tofacitinib

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Generic Name:
tofacitinib
Project Status:
Complete
Therapeutic Area:
Ulcerative colitis
Manufacturer:
Pfizer Canada Inc.
Call for patient/clinician input open:
Brand Name:
Xeljanz
Project Line:
Reimbursement Review
Project Number:
SR0572-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
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
Fee Schedule:
Schedule B
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.
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency 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