ribociclib (Kisqali)

following a full submission assessed under the end of life and orphan medicine process:

ribociclib (Kisqali®) is accepted for use within NHS Scotland.

Indication under review: In combination with an aromatase inhibitor, 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.

A phase III double-blind, randomised controlled study demonstrated that ribociclib plus an aromatase inhibitor significantly improved progression-free survival compared with aromatase inhibitor monotherapy in postmenopausal women with HR-positive, HER2-negative locally advanced or metastatic breast cancer who had not previously received systemic therapy for advanced disease.

This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of ribociclib. This advice is contingent upon the continuing availability of the PAS in NHS Scotland or a list price that is equivalent or lower.

This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.