lebrikizumab

Details

Generic Name:
lebrikizumab
Project Status:
Active
Therapeutic Area:
atopic dermatitis
Manufacturer:
Eli Lilly Canada, Inc.
Call for patient/clinician input open:
Brand Name:
TBC
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 adult and adolescent patients 12 years of age and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Lebrikizumab injection can be used with or without topical corticosteroids.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
​For the treatment of adult and adolescent patients 12 years of age and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Lebrikizumab injection can be used with or without topical corticosteroids.
  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.
Key Milestones2
Call for patient/clinician input openSeptember 20, 2023
Call for patient/clinician input closedNovember 14, 2023
Clarification:

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

Submission receivedNovember 01, 2023
Submission acceptedNovember 16, 2023
Review initiatedNovember 17, 2023
Draft CADTH review report(s) provided to sponsor for commentFebruary 08, 2024
Deadline for sponsors commentsFebruary 20, 2024
CADTH review report(s) and responses to comments provided to sponsorMarch 14, 2024
Expert committee meeting (initial)March 27, 2024
Draft recommendation issued to sponsor-
Clarification:

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

Draft recommendation posted for stakeholder feedback-
End of feedback period-