Last Updated : April 23, 2025
Details
FilesGeneric Name:
asciminib
Project Status:
Active
Therapeutic Area:
Philadelphia chromosome-positive chronic myeloid leukemia
Manufacturer:
Novartis Pharmaceuticals Canada Inc.
Brand Name:
Scemblix
Project Line:
Reimbursement Review
Project Number:
PC0418-000
Tumour Type:
Leukemia
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of adult patients with newly diagnosed or previously
treated Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in
chronic phase (CP).
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
For the treatment of adult patients with newly diagnosed or previously treated Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP).
- 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.
| Call for patient/clinician input open | 30-Jan-25 |
|---|---|
| Call for patient/clinician input closed | 24-Mar-25 |
| Submission received | 10-Mar-25 |
| Submission accepted | 25-Mar-25 |
| Review initiated | 26-Mar-25 |
| Draft CADTH review report(s) provided to sponsor for comment | 11-Jun-25 |
| Deadline for sponsors comments | 20-Jun-25 |
| CDA-AMC review report(s) and responses to comments provided to sponsor | 31-Jul-25 |
| Expert committee meeting (initial) | 13-Aug-25 |
| Draft recommendation issued to sponsor | August 25, 2025 To August 27, 2025 |
| Draft recommendation posted for stakeholder feedback | 04-Sep-25 |
| End of feedback period | 18-Sep-25 |
Files
Last Updated : April 23, 2025