AstraZeneca fails to win NICE backing for breast cancer drug Faslodex

NICE is set to advise the NHS not to use AstraZeneca's (AZ) Faslodex after ruling the drug is no better than existing treatments for a certain type of breast cancer.

Faslodex (fulvestrant) is being appraised as an alternative to aromatase inhibitors for postmenopausal women who have oestrogen-receptor-positive, locally advanced or metastatic breast cancer, and who have already received anti-oestrogen therapy (such as tamoxifen).

The cost effectiveness body's final draft guidance does not recommend the drug in this setting after NICE's independent advisory committee said AZ failed to prove the case for its use.

Sir Andrew Dillon, chief executive of NICE, said: "While there is evidence that fulvestrant can delay the growth of breast cancer, our independent committee found that when used according to its marketing authorisation, its effectiveness is uncertain compared to aromatase inhibitors, which are currently the preferred treatment options on the NHS.

"NICE has to ensure that the NHS provides treatments that bring benefits which are value for money. As fulvestrant has not been proven to be cost-effective, we cannot justify diverting NHS funds from other areas of healthcare in order to fund its use."

Faslodex has an NHS list price of £522.41 for 2 x 5 ml (250 mg) prefilled syringes, the recommended monthly dose following a 500mg 'loading dose' given two weeks after treatment begins. In contrast, a 28-pack of 1mg tablets of AstraZeneca's own Arimidex (anastrozole) costs £5.99 and a 28-pack of 2.5mg tablets of Novartis' Femara (letrozole) costs £84.86.

AZ estimated Faslodex could extend life when compared to using the two aromatase inhibitors, but NICE's advisory committee found considerably uncertainty with this assertion, saying that network meta-analyses showed no statistically significant differences in overall survival.

NICE also said that while Faslodex has been shown to delay cancer growth better than Arimidex, there was no evidence for it being better at this than Femara.

NICE's Final Appraisal Determination (FAD) is its last line of draft guidance. If AZ doesn't appeal against it, which the company has until 24 November to do, then NICE aims to publish final guidance for the NHS in January 2012.