upadacitinib

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Generic Name:
upadacitinib
Project Status:
Complete
Therapeutic Area:
Ulcerative colitis
Manufacturer:
AbbVie
Brand Name:
Rinvoq
Project Line:
Reimbursement Review
Project Number:
SR0730-000
NOC Status at Filing:
Pre NOC
Performance Metric:
N/A delay outside our control - Application held awaiting decision by Health Canada
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, loss of response to, or were intolerant to either conventional therapy or a biologic agent (i.e., tumour necrosis factor-alpha [TNF] antagonists, integrin receptor antagonists or interleukin 12/23 inhibitors).
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
​For the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have demonstrated prior treatment failure, i.e., an inadequate response to, loss of response to, or intolerance to at least one of conventional, and/or biologic therapy.
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/clinician input open21-Mar-22
Call for patient/clinician input closed13-May-22
Clarification:

- Patient input submission received from Crohn’s and Colitis Canada and the Gastrointestinal Society

Submission received18-Apr-22
Submission accepted03-May-22
Clarification:

- Submission was not accepted for review on 02 May 2022

Review initiated04-May-22
Draft CADTH review report(s) provided to sponsor for comment03-Aug-22
Deadline for sponsors comments12-Aug-22
CADTH review report(s) and responses to comments provided to sponsor19-Sep-22
Clarification:

- Submission temporarily suspended

- Additional information has been received and the temporary suspension of the review has been lifted

Expert committee meeting (initial)28-Sep-22
Draft recommendation issued to sponsor27-Jul-23
Clarification:

- CDEC recommendation held pending receipt of NOC and evaluation of the finalized submission requirements

- Submission temporarily suspended

- Additional information has been received and the temporary suspension of the review has been liftted

Draft recommendation posted for stakeholder feedback03-Aug-23
End of feedback period18-Aug-23
Final recommendation issued to sponsor and drug plans01-Sep-23
Final recommendation posted20-Sep-23
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)18-Sep-23
CADTH review report(s) posted16-Nov-23