Last Updated : July 18, 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 CADTH. Reimbursement criteria from CADTH 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 |
Files
Last Updated : July 18, 2024