John Lahart
Question:116. Deputy John Lahart asked the Minister for Health for an update on the accessibility of the drug givinostat for patients with Duchenne muscular dystrophy. [5070/26]
View answerThursday, 22 January 2026
Questions (116)
Written answers
I recognise the importance of providing the best care possible to patients with Duchenne muscular dystrophy (DMD). My Department is closely following the developments in relation to the pricing and reimbursement application for givinostat (Duvyzat®).
Duchenne muscular dystrophy is a rare disease affecting approximately 200 people in Ireland. Its symptoms can severely impact the lives of those living with the disease and their families.
I met with the families of children with DMD and their representative body, Muscular Dystrophy Ireland, in July 2025 and spoke at Muscular Dystrophy Ireland’s national conference in December 2025.
Givinostat, marketed under the brand name Duvyzat®, is a medication used to treat DMD in ambulant patients aged 6 years and older. Conditional marketing authorisation was granted for this indication on the 6th June 2025 by the European Commission.
Under the Health (Pricing and Supply of Medical Goods) Act 2013 the HSE has statutory responsibility for decisions on pricing and reimbursement of medicines.
I met with my Italian counterpart at the EPSCO Council meeting in June 2025 in Luxembourg to ask him to encourage Italfarmaco, the marketing authorisation holder for givinostat, to submit a pricing and reimbursement application to Ireland.
On the 6th August 2025 a pricing and reimbursement application was received by the HSE.
The HSE and the National Centre for Pharmacoeconomics (NCPE) have proactively engaged with the company in relation to the application.
On 15th January 2026, a full HTA dossier was submitted by Italfarmaco to the NCPE.
The HSE has advised that they will assess the application as efficiently as possible and they cannot make any comment on possible outcomes from the ongoing process.