Last Updated : September 17, 2024
Details
FilesGeneric Name:
spesolimab
Project Status:
Active
Therapeutic Area:
generalized pustular psoriasis (GPP)
Manufacturer:
Boehringer Ingelheim (Canada) Ltd.
Call for patient/clinician input open:
Brand Name:
Spevigo
Project Line:
Reimbursement Review
Project Number:
SR0844-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Subcutaneous (prevention) - The prevention of generalized pustular psoriasis (GPP) flares in adults and pediatric patients 12 years of age and older who have a history of GPP flares. Intravenous (treatment) - The treatment of GPP
flares with a GPPGA total score of greater than or equal to 2.
Submission Type:
Initial
Fee Schedule:
Schedule E
Indications:
Spevigo (spesolimab for injection) is indicated for the treatment of generalized pustular psoriasis (GPP), including treatment and prevention of flares, in adults and pediatric patients 12 years of age and older.
- 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 | April 23, 2024 |
|---|---|
| Call for patient/clinician input closed | June 17, 2024 |
| Submission received | June 04, 2024 |
| Submission accepted | June 18, 2024 |
| Review initiated | June 19, 2024 |
| Draft CADTH review report(s) provided to sponsor for comment | September 05, 2024 |
| Deadline for sponsors comments | September 16, 2024 |
| CADTH review report(s) and responses to comments provided to sponsor | October 10, 2024 |
| Expert committee meeting (initial) | October 23, 2024 |
| Draft recommendation issued to sponsor | November 04, 2024 To November 06, 2024 |
| Draft recommendation posted for stakeholder feedback | November 14, 2024 |
| End of feedback period | November 28, 2024 |
Files
Last Updated : September 17, 2024