sofosbuvir velpatasvir voxilaprevir

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Generic 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
Performance Metric:
Achieved
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