5.1 Section 7(6) of the National Institute for Health and Care Excellence (Constitution and Functions) and the Health and Social Care Information Centre (Functions) Regulations 2013 requires clinical commissioning groups, NHS England and, with respect to their public health functions, local authorities to comply with the recommendations in this appraisal within 3 months of its date of publication.
5.2 When NICE recommends a treatment 'as an option', the NHS must make sure it is available within the period set out in the paragraph above. This means that, if a patient has epidermal growth factor receptor mutation-positive locally advanced or metastatic non-small-cell lung cancer and the doctor responsible for their care thinks that afatinib is the right treatment, it should be available for use, in line with NICE's recommendations.
5.3 The Department of Health and the manufacturer have agreed that afatinib will be available to the NHS with a patient access scheme which makes afatinib available with a discount. The size of the discount is commercial in confidence. It is the responsibility of the manufacturer to communicate details of the discount to the relevant NHS organisations. Any enquiries from NHS organisations about the patient access scheme should be directed to PMonccommercial.BRA@boehringer-ingelheim.com
5.4 NICE has developed a costing statement explaining the resource impact of this guidance to help organisations put this guidance into practice.