ruxolitinib

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Generic Name:
ruxolitinib
Project Status:
Complete
Therapeutic Area:
Graft versus host disease
Manufacturer:
Novartis Pharmaceuticals Canada Inc.
Brand Name:
Jakavi
Project Line:
Reimbursement Review
Project Number:
SR0706-000
NOC Status at Filing:
Pre NOC
Performance Metric:
N/A delay outside our control - Temporary suspension and/or submission of new information by sponsor
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of chronic graft-versus-host disease in patients aged 12 years and older who have inadequate response to corticosteroids or other systemic therapies.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
For the treatment of chronic graft-versus-host disease in patients aged 12 years and older who have inadequate response to corticosteroids or other systemic therapies.
Recommendation Type:
Reimburse with clinical criteria and/or conditions
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 open12-Jul-21
Call for patient/clinician input closed03-Sep-21
Clarification:

- Patient input submission received from LC, LLSC, CLL Canada, Myeloma Canada, AAMAC, CMPNRF, CML Network, and CTTC

Submission received10-Aug-21
Submission accepted26-Aug-21
Clarification:

- Submission was not accepted for review on 24 Aug 2021

- Submission temporarily suspended

- Additional information has been received and the temporary suspension of the review has been lifted

Review initiated27-Aug-21
Draft CADTH review report(s) provided to sponsor for comment26-Jan-22
Deadline for sponsors comments04-Feb-22
CADTH review report(s) and responses to comments provided to sponsor11-Mar-22
Expert committee meeting (initial)23-Mar-22
Draft recommendation issued to sponsor08-Jun-22
Draft recommendation posted for stakeholder feedback16-Jun-22
End of feedback period30-Jun-22
Final recommendation issued to sponsor and drug plans15-Jul-22
Final recommendation posted03-Aug-22
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)29-Jul-22
CADTH review report(s) posted20-Oct-22