( Last Updated : June 20, 2022)
Generic Name:
Project Status:
Therapeutic Area:
atopic dermatitis
LEO Pharma Inc.
Brand Name:
Project Line:
Reimbursement Review
Project Number:
NOC Status at Filing:


Manufacturer Requested Reimbursement Criteria1:
For the treatment of adult patients with moderate-to-severe 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), methotrexate, and cyclosporine.
Submission Type:
Fee Schedule:
Schedule A
Tralokinumab is indicated for the treatment of moderate-to-severe atopic dermatitis (AD) in adult patients whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. TRADENAME (tralokinumab) can be used with or without topical corticosteroids.
Recommendation Type:
Do not reimburse
Final Recommendation:
  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 open30-Mar-21
Call for patient/clinician input closed21-May-21

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

Submission received27-Apr-21
Submission accepted11-May-21
Review initiated12-May-21
Draft CADTH review report(s) provided to sponsor for comment04-Aug-21
Deadline for sponsors comments13-Aug-21
CADTH responses on draft review report(s) provided to sponsor10-Sep-21
Expert committee meeting (initial)22-Sep-21
Draft recommendation issued to sponsor20-Oct-21
Draft recommendation posted for stakeholder feedback04-Nov-21
End of feedback period18-Nov-21

- Reconsideration: major revisions requested by sponsor

Expert committee meeting23-Feb-22
Final recommendation issued to sponsor and drug plans07-Mar-22
Final recommendation posted23-Mar-22
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)24-Mar-22
CADTH review report(s) posted17-Jun-22