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eluxadoline

Last Updated: September 18, 2018
Result type: Reports
Project Number: SR0560-000
Product Line: Common Drug Review

Generic Name: eluxadoline

Brand Name: Viberzi

Manufacturer: Allergan Pharma Co.

Indications: Irritable bowel syndrome with diarrhea

Manufacturer Requested Reimbursement Criteria1: As per the Health Canada-approved indication (for the tretment of irritable bowel syndrome with diarrhea (IBS-D) in adults.)

Submission Type: New

Project Status: Complete

Biosimilar: No

Date Recommendation Issued: August 24, 2018

Recommendation Type: Do not reimburse

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 postedJanuary 25, 2018
Patient group input closedMarch 16, 2018
Clarification:

- Patient input submission received

Patient input summary sent for review to patient input groupsMarch 28, 2018
Patient group comments on input summary closedApril 05, 2018
Clarification:

- Patient input summary feedback received

Submission receivedFebruary 23, 2018
Submission accepted for reviewMarch 09, 2018
Review initiatedMarch 14, 2018
Draft CDR review report(s) sent to applicantMay 31, 2018
Comments from applicant on draft CDR review report(s) receivedJune 11, 2018
Redaction requests from applicant on draft CDR review report(s) receivedJune 18, 2018
CDR review team's comments on draft CDR review report(s) sent to applicantJuly 06, 2018
Canadian Drug Expert Committee (CDEC) meetingJuly 18, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plansAugust 01, 2018
Embargo period ended and validation of redacted CDR review report(s) receivedAugust 16, 2018
CDEC Final Recommendation issued to applicant and drug plansAugust 24, 2018
CDEC Final Recommendation postedAugust 29, 2018
Final CDR review report(s) and patient input postedSeptember 18, 2018