Last Updated : June 19, 2024
Details
Generic 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:
Drug Plan Initiated
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 CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.
| Call for patient/clinician input open | 23-Apr-24 |
|---|---|
| Call for patient/clinician input closed | 17-Jun-24 |
| Submission received | 04-Jun-24 |
| Submission accepted | 18-Jun-24 |
| Review initiated | 19-Jun-24 |
| Draft CADTH review report(s) provided to sponsor for comment | 05-Sep-24 |
| Deadline for sponsors comments | 16-Sep-24 |
| CADTH review report(s) and responses to comments provided to sponsor | 10-Oct-24 |
| Expert committee meeting (initial) | 23-Oct-24 |
| Draft recommendation issued to sponsor | November 04, 2024 To November 06, 2024 |
| Draft recommendation posted for stakeholder feedback | 14-Nov-24 |
| End of feedback period | 28-Nov-24 |
Last Updated : June 19, 2024