Elacestrant for treating oestrogen receptor-positive HER2-negative advanced breast cancer with an ESR1 mutation after endocrine treatment

  • Technology appraisal guidance
  • TA1036
  • Published: 
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1 Recommendations

1.1

Elacestrant is recommended as an option 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 treatment plus a cyclin-dependent kinase (CDK) 4 and 6 inhibitor in:

  • women, trans men and non-binary people who have been through the menopause

  • trans women and men.

    Elacestrant is recommended only if:

  • the cancer has progressed after at least 12 months of endocrine treatment plus a CDK 4 and 6 inhibitor, and

  • the company provides it according to the commercial arrangement.

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 endocrine treatment, the cancer may develop an activating mutation (genetic change) in the oestrogen receptor gene (ESR1).

For this evaluation, the company asked for elacestrant to only be considered for ER-positive HER2-negative locally advanced or metastatic breast cancer with an activating ESR1 mutation that has progressed (got worse) after at least 12 months of endocrine treatment plus a CDK 4 and 6 inhibitor. This does not include everyone it is licensed for.

There are no targeted treatments for ER-positive HER2-negative locally advanced or metastatic breast cancer with an activating ESR1 mutation. Standard care is usually everolimus plus exemestane, or for ER-positive HER2-negative PIK3CA-mutated locally advanced or metastatic breast cancer, alpelisib plus fulvestrant.

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.

When considering the condition's severity, and its effect on quality and length of life, the most likely cost-effectiveness estimate is within the range that NICE considers an acceptable use of NHS resources. So, elacestrant is recommended.