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cabotegravir/rilpivirine

Last Updated: April 1, 2020
Result type: Reports
Project Number: SR0628-000
Product Line: Common Drug Review

Generic Name: cabotegravir sodium cabotegravir-rilpivirine

Brand Name: Vocabria and Cabenuva

Manufacturer: ViiV Healthcare ULC

Indications: HIV-1 infection

Manufacturer Requested Reimbursement Criteria1: Vocabria (cabotegravir tablets) is indicated, in combination with EDURANT (rilpivirine tablets), as a complete regimen for short-term treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who are virologically stable and suppressed HIV-1 RNA less than 50 copies/mL) as: an oral lead-in to assess tolerability of cabotegravir prior to initiating Cabenuva, oral bridging therapy for missed Cabenuva injections Cabenuva (cabotegravir and rilpivirine extended release injectable suspensions) is indicated as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in patients who are virologically stable and suppressed (HIV-1 RNA less than 50 copies/mL).

Submission Type: New Combination

Project Status: Active

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 postedJuly 19, 2019
Patient group input closedSeptember 10, 2019
Clarification:

- Patient input submission received from The Alliance for South Asian AIDS Prevention (ASAAP)

Patient input summary sent for review to patient input groupsSeptember 20, 2019
Patient group comments on input summary closedSeptember 26, 2019
Clarification:

- Patient input summary feedback received

Submission receivedAugust 19, 2019
Submission acceptedSeptember 03, 2019
Review initiatedSeptember 04, 2019
Draft CADTH review report(s) sent to sponsorNovember 25, 2019
Comments from sponsor on draft CADTH review report(s) receivedDecember 04, 2019
CADTH review team's comments on draft CADTH review report(s) sent to sponsorJanuary 03, 2020
Canadian Drug Expert Committee (CDEC) meetingJanuary 15, 2020
CDEC recommendation sent to sponsor and drug plansApril 01, 2020
Embargo period endedApril 16, 2020