Section 8(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 evaluation within 3 months of its date of publication.
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 Fabry disease and the doctor responsible for their care thinks that migalastat is the right treatment, it should be available for use, in line with NICE's recommendations.
The Department of Health and the company have agreed that migalastat will be available to the NHS with a patient access scheme which makes migalastat 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 Alasdair MacCulloch, Regional Market Access Director at Amicus Therapeutics, amacculloch@amicusrx.com.