Last Updated : June 20, 2022
Details
FilesGeneric Name:
tralokinumab
Project Status:
Complete
Therapeutic Area:
atopic dermatitis
Manufacturer:
LEO Pharma Inc.
Brand Name:
Adtralza
Project Line:
Reimbursement Review
Project Number:
SR0689-000
NOC Status at Filing:
Pre NOC
Biosimilar:
No
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
Fee Schedule:
Schedule A
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.
Recommendation Type:
Do not reimburse
Final Recommendation:
- 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 | 30-Mar-21 |
| Call for patient/clinician input closed | 21-May-21 |
| Clarification: - Patient input submission received from the Canadian Skin Patient Alliance (CSPA) & Eczéma Québec and the Eczema Society of Canada | |
| Submission received | 27-Apr-21 |
| Submission accepted | 11-May-21 |
| Review initiated | 12-May-21 |
| Draft CADTH review report(s) provided to sponsor for comment | 04-Aug-21 |
| Deadline for sponsors comments | 13-Aug-21 |
| CADTH responses on draft review report(s) provided to sponsor | 10-Sep-21 |
| Expert committee meeting (initial) | 22-Sep-21 |
| Draft recommendation issued to sponsor | 20-Oct-21 |
| Draft recommendation posted for stakeholder feedback | 04-Nov-21 |
| End of feedback period | 18-Nov-21 |
| Clarification: - Reconsideration: major revisions requested by sponsor | |
| Expert committee meeting | 23-Feb-22 |
| Final recommendation issued to sponsor and drug plans | 07-Mar-22 |
| Final recommendation posted | 23-Mar-22 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | 24-Mar-22 |
| CADTH review report(s) posted | 17-Jun-22 |
Files
Last Updated : June 20, 2022