secukinumab

Details

Files
Generic Name:
secukinumab
Project Status:
Active
Therapeutic Area:
Hidradenitis suppurativa
Manufacturer:
Novartis Pharmaceuticals Canada Inc.
Call for patient/clinician input open:
Brand Name:
Cosentyx
Project Line:
Reimbursement Review
Project Number:
SR0781-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Performance Metric:
N/A delay outside our control - Application held awaiting decision by Health Canada
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Cosentyx is indicated for the treatment of adult patients with moderate to severe hidradenitis suppurativa (acne inversa) who have responded inadequately to conventional systemic hidradenitis suppurativa therapy.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Cosentyx is indicated for the treatment of adult patients with moderate to severe hidradenitis suppurativa (acne inversa) who have responded inadequately to conventional systemic hidradenitis suppurativa therapy.
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 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/clinician input open28-Mar-23
Call for patient/clinician input closed23-May-23
Clarification:

- Patient input submission received from the Canadian Skin Patient Alliance (CSPA), HS Heroes, and Hidradenitis & Me Support Group

Submission received10-May-23
Submission accepted25-May-23
Review initiated26-May-23
Draft CADTH review report(s) provided to sponsor for comment10-Aug-23
Deadline for sponsors comments21-Aug-23
CADTH review report(s) and responses to comments provided to sponsor15-Sep-23
Expert committee meeting (initial)27-Sep-23
Clarification:

- CDEC recommendation held pending receipt of NOC and evaluation of the finalized submission requirements.

Draft recommendation issued to sponsor07-Aug-24
Clarification:

- Submission temporarily suspended

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

Draft recommendation posted for stakeholder feedback15-Aug-24
End of feedback period29-Aug-24
Final recommendation issued to sponsor and drug plans12-Sep-24
Final recommendation posted01-Oct-24
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)26-Sep-24
CADTH review report(s) posted-