Last Updated : July 23, 2024
Details
FilesGeneric 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:
- 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.
| Call for patient/clinician input open | 21-Mar-22 |
|---|---|
| Call for patient/clinician input closed | 13-May-22 |
| Clarification: - Patient input submission received from Crohnâs and Colitis Canada and the Gastrointestinal Society | |
| Submission received | 18-Apr-22 |
| Submission accepted | 03-May-22 |
| Clarification: - Submission was not accepted for review on 02 May 2022 | |
| Review initiated | 04-May-22 |
| Draft CADTH review report(s) provided to sponsor for comment | 03-Aug-22 |
| Deadline for sponsors comments | 12-Aug-22 |
| CADTH review report(s) and responses to comments provided to sponsor | 19-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 sponsor | 27-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 feedback | 03-Aug-23 |
| End of feedback period | 18-Aug-23 |
| Final recommendation issued to sponsor and drug plans | 01-Sep-23 |
| Final recommendation posted | 20-Sep-23 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | 18-Sep-23 |
| CADTH review report(s) posted | 16-Nov-23 |
Files
Last Updated : July 23, 2024