Last Updated : June 11, 2020
Details
FilesGeneric Name:
Belimumab
Project Status:
Complete
Therapeutic Area:
systemic lupus erythematosus
Manufacturer:
GlaxoSmithKline Inc.
Call for patient/clinician input open:
Brand Name:
Benlysta
Project Line:
Reimbursement Review
Project Number:
SR0616-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
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
Fee Schedule:
Schedule A
Indications:
systemic lupus erythematosus
Date NOC Issued:
Recommendation Type:
Do not reimburse
Final Recommendation:
- 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 input posted | April 30, 2019 |
| Patient group input closed | June 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 groups | June 21, 2019 |
| Patient group comments on input summary closed | June 28, 2019 |
| Clarification:
- Patient input summary feedback received |
|
| Submission received | May 29, 2019 |
| Submission accepted | June 12, 2019 |
| Review initiated | June 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 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 |
| 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 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 |
Files
Last Updated : June 11, 2020