NICE rejects use of AstraZeneca's Faslodex as first-line breast cancer treatment

The National Institute for Health and Care Excellence published draft guidance Friday recommending against NHS reimbursement of AstraZeneca's Faslodex (fulvestrant) for certain women with breast cancer. According to NICE, the evidence does not demonstrate that the drug, which costs 500 pounds per month ($648), prolongs survival more than existing, less expensive treatments. 

The guidance focuses on postmenopausal women who have oestrogen-receptor-positive, locally advanced breast cancer or breast cancer that has spread to other parts of the body, who have not already been treated with hormonal therapy. NICE's independent appraisal committee noted that while Faslodex stalls the cancer's growth by around three months compared to aromatase inhibitors, the available evidence did not show that this leads to an increase in overall life expectancy. 

Carole Longson, director of the centre for health technology evaluation at NICE, said the agency "has to ensure that the NHS provides treatments that bring benefits which are value for money," adding that since Faslodex "has not been shown to be cost-effective, we can't justify diverting NHS funds from other areas of healthcare in order to fund its use." 

FirstWord reports in this therapy area - KOL Insight Breast Cancer: Find out how KOLs expect the market to evolve, which pipeline treatments are most promising, and which clinical trials will shape treatment decisions. Learn more.

NICE indicated that public consultation on its draft guidance will be accepted until September 25. European regulators expanded approval for Faslodex in July to include first-line treatment of postmenopausal women with oestrogen-receptor-positive, locally advanced or metastatic breast cancer not previously treated with endocrine therapy.

In 2011, NICE issued final guidance indicating that Faslodex was not significantly more effective than existing therapies for postmenopausal women with oestrogen-receptor-positive, locally advanced or metastatic breast cancer, who had already received anti-oestrogen therapy. 

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