Last Updated : August 14, 2024
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
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.
- 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 | 20-Sep-23 |
---|---|
Call for patient/clinician input closed | 14-Nov-23 |
Clarification: - Patient input submission received from the Canadian Skin Patient Alliance, Eczema Society of Canada and Eczéma Québec | |
Submission received | 01-Nov-23 |
Submission accepted | 16-Nov-23 |
Review initiated | 17-Nov-23 |
Draft CADTH review report(s) provided to sponsor for comment | 08-Feb-24 |
Deadline for sponsors comments | 20-Feb-24 |
CADTH review report(s) and responses to comments provided to sponsor | 14-Mar-24 |
Expert committee meeting (initial) | 27-Mar-24 |
Draft recommendation issued to sponsor | 08-Jul-24 |
Clarification: - CDEC recommendation held pending receipt of NOC and evaluation of the finalized submission requirements. | |
Draft recommendation posted for stakeholder feedback | 18-Jul-24 |
End of feedback period | 01-Aug-24 |
Clarification: - Reconsideration: major revisions requested by sponsor | |
Expert committee meeting | 25-Sep-24 |
Files
Last Updated : August 14, 2024