Generic Name: vedolizumab
Brand Name: Entyvio
Manufacturer: Takeda Canada Inc.
Therapeutic Area: Crohn’s disease
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.
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
NOC Status at Filing: Pre NOC
Project Status: Active
Companion Diagnostics: No
Date Recommendation Issued: January 21, 2021
Recommendation Type: Reimburse with clinical criteria and/or conditions
Fee Schedule: Schedule C
- The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.
|Call for patient input open||May 05, 2020|
|Call for patient input closed||June 24, 2020|
- 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||-|