Last Updated : November 19, 2024
Details
FilesGeneric Name:
avapritinib
Project Status:
Active
Therapeutic Area:
Advanced Systemic Mastocytosis
Manufacturer:
Medison Pharma Canada Inc.
Call for patient/clinician input open:
Brand Name:
Ayvakyt
Project Line:
Reimbursement Review
Project Number:
PC0335-000
Call for patient/clinician input closed:
Tumour Type:
Leukemia
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of adult patients with Advanced Systemic Mastocytosis (AdvSM). AdvSM includes patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL).
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
For the treatment of adult patients with advanced systemic mastocytosis (AdvSM). AdvSM includes patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL).
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.
| Call for patient/clinician input open | March 12, 2024 |
|---|---|
| Call for patient/clinician input closed | May 07, 2024 |
| Submission received | April 19, 2024 |
| Submission accepted | May 06, 2024 |
| Review initiated | May 07, 2024 |
| Draft CADTH review report(s) provided to sponsor for comment | July 22, 2024 |
| Deadline for sponsors comments | July 31, 2024 |
| CADTH review report(s) and responses to comments provided to sponsor | August 29, 2024 |
| Expert committee meeting (initial) | September 11, 2024 |
| Draft recommendation issued to sponsor | September 25, 2024 |
| Draft recommendation posted for stakeholder feedback | October 03, 2024 |
| End of feedback period | October 18, 2024 |
| Final recommendation issued to sponsor and drug plans | October 31, 2024 |
| Final recommendation posted | November 19, 2024 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | November 15, 2024 |
| CADTH review report(s) posted | - |
Files
Last Updated : November 19, 2024