Last Updated : July 13, 2023
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 | July 20, 2022 |
|---|---|
| Call for patient/clinician input closed | September 12, 2022 |
| Clarification: - Patient input submission received from The Leukemia & Lymphoma Society of Canada (LLSC). | |
| Submission received | August 18, 2022 |
| Submission accepted | September 01, 2022 |
| Review initiated | September 02, 2022 |
| Draft CADTH review report(s) provided to sponsor for comment | November 17, 2022 |
| Deadline for sponsors comments | November 28, 2022 |
| CADTH review report(s) and responses to comments provided to sponsor | December 22, 2022 |
| Expert committee meeting (initial) | January 11, 2023 |
| Draft recommendation issued to sponsor | January 24, 2023 |
| Draft recommendation posted for stakeholder feedback | February 02, 2023 |
| End of feedback period | February 16, 2023 |
| Clarification: - Reconsideration: major revisions requested by drug programs - Reconsideration accepted | |
| Expert committee meeting | April 12, 2023 |
| Final recommendation issued to sponsor and drug plans | April 26, 2023 |
| Final recommendation posted | May 15, 2023 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | May 11, 2023 |
| CADTH review report(s) posted | July 12, 2023 |
Files
Last Updated : July 13, 2023