Begin main content

sofosbuvir velpatasvir voxilaprevir

Last Updated: November 14, 2017
Result type: Reports
Project Number: SR0529-000
Product Line: Common Drug Review

Generic Name: sofosbuvir velpatasvir voxilaprevir

Brand Name: Vosevi

Manufacturer: Gilead Sciences Canada, Inc.

Indications: Hepatitis C, chronic

Submission Type: New Combination

Project Status: Active

Biosimilar: No

Fee Schedule1: Schedule A

Key Milestones2

Call for patient input posted3July 07, 2017
Patient group input closed3August 28, 2017

Patient input submission received

Patient input summary sent for review to patient input groupsAugust 30, 2017
Patient group comments on input summary closedSeptember 07, 2017

- Patient input summary feedback received

Submission receivedJuly 28, 2017
Submission accepted for reviewAugust 14, 2017
Review initiatedAugust 15, 2017
Draft CDR review report(s) sent to applicantOctober 30, 2017
Comments from applicant on draft CDR review report(s) receivedNovember 08, 2017
Redaction requests from applicant on draft CDR review report(s) receivedNovember 15, 2017
CDR review team's comments on draft CDR review report(s) sent to applicantDecember 01, 2017
Canadian Drug Expert Committee (CDEC) meetingDecember 13, 2017
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plansJanuary 02, 2018
January 04, 2018
  1. Refer to Appendix 1 of the Procedure for the CADTH Common Drug Review for details regarding CDR application fee schedules.
  2. Please refer to the Procedure for the CADTH Common Drug Review for complete details regarding the CDR process and targeted time frames for key milestones.
  3. The call for patient group input is posted 20 business days in advance of the applicant's anticipated date of filing the CDR application. Patient groups have a total of 35 business days for preparing and submitting patient input.
  4. The embargoed CDEC recommendation is held in confidence by all stakeholders and not acted upon until after CADTH has issued the notice of CDEC Final Recommendation.The applicant may make a request for reconsideration or resubmission based on reduced price during the embargo period, and the drug plans may make a request for clarification, as applicable (see section 8 of the Procedure for the CADTH Common Drug Review).
  5. The timing for posting the CDEC Final Recommendation and CDR review report(s) depends on several factors including the need for consultation with the applicant regarding redaction issues.
  6. The time frame required to address a request for clarification at the drug plans' request or request for reconsideration at the applicant's request depends on the amount of work required to address the request and the available dates for CDEC meetings.