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

Generic Name: Belimumab

Brand Name: Benlysta

Manufacturer: GlaxoSmithKline Inc.

Therapeutic Area: systemic lupus erythematosus

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: Initial

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 posted April 30, 2019
Patient group input closed June 19, 2019

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

Patient input summary sent for review to patient input groups June 21, 2019
Patient group comments on input summary closed June 28, 2019

- Patient input summary feedback received

Submission received May 29, 2019
Submission accepted June 12, 2019
Review initiated June 13, 2019

- 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 sponsor September 19, 2019
Comments from sponsor on draft CADTH review report(s) received September 30, 2019
CADTH review team's comments on draft CADTH review report(s) sent to sponsor November 08, 2019
Canadian Drug Expert Committee (CDEC) meeting November 20, 2019
CDEC recommendation sent to sponsor and drug plans December 02, 2019
Embargo period ended January 21, 2020

- Request for extension to embargo period received from the manufacturer

- Embargo extension request granted

- Reconsideration requested

Sponsor's request for reconsideration placed on CDEC agenda April 15, 2020
CDEC Final Recommendation & CADTH review report(s) issued to sponsor and drug plans April 22, 2020
CDEC Final Recommendation posted April 24, 2020
Redaction requests from sponsor on draft CADTH review report(s) received May 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) posted June 10, 2020