trastuzumab deruxtecan (Enhertu)

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

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

Indication under review: as monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens.

SMC restriction: in patients who have received one prior anti-HER2-based regimen.

In a phase III study, trastuzumab deruxtecan was associated with significantly improved progression-free survival compared with an antibody-drug conjugate medication.

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.

SMC has previously issued advice (SMC2388) accepting trastuzumab deruxtecan (Enhertu®) for use within NHSScotland on an interim basis subject to ongoing evaluation and future reassessment as monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens. This advice remains valid.