Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what steps his Department is taking to (a) encourage NHS trusts in Greater Manchester to participate in the Early Access Programme for Givinostat and (b) to help tackle barriers to participation.

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 Early Access Programme (EAP) for givinostat, which must be through one of the 23 NorthStar Centres in the United Kingdom, is decided at an individual National Health Service trust level although there is general advice that trusts should engage with the relevant commissioner if they choose to participate. A NorthStar 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 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 hopes that all NHS trusts, including in Greater Manchester, who receive a request from a NorthStar Centre to provide givinostat to an eligible patient approve this request. NHS England will work with partners to ensure that Trusts understand the urgent need to make access possible for eligible patient.