Last Updated : July 14, 2020
Details
FilesGeneric Name:
vedolizumab
Project Status:
Complete
Therapeutic Area:
Ulcerative Colitis
Manufacturer:
Takeda Canada Inc.
Call for patient/clinician input open:
Brand Name:
Entyvio
Project Line:
Reimbursement Review
Project Number:
SR0635-000
Call for patient/clinician input closed:
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, loss of response to, or were intolerant to either conventional therapy or infliximab, a TNF antagonist.
Submission Type:
Initial
Fee Schedule:
Schedule A
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 | September 19, 2019 |
| Patient group input closed | November 08, 2019 |
| Clarification: - Patient input submission received from Gastrointestinal Society | |
| Patient input summary sent for review to patient input groups | December 10, 2019 |
| Patient group comments on input summary closed | December 17, 2019 |
| Clarification: - Patient input summary feedback received | |
| Submission received | November 21, 2019 |
| Submission accepted | December 05, 2019 |
| Review initiated | December 06, 2019 |
| Draft CADTH review report(s) sent to sponsor | February 27, 2020 |
| Comments from sponsor on draft CADTH review report(s) received | March 09, 2020 |
| CADTH review team's comments on draft CADTH review report(s) sent to sponsor | April 02, 2020 |
| Canadian Drug Expert Committee (CDEC) meeting | April 15, 2020 |
| CDEC recommendation sent to sponsor and drug plans | April 27, 2020 |
| Embargo period ended | May 11, 2020 |
| CDEC Final Recommendation & CADTH review report(s) issued to sponsor and drug plans | May 19, 2020 |
| CDEC Final Recommendation posted | May 21, 2020 |
| Redaction requests from sponsor on draft CADTH review report(s) received | June 02, 2020 |
| Redacted CADTH review report(s) sent to sponsor and drug plans | June 12, 2020 |
| Validation of redacted CADTH review report(s) received | June 19, 2020 |
| Final CADTH review report(s) posted | July 13, 2020 |
Files
Last Updated : July 14, 2020