CDA | Evidence Driven
CDA | Evidence Driven

fostamatinib

Details

Files
Generic Name:
fostamatinib
Project Status:
Complete
Therapeutic Area:
Chronic immune thrombocytopenia
Manufacturer:
Medison Pharma Canada
Brand Name:
Tavalisse
Project Line:
Reimbursement Review
Project Number:
SR0701-000
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to other treatments.
Submission Type:
Initial
Fee Schedule:
Schedule A
Tumour Type:
N/A
Indications:
For the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to other treatments.
Recommendation Type:
Do not reimburse
Final Recommendation:
  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 open 23-Jun-21
Call for patient/clinician input closed 16-Aug-21
Clarification:

- Patient input submission received from Platelet Disorder Support Association
Submission received 22-Jul-21
Submission accepted 06-Aug-21
Review initiated 09-Aug-21
Draft CADTH review report(s) provided to sponsor for comment 22-Oct-21
Deadline for sponsors comments 02-Nov-21
CADTH review report(s) and responses to comments provided to sponsor 03-Dec-21
Expert committee meeting (initial) 15-Dec-21
Draft recommendation issued to sponsor 05-Jan-22
Draft recommendation posted for stakeholder feedback 13-Jan-22
End of feedback period 27-Jan-22
Clarification:

- Reconsideration: major revisions requested by sponsor
Expert committee meeting 23-Mar-22
Final recommendation issued to sponsor and drug plans 05-Apr-22
Final recommendation posted 22-Apr-22
Deadline for sponsor to submit redaction requests on draft CADTH review report(s) 20-Apr-22
CADTH review report(s) posted 13-Jul-22

Files

Recommendation and Reasons View PDF
Clinical and Pharmacoeconomic combined Report View PDF
Patient Group Input Submissions View PDF
Stakeholder feedback on Draft Recommendation View PDF
Last Updated : July 13, 2022