Last Updated : April 10, 2023
Details
FilesGeneric Name:
belimumab
Project Status:
Complete
Therapeutic Area:
Lupus nephritis
Manufacturer:
GlaxoSmithKline Inc.
Brand Name:
Benlysta
Project Line:
Reimbursement Review
Project Number:
SR0746-000
NOC Status at Filing:
Post NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
In addition to standard therapy for treatment of active lupus nephritis in adult patients.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
In addition to standard therapy for treatment of active lupus nephritis in adult patients.
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 | June 08, 2022 |
|---|---|
| Call for patient/clinician input closed | July 29, 2022 |
| Clarification: - Patient input submission received from Canadian Arthritis Patient Alliance, Arthritis Society, Canadian Skin Patient Alliance, CreakyJoints, Arthritis Consumer Experts, The Kidney Foundation of Canada, Lupus Canada, and Lupis Ontario | |
| Submission received | July 07, 2022 |
| Submission accepted | July 22, 2022 |
| Review initiated | July 22, 2022 |
| Draft CADTH review report(s) provided to sponsor for comment | October 06, 2022 |
| Deadline for sponsors comments | October 18, 2022 |
| CADTH review report(s) and responses to comments provided to sponsor | November 11, 2022 |
| Expert committee meeting (initial) | November 23, 2022 |
| Draft recommendation issued to sponsor | December 05, 2022 |
| Draft recommendation posted for stakeholder feedback | December 15, 2022 |
| End of feedback period | January 06, 2023 |
| Final recommendation issued to sponsor and drug plans | January 19, 2023 |
| Final recommendation posted | |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | February 03, 2023 |
| CADTH review report(s) posted | April 10, 2023 |
Files
Last Updated : April 10, 2023