National Centre for Pharmacoeconomics

National Centre for

NCPE Ireland

Ribociclib (Kisqali®)

Ribociclib (Kisqali®) in combination with an aromatase inhibitor (AI) is indicated for the treatment of postmenopausal women with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer as initial endocrine based therapy.

Rapid Review Process Complete
Rapid review received 04/09/2017
Rapid review completed 19/09/2017
Rapid Review outcome Full pharmacoeconomic assessment recommended
Full pharmacoeconomic assessment commissioned by the HSE 25/09/2017
Pre-submission consultation with applicant 23/10/2017
Submission received from applicant 07/02/2018
Preliminary review part I sent to applicant 25/04/2018
Preliminary review part II sent to applicant 22/05/2018
Applicant response to preliminary review part I 25/05/2018
Applicant response to preliminary review part II 10/06/2018
NCPE assessment re-commenced 11/06/2018
Preliminary review part II sent to the applicant 11/07/2018
NCPE assessment re-commenced 20/07/2018
Factual Accuracy sent to the applicant 27/07/2018
NCPE assessment re-commenced 03/08/2018
NCPE assessment completed 13/08/2018
NCPE Assessment Outcome Following NCPE assessment of the company submission, the NCPE recommends that ribociclib (in combination with an aromatase inhibitor) for the treatment of postmenopausal women with HR+/HER2- locally advanced or metastatic BC as initial endocrine-based therapy, not be considered for reimbursement unless cost effectiveness can be improved relative to existing treatments. This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.


The HSE has approved reimbursement following confidential price negotiations; February 2019