anifrolumab

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Generic 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
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:
  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/clinician input openDecember 14, 2021
Call for patient/clinician input closedFebruary 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 receivedJanuary 28, 2022
Submission acceptedFebruary 11, 2022
Review initiatedFebruary 15, 2022
Draft CADTH review report(s) provided to sponsor for commentMay 05, 2022
Deadline for sponsors commentsMay 16, 2022
CADTH review report(s) and responses to comments provided to sponsorJune 10, 2022
Expert committee meeting (initial)June 22, 2022
Draft recommendation issued to sponsorJuly 06, 2022
Draft recommendation posted for stakeholder feedbackJuly 14, 2022
End of feedback periodJuly 28, 2022
Clarification:

- Reconsideration: major revisions requested by sponsor

Expert committee meetingNovember 23, 2022
Draft recommendation issued to sponsorDecember 07, 2022
Draft recommendation posted for stakeholder feedbackDecember 15, 2022
End of feedback periodJanuary 06, 2023
Final recommendation issued to sponsor and drug plansJanuary 20, 2023
Final recommendation postedFebruary 08, 2023
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)February 06, 2023
CADTH review report(s) postedApril 24, 2023