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
- 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 for review | July 12, 2018 |
| Review initiated | July 13, 2018 |
| Draft CDR review report(s) sent to applicant | October 10, 2018 |
| Comments from applicant on draft CDR review report(s) received | October 19, 2018 |
| Redaction requests from applicant on draft CDR review report(s) received | October 26, 2018 |
| CDR review team's comments on draft CDR review report(s) sent to applicant | November 09, 2018 |
| Canadian Drug Expert Committee (CDEC) meeting | November 21, 2018 |
| CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans | December 04, 2018 |
| Embargo period ended and validation of redacted CDR review report(s) received | December 18, 2018 |
| Clarification: - Reconsideration requested | |
| Applicant's request for reconsideration placed on CDEC agenda | February 20, 2019 |
| CDEC Final Recommendation issued to applicant and drug plans | February 27, 2019 |
| CDEC Final Recommendation posted | - |
| Final CDR review report(s) and patient input posted | - |
Tags
digestive system, gastrointestinal tract