NICE fails to see Faslodex value


NICE has not recommended Faslodex (fulvestrant) for women with locally advanced or metastatic breast cancer after its Appraisal Committee declared it was not a good use of NHS resources.

The Committee raised questions over the data supplied by AstraZeneca on the treatment’s efficacy and its cost effectiveness.

Sir Andrew Dillon says the Committee “had not been given any conclusive evidence” that Faslodex extends life or delays tumour progression when compared with current treatment options.

Faslodex was being appraised as an alternative to aromatase inhibitor therapy in postmenopausal women who have locally advanced or metastatic breast cancer, that is oestrogen-receptor-positive.

It is licensed for postmenopausal women with oestrogen receptor positive, locally advanced or metastatic breast cancer for disease relapse on or after adjuvant anti-oestrogen therapy, or disease progression on therapy with an anti-oestrogen.

In line with its European marketing application, the decision by NICE’s independent panel of experts relates to the use of the inhibitor once anti-oestrogen treatments are no longer controlling the spread of the tumour.

But during the appraisal it was not able to consider the clinical and cost effectiveness of the treatment when used outside of its marketing authorisation.

“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 Dillon.

“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.”

NICE’s decision is now open to public decision. The Institute expects to publish final guidance in January 2012.