Last Updated : April 5, 2018
Details
FilesGeneric Name:
sofosbuvir velpatasvir voxilaprevir
Project Status:
Complete
Therapeutic Area:
Hepatitis C, chronic
Manufacturer:
Gilead Sciences Canada, Inc.
Call for patient/clinician input open:
Brand Name:
Vosevi
Project Line:
Reimbursement Review
Project Number:
SR0529-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
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 | July 07, 2017 |
| Patient group input closed | August 28, 2017 |
| Clarification:
Patient input submission received |
|
| Patient input summary sent for review to patient input groups | August 30, 2017 |
| Patient group comments on input summary closed | September 07, 2017 |
| Clarification:
- Patient input summary feedback received |
|
| Submission received | July 28, 2017 |
| Submission accepted for review | August 14, 2017 |
| Review initiated | August 15, 2017 |
| Draft CDR review report(s) sent to applicant | October 30, 2017 |
| Comments from applicant on draft CDR review report(s) received | November 08, 2017 |
| Redaction requests from applicant on draft CDR review report(s) received | November 15, 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 07, 2018 |
Files
Last Updated : April 5, 2018