belimumab

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Generic 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
Performance Metric:
Achieved
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:
  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 openJune 08, 2022
Call for patient/clinician input closedJuly 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 receivedJuly 07, 2022
Submission acceptedJuly 22, 2022
Review initiatedJuly 22, 2022
Draft CADTH review report(s) provided to sponsor for commentOctober 06, 2022
Deadline for sponsors commentsOctober 18, 2022
CADTH review report(s) and responses to comments provided to sponsorNovember 11, 2022
Expert committee meeting (initial)November 23, 2022
Draft recommendation issued to sponsorDecember 05, 2022
Draft recommendation posted for stakeholder feedbackDecember 15, 2022
End of feedback periodJanuary 06, 2023
Final recommendation issued to sponsor and drug plansJanuary 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) postedApril 10, 2023