Last Updated : April 1, 2020
Details
FilesGeneric Name:
upadacitinib
Project Status:
Complete
Therapeutic Area:
Arthritis, Rheumatoid
Manufacturer:
AbbVie
Call for patient/clinician input open:
Brand Name:
Rinvoq
Project Line:
Reimbursement Review
Project Number:
SR0614-000
Call for patient/clinician input closed:
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:
Reimburse in a similar manner to other bDMARD and tsDMARD treatments for moderate to severely active RA.Upadacitinib to be listed for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs), as monotherapy or in combination with methotrexate or other conventional synthetic DMARDs (csDMARDs).
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Arthritis, Rheumatoid
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.
Key Milestones2 |
|
|---|---|
| Call for patient input posted | May 31, 2019 |
| Patient group input closed | July 22, 2019 |
| Clarification:
- Patient input submission received from the Arthritis Consumer Experts, Canadian Arthritis Patient Alliance (CAPA) & The Arthritis Society |
|
| Patient input summary sent for review to patient input groups | July 30, 2019 |
| Patient group comments on input summary closed | August 07, 2019 |
| Clarification:
- Patient input summary feedback received |
|
| Submission received | July 04, 2019 |
| Submission accepted | July 18, 2019 |
| Review initiated | July 22, 2019 |
| Draft CADTH review report(s) sent to sponsor | October 04, 2019 |
| Comments from sponsor on draft CADTH review report(s) received | October 16, 2019 |
| CADTH review team's comments on draft CADTH review report(s) sent to sponsor | November 08, 2019 |
| Canadian Drug Expert Committee (CDEC) meeting | November 20, 2019 |
| CDEC recommendation sent to sponsor and drug plans | January 14, 2020 |
| Embargo period ended | January 28, 2020 |
| CDEC Final Recommendation & CADTH review report(s) issued to sponsor and drug plans | February 04, 2020 |
| CDEC Final Recommendation posted | February 06, 2020 |
| Redaction requests from sponsor on draft CADTH review report(s) received | February 19, 2020 |
| Redacted CADTH review report(s) sent to sponsor and drug plans | - |
| Validation of redacted CADTH review report(s) received | - |
| Final CADTH review report(s) posted | March 31, 2020 |
Files
Last Updated : April 1, 2020