Last Updated : August 4, 2022
Details
FilesGeneric Name:
Ribociclib
Project Status:
Complete
Therapeutic Area:
HR+, HER2- advanced or metastatic breast cancer
Manufacturer:
Novartis Pharmaceuticals Canada Inc.
Brand Name:
Kisqali
Project Line:
Reimbursement Review
Project Number:
PC0194-000
NOC Status at Filing:
Pre NOC
Strength:
200mg
Tumour Type:
Breast
Indications:
Advanced or Metastatic Breast Cancer
Funding Request:
In combination with an aromatase inhibitor (AI) and a luteinizing hormone releasing hormone (LHRH) agonist for the treatment of pre/peri- menopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, as initial endocrine-based therapy
Pre Noc Submission:
Yes
Sponsor:
Novartis Pharmaceuticals Canada Inc.
Submission Date:
Submission Deemed Complete:
Stakeholder Input Deadline ‡:
Check-point meeting:
pERC Meeting:
Initial Recommendation Issued:
Feedback Deadline ‡:
Notification to Implement Issued:
Recommendation Type:
Reimburse with clinical criteria and/or conditions
pERC Meeting:
Final Recommendation Issued:
Files
‡ Patient Advocacy Groups (or individual patients and caregivers when there is no patient group) and Clinicians who are registered with pCODR are eligible to provide Input and Feedback. Deadlines for Input and Feedback are by the end of the pCODR business day (5P.M. Eastern Time) of the date noted.
Last Updated : August 4, 2022