Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, how many patients were in receipt of Givinostat through the Early Access Programme on 10 December 2024; and if he will make an assessment of the potential barriers to accessing the Early Access Programme by patients.

The information on how many patients were in receipt of givinostat through the Early Access Programme (EAP) on 10 December 2024 is not held centrally, as the scheme was set up by the manufacturer.

We have made no assessment of access to the EAP for givinostat, which must be through one of the 23 NorthStar Centres in the United Kingdom. However, participation in the EAP is decided at an individual National Health Service trust level, and a North Star 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 NHS 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 the eligibility criteria.