ribociclib (Kisqali)

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

ribociclib (Kisqali ®) is accepted for restricted use within NHSScotland.

Indication under review: for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with fulvestrant* as initial endocrine-based therapy, or in women who have received prior endocrine therapy.

SMC restriction: women who have relapsed on or within 12 months of completing (neo) adjuvant endocrine therapy, or those who have progressed on first-line endocrine-based therapy for advanced breast cancer.

Ribociclib in combination with fulvestrant significantly increased progression-free survival compared with endocrine monotherapy in women with HR-positive, HER2-negative locally advanced or metastatic breast cancer.

This SMC advice takes account of the benefit of Patient Access Schemes (PAS) that improve the cost effectiveness of ribociclib and fulvestrant. This advice is contingent upon the continuing availability of these PAS in NHSScotland or list prices that are equivalent or lower.
This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.