Last Updated : April 30, 2024
Details
FilesGeneric 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
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:
- 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.
| Call for patient/clinician input open | 20-Jul-22 |
|---|---|
| Call for patient/clinician input closed | 12-Sep-22 |
| Clarification: - Patient input submission received from The Leukemia & Lymphoma Society of Canada (LLSC). | |
| Submission received | 18-Aug-22 |
| Submission accepted | 01-Sep-22 |
| Review initiated | 02-Sep-22 |
| Draft CADTH review report(s) provided to sponsor for comment | 17-Nov-22 |
| Deadline for sponsors comments | 28-Nov-22 |
| CADTH review report(s) and responses to comments provided to sponsor | 22-Dec-22 |
| Expert committee meeting (initial) | 11-Jan-23 |
| Draft recommendation issued to sponsor | 24-Jan-23 |
| Draft recommendation posted for stakeholder feedback | 02-Feb-23 |
| End of feedback period | 16-Feb-23 |
| Clarification: - Reconsideration: major revisions requested by drug programs - Reconsideration accepted | |
| Expert committee meeting | 12-Apr-23 |
| Final recommendation issued to sponsor and drug plans | 26-Apr-23 |
| Final recommendation posted | 15-May-23 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | 11-May-23 |
| CADTH review report(s) posted | 12-Jul-23 |
Files
Last Updated : April 30, 2024