Last Updated : September 21, 2020
Details
FilesGeneric 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
Performance Metric:
Not applicable due to external delays - Application held awaiting decision by Health Canada
Biosimilar:
No
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:
- The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency 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 Canada's Drug Agency review report(s) sent to sponsor | November 25, 2019 |
| Comments from sponsor on draft Canada's Drug Agency review report(s) received | December 04, 2019 |
| Canada's Drug Agency review team's comments on draft Canada's Drug Agency 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 & Canada's Drug Agency 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 Canada's Drug Agency review report(s) received | August 06, 2020 |
| Redacted Canada's Drug Agency review report(s) sent to sponsor and drug plans | August 18, 2020 |
| Validation of redacted Canada's Drug Agency review report(s) received | August 18, 2020 |
| Final Canada's Drug Agency review report(s) posted | September 17, 2020 |
Files
Last Updated : September 21, 2020