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vedolizumab

Last Updated: January 22, 2021
Result type: Reports
Project Number: SR0647-000
Product Line: Reimbursement Review

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

  1. 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.

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 -