CDA | Evidence Driven
CDA | Evidence Driven

lebrikizumab

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Generic 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.
  1. 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.
Key Milestones2
Call for patient/clinician input open20-Sep-23
Call for patient/clinician input closed14-Nov-23
Clarification:

- Patient input submission received from the Canadian Skin Patient Alliance, Eczema Society of Canada and Eczéma Québec

Submission received01-Nov-23
Submission accepted16-Nov-23
Review initiated17-Nov-23
Draft CADTH review report(s) provided to sponsor for comment08-Feb-24
Deadline for sponsors comments20-Feb-24
CADTH review report(s) and responses to comments provided to sponsor14-Mar-24
Expert committee meeting (initial)27-Mar-24
Draft recommendation issued to sponsor08-Jul-24
Clarification:

- CDEC recommendation held pending receipt of NOC and evaluation of the finalized submission requirements.

Draft recommendation posted for stakeholder feedback18-Jul-24
End of feedback period01-Aug-24
Clarification:

- Reconsideration: major revisions requested by sponsor

Expert committee meeting25-Sep-24

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Draft Recommendation View PDF
Last Updated : August 14, 2024