Last Updated : May 8, 2024
Details
Generic Name:
avapritinib
Project Status:
Active
Therapeutic Area:
Advanced Systemic Mastocytosis
Manufacturer:
Medison Pharma Canada Inc.
Call for patient/clinician input open:
Brand Name:
TBC
Project Line:
Reimbursement Review
Project Number:
PC0335-000
Call for patient/clinician input closed:
Tumour Type:
Leukemia
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Anticipated: 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:
Anticipated: 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).
- The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH 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 | - |
| 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 23, 2024 To September 25, 2024 |
| Draft recommendation posted for stakeholder feedback | October 03, 2024 |
| End of feedback period | October 18, 2024 |
Last Updated : May 8, 2024