calaspargase pegol

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Generic Name:
calaspargase pegol
Project Status:
Active
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
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 CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.
Key Milestones2
Call for patient/clinician input open14-Mar-23
Call for patient/clinician input closed09-May-23
Clarification:

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

Submission received12-May-23
Submission accepted29-May-23
Review initiated30-May-23
Draft CADTH review report(s) provided to sponsor for comment29-Aug-23
Deadline for sponsors comments08-Sep-23
CADTH review report(s) and responses to comments provided to sponsor27-Sep-23
Expert committee meeting (initial)11-Oct-23
Draft recommendation issued to sponsor23-Nov-23
Draft recommendation posted for stakeholder feedback30-Nov-23
End of feedback period14-Dec-23
Final recommendation issued to sponsor and drug plans04-Jan-24
Final recommendation posted22-Jan-24
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)18-Jan-24
CADTH review report(s) posted-