capivasertib (Truqap)

following a resubmission assessed under the end of life and orphan equivalent medicine process:

capivasertib (Truqap®) is accepted for restricted use within NHSScotland.

Indication under review: in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative (defined as IHC 0 or 1+, or IHC 2+/ISH-) locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations following recurrence or progression on or after an endocrine based regimen.

SMC restriction: restricted to patients whose disease has progressed following CDK4/6 inhibitor plus aromatase inhibitor therapy.

Evidence from a double-blind, phase III study, demonstrated that addition of capivasertib to fulvestrant significantly improved progression-free survival (PFS) but not overall survival (OS). An indirect comparison suggested no difference in these outcomes between capivasertib-fulvestrant and everolimus-exemestane.

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

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