2 The technology
2.1 Gefitinib (Iressa, AstraZeneca) is a selective inhibitor of epidermal growth factor receptor tyrosine kinase (EGFR-TK) which blocks the signal pathways involved in cell proliferation. By blocking EGFR-TK, gefitinib helps to slow the growth and spread of the cancer. Gefitinib has a UK marketing authorisation for the treatment of adult patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) with activating mutations of EGFR-TK.
2.2 The summary of product characteristics (SPC) states that when assessing the EGFR-TK mutation status of a patient, it is important that a well-validated and robust method is chosen to avoid false-negative and false-positive determinations. The SPC lists the following conditions that may be associated with gefitinib treatment: interstitial lung disease, hepatotoxicity and liver impairment. For full details of adverse effects and contraindications, see the SPC.
2.3 Gefitinib is administered orally as 250-mg film-coated tablets. The recommended dosage is 250 mg daily to be taken until the disease progresses or the clinician advises otherwise.
2.4 The cost for a pack of 250-mg tablets (30 tablets per pack) is £2167.71 (excluding VAT, 'British national formulary' [BNF] edition 59). The manufacturer has agreed with the Department of Health a patient access scheme in which gefitinib for first-line treatment of NSCLC will be available at a single fixed cost of £12,200 per patient irrespective of the duration of treatment. The manufacturer will not invoice the NHS until the third monthly pack of gefitinib is supplied. This means that patients who need less than 3 months of treatment will not incur a charge. The Department of Health considered that this patient access scheme does not constitute an excessive administrative burden on the NHS.