Last Updated : April 9, 2025
Details
FilesGeneric Name:
ruxolitinib
Project Status:
Active
Therapeutic Area:
atopic dermatitis
Manufacturer:
Incyte Biosciences Canada Corporation
Call for patient/clinician input open:
Brand Name:
Opzelura
Project Line:
Reimbursement Review
Project Number:
SR0807-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 12 years of age and older whose disease is not adequately controlled with conventional topical prescription therapies (topical corticosteroids, topical calcineurin inhibitors) or when those therapies are not advisable.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
OPZELURA (ruxolitinib (as ruxolitinib phosphate)) cream 1.5% is indicated for topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 12 years of age and older whose disease is not adequately controlled with conventional topical prescription therapies (topical corticosteroids, topical calcineurin inhibitors) 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 | 14-Sep-23 |
|---|---|
| Call for patient/clinician input closed | 21-Nov-23 |
| Submission received | 27-Oct-23 |
| Submission accepted | 17-Nov-23 |
| Clarification: - Submission was not accepted for review on 10 Nov 2023 | |
| Review initiated | 20-Nov-23 |
| Clarification: - Submission temporarily suspended - Additional information has been received and the temporary suspension of the review has been lifted on 28 Aug 2024 | |
| Draft CADTH review report(s) provided to sponsor for comment | 16-Oct-24 |
| Deadline for sponsors comments | 25-Oct-24 |
| CDA-AMC review report(s) and responses to comments provided to sponsor | 15-Nov-24 |
| Expert committee meeting (initial) | 27-Nov-24 |
| Draft recommendation issued to sponsor | 11-Dec-24 |
| Draft recommendation posted for stakeholder feedback | 19-Dec-24 |
| End of feedback period | 10-Jan-25 |
| Clarification: - Reconsideration: major revisions requested by sponsor - Target CDEC reconsideration meeting date to be determined | |
| Expert committee meeting | 23-Apr-25 |
Files
Last Updated : April 9, 2025