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Last Updated: June 4, 2021
Result type: Reports
Project Number: SR0689-000
Product Line: Reimbursement Review

Generic Name: tralokinumab

Brand Name: TBC

Manufacturer: LEO Pharma Inc.

Therapeutic Area: atopic dermatitis

Indications: 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.

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: Initial

NOC Status at Filing: Pre NOC

Project Status: Active

Companion Diagnostics: No

Fee Schedule: Schedule A

  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 open March 30, 2021
Call for patient/clinician input closed May 21, 2021

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

Submission received April 27, 2021
Submission accepted May 11, 2021
Review initiated May 12, 2021
Draft CADTH review report(s) provided to sponsor for comment July 27, 2021
Deadline for sponsors comments August 06, 2021
CADTH responses on draft review report(s) provided to sponsor September 10, 2021
Expert committee meeting (initial) September 22, 2021
Draft recommendation issued to sponsor October 04, 2021
October 06, 2021
Draft recommendation posted for stakeholder feedback -