Last Updated : April 25, 2024
Details
FilesGeneric 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.
- 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 | December 23, 2021 |
|---|---|
| Call for patient/clinician input closed | February 18, 2022 |
| Clarification: - Patient input submission received from the Platelet Disorder Support Association | |
| Submission received | February 03, 2022 |
| Submission accepted | February 17, 2022 |
| Review initiated | February 18, 2022 |
| 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 comment | September 06, 2023 |
| Deadline for sponsors comments | September 15, 2023 |
| CADTH review report(s) and responses to comments provided to sponsor | October 13, 2023 |
| Expert committee meeting (initial) | October 25, 2023 |
| Draft recommendation issued to sponsor | November 14, 2023 |
| Draft recommendation posted for stakeholder feedback | November 23, 2023 |
| End of feedback period | December 07, 2023 |
| Clarification: - Reconsideration: major revisions requested by sponsor | |
| Expert committee meeting | April 24, 2024 |
Files
Last Updated : April 25, 2024