NICE Recommends Boehringer’s Cancer Drug, Giotrif
Lung cancer patients in England and Wales could gain access to a new treatment after cost regulators, NICE, have recommended Boehringer Ingelheim’s targeted therapy Giotrif (afatinib).
The National Institute for Health and Care Excellence (NICE) has published draft regulatory guidance recommending Giotrif as an option for treating locally advanced or metastatic non-small-cell lung cancer (NSCLC), in patients whose tumours test positive for the EGFR-TK mutation and have not received an EGFR-TK inhibitor.
The prevalence of tumours having EGFR mutations is between 10-15% in Caucasian and 40% in Asian NSCLC patients.
Clinical data from the Phase III LUX-Lung 3 clinical trial demonstrated that patients taking Giotrif as a first-line treatment lived for 11.1 months without their tumour growing again, in comparison to 6.9 months for patients treated with pemetrexed/cisplatin. Participants carrying the two most common EGFR mutations (Del19 or L858R) experienced median progression-free survival of 13.6 months, compared to 6.9 months for those in the comparator arm.
The expected NHS list price for the lung cancer drug is £2,023.28 per pack of 28 tablets (20 mg, 30 mg, 40 mg or 50 mg), resulting in a price of around £22,000 per patient per year, based on a progression-free survival of 11 months. Boehringer Ingelheim have also agreed a patient access scheme with the Department of Health where a confidential discount will be applied for the drug at the point of purchase or invoice.
The regulatory committee concluded that Giotrif is likely to have similar clinical efficacy to the other two NICE-approved treatments for the same type of lung cancer (erlotinib and gefitinib) and that Giotrif is a cost-effective option for the NHS.
As the independent committee is recommending the lung cancer treatment in line with its marketing authorisation, Giotrif can skip the usual appraisal consultation document stage, and go straight to the final regulatory draft stage.
The Scottish Medicines Consortium (SMC) approved funding for Giotrif on NHS Scotland last week.