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 The Welsh Assembly Minister for Health and Social Services has issued directions to the NHS in Wales on implementing NICE technology appraisal guidance. When a NICE technology appraisal recommends the use of a drug or treatment, or other technology, the NHS in Wales must usually provide funding and resources for it within 3 months of the guidance being published.
5.3 When NICE recommends a treatment 'as an option', the NHS must make sure it is available within the period set out in the paragraphs above. This means that, if a patient has active autoantibody-positive systemic lupus erythematosus and the doctor responsible for their care thinks that belimumab is the right treatment, it should be available for use, in line with NICE's recommendations.
5.4 The Department of Health and GlaxoSmithKline have agreed that belimumab will be available to the NHS with a patient access scheme which makes it available with a discount. The size of the discount is commercial in confidence. It is the responsibility of the company 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 the GSK Customer Care Team on 0800 221441.
5.5 Details of the dialogue between NHS England and GlaxoSmithKline about patient eligibility and continuation, the cost of funding belimumab to NHS patients (during the period of data collection, during re-appraisal, and in case the re-appraisal is not positive), the cost of data collection through the BILAG registry, and the cost of conducting the required analyses at the end of the data collection period are included in the managed access document.