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Last Updated: September 17, 2020
Result type: Reports
Project Number: SR0628-000
Product Line: Reimbursement Review

Generic Name: cabotegravir sodium cabotegravir-rilpivirine

Brand Name: Vocabria and Cabenuva

Manufacturer: ViiV Healthcare ULC

Therapeutic Area: HIV-1 infection

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: Initial

Project Status: Complete

Companion Diagnostics: No

Date Recommendation Issued: July 22, 2020

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 postedJuly 19, 2019
Patient group input closedSeptember 10, 2019

- 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

- 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

- Reconsideration requested

Sponsor's request for reconsideration placed on CDEC agendaJuly 15, 2020
CDEC Final Recommendation & CADTH review report(s) issued to sponsor and drug plansJuly 22, 2020
CDEC Final Recommendation postedJuly 24, 2020
Redaction requests from sponsor on draft CADTH review report(s) receivedAugust 06, 2020
Redacted CADTH review report(s) sent to sponsor and drug plansAugust 18, 2020
Validation of redacted CADTH review report(s) receivedAugust 18, 2020
Final CADTH review report(s) postedSeptember 17, 2020