2 The technology
2.1 Erlotinib (Tarceva, Roche Products) is an active inhibitor of the epidermal growth factor receptor tyrosine kinase (EGFR-TK). It blocks the signal pathways involved in cell proliferation and slows the growth and spread of the tumour. It has a UK marketing authorisation 'for the first-line treatment of patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) with EGFR activating mutations'.
2.2 The summary of product characteristics lists the following adverse reactions to erlotinib: diarrhoea, rash, anorexia, gastrointestinal perforation, keratitis and rare cases of hepatic failure. For full details of adverse reactions and contraindications, see the summary of product characteristics.
2.3 Erlotinib is given orally at a recommended dosage of 150 mg/day. The cost of a pack of 30 (150-mg) tablets is £1631.53 (excluding VAT; 'British national formulary' [BNF] edition 63). Dosage reductions (typically to 100 or 50 mg/day) are possible if the clinician considers it appropriate, and erlotinib is also available in tablet strengths of 100 mg and 25 mg. The manufacturer of erlotinib has agreed a patient access scheme (revised in 2012) with the Department of Health in which a confidential discount from the list price is applied to original invoices. The Department of Health considered that this patient access scheme does not constitute an excessive administrative burden on the NHS.