Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, with reference to the Scottish Medicines Consortium’s announcement on 8 October 2018 of the introduction of a revised definition for an ultra-orphan medicine, what assessment his Department has made of the potential merits of adopting the same definition.

The Department has made no such assessment. The National Institute for Health and Care Excellence (NICE) makes recommendations for the National Health Service in England on the use of most new medicines through its technology appraisal programme and also operates a separate highly specialised technologies programme for the evaluation of very high cost drugs for the treatment of very small numbers of patients. NICE operates a topic selection process that includes consideration of individual topics against published criteria and engagement with stakeholders to determine whether topics are suitable for assessment by NICE and, if so, which programme is most appropriate.