Begin main content

dolutegravir / lamivudine

Last Updated: September 13, 2019
Result type: Reports
Project Number: SR0601-000
Product Line: Common Drug Review

Generic Name: dolutegravir / lamivudine

Brand Name: Dovato

Manufacturer: ViiV Healthcare

Indications: HIV-1 infection

Manufacturer Requested Reimbursement Criteria1: Indicated as a complete regimen for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults and adolescents 12 years of age and older and weighing at least 40 kg.

Submission Type: New

Project Status: Active

Biosimilar: No

Companion Diagnostics: No

Fee Schedule: Schedule A

  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.

Key Milestones2

Call for patient input postedJanuary 23, 2019
Patient group input closedMarch 14, 2019

- Patient input submission received from the Canadian Treatment Action Council (CTAC)

Patient input summary sent for review to patient input groupsMarch 21, 2019
Patient group comments on input summary closedMarch 28, 2019

- Patient input summary feedback received

Submission receivedFebruary 21, 2019
Submission accepted for reviewMarch 07, 2019
Review initiatedMarch 08, 2019
Draft CADTH review report(s) sent to sponsorMay 23, 2019
Comments from sponsor on draft CADTH review report(s) receivedJune 03, 2019
Redaction requests from sponsor on draft CADTH review report(s) receivedJune 10, 2019
CADTH review team's comments on draft CADTH review report(s) sent to sponsorJuly 05, 2019
Canadian Drug Expert Committee (CDEC) meetingJuly 17, 2019

CDEC recommendation held pending receipt of NOC and evaluation of the finalized submission requirements.

CDEC recommendation & redacted CADTH review report(s) sent to sponsor and drug plansSeptember 09, 2019
Embargo period ended and validation of redacted CADTH review report(s) receivedSeptember 23, 2019
CDEC Final Recommendation issued to sponsor and drug plansSeptember 30, 2019
CDEC Final Recommendation posted-
Final CADTH review report(s) posted-