trastuzumab deruxtecan (Enhertu)

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

trastuzumab deruxtecan (Enhertu®) is accepted for use within NHSScotland.

Indication under review: as monotherapy for the treatment of adult patients with unresectable or metastatic HER2-low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy.

In an open-label, randomised, phase III study, trastuzumab deruxtecan significantly improved progression-free survival compared with single-agent chemotherapy in patients with HER2-low, hormone receptor-positive, unresectable or metastatic breast cancer who had received one or two lines of prior chemotherapy in the metastatic setting.

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.

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