To ask the Minister of Health when he expects the drug Kuvan, used for Phenylketonuria, to be available in Northern Ireland (i) for those aged over 22; and (ii) for the entire population, other than on a trial basis.

My Department has a formal link with the National Institute for Health and Clinical Excellence (NICE) under which technology appraisals are reviewed locally for their applicability here. Whilst there is a process to check the guidance for legal and policy applicability here, there is no reassessment of the clinical or cost evidence used by NICE in coming to its decisions and forming its advice. Where found to be applicable they are endorsed by my Department for implementation within the Health and Social Care system.

On 20 October 2021 my Department endorsed NICE TA729 which recommends the use of sapropterin (Kuvan) as an option for treating hyperphenylalaninaemia that responds to sapropterin in people with phenylketonuria (PKU), only if they are:

under 18 and a dose of 10 mg/kg is used, only using a higher dose if target blood phenylalanine levels cannot be achieved at 10 mg/kg;

aged 18 to 21 inclusive, continuing the dose they were having before turning 18 or at a maximum dose of 10 mg/kg;

pregnant (from a positive pregnancy test until birth).

The following link to the guidance includes the Committee discussion on the evidence based decision: https://www.nice.org.uk/guidance/ta729