Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, if he will have discussions with (a) Duchenne UK and (b) other patient advocacy groups on steps to increase access to the givinostat early access programme.

The Department has not had any discussions with ITF Pharma UK about the resources or guidance available to National Health Service trusts participating in the early access programme (EAP) for givinostat.

Department officials have had discussions with colleagues in NHS England about the guidance and resources that are available to NHS trusts. NHS England has published guidance for integrated care systems (ICS) on free of charge medicine 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 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/

Under the EAP, givinostat is free to both patients taking part in it, and to the NHS, but NHS trusts must still cover the cost of administering it to patients. While there are no current plans to hold discussions with Duchenne UK on steps to increase access, ministers in the Department are keen to engage with a broad range of stakeholders. Participation in the programme is decided at an individual NHS trust level.