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1 Recommendations

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1 Recommendations

1.1

Elacestrant is not recommended, within its marketing authorisation, for treating oestrogen receptor (ER)-positive HER2-negative, locally advanced or metastatic breast cancer with an activating ESR1 mutation that has progressed after at least 1 line of endocrine therapy including a cyclin-dependent kinase (CDK) 4 and 6 inhibitor in:

  • women, trans men and non-binary people after menopause

  • men.

1.2

This recommendation is not intended to affect treatment with elacestrant that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS healthcare professional consider it appropriate to stop.

Why the committee made these recommendations

ER-positive, HER2-negative is the most common type of breast cancer. After prolonged hormone therapy, the cancer may develop an activating mutation (genetic change) in the oestrogen receptor gene (ESR1). There are no targeted treatments for ER-positive HER2-negative locally advanced or metastatic breast cancer with an activating ESR1 mutation available on the NHS. For this evaluation, the company asked for elacestrant to be considered for ER-positive HER2-negative locally advanced or metastatic breast cancer with an activating ESR1 mutation that gets worse only after at least 12 months of treatment with endocrine therapy and a CDK 4 and 6 inhibitor.

For breast cancer that also has a mutation in the PIK3CA gene, standard care is alpelisib plus fulvestrant. Standard care for breast cancer without a PIK3CA mutation is everolimus plus exemestane. For people who cannot have either of these treatment combinations, tamoxifen or chemotherapy may be offered.

There are no clinical trials directly comparing elacestrant with standard care. Indirect comparisons with standard care suggest that elacestrant increases how long people have before their breast cancer gets worse. But these results are uncertain because the company's target population was chosen after the trial data had already been collected and the sample sizes were small. So, the results could be because of chance. There are also limitations in the methods used to do the indirect comparisons.

There are also uncertainties in the economic model, so the cost-effectiveness estimates are uncertain. Even when considering elacestrant's effects on quality and length of life, the most likely cost-effectiveness estimate is above what NICE considers an acceptable use of NHS resources. So, elacestrant is not recommended.