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dolutegravir / lamivudine

Last Updated: July 30, 2019
Result type: Reports
Project Number: SR0601-000
Product Line: Common Drug Review

Generic Name: dolutegravir / lamivudine

Brand Name: TBC

Manufacturer: ViiV Healthcare

Indications: HIV-1 infection

Manufacturer Requested Reimbursement Criteria1: Indicated for the treatment of Human Immunodeficiency Virus (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
Clarification:

- 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
Clarification:

- 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 applicantMay 23, 2019
Comments from applicant on draft CADTH review report(s) receivedJune 03, 2019
Redaction requests from applicant on draft CADTH review report(s) receivedJune 10, 2019
CADTH review team's comments on draft CADTH review report(s) sent to applicantJuly 05, 2019
Canadian Drug Expert Committee (CDEC) meetingJuly 17, 2019
Clarification:

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

CDEC recommendation & redacted CADTH review report(s) sent to applicant and drug plans-
Embargo period ended and validation of redacted CADTH review report(s) received-