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dolutegravir / lamivudine

Last Updated: October 23, 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: Complete

Biosimilar: No

Companion Diagnostics: No

Date Recommendation Issued: September 30, 2019

Recommendation Type: Reimburse with clinical criteria and/or conditions

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 posted January 23, 2019
Patient group input closed March 14, 2019
Clarification:

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

Patient input summary sent for review to patient input groups March 21, 2019
Patient group comments on input summary closed March 28, 2019
Clarification:

- Patient input summary feedback received

Submission received February 21, 2019
Submission accepted for review March 07, 2019
Review initiated March 08, 2019
Draft CADTH review report(s) sent to sponsor May 23, 2019
Comments from sponsor on draft CADTH review report(s) received June 03, 2019
Redaction requests from sponsor on draft CADTH review report(s) received June 10, 2019
CADTH review team's comments on draft CADTH review report(s) sent to sponsor July 05, 2019
Canadian Drug Expert Committee (CDEC) meeting July 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 sponsor and drug plans September 09, 2019
Embargo period ended and validation of redacted CADTH review report(s) received September 23, 2019
CDEC Final Recommendation issued to sponsor and drug plans September 30, 2019
CDEC Final Recommendation posted October 02, 2019
Final CADTH review report(s) posted October 23, 2019