trastuzumab deruxtecan (Enhertu)

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

trastuzumab deruxtecan (Enhertu®) is accepted for use within NHSScotland on an interim basis subject to ongoing evaluation and future reassessment.

Indication under review: As monotherapy for the treatment of adult patients with unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer who have received two or more prior anti-HER2-based regimens.

In an open-label single-arm phase II study trastuzumab deruxtecan was associated with clinically relevant overall response rates in adults with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens.

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.