Last Updated : October 20, 2022
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:
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:
- 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 | 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 | 26-Jan-22 |
| Deadline for sponsors comments | 04-Feb-22 |
| CADTH review report(s) and responses to comments provided to sponsor | 11-Mar-22 |
| Expert committee meeting (initial) | 23-Mar-22 |
| Draft recommendation issued to sponsor | 08-Jun-22 |
| Draft recommendation posted for stakeholder feedback | 16-Jun-22 |
| End of feedback period | 30-Jun-22 |
| Final recommendation issued to sponsor and drug plans | 15-Jul-22 |
| Final recommendation posted | 03-Aug-22 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | 29-Jul-22 |
| CADTH review report(s) posted | 20-Oct-22 |
Files
Last Updated : October 20, 2022