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
- 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||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||-|