Statement on Duchenne Muscular Dystrophy

Response to emails received: This update 8th June, 2026

I noted following on from last year's briefing that the Minister for Health appeared to be engaging with families of children with Duchenne Duchenne Muscular Dystrophy (DMD) and representative body Muscular Dystrophy Ireland in terms of helping boys who are suffering from this progressive neuromuscular condition. I am aware that this condition is life limiting and causes irreversible muscle loss, so getting any available medical help is of extreme urgency.

There was a lot of hope for a new drug Givinostat (Duvyzat), but it has now been one year since this drug was approved by the European Medicines Agency and Irish boys are still waiting for access.

I've been informed by multiple emails received recently that the HSE Drugs Group is due to meet on the 10th of June to discuss the reimbursement scheme. In this regard, and in order to keep the pressure on, I've submitted a number of parliamentary questions to the Minister directly. Some of these will be referred back to the HSE, but the hope is that any additional query will add to the pressure.

Questions listed below. When I get any responses I will post. In the meantime I hope to be able to attend the briefing in the AV room this Thursday 11th June also:

To ask the Minister for Health what proactive action she and her Department in taking in liaison with the HSE to ensure a timely pricing and reimbursement scheme for Givinostat (Duvyzat®), given that it is a year since conditional marketing authorisation was granted; given that it is a year since she met with families of children with DM and MDI and six months since she spoke at MDI's national conference; and if she will make a statement on the matter.

To ask the Minister for Health what reasons have been provided by the HSE regarding the delay in processing the pricing and reimbursement application for Givinostat, especially since 15th January last when a full HTA dossier was submitted by Italfarmaco to the NCPE; and if she will make a statement on the matter.

To ask the Minister for Health if she has been briefed by the HSE Drugs Group that was due to meet on the 10th of June to consider Givinostat for reimbursement; to outline whether clear timelines for rollout have now been provided; to clarify whether there will be proactive engagement with the HSE and clinical teams to ensure planning begins urgently, so that implementation does not become a further barrier to access; and if she will make a statement on the matter.

To ask the Minister for Health what steps she has taken to ensure that eligibility criteria for Givinostat are aligned with the NICE approach, ensuring access for boys who can walk or who can stand with or without support, so that Irish boys are not disadvantaged compared to those in the North of Ireland and receive equitable access to treatment; and if she will make a statement on the matter.