AstraZeneca's breast cancer drug Faslodex (fulvestrant) does not represent a good use of NHS resources, according to new draft guidance from the National Institute for Health and Clinical Excellence (NICE).
NICE's independent appraisal committee has declined to recommend Faslodex as an alternative to aromatase inhibitor therapy in postmenopausal women who have locally-advanced or metastatic breast cancer that is oestrogen receptor-positive, it says, in preliminary guidance on which the Institute is seeking public comment.
In accordance with Faslodex' marketing authorisation (MA), the committee's provisional recommendation relates to the drug's use once anti-oestrogen treatments such as tamoxifen are no longer controlling the spread of the cancer.
The committee adds that it has not been able to consider the clinical and cost-effectiveness of Faslodex when used outside its MA - for example, after an aromatase inhibitor.
"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," said NICE's chief executive, Sir Andrew Dillon.
"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," said Sir Andrew. "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," he added.
The draft guidance is open for comment until September 13, and Sir Andrew said: "we encourage AstraZeneca, patient organisations and other relevant third parties to comment on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."
AstraZeneca said it was disappointed at the negative preliminary recommendation from NICE, and noted that this had been made "despite clinical evidence demonstrating fulvestrant is shown to halt the growth of breast cancer for nearly nine months, on average, in postmenopausal women with oestrogen-receptive-positive advanced breast cancer who had previously received anti-oestrogen therapy such as tamoxifen."
The firm is "fully confident" in the benefits that its product can bring to suitable patients, and for these women it would like this initial recommendation to be reversed, said AstraZeneca UK marketing company president Mark Jones.
"We will work closely with NICE through the remainder of the consultation process with the aim of securing a positive final decision and thereby making sure that fulvestrant can be made freely available to patients in the NHS," Mr Jones added.
NICE expects to publish its final guidance in January 2012.