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cabotegravir/rilpivirine

Last Updated: September 30, 2019
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 posted July 19, 2019
Patient group input closed September 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 groups September 20, 2019
Patient group comments on input summary closed September 26, 2019
Clarification:

- Patient input summary feedback received

Submission received August 19, 2019
Submission accepted for review September 03, 2019
Review initiated September 04, 2019
Draft CADTH review report(s) sent to sponsor November 25, 2019
Comments from sponsor on draft CADTH review report(s) received December 04, 2019
CADTH review team's comments on draft CADTH review report(s) sent to sponsor January 03, 2020
Canadian Drug Expert Committee (CDEC) meeting January 15, 2020
CDEC recommendation sent to sponsor and drug plans January 27, 2020
To
January 29, 2020