To ask the Minister of Health to outline what steps are being taken to ensure that givinostat, used to treat Duchenne muscular dystrophy, will be available through an Early Access Programme.

Mr Nesbitt (The Minister of Health)

One of my duties is to ensure that Northern Ireland has timely access to clinically effective and cost-effective medicines. We do that through a formal link with the National Institute for Health and Care Excellence (NICE). As givinostat is a new treatment, routine access in the Health and Social Care (HSC) system is based on the outcome of considerations from NICE. NICE is currently evaluating givinostat. Final guidance is not expected until July. There is a route through an early access programme (EAP) ahead of NICE decisions, but responsibility for participation in those EAPs lies with the trusts. A compassionate use scheme such as that works well for therapies and conditions in which no close monitoring of patients is required. However, when monitoring is required, which is the case for givinostat, clinical centres need additional resources — for example, to carry out blood tests and hold additional clinics — to undertake the monitoring safely and sustainably. Although medicines under EAPs are typically provided for free, additional implementation costs will fall to the relevant trust, which is, in this case, the Belfast Trust. Having considered the resource required to administer givinostat safely and efficiently, the trust has advised that it is not able to facilitate this early intervention. Members will be aware of the huge budgetary pressures and saving targets facing all trusts at this time. It would be inappropriate for me or my Department to intervene in the trust's decision, as that risks undermining our well-established processes with NICE that ensure that our population has access to new medicines that have been demonstrated to be clinically effective and cost-effective. Should NICE recommend givinostat, my Department will consider it under the usual processes and endeavour to make the drug available as quickly as possible.

Mr Nesbitt

First of all, I was entirely unaware of your brother. I pass on my condolences to you. I do not want to provide false hope. It is up to NICE to decide whether it is safe to administer or recommend givinostat. NICE is a non-departmental public body (NDPB). It is sponsored by the Department of Health and Social Care (DHSC) in London. It produces national guidance on the promotion of good health and the prevention and treatment of ill health. It makes its recommendations independently. As I have said previously, it would be entirely inappropriate of me to intervene with the Belfast Trust to try to expedite the matter, unfortunately.

Mr McNulty

A 12-year-old Newry boy, Alfie Pentony, has inspired us all with his impassioned and courageous campaign to raise awareness of Duchenne muscular dystrophy. Access to givinostat would dramatically improve outcomes for children such as Alfie. However, given the Minister's earlier comments, what action can his Department take to give hope to families such as Alfie's and others?

Mr Nesbitt

I am aware of the young boy whom the Member has mentioned, and my sympathies lie with him. However, I have to progress within the rules and recommendations and do so safely. The Belfast Trust provides a regional paediatric neuromuscular service through the Royal Belfast Hospital for Sick Children, and that would include the boy to whom the Member has referred. While there is currently no cure for DMD, a variety of treatments can help to manage the condition. Treatment and intervention are provided in the Royal Belfast Hospital for Sick Children through a multidisciplinary team (MDT) approach, and that includes specialist clinicians from neurology, cardiology, respiratory and endocrinology. Physiotherapists are also involved with the patients' care. I hope that that gives the Member some idea of the attention that is paid to young people who, unfortunately, suffer from Duchenne muscular dystrophy.

Mrs Dillon

I thank the Member for sharing his personal experience. Unfortunately, a number of families in my area of Coalisland also have children with Duchenne muscular dystrophy. There is a pathway to bring in medication prior to NICE —.

Madam Principal Deputy Speaker

Question, Linda.

Mrs Dillon

Will the Minister outline whether it is possible to look at it under that guidance?

Mr Nesbitt

I thank the Member for her supplementary question. As I said, there is an EAP, but it is available only from one of the 23 participating so-called NorthStar clinical centres in the United Kingdom. That programme is a clinical network of UK-wide healthcare professionals who are focusing on the best clinical management of DMD. As I said, the Belfast Trust is the regional provider of paediatric neuromuscular services here, so it is the only clinical centre eligible to participate in the NorthStar programme. Provision of givinostat EAP is being offered by the drug manufacturer only through the Belfast Trust in Northern Ireland. It has said that, because of the follow-up and the monitoring required, it is not prepared to do it. I cannot intervene.