Last Updated : January 21, 2025
Details
FilesGeneric Name:
ivosidenib
Project Status:
Complete
Therapeutic Area:
Acute myeloid leukemia (AML)
Manufacturer:
Servier Canada Inc
Call for patient/clinician input open:
Brand Name:
Tibsovo
Project Line:
Reimbursement Review
Project Number:
PC0349-000
Call for patient/clinician input closed:
Tumour Type:
Leukemia
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Ivosidenib in combination
with azacitidine is indicated for the treatment of adult patients with newly
diagnosed acute myeloid leukemia (AML) with an isocitrate dehydrogenase-1
(IDH1) R132 mutation who are not eligible to receive intensive induction chemotherapy.
Submission Type:
Initial
Companion Diagnostics:
Yes
Fee Schedule:
Schedule A
Indications:
TIBSOVO (ivosidenib) in combination with azacitidine is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) with an isocitrate dehydrogenase-1 (IDH1) R132 mutation who are not eligible to receive intensive induction chemotherapy.
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 | February 05, 2024 |
|---|---|
| Call for patient/clinician input closed | April 02, 2024 |
| Clarification: - Patient input submission received from The Leukemia and Lymphoma Society of Canada (LLSC) and Heal Canada | |
| Submission received | March 19, 2024 |
| Submission accepted | April 03, 2024 |
| Review initiated | April 04, 2024 |
| Draft CADTH review report(s) provided to sponsor for comment | June 21, 2024 |
| Deadline for sponsors comments | July 03, 2024 |
| CADTH review report(s) and responses to comments provided to sponsor | August 01, 2024 |
| Expert committee meeting (initial) | August 14, 2024 |
| Draft recommendation issued to sponsor | August 28, 2024 |
| Draft recommendation posted for stakeholder feedback | September 05, 2024 |
| End of feedback period | September 19, 2024 |
| Final recommendation issued to sponsor and drug plans | October 04, 2024 |
| Final recommendation posted | October 23, 2024 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | October 21, 2024 |
| CADTH review report(s) posted | January 21, 2025 |
Files
Last Updated : January 21, 2025