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
- 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 | 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 | - |
| Clarification: - CDEC recommendation held pending receipt of NOC and evaluation of the finalized submission requirements. | |