Final CADTH review report(s) and patient input posted | March 21, 2019 |