glecaprevir pibrentasvir

Details

Files
Generic Name:
glecaprevir pibrentasvir
Project Status:
Complete
Therapeutic Area:
Hepatitis C, chronic
Manufacturer:
AbbVie Corporation
Call for patient/clinician input open:
Brand Name:
Maviret
Project Line:
Reimbursement Review
Project Number:
SR0523-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Performance Metric:
N/A delay outside our control - Temporary suspension and/or submission of new information by sponsor
Biosimilar:
No
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Hepatitis C, chronic
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:

Key Milestones2

Call for patient input posted May 11, 2017
Patient group input closed June 30, 2017
Clarification:

- Patient input submission received

Patient input summary sent for review to patient input groups July 19, 2017
Patient group comments on input summary closed July 26, 2017
Clarification:

- Patient input summary feedback received

Submission received June 09, 2017
Submission accepted for review June 23, 2017
Review initiated June 26, 2017
Draft CDR review report(s) sent to applicant September 28, 2017
Comments from applicant on draft CDR review report(s) received October 10, 2017
Redaction requests from applicant on draft CDR review report(s) received October 17, 2017
CDR review team's comments on draft CDR review report(s) sent to applicant December 01, 2017
Canadian Drug Expert Committee (CDEC) meeting December 13, 2017
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans January 02, 2018
Embargo period ended and validation of redacted CDR review report(s) received January 16, 2018
CDEC Final Recommendation issued to applicant and drug plans January 23, 2018
CDEC Final Recommendation posted January 25, 2018
Final CDR review report(s) and patient input posted February 08, 2018