Patients with a certain type of lung cancer living in England and Wales could soon get access to a new treatment as cost regulators look favourably on Boehringer Ingelheim's targeted therapy Giotrif (afatinib).

The National Institute for Health and Care Excellence (NICE) has published draft guidance recommending Giotrif as an option for treating locally advanced or metastatic non-small-cell lung cancer (NSCLC), specifically in people whose tumours test positive for the EGFR-TK mutation and have not received a EGFR-TK inhibitor.

The prevalence of tumours harbouring EGFR mutations is between 10-15% in Caucasian and 40% in Asian NSCLC patients, and clinical trials have shown that the drug can offer a survival benefit to this subset. 

Data from the Phase III LUX-Lung 3 trial showed that patients taking Giotrif as a first-line treatment lived for 11.1 months without their tumour growing again versus 6.9 months for those treated with pemetrexed/cisplatin, and those carrying the two most common EGFR mutations (Del19 or L858R) experienced median progression-free survival of 13.6 months versus 6.9 months for those in the comparator arm.

The Committee concluded that Giotrif is likely to have similar clinical efficacy to erlotinib and gefitinib, the other two NICE-approved options for this form of lung cancer, and that it is a cost-effective option for the NHS.

The anticipated NHS list price is £2,023.28 per pack of 28 tablets (20 mg, 30 mg, 40 mg or 50 mg), coming in at about £22,000 per patient per year, based on a progression-free survival of 11 months, but BI has agreed a patient access scheme with the Department of Health under which a confidential discount is applied at the point of purchase or invoice.

Because the independent Committee is recommending the treatment in line with its marketing authorisation, its recommendations can leapfrog the usual appraisal consultation document stage to go straight to the final draft stage.

The Scottish Medicines Consortium approved funding for the drug on NHS Scotland last week.