Last Updated : November 28, 2022
Details
FilesGeneric Name:
asciminib
Project Status:
Complete
Therapeutic Area:
Philadelphia chromosome-positive chronic myeloid leukemia
Manufacturer:
Novartis Pharmaceuticals Canada Inc.
Brand Name:
Scemblix
Project Line:
Reimbursement Review
Project Number:
PC0275-000
Tumour Type:
Leukemia
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Asciminib is indicated for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP) previously treated with two or more tyrosine kinase inhibitors.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Asciminib is indicated for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP) previously treated with two or more tyrosine kinase inhibitors.
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 | December 15, 2021 |
| Call for patient/clinician input closed | February 11, 2022 |
| Clarification: - Patient input submission received from The Lymphoma and Leukemia Society of Canada (LLSC), The Canadian CML Network and The Chronic Myelogenous Leukemia Society of Canada. | |
| Submission received | January 20, 2022 |
| Submission accepted | February 03, 2022 |
| Review initiated | February 04, 2022 |
| Draft CADTH review report(s) provided to sponsor for comment | April 21, 2022 |
| Deadline for sponsors comments | May 02, 2022 |
| CADTH review report(s) and responses to comments provided to sponsor | May 27, 2022 |
| Expert committee meeting (initial) | June 08, 2022 |
| Draft recommendation issued to sponsor | June 28, 2022 |
| Draft recommendation posted for stakeholder feedback | July 07, 2022 |
| End of feedback period | July 21, 2022 |
| Final recommendation issued to sponsor and drug plans | August 05, 2022 |
| Final recommendation posted | August 23, 2022 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | August 19, 2022 |
| CADTH review report(s) posted | November 25, 2022 |
Files
Last Updated : November 28, 2022