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
Performance Metric:
N/A delay outside our control - 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:
  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
Final recommendation issued to sponsor and drug plans09-Oct-24
Final recommendation posted15-Nov-24
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)24-Oct-24
CADTH review report(s) posted-

Files

Recommendation and Reason View PDF
Patient and Clinician Group input View PDF
Last Updated : November 21, 2024