CDA | Evidence Driven
CDA | Evidence Driven

avapritinib

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Generic 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).
  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 open12-Mar-24
Call for patient/clinician input closed07-May-24
Submission received19-Apr-24
Submission accepted06-May-24
Review initiated07-May-24
Draft CADTH review report(s) provided to sponsor for comment22-Jul-24
Deadline for sponsors comments31-Jul-24
CADTH review report(s) and responses to comments provided to sponsor29-Aug-24
Expert committee meeting (initial)11-Sep-24
Draft recommendation issued to sponsor25-Sep-24
Draft recommendation posted for stakeholder feedback03-Oct-24
End of feedback period18-Oct-24
Final recommendation issued to sponsor and drug plans31-Oct-24
Final recommendation posted-
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)15-Nov-24
CADTH review report(s) posted-

Files

Draft Recommendation View PDF
Patient and Clinician Group input View PDF
Last Updated : October 31, 2024