Canada’s Drug Agency | Drugs, Health Technologies and Systems.

ribociclib

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Generic 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.
  1. 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.
Key Milestones2
Call for patient/clinician input open07-Nov-24
Call for patient/clinician input closed06-Jan-25
Submission received19-Dec-24
Submission accepted13-Jan-25
Clarification:

- Submission was not accepted for review on 10 January 2025

Review initiated14-Jan-25
Clarification:

- Submission temporarily suspended

- Additional information has been received and the temporary suspension of the review has been lifted

Draft review report(s) provided to sponsor for comment28-Apr-25
Deadline for sponsors comments07-May-25
review report(s) and responses to comments provided to sponsor30-May-25
Expert committee meeting (initial)11-Jun-25
Draft recommendation issued to sponsorJune 23, 2025
To
June 25, 2025
Draft recommendation posted for stakeholder feedback03-Jul-25
End of feedback period17-Jul-25

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Patient and Clinician Group input View PDF
Last Updated : February 4, 2025