22 August 2011

Breast Cancer Drug Not Good Use of Resources, Says Draft Guidance

An independent committee of experts that develops guidance on behalf of the National Institute for Health and Clinical Excellence (NICE) does not believe that a drug, which can be used to delay the growth of a particular type of advanced breast cancer, represents a good use of NHS resources.

Draft guidance, published today (Monday 22 August) for public comment, does not recommend fulvestrant (known commercially as Faslodex and manufactured by AstraZeneca) as an alternative to aromatase inhibitor therapy in postmenopausal women who have locally advanced or metastatic breast cancer, that is oestrogen-receptor-positive. This type of cancer 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).

In accordance with its marketing authorisation, the committee's provisional recommendation relates to the use of fulvestrant once anti-oestrogen treatments (such as tamoxifen) are no longer controlling the spread of the cancer. The committee has not been able to consider the clinical and cost effectiveness of fulvestrant when used outside of its marketing authorisation, e.g. after an aromatase inhibitor.

Sir Andrew Dillon, Chief Executive of NICE said: “While it is important for women with locally advanced or metastatic breast cancer to have a range of options, NICE has to ensure that the NHS provides treatments that bring benefits which are value for money.

“After analysing the evidence comparing fulvestrant's clinical effectiveness with aromatase inhibitor therapy, our independent committee found that the estimates of overall survival and time to tumour progression were very 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, which is currently used in the NHS.

“We encourage AstraZeneca, patient organisations and other relevant third parties to comment on this preliminary recommendation during this public consultation period so that they can contribute to the development of this guidance."

NICE's final guidance will determine whether or not the NHS is legally obliged to allocate funding for fulvestrant as an alternative to aromatase inhibitors for the treatment of locally advanced or metastatic breast cancer after anti-oestrogen treatment. Until NICE issues final guidance, these decisions should continue to be made locally by NHS bodies.

Those wishing to comment on NICE's draft recommendations have until 13 September to do so. NICE's independent committee will then meet again to review the comments received. NICE expects to publish its final guidance for the NHS in January 2012.


About the draft guidance (appraisal consultation document)

1. For further information about the appraisal consultation document of “Fulvestrant for the treatment of locally advanced or metastatic breast cancer after anti-oestrogen treatment”, visit: http://guidance.nice.org.uk/TA/Wave23/15. Contactthe press office for embargoed copies of the draft guidance.

2. 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.

3. 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. For further information about ICERs, visit: www.nice.org.uk/newsroom/features/measuringeffectivenessandcosteffectivenesstheqaly.jsp

4. Aromatase inhibitors are a group of cancer drugs that reduce the levels of oestrogen in the body. They are a type of hormone therapy. Aromatase inhibitors work by blocking the production of oestrogen in the body and are effective in treating hormone-receptor-positive breast cancer.

5. 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 Evidence Review Group's estimate of mean overall survival for women on 500mg of fulvestrant was 36 months, for anastrozole it was 32 months and for letrozole it was 31 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. For further information about NICE's end-of-life criteria, visit: www.nice.org.uk/aboutnice/howwework/devnicetech/endoflifetreatments.jsp

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 -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.