Last Updated : September 18, 2024
Details
FilesGeneric Name:
tralokinumab
Project Status:
Complete
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
Performance Metric:
Achieved
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.
Recommendation Type:
Do not reimburse
Final Recommendation:
- The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency will be documented in the final recommendation, if applicable.
| Call for patient/clinician input open | April 21, 2023 |
|---|---|
| Call for patient/clinician input closed | June 19, 2023 |
| Clarification: - Patient input submission received from Eczema Society of Canada and Eczéma Québec & Canadian Skin Patient Alliance | |
| Submission received | June 05, 2023 |
| Submission accepted | June 19, 2023 |
| Review initiated | June 20, 2023 |
| Draft CADTH review report(s) provided to sponsor for comment | September 05, 2023 |
| Deadline for sponsors comments | September 14, 2023 |
| CADTH review report(s) and responses to comments provided to sponsor | October 13, 2023 |
| Expert committee meeting (initial) | October 25, 2023 |
| Draft recommendation issued to sponsor | November 07, 2023 |
| Draft recommendation posted for stakeholder feedback | November 16, 2023 |
| End of feedback period | November 30, 2023 |
| Clarification: - Reconsideration: major revisions requested by sponsor | |
| Expert committee meeting | April 24, 2024 |
| Final recommendation issued to sponsor and drug plans | May 08, 2024 |
| Final recommendation posted | May 27, 2024 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | May 23, 2024 |
| CADTH review report(s) posted | September 17, 2024 |
Files
Last Updated : September 18, 2024