Last Updated : April 24, 2023
Details
FilesGeneric Name:
anifrolumab
Project Status:
Complete
Therapeutic Area:
Systemic lupus erythematosus
Manufacturer:
AstraZeneca Canada Inc.
Brand Name:
Saphnelo
Project Line:
Reimbursement Review
Project Number:
SR0717-000
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
As addition to standard therapy for the treatment of adult patients with active, autoantibody positive, systemic lupus erythematosus (SLE).
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
As addition to standard therapy for the treatment of adult patients with active, autoantibody positive, systemic lupus erythematosus (SLE).
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 Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency will be documented in the final recommendation, if applicable.
| Call for patient/clinician input open | December 14, 2021 |
|---|---|
| Call for patient/clinician input closed | February 11, 2022 |
| Clarification: - Patient input submission received from the Canadian Arthritis Patient Alliance / Arthritis Society/ Canadian Skin Patient Alliance, Lupus Canada and Lupus Ontario | |
| Submission received | January 28, 2022 |
| Submission accepted | February 11, 2022 |
| Review initiated | February 15, 2022 |
| Draft CADTH review report(s) provided to sponsor for comment | May 05, 2022 |
| Deadline for sponsors comments | May 16, 2022 |
| CADTH review report(s) and responses to comments provided to sponsor | June 10, 2022 |
| Expert committee meeting (initial) | June 22, 2022 |
| Draft recommendation issued to sponsor | July 06, 2022 |
| Draft recommendation posted for stakeholder feedback | July 14, 2022 |
| End of feedback period | July 28, 2022 |
| Clarification: - Reconsideration: major revisions requested by sponsor | |
| Expert committee meeting | November 23, 2022 |
| Draft recommendation issued to sponsor | December 07, 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 20, 2023 |
| Final recommendation posted | February 08, 2023 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | February 06, 2023 |
| CADTH review report(s) posted | April 24, 2023 |
Files
Last Updated : April 24, 2023