Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, whether his Department has considered providing (a) funding and (b) other support to NHS Trusts to participate in early access programmes for (i) Givinostat for Duchenne Muscular Dystrophy and (ii) other medicines.

The Department understands the importance of rapid patient access to new medicines for patients with Duchenne muscular dystrophy, and has worked with NHS England to consider the issues raised by the givinostat early access programme. The first National Institute for Health and Care Excellence (NICE) committee meeting for givinostat took place on 10 July 2025, with a provisional date for a decision in September. If the manufacturer, Italfarmaco, can offer a cost-effective price to enable a positive NICE recommendation, NHS England is ready to work with the company to explore immediate funding options for the treatment.

Although medicines administered via company-sponsored early access programmes (EAPs) are licensed, EAPs do not share common clinical, data, or regulatory standards, meaning each one demands a new protocol to be devised and delivered by each participating trust, and that can create significant pressures on clinical and financial resources.

It would not be appropriate for the Government or NHS England to issue any form of national direction around the participation in these early access programmes as it would both pre-empt and undermine the role of NICE, whose very purpose is to advise the National Health Service on whether or not particular treatments should be made routinely available on the NHS.

The Government does, however, support patients getting early access to new, innovative medicines through established routes such as the Early Access to Medicines Scheme.