Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, if his Department will urge CEOs of relevant Trusts to provide (a) financial and (b) personnel support so that administration of givinostat can begin in weeks.

The National Institute for Health and Care Excellence (NICE) makes recommendations for the National Health Service on whether new licensed medicines should be routinely funded by the NHS independently, based on an assessment of their costs and benefits. The NHS in England is legally required to fund medicines recommended by the NICE, normally within three months of the publication of final guidance. The NICE is currently evaluating givinostat, and its Appraisal Committee will meet to consider its recommendations in May 2025.

ITF Pharma UK, the United Kingdom marketing authorisation holder for givinostat, is providing access to givinostat through a type of compassionate use scheme called an Early Access Programme (EAP). NHS England does not have any initiatives to encourage participation in compassionate use schemes, which are the responsibility of individual pharmaceutical companies. Participation in the EAP for givinostat, which must be through one of the 23 NorthStar Centres in the UK, is decided at an individual NHS trust level, although there is general advice that trusts should engage with the relevant commissioner if they choose to participate. A NorthStar Centre will not be able to provide givinostat if its local trust has not approved participation. Under the EAP, givinostat is free to both patients taking part in it and to the NHS, but the trusts must still cover the cost of administering it to patients. Only Duchenne muscular dystrophy clinicians can make requests for givinostat for their patients. Decisions are made on a case-by-case basis for individual named patients aligned to eligibility criteria.