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Draft guidance, published today (Monday 22 August) for public comment, does not recommend fulvestrant (known commercially as Faslodex and manufactured by AstraZeneca) as an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.