Last Updated : August 30, 2024
Details
FilesGeneric Name:
cabotegravir
Project Status:
Active
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
Performance Metric:
Achieved
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 | 14-Dec-23 |
|---|---|
| Call for patient/clinician input closed | 12-Feb-24 |
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 | 01-Feb-24 |
| Submission accepted | 15-Feb-24 |
| Review initiated | 16-Feb-24 |
| Draft CADTH review report(s) provided to sponsor for comment | 07-May-24 |
| Deadline for sponsors comments | 16-May-24 |
| CADTH review report(s) and responses to comments provided to sponsor | 14-Jun-24 |
| Expert committee meeting (initial) | 26-Jun-24 |
| Draft recommendation issued to sponsor | 09-Jul-24 |
| Draft recommendation posted for stakeholder feedback | 18-Jul-24 |
| End of feedback period | 01-Aug-24 |
| Final recommendation issued to sponsor and drug plans | 14-Aug-24 |
| Final recommendation posted | 30-Aug-24 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | 28-Aug-24 |
| CADTH review report(s) posted | - |
Files
Last Updated : August 30, 2024