Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what discussions his Department has had with (a) NHS England and (b) ITF Pharma UK to ensure that NHS Trusts have the necessary resources and guidance to take part in the Early Access Programme for givinostat.

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. The National Institute for Health and Care Excellence (NICE) recently published guidance that recommends the medicine vamorolone for treating Duchenne muscular dystrophy in people 4 years old and over. The National Health Service is required to fund medicines recommended by NICE, normally within three months of the publication of final guidance.

The Department has not had any discussions with ITF Pharma UK about resources or guidance available to NHS trusts participating in the early access programme for givinostat. Departmental 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 medicines schemes such as early access programmes, 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/