ruxolitinib


( Last Updated : October 3, 2022)
Generic Name:
ruxolitinib
Project Status:
Active
Therapeutic Area:
Graft versus host disease
Manufacturer:
Novartis Pharmaceuticals Canada Inc.
Brand Name:
Jakavi
Project Line:
Reimbursement Review
Project Number:
SR0688-000
NOC Status at Filing:
Pre NOC

Details


Manufacturer Requested Reimbursement Criteria1:
For the treatment of acute 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 acute graft-versus-host disease in patients aged 12 years and older who have inadequate response to corticosteroids or other​ systemic therapie​​​​s.
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 CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.

Key Milestones

Call for patient/clinician input open 12-Jul-21
Call for patient/clinician input closed 03-Sep-21
Clarification:

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

Submission received 10-Aug-21
Submission accepted 26-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 initiated 27-Aug-21
Draft CADTH review report(s) provided to sponsor for comment 10-Mar-22
Deadline for sponsors comments 21-Mar-22
CADTH review report(s) and responses to comments provided to sponsor 14-Apr-22
Expert committee meeting (initial) 27-Apr-22
Clarification:

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

- Deferred to July 27, 2022 CDEC meeting

Draft recommendation issued to sponsor 09-Aug-22
Draft recommendation posted for stakeholder feedback 18-Aug-22
End of feedback period 02-Sep-22
Clarification:

- Deadline for patient groups and clinician groups to provide feedback on the draft recommendations is 06-Sep-2022

Final recommendation issued to sponsor and drug plans 15-Sep-22
Final recommendation posted 03-Oct-22
Deadline for sponsor to submit redaction requests on draft CADTH review report(s) 29-Sep-22
CADTH review report(s) posted