Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, whether his Department is taking steps to ensure that all eligible NHS Trusts participate in the early access programme for givinostat.

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). Under the EAP, givinostat is free to both patients taking part in it and to the National Health Service, 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.

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, so that any impacts on the wider service can be taken into account. A NorthStar Centre will not be able to provide givinostat if its local trust has not approved participation.

NHS England has published guidance for integrated care systems (ICS) on free of charge medicines schemes such as EAPs, including providing advice on potential financial, administrative, and clinical risks. The guidance aims to support the NHS to drive value from the medicines and ensure consistent and equitable access to medicines across England. ICSs should follow the recommendations to determine whether to implement any free of charge scheme, including assessing suitability and any risks in the short, medium, and long term. The guidance is available at the following link:

https://www.england.nhs.uk/long-read/free-of-charge-foc-medicines-schemes-national-policy-recommendations-for-local-systems/