Elacestrant
Locally advanced or metastatic breast cancer in men and postmenopausal women with ER+/HER2- disease, an activating ESR1 variant, and disease progression following at least one line of endocrine therapy including a CDK4/6 inhibitor.
Decision on record
- Meeting Mar 2025 Not recommended ER+/HER2- locally advanced or metastatic breast cancer with ESR1 variant
From the public summary
7.1 The PBAC did not recommend the listing of elacestrant for the treatment of patients with ER+ HER2- locally advanced or metastatic breast cancer in patients whose tumours have evidence of activating ESR1 variants. The PBAC considered that in the heavily pre-treated population included in the clinical trial for elacestrant, the control arm of fulvestrant was inappropriate for many patients and was not representative of standard of care.PSD · Mar 2025
7.2 The PBAC considered there is a moderate clinical need for additional effective therapies in HR+/HER2 metastatic breast cancer, particularly noting that fulvestrant has very limited efficacy and its method of administration is painful and distressing for many patients, as outlined in the consumer comments.PSD · Mar 2025
6.33 The submission presented a modelled economic evaluation, based on the direct randomised trial, EMERALD, comparing elacestrant to SOC (fulvestrant or an AI monotherapy) in a population of patients with ER+/HER2- mBC who have disease progression following at least one line of ET, including a CDK4/6i, and who test positive for an ESR1-variant (termed by the submission as the ‘label population’).PSD · Mar 2025
OFFICIAL Public Summary Document – March 2025 PBAC Meeting PASC, which considered that cost modelling for both NGS and digital droplet polymerase chain reaction (ddPCR) methodology in the detection of ESR1 variants should be included in the assessment (p16, 1782 Ratified PICO Confirmation, August 2024 PASC meeting).PSD · Mar 2025
extracted from blood (liquid biopsy), elacestrant is superior to SOC in terms of effectiveness with a different and manageable safety profile.PSD · Mar 2025
6.25 The submission described NGS testing for ESR1 variants in ctDNA from liquid biopsy and treatment with elacestrant as superior in terms of effectiveness having a different and manageable safety profile compared to no testing and SOC (fulvestrant or AI monotherapy).PSD · Mar 2025
6.2 The PBAC noted and welcomed the input from individuals (1), health care professionals (2) and organisations (3) via the Consumer Comments facility on the PBS website. The comments from individuals, healthcare professionals and consumer groups (Rare Cancers Australia and Breast Cancer Network Australia) described the advantages of an oral treatment, noting that monthly fulvestrant injections are extremely painful, distressing and debilitating and less …PSD · Mar 2025
6.3 The Medical Oncology Group of Australia (MOGA) also expressed its strong support for the elacestrant submission, categorising it as one of the therapies of “highest priority for PBS listing” on the basis of the EMERALD 3 trial.PSD · Mar 2025
Cost-effectiveness
ICER value not stated in the provided text; document text is incomplete at section 5.
Decision context
PopulationMen and postmenopausal women with ER+/HER2- locally advanced or metastatic breast cancer with an activating ESR1 variant who have disease progression following at least one line of endocrine therapy including a CDK4/6 inhibitor.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2025 | Not recommended | standard of care (fulvestrant or aromatase inhibitor monotherapy) | — | RCT · PFS |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| EMERALD | Ph 3 | 478 | Progression-free Survival in ESR1-mut Participants | completed |
Codependent tests
| Service | Biomarker | MSAC outcome | Year |
|---|---|---|---|
| ESR1 variant testing in circulating tumour DNA (ctDNA) for breast cancer | activating estrogen receptor 1 (ESR1) variants | not supported | 2025 |
Consumer voice
Individuals, healthcare professionals, and consumer organisations (Rare Cancers Australia and Breast Cancer Network Australia) highlighted the significant burden of monthly fulvestrant injections, describing them as extremely painful, distressing, and debilitating, particularly for those in rural and remote areas. They noted that elacestrant's oral formulation and progression-free survival benefit
monthly fulvestrant injections are extremely painful, distressing and debilitating and less accessible for people living in rural and remote areas Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to men and postmenopausal women; TGA label includes all patients without sex/menopausal status specification.