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bictegravir/emtricitabine/tenofovir alafenamide

Last Updated: November 27, 2018
Result type: Reports
Project Number: SR0567-000
Product Line: Reimbursement Review

Generic Name: bictegravir/emtricitabine/tenofovir alafenamide

Brand Name: Biktarvy

Manufacturer: Gilead Sciences Canada, Inc.

Therapeutic Area: HIV-1 infection

Indications: HIV-1 infection

Manufacturer Requested Reimbursement Criteria1: A complete regimen for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults with no known substitution associated with resistance to the individual components of TBD (bictegravir/emtricitabine/tenofovir alafenamide).

Submission Type: Initial

Project Status: Complete

Biosimilar: No

Companion Diagnostics: No

Date Recommendation Issued: October 25, 2018

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 postedApril 02, 2018
Patient group input closedMay 22, 2018

- Patient input submission received

Patient input summary sent for review to patient input groupsJune 07, 2018
Patient group comments on input summary closedJune 14, 2018

- Patient input summary feedback received

Submission receivedApril 30, 2018
Submission accepted for reviewMay 14, 2018
Review initiatedMay 16, 2018
Draft CDR review report(s) sent to applicantJuly 31, 2018
Comments from applicant on draft CDR review report(s) receivedAugust 10, 2018
Redaction requests from applicant on draft CDR review report(s) receivedAugust 17, 2018
CDR review team's comments on draft CDR review report(s) sent to applicantSeptember 07, 2018
Canadian Drug Expert Committee (CDEC) meetingSeptember 19, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plansOctober 03, 2018
Embargo period ended and validation of redacted CDR review report(s) receivedOctober 18, 2018
CDEC Final Recommendation issued to applicant and drug plansOctober 25, 2018
CDEC Final Recommendation postedOctober 29, 2018
Final CDR review report(s) and patient input postedOctober 29, 2018