fostemsavir

Details

Files
Generic Name:
fostemsavir
Project Status:
Complete
Therapeutic Area:
Human immunodeficiency virus type 1 (HIV-1)
Manufacturer:
ViiV Healthcare ULC
Brand Name:
Rukobia
Project Line:
Reimbursement Review
Project Number:
SR0760-000
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Rukobia (fostemsavir extended release tablets) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced (HTE) adults with multidrug-resistant HIV-1 infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen due to resistance, intolerance or safety considerations.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
​Rukobia (fostemsavir extended release tablets) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced (HTE) adults with multidrug-resistant HIV-1 infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen due to resistance, intolerance or safety considerations.
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 openSeptember 29, 2022
Call for patient/clinician input closedNovember 18, 2022
Clarification:

- Patient input submission received from Community-Based Research Centre

Submission receivedOctober 28, 2022
Submission acceptedNovember 11, 2022
Review initiatedNovember 14, 2022
Draft CADTH review report(s) provided to sponsor for commentFebruary 03, 2023
Deadline for sponsors commentsFebruary 14, 2023
CADTH review report(s) and responses to comments provided to sponsorMarch 09, 2023
Expert committee meeting (initial)March 22, 2023
Draft recommendation issued to sponsorApril 03, 2023
Draft recommendation posted for stakeholder feedbackApril 13, 2023
End of feedback periodApril 27, 2023
Clarification:

- Reconsideration: minor revisions requested by sponsor

- Request for reconsideration not accepted

Final recommendation issued to sponsor and drug plansMay 10, 2023
Final recommendation postedMay 29, 2023
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)May 25, 2023
CADTH review report(s) postedJuly 26, 2023