Last Updated : April 12, 2018
Details
FilesGeneric 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 |
Files
Last Updated : April 12, 2018