CADTH | Evidence Driven
CADTH | Evidence Driven

tralokinumab

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Generic 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.
  1. 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.
Key Milestones2
Call for patient/clinician input open21-Apr-23
Call for patient/clinician input closed19-Jun-23
Clarification:

- Patient input submission received from Eczema Society of Canada and Eczéma Québec & Canadian Skin Patient Alliance

Submission received05-Jun-23
Submission accepted19-Jun-23
Review initiated20-Jun-23
Draft CADTH review report(s) provided to sponsor for comment05-Sep-23
Deadline for sponsors comments14-Sep-23
CADTH review report(s) and responses to comments provided to sponsor13-Oct-23
Expert committee meeting (initial)25-Oct-23
Draft recommendation issued to sponsor07-Nov-23
Draft recommendation posted for stakeholder feedback16-Nov-23
End of feedback period30-Nov-23
Clarification:

- Reconsideration: major revisions requested by sponsor

Files

Draft Recommendation View PDF
Last Updated : December 1, 2023