elacestrant (Korserdu)

following a resubmission:

elacestrant (Korserdu®) is accepted for restricted use within NHSScotland.

Indication under review: as monotherapy for the treatment of postmenopausal women, and men, with estrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer with an activating ESR1 mutation who have disease progression following at least one line of endocrine therapy including a CDK 4/6 inhibitor.

SMC restriction: patients who have disease progression after receiving ≥12 months prior treatment with endocrine therapy plus a cyclin-dependent kinase (CDK) 4/6 inhibitor.

In an open-label phase III study, elacestrant significantly improved progression-free survival (PFS) compared with investigator’s choice of endocrine monotherapy, which may be relevant in a small proportion of patients in Scotland. Indirect data suggested elacestrant may improve PFS versus everolimus-exemestane, which may also be used in a small subset of patients. Indirect evidence did not suggest a difference between elacestrant and capecitabine, the comparator considered most relevant to Scottish practice.

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.