1.1 Fulvestrant is not recommended, within its marketing authorisation, for treating locally advanced or metastatic oestrogen-receptor positive breast cancer in postmenopausal women who have not had endocrine therapy before.
1.2 This recommendation is not intended to affect treatment with fulvestrant 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 clinician consider it appropriate to stop.
Why the committee made this recommendation
People with untreated disease are first offered an aromatase inhibitor, either anastrozole or letrozole. These drugs are considered to be similarly effective. Tamoxifen is used for women in whom an aromatase inhibitor is not tolerated or is contraindicated. Fulvestrant is a further treatment option that may have additional benefits for some women. However, the final results on overall survival from the FALCON trial are not available yet, so it is unclear whether fulvestrant will extend overall survival compared with aromatase inhibitors.
Because of the uncertainty in the clinical evidence, the cost effectiveness of fulvestrant compared with existing treatments is highly uncertain. However, it is likely to be above the range normally considered a cost-effective use of NHS resources, so fulvestrant cannot be recommended.