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belimumab

Last Updated: June 10, 2020
Result type: Reports
Project Number: SR0616-000
Product Line: Common Drug Review

Generic Name: Belimumab

Brand Name: Benlysta

Manufacturer: GlaxoSmithKline Inc.

Indications: systemic lupus erythematosus

Manufacturer Requested Reimbursement Criteria1: For the treatment of SLE patients who meet the following eligibility criteria: Adult patients age 18 years or older; AND Patients with active, antibody-positive SLE; AND Currently receiving standard therapy; AND Has a disease activity SELENA-SLEDAI score 8. If no improvements are observed in a patient’s SLE disease activity and/or symptoms after 6 months, use should be discontinued.

Submission Type: New

Project Status: Complete

Biosimilar: No

Companion Diagnostics: No

Date Recommendation Issued: April 22, 2020

Recommendation Type: Do not reimburse

Fee Schedule: Schedule A

  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 input postedApril 30, 2019
Patient group input closedJune 19, 2019
Clarification:

- Patient input submission received from The Arthritis Society and Canadian Arthritis Patient Alliance

Patient input summary sent for review to patient input groupsJune 21, 2019
Patient group comments on input summary closedJune 28, 2019
Clarification:

- Patient input summary feedback received

Submission receivedMay 29, 2019
Submission acceptedJune 12, 2019
Review initiatedJune 13, 2019
Clarification:

- Submission temporarily suspended pending receipt and review of information

- Additional information has been received and the temporary suspension of the review has been lifted

Draft CADTH review report(s) sent to sponsorSeptember 19, 2019
Comments from sponsor on draft CADTH review report(s) receivedSeptember 30, 2019
CADTH review team's comments on draft CADTH review report(s) sent to sponsorNovember 08, 2019
Canadian Drug Expert Committee (CDEC) meetingNovember 20, 2019
CDEC recommendation sent to sponsor and drug plansDecember 02, 2019
Embargo period endedJanuary 21, 2020
Clarification:

- Request for extension to embargo period received from the manufacturer

- Embargo extension request granted

- Reconsideration requested

Sponsor's request for reconsideration placed on CDEC agendaApril 15, 2020
CDEC Final Recommendation & CADTH review report(s) issued to sponsor and drug plansApril 22, 2020
CDEC Final Recommendation postedApril 24, 2020
Redaction requests from sponsor on draft CADTH review report(s) receivedMay 06, 2020
Redacted CADTH review report(s) sent to sponsor and drug plans-
Validation of redacted CADTH review report(s) received-
Final CADTH review report(s) postedJune 10, 2020