Last Updated : July 26, 2023
Details
FilesGeneric 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
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:
- 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 | September 29, 2022 |
|---|---|
| Call for patient/clinician input closed | November 18, 2022 |
| Clarification: - Patient input submission received from Community-Based Research Centre | |
| Submission received | October 28, 2022 |
| Submission accepted | November 11, 2022 |
| Review initiated | November 14, 2022 |
| Draft CADTH review report(s) provided to sponsor for comment | February 03, 2023 |
| Deadline for sponsors comments | February 14, 2023 |
| CADTH review report(s) and responses to comments provided to sponsor | March 09, 2023 |
| Expert committee meeting (initial) | March 22, 2023 |
| Draft recommendation issued to sponsor | April 03, 2023 |
| Draft recommendation posted for stakeholder feedback | April 13, 2023 |
| End of feedback period | April 27, 2023 |
| Clarification: - Reconsideration: minor revisions requested by sponsor - Request for reconsideration not accepted | |
| Final recommendation issued to sponsor and drug plans | May 10, 2023 |
| Final recommendation posted | May 29, 2023 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | May 25, 2023 |
| CADTH review report(s) posted | July 26, 2023 |
Files
Last Updated : July 26, 2023