The National Institute for Health and Care has issued final guidelines rejecting AstraZeneca’s Faslodex for certain patients with breast cancer.

Faslodex (fulvestrant) is not recommended, as per its marketing authorisation, for treating locally advanced or metastatic oestrogen-receptor positive breast cancer in postmenopausal women who have not had endocrine therapy before.

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.

However, the Institute said final data on the drug’s impact on overall survival are not yet available, with results from the Falcon trial not expected until the end of next year, leaving it unclear whether Faslodex will extend overall survival compared with current standard treatment with aromatase inhibitors.

Because of this, the cost effectiveness of the drug compared with existing treatments “is highly uncertain”, but “it is likely to be above the range normally considered a cost-effective use of NHS resources,” according to the guidance.

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, which was approved for first line use in breast cancer patients in Europe in July last year.