Last Updated : January 6, 2025
Details
FilesGeneric Name:
lebrikizumab
Project Status:
Active
Therapeutic Area:
atopic dermatitis
Manufacturer:
Eli Lilly Canada, Inc.
Call for patient/clinician input open:
Brand Name:
Ebglyss
Project Line:
Reimbursement Review
Project Number:
SR0819-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Performance Metric:
Not applicable due to external delays - Application held awaiting decision by Health Canada
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
As per proposed indication; for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years of age and older with a body weight of at least 40 kg, whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
For the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years of age and older with a body weight of at least 40 kg, whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
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 | September 20, 2023 |
|---|---|
| Call for patient/clinician input closed | November 14, 2023 |
Clarification: - Patient input submission received from the Canadian Skin Patient Alliance, Eczema Society of Canada and Eczéma Québec | |
| Submission received | November 01, 2023 |
| Submission accepted | November 16, 2023 |
| Review initiated | November 17, 2023 |
| Draft CADTH review report(s) provided to sponsor for comment | February 08, 2024 |
| Deadline for sponsors comments | February 20, 2024 |
| CADTH review report(s) and responses to comments provided to sponsor | March 14, 2024 |
| Expert committee meeting (initial) | March 27, 2024 |
| Draft recommendation issued to sponsor | July 08, 2024 |
Clarification: - CDEC recommendation held pending receipt of NOC and evaluation of the finalized submission requirements. | |
| Draft recommendation posted for stakeholder feedback | July 18, 2024 |
| End of feedback period | August 01, 2024 |
Clarification: - Reconsideration: major revisions requested by sponsor | |
| Expert committee meeting | September 25, 2024 |
| Final recommendation issued to sponsor and drug plans | October 09, 2024 |
| Final recommendation posted | November 15, 2024 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | October 24, 2024 |
| CADTH review report(s) posted | - |
Files
Last Updated : January 6, 2025