Last Updated : January 18, 2023
Details
FilesGeneric 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 therapies.
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
- 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 open | July 12, 2021 |
| Call for patient/clinician input closed | September 03, 2021 |
| Clarification: - Patient input submission received from LC, LLSC, CLL Canada, Myeloma Canada, AAMAC, CMPNRF, CML Network, and CTTC | |
| Submission received | August 10, 2021 |
| Submission accepted | August 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 initiated | August 27, 2021 |
| Draft CADTH review report(s) provided to sponsor for comment | March 10, 2022 |
| Deadline for sponsors comments | March 21, 2022 |
| CADTH review report(s) and responses to comments provided to sponsor | April 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 sponsor | August 09, 2022 |
| Draft recommendation posted for stakeholder feedback | August 18, 2022 |
| End of feedback period | September 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 plans | September 15, 2022 |
| Final recommendation posted | October 03, 2022 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | September 29, 2022 |
| CADTH review report(s) posted | January 18, 2023 |
Files
Last Updated : January 18, 2023