Last Updated : September 16, 2020
Details
FilesGeneric Name:
ustekinumab
Project Status:
Complete
Therapeutic Area:
Ulcerative colitis
Manufacturer:
Janssen Inc.
Call for patient/clinician input open:
Brand Name:
Stelara/Stelara I.V
Project Line:
Reimbursement Review
Project Number:
SR0627-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
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 with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies.
Submission Type:
Initial
Fee Schedule:
Schedule B
Indications:
Ulcerative colitis
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 | July 12, 2019 |
| Patient group input closed | September 03, 2019 |
| Clarification:
- Patient input submission received from Crohn's and Colitis Foundation of Canada and Gastrointestinal (GI) Society |
|
| Patient input summary sent for review to patient input groups | September 06, 2019 |
| Patient group comments on input summary closed | September 13, 2019 |
| Clarification:
- Patient input summary feedback received |
|
| Submission received | August 12, 2019 |
| Submission accepted | August 26, 2019 |
| Review initiated | August 27, 2019 |
| Draft CADTH review report(s) sent to sponsor | November 18, 2019 |
| Comments from sponsor on draft CADTH review report(s) received | November 27, 2019 |
| CADTH review team's comments on draft CADTH review report(s) sent to sponsor | January 03, 2020 |
| Canadian Drug Expert Committee (CDEC) meeting | January 15, 2020 |
| CDEC recommendation sent to sponsor and drug plans | January 29, 2020 |
| Embargo period ended | March 12, 2020 |
| Clarification:
- Request for extension to embargo period received from the sponsor - Embargo extension request granted - Reconsideration requested |
|
| Sponsor's request for reconsideration placed on CDEC agenda | June 17, 2020 |
| CDEC recommendation sent to sponsor and drug plans | June 24, 2020 |
| Embargo period ended | July 09, 2020 |
| CDEC Final Recommendation & CADTH review report(s) issued to sponsor and drug plans | July 16, 2020 |
| CDEC Final Recommendation posted | July 20, 2020 |
| Redaction requests from sponsor on draft CADTH review report(s) received | July 30, 2020 |
| Redacted CADTH review report(s) sent to sponsor and drug plans | August 12, 2020 |
| Validation of redacted CADTH review report(s) received | August 19, 2020 |
| Final CADTH review report(s) posted | September 14, 2020 |
Files
Last Updated : September 16, 2020