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Last Updated: July 13, 2020
Result type: Reports
Project Number: SR0635-000
Product Line: Reimbursement Review

Generic Name: vedolizumab

Brand Name: Entyvio

Manufacturer: Takeda Canada Inc.

Therapeutic Area: Ulcerative Colitis

Indications: Ulcerative Colitis

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

Project Status: Complete

Companion Diagnostics: No

Date Recommendation Issued: May 19, 2020

Recommendation Type: Reimburse with clinical criteria and/or conditions

Fee Schedule: Schedule A

  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 postedSeptember 19, 2019
Patient group input closedNovember 08, 2019

- Patient input submission received from Gastrointestinal Society

Patient input summary sent for review to patient input groupsDecember 10, 2019
Patient group comments on input summary closedDecember 17, 2019

- Patient input summary feedback received

Submission receivedNovember 21, 2019
Submission acceptedDecember 05, 2019
Review initiatedDecember 06, 2019
Draft CADTH review report(s) sent to sponsorFebruary 27, 2020
Comments from sponsor on draft CADTH review report(s) receivedMarch 09, 2020
CADTH review team's comments on draft CADTH review report(s) sent to sponsorApril 02, 2020
Canadian Drug Expert Committee (CDEC) meetingApril 15, 2020
CDEC recommendation sent to sponsor and drug plansApril 27, 2020
Embargo period endedMay 11, 2020
CDEC Final Recommendation & CADTH review report(s) issued to sponsor and drug plansMay 19, 2020
CDEC Final Recommendation postedMay 21, 2020
Redaction requests from sponsor on draft CADTH review report(s) receivedJune 02, 2020
Redacted CADTH review report(s) sent to sponsor and drug plansJune 12, 2020
Validation of redacted CADTH review report(s) receivedJune 19, 2020
Final CADTH review report(s) postedJuly 13, 2020