abemaciclib (Verzenios)

following a full submission:

abemaciclib (Verzenios®) is accepted for use within NHSScotland.

Indication under review: in combination with endocrine therapy for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive early breast cancer at high risk of recurrence. In pre- or perimenopausal women, aromatase inhibitor endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.

In an open-label, randomised, phase III study, the addition of abemaciclib to adjuvant endocrine therapy improved invasive disease-free survival (IDFS) compared with endocrine therapy alone in patients with HR-positive, HER2-negative, node-positive early breast cancer at high risk of recurrence. The cohort of study patients with either at least four positive axillary lymph nodes or one to three positive axillary lymph nodes plus either grade 3 disease and/or tumour size ≥5cm supported the evidence for patients of high risk of recurrence in clinical practice.

This advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower.