Last Updated : January 14, 2025
Details
FilesGeneric Name:
cabotegravir
Project Status:
Complete
Therapeutic Area:
HIV-1 infection, pre-exposure prophylaxis
Manufacturer:
ViiV Healthcare ULC
Call for patient/clinician input open:
Brand Name:
Apretude
Project Line:
Reimbursement Review
Project Number:
SR0825-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For at-risk adults and adolescents aged 12 years and older and weighing at least 35 kg for PrEP to reduce the risk of sexually acquired HIV-1 infection.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
For at-risk adults and adolescents aged 12 years and older and weighing at least 35 kg for PrEP to reduce the risk of sexually acquired 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.
| Call for patient/clinician input open | December 14, 2023 |
|---|---|
| Call for patient/clinician input closed | February 12, 2024 |
| Clarification: - Patient input submission received from Peer Outreach Support Services & Education (POSSE), Africans in Partnership Against AIDS, Community-Based Research Centre, CATIE and HIV Network of Edmonton Society | |
| Submission received | February 01, 2024 |
| Submission accepted | February 15, 2024 |
| Review initiated | February 16, 2024 |
| Draft CADTH review report(s) provided to sponsor for comment | May 07, 2024 |
| Deadline for sponsors comments | May 16, 2024 |
| CADTH review report(s) and responses to comments provided to sponsor | June 14, 2024 |
| Expert committee meeting (initial) | June 26, 2024 |
| Draft recommendation issued to sponsor | July 09, 2024 |
| Draft recommendation posted for stakeholder feedback | July 18, 2024 |
| End of feedback period | August 01, 2024 |
| Final recommendation issued to sponsor and drug plans | August 14, 2024 |
| Final recommendation posted | August 30, 2024 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | August 28, 2024 |
| CADTH review report(s) posted | January 14, 2025 |
Files
Last Updated : January 14, 2025