fostemsavir


( Last Updated : November 25, 2022)
Generic Name:
fostemsavir
Project Status:
Active
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

Details


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.
  1. 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.

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 02, 2023
Deadline for sponsors commentsFebruary 13, 2023
CADTH review report(s) and responses to comments provided to sponsorMarch 10, 2023
Expert committee meeting (initial)March 22, 2023
Draft recommendation issued to sponsorApril 03, 2023
To
April 05, 2023
Draft recommendation posted for stakeholder feedbackApril 13, 2023
End of feedback periodApril 27, 2023