treosulfan

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Generic Name:
treosulfan
Project Status:
Complete
Therapeutic Area:
Conditioning treatment prior to stem cell transplantation for acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS)
Manufacturer:
Medexus Pharmaceuticals Inc.
Call for patient/clinician input open:
Brand Name:
Trecondyv
Project Line:
Reimbursement Review
Project Number:
PC0324-000
Call for patient/clinician input closed:
Tumour Type:
Leukemia
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
In combination with fludarabine as part of conditioning treatment prior to allogeneic hematopoietic stem cell transplantation (alloHSCT) in adult patients with AML or MDS at increased risk for standard conditioning therapies.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
In combination with fludarabine as part of conditioning treatment prior to allogeneic hematopoietic stem cell transplantation (alloHSCT) in adult patients with AML or MDS at increased risk for standard conditioning therapies.
Recommendation Type:
Reimburse with clinical criteria and/or conditions
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 openJune 02, 2023
Call for patient/clinician input closedJuly 28, 2023
Clarification:

- Patient input submission received from The Leukemia & Lymphoma Society of Canada (LLSC)

Submission receivedJuly 14, 2023
Submission acceptedAugust 08, 2023
Clarification:

- Submission was not accepted for review on 28 Jul 23

Review initiatedAugust 09, 2023
Draft CADTH review report(s) provided to sponsor for commentNovember 09, 2023
Deadline for sponsors commentsNovember 21, 2023
CADTH review report(s) and responses to comments provided to sponsorDecember 21, 2023
Expert committee meeting (initial)January 10, 2024
Draft recommendation issued to sponsorJanuary 22, 2024
Draft recommendation posted for stakeholder feedbackFebruary 01, 2024
End of feedback periodFebruary 15, 2024
Final recommendation issued to sponsor and drug plansFebruary 28, 2024
Final recommendation postedMarch 18, 2024
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)March 13, 2024
CADTH review report(s) postedJune 06, 2024