Fulvestrant for the treatment of locally advanced or metastatic breast cancer

2 The technology

2.1 Fulvestrant (Faslodex, AstraZeneca) is an oestrogen antagonist belonging to a class of agents known as selective oestrogen receptor down-regulators (SERDs). Fulvestrant has a UK marketing authorisation for 'the treatment of 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'. The recommended dose is 500 mg (administered as two intramuscular injections of 250 mg) every month, with an additional 500 mg dose given 2 weeks after the initial dose.

2.2 According to the summary of product characteristics, the most common side effects associated with fulvestrant are nausea, vomiting, diarrhoea, venous thromboembolism, anorexia, headache, asthenia, urinary-tract infections, hot flushes, back pain, rash, injection-site reactions and hypersensitivity reactions ('British national formulary' [BNF] edition 61). For full details of side effects and contraindications, see the summary of product characteristics.

2.3 The current NHS list price of fulvestrant is £522.41 for 2 x 5 ml (250 mg) prefilled syringes (excluding VAT; BNF edition 61). The first month of treatment with fulvestrant 500 mg includes an additional loading dose administered 2 weeks after the initial dose, resulting in a cost of £1044.82 for the first month. In subsequent months, the cost of fulvestrant 500 mg is £522.41 per month. Costs may vary in different settings because of negotiated procurement discounts.