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:
SR0688-000
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 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 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 openJuly 12, 2021
Call for patient/clinician input closedSeptember 03, 2021
Clarification:

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

Submission receivedAugust 10, 2021
Submission acceptedAugust 26, 2021
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 initiatedAugust 27, 2021
Draft CADTH review report(s) provided to sponsor for commentMarch 10, 2022
Deadline for sponsors commentsMarch 21, 2022
CADTH review report(s) and responses to comments provided to sponsorApril 14, 2022
Expert committee meeting (initial)April 27, 2022
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 sponsorAugust 09, 2022
Draft recommendation posted for stakeholder feedbackAugust 18, 2022
End of feedback periodSeptember 02, 2022
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 plansSeptember 15, 2022
Final recommendation postedOctober 03, 2022
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)September 29, 2022
CADTH review report(s) postedJanuary 18, 2023