An independent committee of experts that develops guidance on behalf of the U.K. National Institute for Health and Clinical Excellence does not believe that fulvestrant, which can be used to delay the growth of a particular type of advanced breast cancer, represents a good use of National Health Service resources.
Draft guidance, published Aug. 22 for public comment, does not recommend fulvestrant (known commercially as Faslodex and manufactured by AstraZeneca) as an alternative to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 estrogen-receptor positive.
In accordance with its marketing authorization, the committee’s provisional recommendation relates to the use of fulvestrant once antiestrogen 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 it is used outside of its marketing authorization (for example, after an aromatase inhibitor).
Sir Andrew Dillon, chief executive of NICE, said in a written statement that "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."
NICE’s final guidance will determine whether 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 antiestrogen 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 Sept. 13 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.