CDA | Evidence Driven
CDA | Evidence Driven

nelarabine

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Generic Name:
nelarabine
Project Status:
Complete
Therapeutic Area:
T-cell acute lymphoblastic leukemia
Manufacturer:
N/A
Call for patient/clinician input open:
Brand Name:
Atriance
Project Line:
Reimbursement Review
Project Number:
PC0307-000
Call for patient/clinician input closed:
Tumour Type:
Leukemia
NOC Status at Filing:
N/A
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Nelarabine (Atriance) for addition to front-line multi-agent therapy of pediatric, adolescent, and young adult (AYA) patients (aged 130 years at diagnosis) with intermediate- or high-risk T-cell acute lymphoblastic leukemia (T-ALL).
Submission Type:
Non-sponsored Submission
Fee Schedule:
N/A
Indications:
Nelarabine (Atriance) for addition to front-line multi-agent therapy of pediatric, adolescent, and young adult (AYA) patients (aged 1—30 years at diagnosis) with intermediate- or high-risk T-cell acute lymphoblastic leukemia (T-ALL).
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 open30-Jan-23
Call for patient/clinician input closed27-Mar-23
Clarification:

- Patient input submission received from Leukemia & Lymphoma Society of Canada

Submission received06-Mar-23
Submission accepted21-Mar-23
Review initiated22-Mar-23
Draft CADTH review report(s) provided to sponsor for comment21-Jun-23
Deadline for sponsors comments30-Jun-23
CADTH review report(s) and responses to comments provided to sponsor27-Jul-23
Expert committee meeting (initial)09-Aug-23
Draft recommendation issued to sponsor23-Aug-23
Draft recommendation posted for stakeholder feedback31-Aug-23
End of feedback period15-Sep-23
Final recommendation issued to sponsor and drug plans29-Sep-23
Final recommendation posted19-Oct-23
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)17-Oct-23
CADTH review report(s) posted24-Nov-23

Files

Recommendation and Reasons View PDF
Clinical, Pharmacoeconomic, and Stakeholder Input Combined Report View PDF
Stakeholder Feedback on Draft Recommendation View PDF
Last Updated : January 26, 2024