Elacestrant (Orserdu®). HTA ID: 26053

Assessment Status Rapid Review Complete
HTA ID 26053
Drug Elacestrant
Brand Orserdu®
Indication Elacestrant (Orserdu®) as monotherapy for the treatment of postmenopausal women, and men, with estrogen receptor (ER)-positive, human epidermal factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with an activating oestrogen receptor 1 (ESR1) mutation who have disease progression following at least one line of endocrine therapy including a CDK 4/6 inhibitor^.
Assessment Process
Rapid review commissioned 01/10/2026
Rapid review completed 22/10/2026
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost-effectiveness of elacestrant (Orserdu®) compared with the current standard of care.

^The Applicant is seeking reimbursement in a subpopulation: Patients with ER-positive, HER2-negative locally advanced or metastatic breast cancer with an activating ESR1 mutation who have disease progression following ≥ 12 months prior treatment with ET + CDK4/6i