Breast cancer drug not proven to be better than existing treatments, says final guidance

Final guidance for the NHS published today (14 December) by the National Institute for Health and Care Excellence (NICE) concludes that a breast cancer drug does not work significantly better than existing treatments, and so its widespread use on the NHS would not be an effective use of resources.

The guidance does not recommend the use of fulvestrant (known commercially as Faslodex and manufactured by AstraZeneca) on the NHS in accordance with its marketing authorisation - i.e. as an alternative to aromatase inhibitors for postmenopausal women who have oestrogen-receptor-positive, locally advanced or metastatic breast cancer, and who have already received anti-oestrogen therapy.

Although AstraZeneca estimated that fulvestrant could extend life when compared to using the aromatase inhibitors currently prescribed, anastrozole and letrozole, NICE's independent committee found these estimates to be considerably uncertain. The Committee concluded that it had not been given any conclusive evidence that fulvestrant extends life or delays tumour progression any more than aromatase inhibitor therapy.

This guidance means that NHS doctors should not prescribe fulvestrant as an alternative to aromatase inhibitors for these women, after they have received anti-oestrogen treatment (e.g. tamoxifen). But importantly, the guidance also states that women, who are currently receiving fulvestrant in this way, should be able to continue to do so, until they and their doctors consider it appropriate to stop. Decisions on using fulvestrant outside of its licensed indication (e.g. after an aromatase inhibitor) are still made at local NHS levels.

Sir Andrew Dillon, Chief Executive of NICE said: "While there is evidence that fulvestrant can delay the growth of breast cancer, our independent advisory committee found that when used according to its marketing authorisation, its effectiveness is uncertain compared to aromatase inhibitors, which are currently the preferred treatment options on the NHS. Confidence about the additional benefits new treatments bring is important both for patients and for those who have responsibility for managing the resources available to the NHS."


Notes to Editors

About the final guidance

1. For further information about NICE's guidance on Fulvestrant for the treatment of locally advanced or metastatic breast cancer, visit:

2. Oestrogen-receptor-positive breast cancer is a type of cancer that grows because of reactions between oestrogen (a hormone found naturally in the body) and the proteins found on the surface of the cancer cells (called receptors). The committee considered that it was likely that the population covered by the marketing authorisation of fulvestrant is small (given the restriction to patients who have previously received an anti-oestrogen, the declining use of tamoxifen and the increasing use of aromatase inhibitors), but the precise population size is uncertain.

3. Fulvestrant (Faslodex, AstraZeneca) is an oestrogen antagonist belonging to a class of agents known as selective oestrogen receptor down-regulators (SERDS). It is licensed for “postmenopausal women with oestrogen receptor positive, locally advanced or metastatic breast cancer for disease relapse on or after adjuvant anti-oestrogen therapy, or disease progression on therapy with an anti-oestrogen”. The recommended dose is 500mg, administered every month as two slow intramuscular injections of 250mg. In addition to this, there is a 500mg dose given two weeks after the treatment has been initiated.

4. The current NHS list price of fulvestrant is £522.41 for 2 x 5 ml (250 mg) prefilled syringes, excluding VAT. The first month of treatment costs £1044.82, on account of the additional loading dose. After that, fulvestrant is £522.41 per month. Costs may vary locally. The committee concluded that the Incremental Cost Effectiveness Ratio (ICER) of £35,000 per QALY gained for fulvestrant 500mg compared with anastrozole was the most plausible estimate presented, but that this estimate was associated with considerable uncertainty. For further information about ICERs, visit:

5. Aromatase inhibitors are a group of cancer drugs that are a type of hormone therapy. They work by blocking the production of oestrogen in the body and are effective in treating hormone-receptor-positive breast cancer. According to the British National Formulary, a 28-pack of 1mg anastrozole tablets costs £5.99 and a 28-pack of 2.5mg letrozole tablets costs £84.86. For further information, visit:

6. The committee concluded that fulvestrant did not fulfil all of the end-of-life criteria. This is because the CONFIRM trial showed that fulvestrant is indicated for women who have a life expectancy greater than 24 months. For further information about NICE's end-of-life criteria, visit:

About NICE

1. The National Institute for Health and Care Excellence (NICE) is the independent organisation responsible for providing national guidance and standards on the promotion of good health and the prevention and treatment of ill health

2. NICE produces guidance in three areas of health:

  • public health - guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector
  • health technologies - guidance on the use of new and existing medicines, treatments, medical technologies (including devices and diagnostics) and procedures within the NHS
  • clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS

3. NICE produces standards for patient care:

  • quality standards - these reflect the very best in high quality patient care, to help healthcare practitioners and commissioners of care deliver excellent services
  • Quality and Outcomes Framework - NICE develops the clinical and health improvement indicators in the QOF, the Department of Health scheme which rewards GPs for how well they care for patients

4. NICE provides advice and support on putting NICE guidance and standards into practice through its implementation programme, and it collates and accredits high quality health guidance, research and information to help health professionals deliver the best patient care through NHS Evidence.

This page was last updated: 13 December 2011

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Copyright 2014 National Institute for Health and Care Excellence. All rights reserved.