eluxadoline

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Generic 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:
  1. 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