To ask the Minister of Health for an update on efforts to provide Givinostat through the Early Access Programme.

Compassionate use schemes such as Early Access Programmes (EAP) permit health providers to make new licensed treatments available to patients free of charge while they are being assessed for clinical and cost-effectiveness by the National Institute for Health and Care Excellence (NICE). However, these schemes do not provide any additional resources which are often required to safely administer the drug and monitor patients, as is the case with givinostat.

Whilst it is an operational decision for Health and Social Care Trusts to participate in an EAP and to identify the additional resources required prior to a recommendation by NICE, all our Health and Social Care Trusts are constrained by the severe budgetary pressures currently facing the Health and Social Care (HSC) system and the urgent need to reduce costs.

It is my understanding that in light of this, it has not been possible for the Belfast Trust to identify the additional funding that would be required to support the EAP for givinostat.

However, I am acutely aware of the time-sensitive need to access givinostat promptly, and so I have requested that the Belfast Trust put plans in place to enable implementation to proceed at pace in the event of a positive recommendation by NICE this Autumn.