NICE turns down AZ’ Faslodex for breast cancer

It is looking unlikely that AstraZeneca’s breast cancer drug Faslodex will be routinely funded on the NHS to delay growth of a specific type of breast cancer, after cost regulators concluded that its benefit over existing therapies has not been shown at this time.

Faslodex (fluvestrant) is approved for women with oestrogen-receptor-positive, locally advanced breast cancer or breast cancer that has spread to other parts of the body, who have not already had treatment with hormonal therapy (aromatase inhibitors or tamoxifen).

According to the data from the Phase III FALCON trial, median progression-free survival (PFS) was significantly longer with Faslodex than with anastrozole, at 16.6 months versus 13.8 months.

Matthew Ellis, study investigator, and director of the Lester and Sue Smith Breast Center in the Dan L Duncan Comprehensive Cancer Center at Baylor College of Medicine in Houston, previously highlighted the 20 percent reduction in disease progression or death observed with fulvestrant compared to the current standard therapy as "an advance in the management" patients.

But in draft guidelines published today, the National Institute for Health and Care Excellence says current evidence "does not prove that [Faslodex] prolongs survival more than existing, less expensive treatments for specific postmenopausal women."

The Committee agreed that the drug stalls the cancer’s growth by around three months compared to aromatase inhibitors, but felt that it’s too early to determine from the available evidence whether this translates into an increase in overall survival.

"There is a need for more effective treatments for locally advanced or metastatic breast cancer to delay the need for chemotherapy and to extend survival. But NICE has to ensure that the NHS provides treatments that bring benefits which are value for money," said rofessor Carole Longson, director of the centre for health technology evaluation at NICE.

"As fulvestrant 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."

Given by injection once-a-month, the list price of Faslodex (before discounts) is £522.41 per pack of 2 × 250-mg prefilled syringes, with the average cost per course of treatment estimated at £15,841, based on the company’s economic analysis.

Around 1,200 women would be eligible for treatment with the drug.