Last Updated : April 30, 2021
Details
FilesGeneric Name:
vedolizumab
Project Status:
Complete
Therapeutic Area:
Crohn’s disease
Manufacturer:
Takeda Canada Inc.
Call for patient/clinician input open:
Brand Name:
Entyvio
Project Line:
Reimbursement Review
Project Number:
SR0647-000
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 Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to immunomodulators or a TNF antagonist; or have had an inadequate response, intolerance, or demonstrated dependence on corticosteroids.
Submission Type:
Initial
Fee Schedule:
Schedule C
Indications:
For the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to immunomodulators or a TNFα antagonist; or have had an inadequate response, intolerance, or demonstrated dependence on corticosteroids.
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 open | May 05, 2020 |
| Call for patient input closed | June 24, 2020 |
| Clarification:
- Patient input submission received from Crohn's and Colitis Canada and Gastrointestinal Society |
|
| Submission received | July 23, 2020 |
| Submission accepted | August 07, 2020 |
| Review initiated | August 10, 2020 |
| Draft CADTH review report(s) provided to sponsor for comment | October 29, 2020 |
| Deadline for sponsors comments | November 09, 2020 |
| CADTH responses on draft review report(s) provided to sponsor | November 27, 2020 |
| Expert committee meeting (initial) | December 09, 2020 |
| Draft recommendation issued to sponsor | December 21, 2020 |
| End of embargo period | January 12, 2021 |
| Final recommendation issued to sponsor and drug plans | January 19, 2021 |
| Final recommendation posted | January 22, 2021 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | February 02, 2021 |
| CADTH review report(s) posted | April 29, 2021 |
Files
Last Updated : April 30, 2021