ruxolitinib

Details

Generic Name:
ruxolitinib
Project Status:
Active
Therapeutic Area:
atopic dermatitis
Manufacturer:
Incyte Biosciences Canada Corporation
Call for patient/clinician input open:
Brand Name:
TBC
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 treatment of atopic dermatitis in patients 12 years of age and older whose disease is not adequately controlled with conventional topical prescription therapies (topical calcineurin inhibitors, topical corticosteroids) or when those therapies are not advisable.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
​ruxolitinib cream is indicated for topical treatment of atopic dermatitis in patients 12 years of age and older 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 open14-Sep-23
Call for patient/clinician input closed21-Nov-23
Submission received27-Oct-23
Submission accepted17-Nov-23
Clarification:

- Submission was not accepted for review on 10 Nov 2023

Review initiated20-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 comment15-Oct-24
Deadline for sponsors comments24-Oct-24
CADTH review report(s) and responses to comments provided to sponsor15-Nov-24
Expert committee meeting (initial)27-Nov-24
Draft recommendation issued to sponsorDecember 09, 2024
To
December 11, 2024
Draft recommendation posted for stakeholder feedback18-Dec-24
End of feedback period09-Jan-25