cabotegravir/rilpivirine


( Last Updated : September 21, 2020)
Generic Name:
cabotegravir sodium cabotegravir-rilpivirine
Project Status:
Complete
Therapeutic Area:
HIV-1 infection
Manufacturer:
ViiV Healthcare ULC
Call for patient/clinician input open:
Brand Name:
Vocabria and Cabenuva
Project Line:
Reimbursement Review
Project Number:
SR0628-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC

Details


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
Fee Schedule:
Schedule A
Indications:
HIV-1 infection
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
  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 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 April 01, 2020
Embargo period ended April 16, 2020
Clarification:

- Reconsideration requested

Sponsor's request for reconsideration placed on CDEC agenda July 15, 2020
CDEC Final Recommendation & CADTH review report(s) issued to sponsor and drug plans July 22, 2020
CDEC Final Recommendation posted July 24, 2020
Redaction requests from sponsor on draft CADTH review report(s) received August 06, 2020
Redacted CADTH review report(s) sent to sponsor and drug plans August 18, 2020
Validation of redacted CADTH review report(s) received August 18, 2020
Final CADTH review report(s) posted September 17, 2020