CDA | Evidence Driven
CDA | Evidence Driven

spesolimab

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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:
Initial
Fee Schedule:
Schedule E
Indications:
Spevigo (spesolimab injection/ spesolimab for injection) is indicated for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age and older and weighing at least 40 kg.
  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.

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Key Milestones2
Call for patient/clinician input open23-Apr-24
Call for patient/clinician input closed17-Jun-24
Submission received04-Jun-24
Submission accepted18-Jun-24
Review initiated19-Jun-24
Draft CADTH review report(s) provided to sponsor for comment05-Sep-24
Deadline for sponsors comments16-Sep-24
CADTH review report(s) and responses to comments provided to sponsor10-Oct-24
Expert committee meeting (initial)23-Oct-24
Draft recommendation issued to sponsor05-Nov-24
Draft recommendation posted for stakeholder feedback14-Nov-24
End of feedback period28-Nov-24

Files

Draft Recommendation View PDF
Patient and Clinician Group input View PDF
Last Updated : November 14, 2024