asciminib

Details

Generic 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).
  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 open30-Jan-25
Call for patient/clinician input closed24-Mar-25
Submission received10-Mar-25
Submission accepted25-Mar-25
Review initiated26-Mar-25
Draft CADTH review report(s) provided to sponsor for comment11-Jun-25
Deadline for sponsors comments20-Jun-25
CADTH review report(s) and responses to comments provided to sponsor31-Jul-25
Expert committee meeting (initial)13-Aug-25
Draft recommendation issued to sponsorAugust 25, 2025
To
August 27, 2025
Draft recommendation posted for stakeholder feedback04-Sep-25
End of feedback period18-Sep-25