Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, if he will take steps to ensure that Sapropterin (Kuvan) may be prescribed in doses greater than 10mg in the event that there is an identified clinical need.

The National Institute for Health and Care Excellence (NICE) is the independent body responsible for providing evidence-based guidance for the National Health Service on whether medicines represent a clinical and cost-effective use of resources. NICE is currently developing recommendations for the NHS on the use of sapropterin for the treatment of phenylketonuria and it would not be appropriate for Ministers to intervene in the development of its guidance.

NICE published draft guidance on the use of sapropterin for consultation on 25 February 2021 which recommends its use for children under 18 up to a dose of 10mg/kg. NICE will carefully consider the comments received in developing its final recommendations. NICE expects to publish its final guidance on sapropterin in June 2021.