Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, if he will make an assessment of the potential merits of approving Givinostat for use to treat Duchenne Muscular Dystrophy in (a) Royal Cornwall Hospital Trust and (b) other NHS trusts.

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 NICE, normally within three months of the publication of final guidance. NICE is currently evaluating givinostat for the treatment of Duchenne muscular dystrophy and its Appraisal Committee will meet to consider its recommendations in May 2025.

Ahead of NICE’s evaluation, ITF Pharma UK, the United Kingdom’s marketing authorisation holder for givinostat, is providing access to givinostat through a type of compassionate use scheme called an Early Access Programme (EAP). 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.