Last Updated : September 18, 2018
Details
FilesGeneric Name:
eluxadoline
Project Status:
Complete
Therapeutic Area:
Irritable bowel syndrome with diarrhea
Manufacturer:
Allergan Pharma Co.
Brand Name:
Viberzi
Project Line:
Reimbursement Review
Project Number:
SR0560-000
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
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
Fee Schedule:
Schedule A
Indications:
Irritable bowel syndrome with diarrhea
Recommendation Type:
Do not reimburse
Final Recommendation:
- The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency 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 |
Files
Last Updated : September 18, 2018