Last Updated : April 25, 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 | 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 To July 11, 2024 |
| Draft recommendation posted for stakeholder feedback | July 18, 2024 |
| End of feedback period | August 01, 2024 |
Last Updated : April 25, 2024