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cabotegravir/rilpivirine

Last Updated: January 15, 2020
Result type: Reports
Project Number: SR0628-000
Product Line: Common Drug Review

Generic Name: cabotegravir-rilpivirine cabotegravir sodium

Brand Name: TBC

Manufacturer: ViiV Healthcare ULC

Indications: HIV-1 infection

Manufacturer Requested Reimbursement Criteria1: cabotegravir-rilpivirine is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults to replace the current antiretroviral regimen in patients who are virologically suppressed (HIV-1 RNA less than 50 copies/mL). cabotegravir sodium is indicated in combination with EDURANT (rilpivirine) as a complete regimen for short-term treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who are virologically 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 plansJanuary 27, 2020
To
January 29, 2020