Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what assessment his Department has made of whether Kuvan should be assessed through NICE's highly-specialised technology appraisal.

Decisions on whether individual medicines are suitable for assessment by the National Institute for Health and Care Excellence (NICE), and whether they meet the criteria for the highly specialised technologies programme, are taken through an established topic selection process.

The process is overseen by NICE and includes consideration against published criteria by a topic selection panel and engagement with stakeholders. Although NHS England, NHS Improvement and the Department provide input and are part of this panel, the decision-making process is led by NICE. Kuvan for the treatment of phenylketonuria was last considered by the topic selection panel on 15 February 2019.

In the absence of guidance from NICE, it is for National Health Service organisations and healthcare professionals to make decisions on whether to fund Kuvan on the basis of an assessment of the available evidence. Treatment for patients with phenylketonuria who are not receiving Kuvan or for who Kuvan is not effective includes dietary protein restriction combined with dietary supplements.