Last Updated : April 2, 2024
Details
FilesGeneric 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:
- 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.
| Call for patient/clinician input open | March 14, 2023 |
|---|---|
| Call for patient/clinician input closed | May 09, 2023 |
| Clarification: - Patient input submission received from eukemia & Lymphoma Society of Canada | |
| Submission received | May 12, 2023 |
| Submission accepted | May 29, 2023 |
| Review initiated | May 30, 2023 |
| Draft CADTH review report(s) provided to sponsor for comment | August 29, 2023 |
| Deadline for sponsors comments | September 08, 2023 |
| CADTH review report(s) and responses to comments provided to sponsor | September 27, 2023 |
| Expert committee meeting (initial) | October 11, 2023 |
| Draft recommendation issued to sponsor | November 23, 2023 |
| Draft recommendation posted for stakeholder feedback | November 30, 2023 |
| End of feedback period | December 14, 2023 |
| Final recommendation issued to sponsor and drug plans | January 04, 2024 |
| Final recommendation posted | January 22, 2024 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | January 18, 2024 |
| CADTH review report(s) posted | April 02, 2024 |
Files
Last Updated : April 2, 2024