An tOrd Gnó - Order of Business (Resumed)
Seanad Éireann — 2026-06-09
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Teresa Costello (FF), Agricultural Panel

I want to speak once again about givinostat and the urgent need for Irish boys living with Duchenne muscular dystrophy to finally gain access to that drug. Tomorrow marks an important point in the reimbursement process and on Thursday, 11 June, it will be exactly one year since the day we gathered outside and inside Leinster House to explain and show the reality for people living with Duchenne muscular dystrophy.
Those families are still waiting for access to givinostat. Duchenne is the most common and one of the most severe genetic conditions diagnosed in childhood. It almost exclusively affect boys and causes progressive muscle-wasting, loss of mobility, heart disease and respiratory failure, and it ultimately shortens lives. Time is something these boys do not have.
I will go through the timeline quickly. On 6 June 2025, givinostat received European Medicines Agency, EMA, approval. In July 2025, the manufacturer submitted it for reimbursement in Ireland. In August, the National Centre for Pharmacoeconomics, NCPE, initiated a full health technology assessment, HTA. In September, pre-submission consultation took place. In November, patient submissions were gathered by advocacy groups. In January, the full HTA dossier was submitted. In March, the NCPE completed its assessment and stated reimbursement could not be recommended unless cost-effectiveness improved. That sounds harsh but it was not the final decision. In March, commercial negotiations began. On 10 June, tomorrow, this medicine comes before the drugs group. The drugs group could make a recommendation to the senior leadership team in the HSE, which is the final decision-making authority, or can refer it for further review to the technical review committee for rare diseases.
I am running out of time. These people with Duchenne muscular dystrophy are running out of time, as are the people with Friedreich's ataxia. These are muscle wasting diseases. Two drugs are available that can halt the damage being done and preserve these people's dignity. I am passionate about this and desperately want these drugs to be available to these people.

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Record URI: https://data.oireachtas.ie/akn/ie/debateRecord/seanad/2026-06-09/debate/main
Retrieved: 2026-08-14T04:55:01+00:00
Sitting date: 2026-06-09