Generic Name: eluxadoline
Brand Name: Viberzi
Manufacturer: Allergan Pharma Co.
Therapeutic Area: Irritable bowel syndrome with diarrhea
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: Initial
Project Status: Complete
Biosimilar: No
Date Recommendation Issued: August 24, 2018
Recommendation Type: Do not reimburse
Fee Schedule: Schedule A
- 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 posted | January 25, 2018 |
| Patient group input closed | March 16, 2018 |
| Clarification: - Patient input submission received | |
| Patient input summary sent for review to patient input groups | March 28, 2018 |
| Patient group comments on input summary closed | April 05, 2018 |
| Clarification: - Patient input summary feedback received | |
| Submission received | February 23, 2018 |
| Submission accepted for review | March 09, 2018 |
| Review initiated | March 14, 2018 |
| Draft CDR review report(s) sent to applicant | May 31, 2018 |
| Comments from applicant on draft CDR review report(s) received | June 11, 2018 |
| Redaction requests from applicant on draft CDR review report(s) received | June 18, 2018 |
| CDR review team's comments on draft CDR review report(s) sent to applicant | July 06, 2018 |
| Canadian Drug Expert Committee (CDEC) meeting | July 18, 2018 |
| CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans | August 01, 2018 |
| Embargo period ended and validation of redacted CDR review report(s) received | August 16, 2018 |
| CDEC Final Recommendation issued to applicant and drug plans | August 24, 2018 |
| CDEC Final Recommendation posted | August 29, 2018 |
| Final CDR review report(s) and patient input posted | September 18, 2018 |