CDA | Evidence Driven
CDA | Evidence Driven

cabotegravir

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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:
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:
  1. 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/clinician input open14-Dec-23
Call for patient/clinician input closed12-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 received01-Feb-24
Submission accepted15-Feb-24
Review initiated16-Feb-24
Draft CADTH review report(s) provided to sponsor for comment07-May-24
Deadline for sponsors comments16-May-24
CADTH review report(s) and responses to comments provided to sponsor14-Jun-24
Expert committee meeting (initial)26-Jun-24
Draft recommendation issued to sponsor09-Jul-24
Draft recommendation posted for stakeholder feedback18-Jul-24
End of feedback period01-Aug-24
Final recommendation issued to sponsor and drug plans14-Aug-24
Final recommendation posted30-Aug-24
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)28-Aug-24
CADTH review report(s) posted-

Files

Recommendation and Reason View PDF
Patient and Clinician Group Input View PDF
Last Updated : October 23, 2024