2 The technology
2.1 Afatinib (Giotrif, Boehringer Ingelheim) is an irreversible tyrosine kinase inhibitor (TKI) that blocks the epidermal growth factor receptor (EGFR) ErbB1 and other members of the ErbB family. The ErbB family is involved in the growth, migration and metabolism of tumour cells. Afatinib has a marketing authorisation as a monotherapy 'for the treatment of EGFR TKI-naive adult patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) with activating EGFR mutation(s)'.
2.2 The summary of product characteristics lists the following very common adverse reactions for afatinib: diarrhoea, rash/acne, blistering and dry skin conditions, pruritus, decreased appetite, nose bleed, stomatitis (inflammation in the mouth) and paronychia (nail infection). For full details of adverse reactions and contraindications, see the summary of product characteristics.
2.3 Afatinib is given orally at a recommended dosage of 40 mg once daily. The dosage may be increased to a maximum of 50 mg/day in the first 3 weeks in patients who are able to tolerate 40 mg/day without adverse reactions of greater than grade 1 severity. For patients who have more severe adverse reactions, the dose may be reduced (usually by 10 mg decrements) or treatment interrupted or discontinued. For full details see the summary of product characteristics. The NHS list price, provided by the manufacturer, is £2023.28 per pack of 28 tablets (20 mg, 30 mg, 40 mg or 50 mg). The manufacturer stated that the NHS list price per course of treatment is expected to be around £22,000 per patient, based on a progression-free survival of 11 months. The manufacturer of afatinib has agreed a patient access scheme with the Department of Health in which a confidential discount is applied at the point of purchase or invoice. The Department of Health considered that this patient access scheme does not constitute an excessive administrative burden on the NHS.