In draft guidance, the National Institute for Health and Clinical Excellence recommended against the use of AstraZeneca's Faslodex (fulvestrant) in certain women with breast cancer as it does not represent "a good use of NHS resources."

 

 

The guidance applies to use of the drug as an alternative to aromatase inhibitor therapy in postmenopausal women who have locally advanced or metastatic breast cancer that is oestrogen-receptor positive.

 

 

NICE chief executive Andrew Dillon noted that the agency's appraisal committee "concluded that it had not been given any conclusive evidence that [Faslodex] extends life or delays tumour progression any more than aromatase inhibitor therapy, which is currently used in the NHS." Dillon added that after considering evidence comparing Faslodex's clinical effectiveness with aromatase inhibitor therapy, the committee "found that the estimates of overall survival and time to tumour progression were very uncertain."

 

 

"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," Dillon commented. A final ruling from the agency is expected in January next year.

 

 

In response, AstraZeneca said NICE's decision had been made "despite clinical evidence demonstrating [Faslodex] is shown to halt the growth of breast cancer for nearly nine months" in this indication.

 

 

Mark Jones, the company's president of UK marketing, noted that "we would like this initial recommendation to be reversed," adding that the drugmaker "will work closely with NICE through the remainder of the consultation process with the aim of securing a positive final decision."

 

 

(Ref: The Wall Street Journal, NICE)