treosulfan

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Generic Name:
treosulfan
Project Status:
Active
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
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 CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.
Key Milestones2
Call for patient/clinician input open02-Jun-23
Call for patient/clinician input closed28-Jul-23
Clarification:

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

Submission received14-Jul-23
Submission accepted08-Aug-23
Clarification:

- Submission was not accepted for review on 28 Jul 23

Review initiated09-Aug-23
Draft CADTH review report(s) provided to sponsor for comment09-Nov-23
Deadline for sponsors comments21-Nov-23
CADTH review report(s) and responses to comments provided to sponsor21-Dec-23
Expert committee meeting (initial)10-Jan-24
Draft recommendation issued to sponsor22-Jan-24
Draft recommendation posted for stakeholder feedback01-Feb-24
End of feedback period15-Feb-24
Final recommendation issued to sponsor and drug plans28-Feb-24
Final recommendation posted18-Mar-24
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)13-Mar-24
CADTH review report(s) posted-