abemaciclib (Verzenios)

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

abemaciclib (Verzenios®) 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: for use in women who have progressed on or after (neo) adjuvant endocrine therapy, or progressed during first-line endocrine-based therapy for advanced breast cancer

In a phase III randomised study in women with HR-positive, HER2-negative advanced breast cancer who had received prior endocrine therapy, abemaciclib in combination with fulvestrant significantly increased progression-free survival compared with endocrine monotherapy.

This SMC advice takes account of the benefit of Patient Access Schemes (PAS) that improve the cost effectiveness of abemaciclib 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 the views from a Patient and Clinician Engagement (PACE) meeting.

* For SMC advice relating to the use of abemaciclib in combination with an aromatase inhibitor in this setting, please refer to SMC2135.