Last Updated : December 1, 2023
Details
FilesGeneric Name:
tralokinumab
Project Status:
Active
Therapeutic Area:
atopic dermatitis (AD)
Manufacturer:
LEO Pharma Inc.
Call for patient/clinician input open:
Brand Name:
Adtralza
Project Line:
Reimbursement Review
Project Number:
SR0787-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of patients aged 12 years and older with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable and who had an adequate trial or be ineligible for each of the following therapies: phototherapy (where available) and off-label immunosuppressants.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Adtralza (tralokinumab injection) is indicated for the treatment of moderate-to-severe atopic dermatitis in adult and adolescent patients 12 years and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Adtralza can be used with or without topical corticosteroids.
- 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 | 21-Apr-23 |
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Call for patient/clinician input closed | 19-Jun-23 |
Clarification: - Patient input submission received from Eczema Society of Canada and Eczéma Québec & Canadian Skin Patient Alliance | |
Submission received | 05-Jun-23 |
Submission accepted | 19-Jun-23 |
Review initiated | 20-Jun-23 |
Draft CADTH review report(s) provided to sponsor for comment | 05-Sep-23 |
Deadline for sponsors comments | 14-Sep-23 |
CADTH review report(s) and responses to comments provided to sponsor | 13-Oct-23 |
Expert committee meeting (initial) | 25-Oct-23 |
Draft recommendation issued to sponsor | 07-Nov-23 |
Draft recommendation posted for stakeholder feedback | 16-Nov-23 |
End of feedback period | 30-Nov-23 |
Clarification: - Reconsideration: major revisions requested by sponsor |
Files
Last Updated : December 1, 2023