Ribociclib (Kisqali®)

Assessment Status Assessment Process Complete
Drug Ribociclib
Brand Kisqali®
Indication 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.
Assessment Process
Rapid review commissioned 04/09/2017
Rapid review completed 19/09/2017
Rapid review outcome Full Pharmacoeconomic Assessment Recommended
Full pharmacoeconomic assessment commissioned by HSE 25/09/2017
Pre-submission consultation with Applicant 23/10/2017
Full submission received from Applicant 07/02/2018
Preliminary review sent to Applicant 25/04/2018
NCPE assessment re-commenced 25/05/2018
Follow-up to preliminary review sent to Applicant 22/05/2018
NCPE assessment re-commenced 11/06/2018
Additional follow-up to Preliminary Review sent to Applicant 11/07/2018
NCPE assessment re-commenced 20/07/2018
Factual accuracy sent to 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.

Technical Summary

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.