crisantaspase recombinant

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Generic Name:
crisantaspase recombinant
Project Status:
Complete
Therapeutic Area:
Acute lymphoblastic leukemia
Manufacturer:
Jazz Pharmaceuticals Canada Inc.
Brand Name:
Rylaze
Project Line:
Reimbursement Review
Project Number:
PC0301-000
Tumour Type:
Leukemia
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Rylaze (crisantaspase recombinant) is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of: Acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients 1 year or older who have developed hypersensitivity to E. coli-derived asparaginase.
Submission Type:
Initial
Fee Schedule:
Schedule A
Tumour Type:
Leukemia
Indications:
Rylaze (crisantaspase recombinant) is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of: Acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients 1 year or older who have developed hypersensitivity to E. coli-derived asparaginase.
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 open20-Jul-22
Call for patient/clinician input closed12-Sep-22
Clarification:

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

Submission received18-Aug-22
Submission accepted01-Sep-22
Review initiated02-Sep-22
Draft CADTH review report(s) provided to sponsor for comment17-Nov-22
Deadline for sponsors comments28-Nov-22
CADTH review report(s) and responses to comments provided to sponsor22-Dec-22
Expert committee meeting (initial)11-Jan-23
Draft recommendation issued to sponsor24-Jan-23
Draft recommendation posted for stakeholder feedback02-Feb-23
End of feedback period16-Feb-23
Clarification:

- Reconsideration: major revisions requested by drug programs

- Reconsideration accepted

Expert committee meeting12-Apr-23
Final recommendation issued to sponsor and drug plans26-Apr-23
Final recommendation posted15-May-23
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)11-May-23
CADTH review report(s) posted12-Jul-23