Last Updated : February 16, 2024
Details
Generic 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:
TBC
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:
In at-risk individuals weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
In at-risk individuals weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection.
- 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.
| 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 | 06-May-24 |
| Deadline for sponsors comments | 15-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 | July 09, 2024 To July 11, 2024 |
| Draft recommendation posted for stakeholder feedback | 18-Jul-24 |
| End of feedback period | 01-Aug-24 |
Last Updated : February 16, 2024