Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, whether he has had discussions with NHS England on the reason that some NHS Trusts are not yet offering access to givinostat through the Early Access Programme.

The Department understands the impact that Duchenne muscular dystrophy has on those living with it and their families, and the urgent need for new treatment options.

Officials from the Department have had discussions with NHS England regarding access to givinostat through the Early Access Programme (EAP). Under the EAP, givinostat is free to both the patients taking part in it, and to the National Health Service, although NHS trusts must still cover the cost of administering it to patients.

Participation to the programme is decided at an individual NHS trust level and NHS England has published guidance for integrated care systems (ICS) on free of charge medicines schemes such as EAPs, including providing advice on the potential financial, administrative, and clinical risks. The guidance aims to support the NHS to drive value from 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 schemes, 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/