avatrombopag

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Generic Name:
avatrombopag
Project Status:
Active
Therapeutic Area:
Chronic immune thrombocytopenia (ITP)
Manufacturer:
Sobi Canada, Inc.
Call for patient/clinician input open:
Brand Name:
Doptelet
Project Line:
Reimbursement Review
Project Number:
SR0721-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
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 a previous treatment.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
For the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.
  1. 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.
Key Milestones2
Call for patient/clinician input open23-Dec-21
Call for patient/clinician input closed18-Feb-22
Clarification:

- Patient input submission received from the Platelet Disorder Support Association

Submission received03-Feb-22
Submission accepted17-Feb-22
Review initiated18-Feb-22
Clarification:

- Submission temporarily suspended

- Additional information has been received and the temporary suspension of the review has been lifted

Draft CADTH review report(s) provided to sponsor for comment06-Sep-23
Deadline for sponsors comments15-Sep-23
CADTH review report(s) and responses to comments provided to sponsor13-Oct-23
Expert committee meeting (initial)25-Oct-23
Draft recommendation issued to sponsor14-Nov-23
Draft recommendation posted for stakeholder feedback23-Nov-23
End of feedback period07-Dec-23
Clarification:

- Reconsideration: major revisions requested by sponsor

- Target CDEC reconsideration meeting date to be determined

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