Last Updated : February 4, 2025
Details
FilesGeneric Name:
ribociclib
Project Status:
Active
Therapeutic Area:
Adjuvant treatment of HR-positive, HER2-negative early breast cancer
Manufacturer:
Novartis Pharmaceuticals Canada Inc.
Call for patient/clinician input open:
Brand Name:
Kisqali
Project Line:
Reimbursement Review
Project Number:
PC0395-000
Call for patient/clinician input closed:
Tumour Type:
Breast
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Ribociclib is indicated: for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer (eBC), in combination with an aromatase inhibitor (AI). in pre- or perimenopausal women, or men, the AI should be combined with a luteinizing hormone-releasing hormone (LHRH) agonist.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Ribociclib is indicated: • for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer (eBC), in combination with an aromatase inhibitor (AI). • in pre- or perimenopausal women, or men, the AI should be combined with a luteinizing hormone-releasing hormone (LHRH) agonist.
- 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 | November 07, 2024 |
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Call for patient/clinician input closed | January 06, 2025 |
Submission received | December 19, 2024 |
Submission accepted | January 13, 2025 |
Clarification: - Submission was not accepted for review on 10 January 2025 | |
Review initiated | January 14, 2025 |
Clarification: - Submission temporarily suspended - Additional information has been received and the temporary suspension of the review has been lifted | |
Draft CADTH review report(s) provided to sponsor for comment | April 17, 2025 |
Deadline for sponsors comments | April 30, 2025 |
CADTH review report(s) and responses to comments provided to sponsor | May 30, 2025 |
Expert committee meeting (initial) | June 11, 2025 |
Draft recommendation issued to sponsor | June 23, 2025 To June 25, 2025 |
Draft recommendation posted for stakeholder feedback | July 03, 2025 |
End of feedback period | July 17, 2025 |
Files
Last Updated : February 4, 2025