calaspargase pegol

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Generic Name:
calaspargase pegol
Project Status:
Complete
Therapeutic Area:
Acute lymphoblastic leukemia (ALL)
Manufacturer:
Servier Canada Inc.
Call for patient/clinician input open:
Brand Name:
Asparlas
Project Line:
Reimbursement Review
Project Number:
PC0321-000
Call for patient/clinician input closed:
Tumour Type:
Leukemia
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
A component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukaemia (ALL) in pediatric and young adult patients age 1 to 21 years.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
A component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukaemia (ALL) in pediatric and young adult patients age 1 to 21 years.
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 openMarch 14, 2023
Call for patient/clinician input closedMay 09, 2023
Clarification:

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

Submission receivedMay 12, 2023
Submission acceptedMay 29, 2023
Review initiatedMay 30, 2023
Draft CADTH review report(s) provided to sponsor for commentAugust 29, 2023
Deadline for sponsors commentsSeptember 08, 2023
CADTH review report(s) and responses to comments provided to sponsorSeptember 27, 2023
Expert committee meeting (initial)October 11, 2023
Draft recommendation issued to sponsorNovember 23, 2023
Draft recommendation posted for stakeholder feedbackNovember 30, 2023
End of feedback periodDecember 14, 2023
Final recommendation issued to sponsor and drug plansJanuary 04, 2024
Final recommendation postedJanuary 22, 2024
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)January 18, 2024
CADTH review report(s) postedApril 02, 2024