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Breast Cancer Drug not Proven to be Better than Existing Treatments, says Draft Guidance

In its latest draft guidance, the National Institute for Health and Clinical Excellence (NICE) intends to advise the NHS against routinely prescribing a drug that can be used to delay the growth of a particular type of breast cancer. This is because NICE's independent advisory committee does not believe that the evidence submitted by the drug's manufacturer proves that it works significantly better than existing treatments, and so its widespread use would not be a good use of resources.

Published today (10 November), the final appraisal determination (FAD) does not recommend the use of fulvestrant (known commercially as Faslodex and manufactured by AstraZeneca) on the NHS 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 (such as tamoxifen).

Although AstraZeneca estimated that fulvestrant could extend life when compared to using the aromatase inhibitors, anastrozole and letrozole, the committee found this to be considerably uncertain (i.e. network meta-analyses showed no statistically significant differences in overall survival). Also, while fulvestrant is shown to delay cancer growth better than anastrozole, there is no evidence that it is better at this than letrozole.

Following this advice would mean that NHS doctors should not consider prescribing fulvestrant as an alternative to aromatase inhibitors for these women, after their anti-oestrogen treatment. However, the draft guidance also states that women, who are currently receiving fulvestrant in this way, should be able to continue to do so, until they and their doctors consider it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 made at local NHS levels.


"While there is evidence that fulvestrant can delay the growth of breast cancer, our independent 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.

"NICE has to ensure that the NHS provides treatments that bring benefits which are value for money. As fulvestrant has not been proven to be cost-effective, we cannot justify diverting NHS funds from other areas of healthcare in order to fund its use."

The latest draft recommendations are now open to appeal. NICE has not yet published final guidance for the NHS on the use of this drug.

The FAD follows a previous draft (called the appraisal consultation document, ACD) that was published for public comment in August.

If no appeals are received by Thursday 24 November, NICE hopes to publish final guidance for the NHS in January 2012.


Notes to Editors

About the draft guidance (final appraisal determination)

1. For further information about the final appraisal determination of Fulvestrant for the treatment of locally advanced or metastatic breast cancer after anti-oestrogen treatment, visit the Fulvestrant webpage. Contact the press office for embargoed copies of the draft guidance.

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 is the most plausible estimate, but that this estimate was associated with considerable uncertainty. Further information about ICERs.

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 the BNF website.

6. The committee concluded that fulvestrant did not fulfil all of the end-of-life criteria. This is because the CONFIRM trial showed that it is given to women who have a life expectancy greater than 24 months. The Committee also noted that, although fulvestrant was associated with an extension of life of at least an additional 3 months compared with anastrozole and letrozole, these results were based on the overall survival results obtained in the manufacturer's economic model, which were associated with considerable uncertainty. Further information about NICE's end-of-life criteria.

7. Further information about the appeals process.

About NICE

1. The National Institute for Health and Clinical 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 -

health technologies -

clinical practice -

guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS guidance on the use of new and existing medicines, treatments, medical technologies (including devices and diagnostics) and procedures within the NHS 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

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quality standards

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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 - these reflect the very best in high quality patient care, to help healthcare practitioners and commissioners of care deliver excellent services

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

This page was last updated: 09 November 2011


Until NICE issues final guidance, decisions regarding the use of fulvestrant should continue to be made locally by the NHS.


Sir Andrew Dillon, Chief Executive of NICE said:

Posted: November 2011