Last Updated : September 25, 2024
Details
FilesGeneric Name:
avatrombopag
Project Status:
Complete
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
Performance Metric:
N/A delay outside our control - Temporary suspension and/or submission of new information by sponsor
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.
Recommendation Type:
Do not reimburse
Final Recommendation:
- 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.
| Call for patient/clinician input open | 23-Dec-21 |
|---|---|
| Call for patient/clinician input closed | 18-Feb-22 |
| Clarification: - Patient input submission received from the Platelet Disorder Support Association | |
| Submission received | 03-Feb-22 |
| Submission accepted | 17-Feb-22 |
| Review initiated | 18-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 comment | 06-Sep-23 |
| Deadline for sponsors comments | 15-Sep-23 |
| CADTH review report(s) and responses to comments provided to sponsor | 13-Oct-23 |
| Expert committee meeting (initial) | 25-Oct-23 |
| Draft recommendation issued to sponsor | 14-Nov-23 |
| Draft recommendation posted for stakeholder feedback | 23-Nov-23 |
| End of feedback period | 07-Dec-23 |
| Clarification: - Reconsideration: major revisions requested by sponsor | |
| Expert committee meeting | 24-Apr-24 |
| Final recommendation issued to sponsor and drug plans | 08-May-24 |
| Final recommendation posted | 27-May-24 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | 23-May-24 |
| CADTH review report(s) posted | 25-Sep-24 |
Files
Last Updated : September 25, 2024