3163. Deputy Cathal Crowe asked the Minister for Health to report on the approval process of givinostat; and the estimated timeline for its reimbursement by the HSE. [55035/26]

The Health Service Executive (HSE) has statutory responsibility for decisions on pricing and reimbursement of medicines, in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013.

Givinostat (Duvyzat®) which is indicated for the treatment of Duchenne Muscular Dystrophy in ambulant patients, aged 6 years and older, and with concomitant corticosteroid treatment was added to the HSE Reimbursement List under the High Tech Scheme on the 1st July 2026. [www.sspcrs.ie/libr/html/monthlyproductupdate.pdf]